REPUBLIC OF KENYA

MINISTRY OF HEALTH

INTEGRATED GUIDELINE FOR

TUBERCULOSIS, LEPROSY AND
LUNG DISEASE

2021
 REPUBLIC OF KENYA

MINISTRY OF HEALTH

INTEGRATED GUIDELINE FOR

TUBERCULOSIS, LEPROSY AND
LUNG DISEASE

2021
 Any part of this document may be freely reviewed, quoted, reproduced or translated in full or in
part, provided the source is acknowledged. It may not be sold or used for commercial purposes.

Published by:

Ministry of Health
Afya House, Cathedral Road
PO Box 30016 Nairobi 00100
http://www.health.go.ke

ii Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Table of Contents
List of Abbreviations .................................................................................................................................................................. ix
Foreword .........................................................................................................................................................................................xiii
Acknowledgement ...................................................................................................................................................................xiv

CHAPTER 1: INTRODUCTION TO THE INTEGRATED GUIDELINE FOR TUBERCULOSIS,

LEPROSY AND LUNG DISEASE ......................................................................................... 1
1.2 Introduction ..........................................................................................................................................................................1
1.1.2 Tuberculosis ......................................................................................................................................................... 2
1.1.2 Leprosy .................................................................................................................................................................... 2
1.1.3 Lung Health.......................................................................................................................................................... 2
1.2 Strategic Focus ................................................................................................................................................................. 3
1.3 Diagnosis and Case Finding ................................................................................................................................... 3
1.4 Integrated Care Provision ........................................................................................................................................ 3
1.5 Nutrition Status Assessment .................................................................................................................................. 4
1.6 Advocacy & Communication ................................................................................................................................ 4
1.7 Recording & Reporting ............................................................................................................................................... 4
1.8 Scope of the guidelines ............................................................................................................................................. 4
1.9 Target audience .............................................................................................................................................................. 5

CHAPTER 2: APPROACHES TO FINDING PEOPLE WITH TUBERCULOSIS ...............................7

2.1. Introduction ......................................................................................................................................................................... 7
2.2. Setting .....................................................................................................................................................................................8
2.3. Facility Based Active Case Finding (FB-ACF).............................................................................................8
2.4. Contact Management ...............................................................................................................................................16
2.5. Community Outreaches...........................................................................................................................................21

CHAPTER 3: MANAGEMENT OF DRUG SUSCEPTIBLE TUBERCULOSIS (DSTB) IN ADULTS 25

3.1 Introduction ...................................................................................................................................................................... 25
 (PEWWMǻGEXMSRSJ8YFIVGYPSWMW..............................................................................................................................26
3.3 Diagnosis of Tuberculosis ...................................................................................................................................... 27
3.4 Baseline Work Up for Newly Diagnosed Tuberculosis.....................................................................31
3.5 Role of Chest x-ray (CXR) in Tuberculosis Screening and Diagnosis .....................................31
3.6 Diagnosis of Extrapulmonary TB ......................................................................................................................36
3.7 Treatment of Drug Susceptible Tuberculosis .........................................................................................39
3.8 Special Considerations in the Management of TB ............................................................................. 44
 8'8VIEXQIRX4YXGSQI)IǻRMXMSRW ................................................................................................................ 45
3.10 Complications of Pulmonary Tuberculosis............................................................................................... 45
3.11 Treatment Preparation, Initiation and Follow Up ................................................................................. 47

Integrated Guideline for Tuberculosis, iii

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  8VIEXQIRX7IWTSRWI+SPPS[YTJSV'EGXIVMSPSKMGEPP](SRǻVQIH8' ..................................49
3.13 Treatment Interruption ..............................................................................................................................................51
 (SQQSR&HZIVWI*ǺIGXWSJ+MVWX1MRI&RXM8YFIVGYPSYW)VYKW ............................................. 53
3.15 Dietary Considerations for Persons on First Line Anti-TB Medicines ................................... 55

CHAPTER 4: TUBERCULOSIS IN CHILDREN .................................................................................... 57

4.1 Introduction ......................................................................................................................................................................58
4.2 Diagnosis of TB in children ...................................................................................................................................59
4.3 Treatment of Drug Sensitive Tuberculosis in Children .................................................................... 73
4.5 TB and HIV Co-infection in Children .............................................................................................................84
4.6 Prevention of TB in Children ................................................................................................................................89
4.7 Child Nutrition and TB .............................................................................................................................................. 92
4.8 TB in Special Circumstances in Childhood ..............................................................................................96

CHAPTER 5: LABORATORY DIAGNOSIS OF TB ................................................................................. 99

5.1 Introduction ......................................................................................................................................................................99
5.2 Laboratory Diagnosis of TB ............................................................................................................................... 100
5.3 Specimen Collection ............................................................................................................................................... 101
5.4 Laboratory Request form.....................................................................................................................................104
5.5 Transport and Packaging .....................................................................................................................................105
5.6 Laboratory Testing ....................................................................................................................................................107
5.7 Test Turnaround Time ..............................................................................................................................................112
5.8 External Quality Assessment ............................................................................................................................ 118
5.9 Laboratory Infection Prevention Control .................................................................................................. 118

CHAPTER 6: TUBERCULOSIS IN SPECIAL CONDITIONS ............................................................ 119

6.1 Introduction ....................................................................................................................................................................120
6.2 TB and HIV Co-Infection .......................................................................................................................................120
6.3 TB and Diabetes Mellitus .....................................................................................................................................135
6.4 TB in Mental Health and Substance-Dependence ..........................................................................145
6.5 TB and Liver Disease............................................................................................................................................... 147
6.6 TB and Kidney Disease..........................................................................................................................................148
6.7 TB in Pregnancy and Lactation .......................................................................................................................150

CHAPTER 7: NUTRITION ASSESSMENT, COUNSELING AND SUPPORT IN TB ..................151

7.1 Introduction .....................................................................................................................................................................151
7.2 Components of a Healthy Diet ........................................................................................................................153
7.3 Relationship between Nutrition TB, Leprosy and Lung Disease ...........................................154
7.4 Interaction between TB and Malnutrition................................................................................................154

iv Integrated Guideline for Tuberculosis,

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7.5 Role of nutrition in TB, Leprosy and Lung Disease ..........................................................................155
7.6 Nutrition care process ............................................................................................................................................156
7.7 Components of nutrition assessment, counseling and support ...........................................156
7.8 Types of Nutrition Assessment ....................................................................................................................... 157
7.9 Making a Nutrition Diagnosis ............................................................................................................................159
7.10 Nutrition in special conditions......................................................................................................................... 166

CHAPTER 8: DRUG RESISTANT TUBERCULOSIS (DRTB) ........................................................... 173

8.1 Introduction to DRTB............................................................................................................................................... 173
8.2 Basic Concept(s) on Drug Resistance Development ..................................................................... 173
 (PEWWMǻGEXMSRSJ)VYK7IWMWXERX8' .............................................................................................................. 175
8.4 Diagnosis of Drug Resistant TB ....................................................................................................................... 177
8.5 Treatment.........................................................................................................................................................................179
8.6 DR TB in Special Situations ................................................................................................................................192
8.7 DR TB Treatment Monitoring and Follow up .........................................................................................194
8.8 DR TB Treatment Outcomes............................................................................................................................. 196
 )78'8VIEXQIRX+EMPYVIWcccƾƾƾƾƾƾƾƾƾƾƾ....................................................................................................197
 &HZIVWI7IEGXMSRWERHXLIMV2EREKIQIRXƾƾƾƾƾƾƾƾ......................................................................198
 ;-4,VSYTMRKSJ)78'2IHMGMRIW[MXL(SQQSR&HZIVWI)VYK7IEGXMSRWƾƾƾƾƾƾ
 5SWXXVIEXQIRX+SPPS[YTƾƾƾƾƾƾƾƾƾƾƾƾƾ .................................................................................................. 213

CHAPTER 9: NON-TUBERCULOUS MYCOBACTERIUM (NTM) ................................................. 215

9.1 Epidemiology ................................................................................................................................................................ 215
9.2 Associated Risk Factors ........................................................................................................................................216
9.3 Clinical Presentation ................................................................................................................................................216
9.4 Investigations (Important considerations) ...............................................................................................216
9.5 Management of NTM.............................................................................................................................................. 217

CHAPTER 10: TUBERCULOSIS INFECTION PREVENTION AND CONTROL (IPC)............. 219

10.1 Introduction ....................................................................................................................................................................219
10.2 TB Infection Prevention Control Measures .............................................................................................219
10.3 Tuberculosis Laboratory Safety ..................................................................................................................... 228
10.4 Infection Prevention at Radiology Departments ............................................................................... 236
10.5 Prevention and Control of TB Transmission within the Community ................................... 236
10.6 IPC in Congregate Settings ............................................................................................................................... 236
10.7 Infection Control and Isolation of TB Patients ..................................................................................... 238
10.8 Evaluation of TB Infection Control Measures....................................................................................... 239

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 CHAPTER 11: MANAGEMENT OF LATENT TB INFECTIONS ...................................................... 241
11.1 Introduction ....................................................................................................................................................................242
11.2 Targeted Populations for TPT ...........................................................................................................................243
11.3 Risk factors for Latent TB Infections ........................................................................................................... 244
11.4 How to rule out active TB ................................................................................................................................... 244
11.5 Diagnosis and Testing of Latent TB Infections.................................................................................... 246
11.6 TB Preventive Therapy Options ..................................................................................................................... 246
11.7 TPT Outcomes ............................................................................................................................................................. 251
11.8 Follow up after Completion of TPT .............................................................................................................. 251
11.9 TPT Adherence ............................................................................................................................................................252
11.10 Monitoring and Evaluation ................................................................................................................................. 254

CHAPTER 12: DIFFERENTIATED APPROACH TO TB CONTROL ...............................................257

12.1 Introduction ....................................................................................................................................................................257
12.2 Problem statement .................................................................................................................................................257
 /YWXMǻGEXMSR .................................................................................................................................................................... 258
 4FNIGXMZIWSJHMǺIVIRXMEXIHGEVIMR8YFIVGYPSWMW2EREKIQIRX............................................ 259
 2SHYPIWMR)MǺIVIRXMEXIH(EVI ....................................................................................................................... 259
 )MǺIVIRXMEXIH(EVI&TTVSEGLIWJSV8'0I]5STYPEXMSRW ............................................................ 264

CHAPTER 13: CHRONIC LUNG DISEASES .........................................................................................273

Introduction ..................................................................................................................................................................................273
13.1 Asthma ...............................................................................................................................................................................274
13.2 Chronic Obstructive Pulmonary Disease (COPD) ............................................................................. 285
13.3 Post-Tuberculosis Lung Disease (PTLD) .................................................................................................290
13.4 Interstitial Lung Diseases (ILDs) ......................................................................................................................301
13.5 Lung Cancer ................................................................................................................................................................. 303

CHAPTER 14: LEPROSY.............................................................................................................................305

14.1 Introduction ...................................................................................................................................................................305
14.2 Background ...................................................................................................................................................................306
14.4 Pathophysiology ........................................................................................................................................................ 307
14.5 Clinical Presentation of Disease ....................................................................................................................305
14.6 Diagnosis of Leprosy ..............................................................................................................................................309
14.7 Laboratory Diagnosis of Leprosy ................................................................................................................... 313
 )MǺIVIRXMEP)MEKRSWMW...............................................................................................................................................314
14.9 Immunology of Leprosy........................................................................................................................................315
(PEWWMǻGEXMSRSJ1ITVSW]....................................................................................................................................... 317
14.11 Disability Grading .......................................................................................................................................................318
14.12 Leprosy Management ............................................................................................................................................318

vi Integrated Guideline for Tuberculosis,

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14.13 How to Conduct a Voluntary Muscle Testing and Sensitisation Test (VMT/ST)........ 320
14.14 Management of Leprosy Complications ..................................................................................................323
14.15 The Eye in Leprosy ...................................................................................................................................................325
14.16 Foot Care in Leprosy................................................................................................................................................327
14.17 Common Deformities & Disabilities ............................................................................................................ 328
14.18 Health Education to Patients on Leprosy ............................................................................................... 328
14.19 Special Cases and their Treatment .............................................................................................................. 329
14.20 Leprosy Relapse ........................................................................................................................................................ 329
14.21 Rehabilitation ................................................................................................................................................................ 331
14.22 Leprosy Active Case Finding .............................................................................................................................332
14.23 Monitoring and Evaluation ..................................................................................................................................332

CHAPTER 15: PHARMACOVIGILANCE ................................................................................................335

)IǻRMXMSRWSJXIVQW ............................................................................................................................................................... 335

CHAPTER 16: COMMODITY MANAGEMENT ....................................................................................359

 +SVIGEWXMRKERH6YERXMǻGEXMSR.......................................................................................................................360
 6YERXMǻGEXMSR2IXLSHWYWIHMR8'(SQQSHMXMIW ...........................................................................360
16.4 Stock Keeping Records ........................................................................................................................................ 362
16.5 Patient Pack and Supply Box Management ......................................................................................... 362

CHAPTER 17: PATIENT SUPPORT, HUMAN RIGHTS AND SOCIAL PROTECTION ............363
17.1 Introduction ................................................................................................................................................................... 363
17.2 Universal Health Coverage in TB, Leprosy & Lung Health........................................................ 364
17.3 Social Protection........................................................................................................................................................ 367
17.4 Human Rights and TB, Leprosy & Lung Disease ...............................................................................372

CHAPTER 18: ADVOCACY AND COMMUNICATION ......................................................................387

18.1 Advocacy............................................................................................................................................................................. 387
18.2 Communication .............................................................................................................................................................389

CHAPTER 19: ENGAGING COMMUNITIES, PATIENTS, AND NON-STATE ACTORS (NSA)

IN TB, LEPROSY, AND LUNG HEALTH CARE SERVICES ..................................404

CHAPTER 20: MONITORING & EVALUATION ...................................................................................425

20.1 Introduction ................................................................................................................................................................... 425
20.2 Recording and Reporting.................................................................................................................................... 425
20.3 Data Management ....................................................................................................................................................427
 &VGLMZMRK (SRǻHIRXMEPMX]................................................................................................................................. 428
20.5 Roles and Responsibilities ................................................................................................................................. 429

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 ANNEXES .....................................................................................................................................441
Annex 1: List of Contributors ........................................................................................................................................441
Annex 2: TB Diagnostic Algorithm (Adults) ...................................................................................................... 443
Annex 3: TB Diagnostic Algorithm (Children) .................................................................................................. 444
Annex 4: CAGE and CAGE AID Scoring Introduction and Scoring Sheet
(Alcohol Abuse) ............................................................................................................................................... 445
Annex 5: CAGE-AID Alcohol Abuse Screening Questionnaire ...........................................................446
Annex 6: CRAFFT Screening Tool for Adolescent Substance Abuse ........................................... 447
Annex 7: CRAFFT Screening Tool: Scoring and Interpretation .......................................................... 448
Annex 8: PHQ-9 Questionnaire .................................................................................................................................. 449
Annex 9: PHQ-9 Patient Depression Scoring tool .......................................................................................450
&RRI\.QQYRI7IGSRWXMXYXMSR.RǼEQQEXSV]]RHVSQI .7. ....................................................451
Annex 11: Nutrition Interventions and Considerations ............................................................................... 454
Annex 12: TB Infection Control Assessment Tool...........................................................................................456
&RRI\&TTVSEGLXS)MǺIVIRXMEXIH(EVIJSV8' ......................................................................................... 459
Annex 14: Adherence Counselling Checklist for TB......................................................................................461
Annex 15: Yellow Forms (ADR Reporting Forms)............................................................................................ 462
Annex 16: Pink Form (Poor Quality Medicine Reporting Form) ............................................................ 463
Annex 17: White Form (Patient Alert card)...........................................................................................................464
Annex 18: Criteria for Issue of Patient Alert Card ............................................................................................465
Annex 19: Adverse Transfusion Reaction Form ................................................................................................466
Annex 20: AEFI Reporting Form ................................................................................................................................... 467
Annex 21: Medical Devices Incident Reporting Form ..................................................................................468
Annex 22: Medication Error Reporting Form ......................................................................................................469
Annex 23: Roles of Commodities Security and Management Team................................................ 470
Annex 24: WHO DRTB Medicine Grouping...........................................................................................................474

REFERENCES ................................................................................................................................479

viii Integrated Guideline for Tuberculosis,

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List of Abbreviations
AATD Alpha-1- antitrypsin COPD Chronic Obstructive Pulmonary
Disease
ABC Abacavir
CoK Constitution of Kenya
ABPA Allergic Bronchopulmonary
Aspergillosis CPT Co-trimoxazole Preventive
Therapy
ACCE Advocacy Communication and
Community Engagement CSF Cerebrospinal Fluid

ACE 1 Angiotensin Converting CT Computerized Tomography

Enzyme Scan

ADRs Adverse drug reactions CTLC County TB and Leprosy

Coordinator
ADR Adverse Drug Reaction
CTX Cotrimoxazole
ADSM Active TB drug safety,
monitoring and management CXR Chest X-Ray

AE Adverse events DALYs Disability-adjusted life years

AFB Acid Fast Bacilli DBS Dried Blood Spot

AHR Airway hyper-responsiveness DM Diabetes Mellitus

AIDS &GUYMVIHMQQYRSHIǻGMIRG] DNA Deoxyribonucleic Acid

syndrome
DOT Directly Observed Therapy
AKD Acute Kidney Disease
DRT Drug Resistance Testing
AKI Acute Kidney Injury
DR-TB Drug Resistant Tuberculosis
AP Antero-posterior view (on
DST Drug Susceptibility Testing
chest X-ray)
DS-TB Drug Sensitive Tuberculosis
ARI Acute Respiratory Infections
DTG Dolutegravir
ART Antiretroviral Therapy
EFV Efavirenz
ARV Antiretroviral drug(s)
ENT Ear Nose and Throat
ATV Atazanavir
EPTB Extrapulmonary Tuberculosis
ATV/r Atazanavir/ritonavir
ESR Erythrocyte Sedimentation Rate
BCG Bacillus Calmette-Guerin
FBS Fasting Blood Sugar
BD Twice daily
FDC Fixed-dose Combination
BMI Body mass index
FEV Forced Expiratory Volume
BNP Brain natriuretic Peptide
FNA Fine needle Aspiration
CCC Comprehensive Care Centre
FVC Forced Vital Capacity
CHV Community Health Volunteer
GBV Gender Based Violence
CHW Community Health Worker
GERD ,EWXVSIWSTLEKIEPVIǼY\
CKD Chronic Kidney Disease
disease

Integrated Guideline for Tuberculosis, ix

Leprosy and Lung Disease | 2021
 GFR Glomerular Filtration Rate MAM Moderate Acute Malnutrition
GINA Global Initiative for Asthma MCG Micrograms
GOLD Global Initiative for Chronic MDR-TB Multidrug-Resistant
Obstructive Lung Disease Tuberculosis
HAART Highly Active Antiretroviral MMP-12 Matrix metalloproteinase 12
Therapy
MRI Magnetic Resonance Imaging
HEI HIV Exposed Infant
MTB Mycobaterium Tuberculosis
HIV -YQER.QQYRSHIǻGMIRG]
MUAC Mean Upper Arm
Virus
Circumference
HRCT High Resolution Computed
NAAT 3YGPIMG&GMH&QTPMǻGEXMSR8IWX
Tomography
NAC N-Acetylcysteine
ICF .RXIRWMǻIH(EWI+MRHMRK
NACS Nutrition assessment,
ICS Inhaled corticosteroids
counseling and support
IEC Information, Education and
NASCOP National AIDS and STI Control
Communication
Program
IGRA Interferon Gamma Release
NGO Non-Governmental
Assay
Organization
ILD Interstitial Lung Disease
NHIF National Hospital Insurance
INH Isoniazid Fund
IPT Isoniazid Preventive Therapy NNRTI Non-nucleoside Reverse
Transcriptase Inhibitors
IPV Intimate Partner Violence
NPH Neutral protamine Hagedorn
IRIS Immune Reconstitution
.RǼEQQEXSV]]RHVSQI NRT Nicotine Replacement Therapy
KHIS Kenya Health Information NRTI Nucleoside/Nucleotide
System Reverse Transcriptase
Inhibitors
LABA 1SRKEGXMRKEKSRMWXW
NSAIDs Non Steroidal Anti-
LAM Lipoarabinomannan
MRǼEQQEXSV])VYKW
LAMA Long Acting Muscarinic
NSCLC Non- small cell lung cancer
Antagonist
NSP National Strategic Plan
LIP Lymphoid Interstitial
Pneumonia NVP Nevirapine
LLN Lower limit of normal OD Once daily
LN Lymph Node OGLA Oral Glucose Lowering Agent
LPA Line Probe Assay OI Opportunistic infection
LPV Lopinavir PCP Pneumocystis Pneumonia
LPV/r Lopinavir/ritonavir PCR Polymerase chain reaction
LRTI Lower respiratory tract PEF 5IEOI\TMVEXSV]ǼS[
infection

x Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
PHQ-9 Patient Health Questionnaire 9 SCLC Small cell lung cancer
PI Protease Inhibitors SCTLC Sub County TB and Leprosy
Coordinator
PLHIV People Living With HIV
SFP Supplementary feeding
PMDI Pressurised Metered Dose
program
Inhalers
SHS Second Hand Smoke
PNS Post nasal space
SLE Systemic Lupus
PPB Pharmacy and poison board
Erythematosus
PTLD Post TB Lung Disease
SOP Standard Operating Procedure
PV Pharmacovigilance
TB Tuberculosis
QF-GIT QuantiFERON-TB Gold In-Tube
TDF Tenofovir Disoproxil Fumarate
Assay
TPT Tuberculosis Preventive
RAL Raltegravir
Therapy
RIF Rifampicin
TST Tuberculin Skin Test
RMNCH Reproductive Maternal and
UHC Universal Health Coverage
Child Health
UNAIDS Joint United Nations
RSV Respiratory Syncytial Virus
Programme on HIV and AIDS
RTIs Respiratory tract infections
VL Viral load
RTV Ritonavir
WHO World Health Organization
RUTF Ready to use therapeutic feeds
XDR-TB Extensively Drug-Resistant
SABA Short acting beta agonist Tuberculosis
SAEs Severe adverse events 3TC Lamivudine
SAM Severe Acute Malnutrition

Integrated Guideline for Tuberculosis, xi

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xii Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
Foreword
T he Division of National Tuberculosis, Leprosy and Lung Disease Program
(DNTLD-Program) is mandated to develop policies and guidelines
for the management of Tuberculosis (TB), Leprosy and Lung Health in
the country. Tuberculosis is a major driver of morbidity and mortality in
0IR]E EǺIGXMRK EPP EKI KVSYTW 8LI FYVHIR MW KVIEXIWX EQSRK TISTPI
in the economically productive age group; 25 to 44 years. The country
misses over 40% of all TB cases. Kenya is in the post elimination phase
of Leprosy however; the Coast and Western regions still report Leprosy
cases every year. Major gaps still exist in the detection and management
of TB, Leprosy and other lung disease. This guideline seeks to address
these gaps by providing evidence-based approaches in the prevention
and management of these diseases.

This guideline is a revision of the 2017 Integrated TB, Leprosy and Lung
disease guideline. The key thematic areas covered are: Diagnosis and
treatment of TB, drug resistant TB and TB in special conditions, nutrition,
infection prevention and control, lung health, leprosy, pharmacovigilance
and commodity management, community engagement, communication
and advocacy. In addition, the 2021 guideline has incorporated novel
thematic areas that will improve the quality of care for patients, these
MRGPYHI&GXMZIGEWIǻRHMRKWXVEXIKMIW1EXIRX8'.RJIGXMSR-YQER7MKLXW
ETTVSEGLIWERHHMǺIVIRXMEXIHGEVI

The guideline has taken into consideration a patient centered approach

towards the management of TB, Leprosy and Lung Disease. It outlines
at risk populations for TB and provides evidence-based strategies
XS[EVHWǻRHMRKXLIQMWWMRKTISTPI[MXL8'JVSRXWXLIYWISJRI[IVERH
more sensitive TB diagnostic techniques, incorporates use of the newer
shorter-term regimen for treatment of Latent TB infection and provides
for individualized care of DR TB patients. With the high burden of TB in the
country, the guideline provides for contact management for all contacts
SJTYPQSREV]FEGXIVMSPSKMGEPP]GSRǻVQIH8'TEXMIRXWXSIRWYVIXLI]EVI
evaluated and provided with the appropriate treatment.

The goal of this guideline is to provide guidance to the health care workers
at all levels on the prevention, diagnosis and management of TB, Leprosy
and Lung Disease. It further acts as a reference document for medical
students, tutors/lecturers, researchers and the entire community on
matters pertaining to TB, Leprosy and Lung Disease.

The mission of the DNTLD program is to accelerate the reduction of TB,

Leprosy and lung disease burden through provision of people centered,
YRMZIVWEPP] EGGIWWMFP] EGGITXEFPI ERH EǺSVHEFPI UYEPMX] WIVZMGIW MR
0IR]E &PP IǺSVXW WLSYPH FI KIEVIH XS[EVHW EXXEMRQIRX SJ XLI REXMSREP
targets as provided in the national strategic plan 2019-2023 and the global
move towards ending TB.
.XMWQ]WMRGIVILSTIXLEXEPPLIEPXLGEVI[SVOIVW[MPPǻRHXLIMRXIKVEXIH
guideline useful for successful implementation of Tuberculosis, Leprosy
and lung disease control activities.

Dr. Patrick Amoth

Ag. Director General,
Ministry of Health
Integrated Guideline for Tuberculosis, xiii
Leprosy and Lung Disease | 2021
 Acknowledgement
T he Ministry of Health and the Division of National Tuberculosis, Leprosy
and Lung Disease Program (DNTLD-P) sincerely appreciate the

to the review of the Integrated Tuberculosis, Leprosy and Lung Disease

guideline. The review of this guideline involved extensive deliberations with
various stakeholders through consultative meetings and review of existing
evidence.

Principal Secretary, Head of Directorate of Medical Services/Preventive and

Promotive Health and Head Department of National Strategic Public Health
Programs..

We are grateful to the following institutions and persons without whose

Centre for Health Solutions- through the USAID funded TB Accelerated

Response and Care II, KCCB Komesha TB, Clinton Health Access Initiative,
World Health Organization, Amref Health Africa in Kenya, Respiratory
Society of Kenya, Centers for Disease Control, Global Fund, Kenya Medical
Training College, KELIN, Kenyatta National Hospital, DNTLD-P and County

We also appreciate all those who might have contributed in one way or the

and appreciated.

Special gratitude also goes to the peer reviewers who participated in the

Dr. Waqo Erjesa

Head, Division of National Tuberculosis,
Leprosy and Lung Diseases Program

xiv Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
INTRODUCTION TO THE
INTEGRATED GUIDELINE FOR
TUBERCULOSIS, LEPROSY
1
AND LUNG DISEASE

1.1 Introduction
Respiratory diseases are responsible for a Kenya is one of the 30
considerable burden SJWYǺIVMRK and death in all age high burden TB, TB/HIV
groups worldwide. The most frequently occurring and MDR countries in the
respiratory diseases include pneumonias, acute world, According to WHO
respiratory infections (ARI), tuberculosis (TB),
asthma, chronic obstructive pulmonary disease
(COPD) and lung cancer.

426/100,000
1.1.1 Tuberculosis Overall national prevalence,
according to the 2015/2016
Tuberculosis has existed for millenia and remains Kenya prevalence survey
a major global health problem. It is an infectious
disease caused by a bacillus belonging to a group
of bacteria in the mycobacterium tuberculosis
complex. Despite it being a preventable and
curable disease, Tuberculosis is the leading
cause of death due to a single infectious agent.
According to WHO, Kenya is one of the 30
high burden TB, TB/HIV and MDR countries in
the world. The 2015/2016 Kenya prevalence 40%
survey, found an overall national prevalence Approximate number
of 426/100,000 and demonstrated that Kenya of people with TB
that Kenya misses
misses approximately 40% of people with TB. It
(2015/2016 Kenya
also found that, screening for TB using cough of Prevalence Survey)
more than two weeks would have missed 52% of
the cases. Sixty-seven percent of the prevalent
cases with at least one TB related symptom
had not sought any health care prior to the
survey; majority of whom were men. Among the

Integrated Guideline for Tuberculosis, 1

Leprosy and Lung Disease | 2021
 prevalent cases who had sought prior care for their respiratory symptoms,
80% of them had not been diagnosed with TB before the survey. In 2019,
0IR]EVITSVXIHGEWIWSJEPPJSVQWSJ8'[MXL SJEPPGEWIWRSXMǻIH
being children below 15 years of age.

8LMWMWXLIǻVWXMRXIKVEXIH8'KYMHIPMRIXSFITVSHYGIHMRXLITSWXIVESJ
the Sustainable Development Goals (SDGs) and the End TB Strategy, which
have superseded the Millennium Development Goals (2000–2015) and the
Stop TB Strategy (2006–2015), respectively. The SDGs were adopted by the
UN in September 2015 and cover the period 2016–2030. The End TB Strategy
spans a 20-year timeframe (2016–2035) and was unanimously endorsed by
WHO’s Member States at the 2014 World Health Assembly. The SDGs and
the End TB Strategy share a common aim: to end the global TB epidemic.
Targets set in the End TB Strategy include a 90% reduction in TB deaths and
an 80% reduction in TB incidence by 2030, compared with 2015.

1.1.2 Leprosy
In 1991, the World Health Assembly passed a resolution to “eliminate”
PITVSW]EWETYFPMGLIEPXLTVSFPIQF]XLI]IEV*PMQMREXMSRHIǻRIH
as a registered prevalence rate of less than 1 case per 10 000 persons,
was realized globally in the year 2000 and in most countries by 2005. This
achievement was driven by the utilization of multiple drug therapy (MDT) as
a strategy for elimination of leprosy. Kenya is in the post elimination phase of
leprosy control, having achieved the WHO elimination target of less than 1
case per 10,000 people in 1989. Despite being in the post elimination phase
MR PITVSW] GSRXVSP 0IR]E RSXMǻIH  PITVSW] GEWIW MR  ERH MRGVIEWI
from 110 in 2018. Majority (90%) of these cases were characterized with
multi-bacillary (infectious type). A number of counties in the western and
coastal regions are endemic for leprosy, although sporadic cases have also
been reported in non-endemic counties. Despite the apparent low number
SJGEWIWVITSVXIHERRYEPP]MR0IR]E SJXLIGEWIWRSXMǻIHMR[IVI
RSXMǻIH MR TEXMIRXW FIPS[  ]IEVW SJ EKI WYKKIWXMRK EGXMZI XVERWQMWWMSR
of leprosy in the community. Geographical variations are a striking feature
of leprosy at every level. In Kenya, most new leprosy cases have been
HSGYQIRXIHMR0[EPI0MPMǻ0MWYQYME]E-SQEFE]ERH'YWMEGSYRXMIW

1.1.3 Lung Health

The lung diseases asthma and chronic obstructive pulmonary disease
(COPD) are very common. According to WHO, around the world 300 million
people have asthma and 200 million have COPD. Low- to middle-income
countries (LMICs) such as Kenya shoulder the burden of asthma and
COPD. These diseases interfere with the lives of people, they stop people
working and cost them money. The diseases also hold back countries from
developing. The Ministry of Health through the division of National TB and
Leprosy program has highlighted asthma and COPD as national priorities.

2 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
1.2 Strategic Focus
The National Tuberculosis, Leprosy and Lung Program (NLTD-P) strategic
focus is to reduce the burden of lung disease and render Kenya free of TB
ERHPITVSW]F]ǻRHMRKXLIQMWWMRKTISTPI[MXL8'1ITVSW]ERHTVSZMHMRK
timely and quality diagnosis, treatment and prevention to all high-risk
populations. The NTLD-P is mandated to develop policies, build capacity
and provide technical assistance to the devolved county system in Kenya.
The program implements interventions within the framework of the National
Strategic Plan for Tuberculosis, 2019-2023.

1.3 Diagnosis and Case Finding

The program is strengthening the surveillance system to ensure early
testing and diagnosis through adoption of a new integrated diagnostic
algorithm that incorporates chest x-ray for screening for TB, expansion of
WHO recommended molecular GeneXpert and Line Probe Assays tests,
as well as TB LAM and QuantiFERON Gamma. Additionally, facility based
EGXMZIGEWIǻRHMRKXLVSYKLW]WXIQEXMGWGVIIRMRKSJEPPTEXMIRXWTVIWIRXMRK
to the health facilities, regardless of the presenting complaints, has been
prioritized and is being implemented nationally to identify people with TB.
4XLIV GEWI ǻRHMRK WXVEXIKMIW MRGPYHI XEVKIXIH GSQQYRMX] SYXVIEGLIW
contact tracing and screening and implementation of strategic innovative
initiatives.

The patient pathway analysis conducted in 2017 demonstrated that 42%

of the population preferred to seek initial care at the private facilities (15%,
informal; 27% formal). Therefore, robust engagement with the private sector
in TB prevention, care and control has been prioritized to ensure all private
WIGXSVTPE]IVWLEZIFIIRIRKEKIHMRXLIǻKLXEKEMRWXXLIITMHIQMG8LMW
LEWVIEPM^IHEGSRXVMFYXMSRSJ XSXLIXSXEPGEWIWRSXMǻIHMR

1.4 Integrated Care Provision

Further, integration of TB services at service delivery points in other
program areas has also been instrumental in providing holistic TB
prevention, care and control services. TB/HIV collaborative interventions
EVIFIMRKMQTPIQIRXIH[MXLMRXIRWMǻIH8'WGVIIRMRK-.:8IWXMRKEQSRK
TB patients, prompt ART initiation among TB/HIV co-infected patients and
TB preventive therapy among others. In 2019, the HIV testing rates of TB
patients was 98% with a co-infection rate of 26% and ART uptake of 96%.
The treatment success rate for the 2018 cohort was 84% against a target
of 90%. Other integration areas include; TB and diabetes, reproductive,
maternal and neonatal and child health (RMNCH) where screening and
diagnosis for TB is being implemented.

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Leprosy and Lung Disease | 2021
 1.5 Nutrition Status Assessment
Nutritional status is an important determinant of resistance to infection.
Malnutrition increases the risk of developing TB and the vice versa. This
predisposes the population to a higher risk of unfavorable outcome. In 2017,
the NTLD-P conducted a TB Catastrophic Cost survey that found between
  ERH  SJ 8' EǺIGXIH LSYWILSPHW I\TIVMIRGIH JSSH MRWIGYVMX]
Nutritional status assessment, intervention and monitoring is a crucial
component of TB care and management. In 2019, 45% of the diagnosed
drug susceptible and 54% of drug resistant TB were undernourished at the
time of diagnosis.

1.6 Advocacy & Communication

The current advocacy and communication strategies identify the need to
create an enabling environment for prevention of lung diseases. Advocacy
[MPPXEVKIXXLSWIMRTSWMXMSRWSJEYXLSVMX]XSMRǼYIRGILYQERǻRERGMEPERH
QEXIVMEP VIWSYVGIW XS WXVIRKXLIR XLI ǻKLX EKEMRWX8' 1ITVSW] ERH SXLIV
lung diseases. Additionally, community advocacy takes advantage of
community-level structures such as community health volunteers to create
public demand for TB, leprosy and lung disease services. In this regard,
health care providers are crucial channels of advocacy and communication
while at the same time being targeted with messages to counter the
risks arising from occupational hazards.

1.7 Recording & Reporting

Case recording and reporting of TB, leprosy and other lung disease is an
important process for monitoring and evaluating disease control activities
at the health facility, county and national levels. Accurate, complete and
timely data collection is an overarching guiding principle for the program.
Every health care provider who treats TB, leprosy and other lung disease has
the professional responsibility to record and report all cases treated using
standardized tools provided by the program. The national TB program is
responsible for providing standardized recording and reporting tools which
should be used at all service delivery points. This in turn is aggregated at
national level to establish how well the NTLD-P is closer to achieving the
currently set programmatic performance indicators.

4 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
1.8 Scope of the guidelines
The objective of these consolidated guidelines is to provide a public health
approach and clinical guidance to the management of TB, leprosy and lung
diseases. It aims at providing guidance and building capacity among health
care workers (HCWs) on the provision of quality and universally acceptable
services in diagnosis, treatment, prevention and rehabilitation of patients
with these conditions. Additionally, it aims at providing guidance on linking
community activities for TB and leprosy with the work of NTLD-P so that
IǺSVXW SJ XLI LIEPXL W]WXIQW EVI I\XIRHIH ERH VIEGL EW QER] TISTPI
as possible, and create demand for quality services. Towards this, it also
calls for enhanced collaboration and coordination between the health
care workers, communities, state and non-state actors, in order to realize
universal coverage and comprehensive care in TB, leprosy & lung health
services.

These guidelines are organized into the following sections: Case Finding
strategies for TB,

TB in adults, TB in children, Laboratory diagnosis of TB, TB in Special

conditions, Nutrition in TB, Drug Resistance TB, Non-tuberculous
Mycobacteria, IPC, LTBI, )MǺIVIRXMEXIH GEVI SJ8' 1YRK -IEPXL 1ITVSW]
Pharmacovigilance, ADSM, Commodity Management, Patient support,
Human rights and Social protection, Communication and Advocacy,
Community engagement, M&E

1.9 Target audience

The guidelines are targeted to all HCWs of various cadres who manage TB,
Leprosy and Lung disease. They will also be used as part of the curriculum
to those undergoing pre-service clinical training. They will assist the county
managers who are tasked with the planning and resource allocation to
ensure the needs of the patients are catered for. They will also assist policy
makers and other line ministries in the national government working in
areas of health, social services, prison services or immigration in decision
making related to tuberculosis, leprosy and lung disease. The guidelines
will be a reference for all partners and organizations that are involved in
the management of these patients.

Integrated Guideline for Tuberculosis, 5

Leprosy and Lung Disease | 2021
6 Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
APPROACHES TO
FINDING PEOPLE WITH
TUBERCULOSIS
2

2.1. Introduction
TB program is mandated to ensure provision of quality
care for TB patients and enhance preventive strategies in
the country. Of utmost priority is to mop out cases from Integration of ACF
the community to minimize the likelihood of continuous indicators in mainstream
MOH tools
transmission in the population. Finding people with TB
VIUYMVIW W]RIVKMWXMG IǺSVXW JVSQ OI] WXEOILSPHIVW ERH Screening for TB (Under
5 and over 5) MOH 204A
can either be passive or active. and MOH 204B
Reporting on MOH 711

5EWWMZIGEWIǻRHMRK
Strengthening contact
7IUYMVIW XLEX EǺIGXIH MRHMZMHYEPW EVI E[EVI SJ XLIMV management process
symptoms, have access to health facilities, and are Line listing contacts
evaluated by health workers or volunteers who recognize of pulmonary
bacteriologically
the symptoms of TB and who have access to a reliable
GSRǻVQIHGEWIW
laboratory. and invitation for TB
screening
Yield of diagnosed TB
2.1.1 Active TB Case Finding cases from contacts and
under 5 initiated on TPT
.WXLIW]WXIQEXMGMHIRXMǻGEXMSRSJTVIWYQTXMZI8'GEWIW
from a predetermined target group/population by doing
Guidance on conducting
symptomatic screening, detailed history taking, physical
facility outreaches.
examinations and further laboratory and/or radiological
investigations to diagnose TB.

2.1.3 Presumptive TB case

 ƽ This refers to a patient who presents with symptoms
ERHSVWMKRWWYKKIWXMZISJc8'c TVIZMSYWP]ORS[REW
Ec8'cWYWTIGX

Integrated Guideline for Tuberculosis, 7

Leprosy and Lung Disease | 2021
  ƽ The determination of a true presumptive TB case should only be made by a clinician
after detailed history taking and clinical examination to rule out other causes of
respiratory illness.

2.2. Setting
8'GEWIǻRHMRKGERFIGSRHYGXIHEXXLILIEPXLJEGMPMXMIWERHEXXLIGSQQYRMX]PIZIP
These include:

1. Public and private health facilities including pharmacies, laboratories and

individual clinics

2. Community

a. Congregate settings e.g. prisons, schools, barracks, drug dens, refugee

camps, places of worship and medical camps

b. Workplaces

&TTVSEGLIWXS8'GEWIǻRHMRK
Facility Based Active Case Finding (FB-ACF) involves screening for TB among all persons
visiting a health facility at all service delivery points regardless of the presenting signs and
symptoms.
Contact management involves systematic investigation of people who are in close contact
with patients with infectious TB disease (index cases) and also reverse contact tracing for
children under 5 years. After investigation, contacts found to have TB disease should be treated
for TB according the National TB Treatment guidelines. Contacts without TB disease should be
assessed for eligibility to TB Preventive Therapy (Refer to chapter 11 on LTBI).
Community outreach interventions including:
ƽ Targeting congregate settings e.g., prisons, schools, drug dens, barracks, refugee camps,
places of worship; workplaces, informal settlements, targeting the elderly among others.
ƽ Other innovative approaches such as self-screening with linkage to health facilities

2.3. Facility Based Active Case Finding (FB-ACF)

2.3.1. Advocacy
Ownership by the management team is the cornerstone for successful execution of FB-
ACF at a health facility. Hospital managers should spearhead FB-ACF by ensuring that;

ƽ All the frontline Health Care Workers have undergone sensitization on FB-ACF
(this should be done in liaison with the TB coordinators)

ƽ Appointment of an ACF focal person; he/she should be a clinician working at the

Outpatient Department (OPD)

8 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ In liaison with the ACF focal person, each service delivery point (SDP) should
calculate its targets based on their workload

ƽ During facility monthly meetings, ACF should be discussed and each SDP
TVIWIRXWXLIMVTVSKVIWWEKEMRWXXEVKIXWLMKLPMKLXXLIFIWXTVEGXMGIWERHMHIRXMǻIW
key challenges/gaps/areas of improvement.

ƽ Continuous quality improvement should be undertaken.

2.3.2. Patient Flow

TB screening should be administered to all patients presenting to the health facility
VIKEVHPIWWSJTVIWIRXMRKWMKRWERHW]QTXSQW5VSTIVYRHIVWXERHMRKSJXLITEXMIRXǼS[
which is unique to each health facility provides a head start in ACF implementation. Back
and forth of patients through the same departments should be avoided by ensuring that
the patient is attended to holistically to reduce time taken at the health facility.

2.3.3. TB screening and Care Cascade

All patients should undergo the following;

1. Vital signs should be taken (fever as a key sign will be elicited at this point)

2. The triage personnel conducts TB symptomatic screening, the cardinal signs and
symptoms of TB are:

ƽ Cough of any duration

ƽ Unintended weight loss

ƽ Drenching night sweats

ƽ Hotness of body

ƽ Chest Pain

ƽ '2.PIWWXLERSJ^WGSVIǷ

For children, in addition to the above, the following should be considered;

ƽ History of frequent respiratory tract infections

ƽ Failure to Thrive

ƽ Reduced Playfulness

ƽ Lethargy and irritability

ƽ History of contact with a known TB case

3. All coughers should be fast tracked for assessment by a clinician.

4. The clinician performs detailed history taking and physical examination to

determine the true presumptive TB cases to be sent for investigation for TB.
Presumptive TB cases should be documented in the presumptive TB register and
a sputum request form generated Ŧ±ĮĮƐ ĀåĮÚžƐ žĚŇƣĮÚƐ ÆåƐ ŤŹŇŤåŹĮDžƐ ĀĮĮåÚƐ üŇŹƐ ŤŹŇķŤƒƐ
ŹåĮ±DžƐŇüƐŹåžƣĮƒžŧũ

Integrated Guideline for Tuberculosis, 9

Leprosy and Lung Disease | 2021
 5. Presumptive TB cases should be sent to the laboratory/designated area for
collection of samples after which the patient is advised on how to collect their
results, then exited through normal facility procedures. In some facilities, clinicians
can be sensitized on procedure for sample collection and a designated cough
EVIEMHIRXMǻIHXLMW[MPPQMRMQM^ISR[SVOPSEHWIRXXSXLIPEFSVEXSV]

6. 5EXMIRXW [LS EVI GSRǻVQIH 8' TSWMXMZI JVSQ XLI PEFSVEXSV] WLSYPH FI XVEGIH
(phone tracing and where necessary home tracing), initiated on treatment and
followed up. Those who receive a negative laboratory result should be followed
up closely, should symptoms persist; further investigations can to be done to
help confer a clinical diagnosis.

In the current TB diagnostic algorithm (Annex 2 & 3), chest X-ray can be used as a diagnostic
tool for children. In settings where chest X-ray is readily available, it can be used as a
screening tool and only those who are suggestive of TB should be referred for sample
collection.

2.3.4. Linkage
Proper linkage at every step of patient’s care is important to minimize leakages in the
ACF cascade. Depending on the facility policy and human resources available, CHWs/
CHVs/peer educators should link presumptive TB cases from the clinician to the
laboratory and further to the chest clinic for those initiating TB treatment. Linkage also
entails active phone and home tracing for those who with positive TB results to initiate
treatment.

2.3.5. Recording and Reporting

Timely documentation is a key tentacle in the implementation of FB-ACF and as such
the following recording and reporting tools are required:

ƽ ACF screening tool - this outlines the cardinal signs and symptoms for TB and is
used for symptomatic screening for TB

ƽ OPD Register (MOH 204A & B) contains a column where the status of TB screening
should be documented; this column provides information for all patients screened
for TB at the health facility.

ƽ Presumptive TB register - this is a register containing demographic and clinical

MRJSVQEXMSR JSV MHIRXMǻIH TVIWYQTXMZI8' GEWIW  WLSYPH FI ǻPPIH EX XLI GPMRMGMER
desk

ƽ TYXYQ7IUYIWX+SVQ9TSRWYGGIWWJYPMHIRXMǻGEXMSRSJETVIWYQTXMZI8'GEWI
XLIWTYXYQVIUYIWXJSVQWLSYPHFIHYP]ǻPPIHF]XLIGPMRMGMER8LIVIUYIWXJSVQ
should be updated with details of the referring clinician to ensure seamless relay
of results.

10 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ TB laboratory register – Upon receipt of the TB lab request form, the laboratory
SǽGIVWLSYPHGSRǻVQXLIHIXEMPWERHVIKMWXIVXLITEXMIRXWMRXLIPEFSVEXSV]VIKMWXIV
The referring department/peripheral health facility should be documented. The
presumptive TB case is then provided with a falcon tube and instructed on how
to collect a quality sample.

ƽ ACF Departmental Summary Tool - this is the monthly summary of the ACF
workload per Service Delivery Point, it provides a total of the number of patients
SǺIVIH 8' WGVIIRMRK ERH XLIMV QSZIQIRX EGVSWW XLI IRXMVI GEVI GEWGEHI .X
WLSYPH FI ǻPPIH EX XLI IRH SJ XLI QSRXL F] XLI HITEVXQIRXEP MRGLEVKI ERH
obtains information from the OPD register, tally sheets, presumptive TB register,
laboratory register and TB treatment register.

ƽ ACF Facility Summary Tool - this is the monthly summary of the ACF workload at
XLIJEGMPMX]MXHSGYQIRXWXLIRYQFIVSJTEXMIRXWSǺIVIH8'WGVIIRMRKERHXLIMV
movement across the entire care cascade. It collates information from the ACF
HITEVXQIRXEPWYQQEV]XSSPERHWLSYPHFIǻPPIHEXXLIIRHSJXLIQSRXLF]XLI
records department at the facility.

ƽ MOH 711 - Select indicators from the ACF facility summary tool should be
populated in MOH 711

ƽ KHIS – Select indicators populated in MOH 711 should be uploaded into KHIS

The following should take place for successful implementation of ACF

ƽ 4VMIRXEXMSR SJ LIEPXL JEGMPMX] QEREKIQIRX XIEQ ERH LIEPXL JEGMPMX] WXEǺ SR UYEPMX]
improvement in TB case detection
ƽ Formation of a TB coordinating team by the health facility management. (This can be
integrated with other teams e.g. HIV coordinating team)
ƽ Appointment of a health facility ACF TB focal person who should monitor ACF
implementation per SDP and intervene promptly in case of any hitches
ƽ Inclusion of TB case detection as a permanent agenda in the health facility clinical
meetings by the health facility management
ƽ TB coordinating team & ACF focal person to support each SDP to calculate their TB case
detection targets based on their workload
ƽ As a routine activity that should be entrenched in the health facility procedures; daily
health education sessions with TB as an agenda, should be conducted to patients to
create awareness
ƽ Use of presumptive TB registers in all service delivery points in the health facility. A separate
presumptive TB register should be kept for outreaches. All clients who screen positive
for TB symptoms and subsequently undergo detailed assessment by a clinician and are
determined to be true presumptive TB cases, should be recorded in the presumptive TB
register.
ƽ Introduction of Pediatric TB screening tool & presumptive register in various children-
WTIGMǻG WIVZMGI HIPMZIV] TSMRXW MRGPYHMRK 32(- GPMRMGW 3YXVMXMSR GPMRMG 5IHMEXVMG 45)
clinic and all Pediatric wards. Accelerated TB case detection among children who are a
high risk cohort for severe TB.
ƽ &PP)5W9RMXWSVGPMRMGWWLSYPHVITSVXSR8'GEWIǻRHMRKMRHMGEXSVWQSRXLP]ƳTIVJSVQERGI
on FB-ACF, contact investigation and community outreach interventions.

Integrated Guideline for Tuberculosis, 11

Leprosy and Lung Disease | 2021
 ƽ Health facilities should evaluate FB-ACF performance every month and take measures to
resolve any pending challenges. This activity should be led by the Facility in charge, ACF
committee and ACF focal person. Discussions should be documented and form a basis for
continuous quality improvement.
ƽ YTTSVXMZIWYTIVZMWMSRERHQIRXSVWLMTXSYRMXGPMRMGWXEǺWLSYPHFIGSRHYGXIHVIKYPEVP]

2.3.6. Target Setting

Targets provide a premise upon which performance can be assessed and lays a basis for
continuous quality improvement. Targets vary depending on the catchment population
and facility workload. Each health facility and subsequently service delivery point,
should set their targets monthly in liaison with the ACF Focal person.

Based on their workload, the following guiding principles should be used;

ƽ 15-30% of all patients seen at the health facility have respiratory infection

ƽ 60-80% of the patients presenting with respiratory infections are presumptive TB

cases and should be investigated to rule out TB

ƽ At least 10% of presumptive TB patients should be TB cases (Bacteriologically

GSRǻVQIHERHGPMRMGEPP]HMEKRSWIH

ƽ 10-15% of TB cases should be children under 15 years of age.

2.3.7. Monitoring
2SRMXSVMRK MW FSXL MRXIVREP ERH I\XIVREP ERH WLSYPH FI HSRI GSRXMRYSYWP] XS ǼEK SYX
underperformance early and plan for corrective action. Internally, during the facility
monthly meetings, performance/progress against targets per SDP should be reviewed,
best practices and challenges highlighted, to encourage cross-learning.

Periodic county and sub county supervisions should incorporate key indicators on FB-
&(+XSEWWIWWXLITVSKVIWWSR8'GEWIǻRHMRK8LMWWLSYPHTVSZMHIERSTTSVXYRMX]JSV
continuous mentorship and sensitization.

2.3.8. Continuous Quality Improvement

In FB-ACF, each facility should strive to get better by learning through the process. This
GERFIEXXEMRIHF]IRWYVMRKIǽGMIRG]MRWGVIIRMRKIRLERGMRKELMKLMRHI\SJWYWTMGMSR
among Health Care Workers and closing leaks in the care cascade hence minimizing on
RYQFIVWRIIHIHXSWGVIIRXSKIXEGSRǻVQIH8'GEWI

Continuous quality improvement should be undertaken as per the steps below;

ƽ Establish a Quality Improvement team

ƽ )IǻRIXLITVSFPIQF]GPIEVP]IWXEFPMWLMRKXLIEGXYEPZIVWYWHIWMVIHTIVJSVQERGI
of a key indicator

12 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ Agree upon opportunity for improvement and determine methodology to be
used

ƽ Monitor and evaluate the entire process

ƽ Repeat this process until desired performance/standards are attained

Note:
ƽ 8EVKIXWIXXMRKMWFEWIHSRXLI[SVOPSEHSJXLIJEGMPMX]ERHQE]ZEV]EGVSWWXLI]IEV
ƽ 5VSTSVXMSR SJ GPMIRXW[MXL VIWTMVEXSV] GSRHMXMSRW EQSRK XLI 45) EXXIRHERGIZEV] JVSQ
one location to another, based on morbidity pattern in the geographical area.
ƽ 8LIGPMRMGMEREWWIWWQIRX LMWXSV]XEOMRKERHTL]WMGEPI\EQMREXMSRMWOI]MRHIXIVQMRMRK
the quality of care to the patients as well as establishing the true presumptive TB cases to
be investigated.
ƽ 2SRXLP] VIZMI[ SJ HEXE XLVSYKL IEGL WXIT MR XLI TEXMIRX GEVI GEWGEHI MW OI] MR HIXIV-
mining leakages. The review should involve health care workers; linkage assistants, re-
GSVHWSǽGIVWGPMRMGMERWHITEVXQIRXEPLIEHW&(+8'JSGEPTIVWSR8'-.:GSSVHMREXSV
laboratory technician, pharmacist, CHEW and facility in-charge. Where applicable, the
Sub County team should be in attendance (Sub County TB and Leprosy Coordinator/Sub
(SYRX]GPMRMGEPSǽGIVYF(SYRX]5YFPMG-IEPXL4ǽGIVYF(SYRX]2IHMGEP1EFSVEXSV]
Coordinator).

2.3.9. Roles and responsibilities

A. Role of front-line health care workers
a) Triaging personnel (HCWs/CHVs/cough monitors/records person)

ƽ Initial symptomatic TB screening and referral to the clinician.

ƽ Link clients to the clinician, laboratory and treatment

ƽ +SPPS[ YT GSRǻVQIH 8' TEXMIRXW [LS JEMP XS VIXYVR JSV XVIEXQIRX MRMXMEXMSR F]
CHVs).

ƽ Contact tracing and referral of people with signs and symptoms of TB from
community

b) Clinicians at all Service Delivery Points

ƽ Clinical evaluation through conducting detailed history taking and physical

examination to determine true presumptive TB cases. Provide health education
to the presumptive TB cases to understand why investigations are required to
rule out TB.

ƽ Document on the presumptive TB register, complete the TB laboratory request

form and send presumptive TB cases for GeneXpert/ smear microscopy (CXR as
appropriate)

ƽ Populate in the presumptive TB register the laboratory results once received.

Integrated Guideline for Tuberculosis, 13

Leprosy and Lung Disease | 2021
 ƽ Interpret the laboratory results and manage the patients accordingly.

ƽ If TB is diagnosed whether bacteriologically or clinically, prescribe and refer

patients to TB clinic for treatment initiation, contact management and follow up.

ƽ Review the TB screening data across the care cascade and present in the ACF
monthly meetings.

ƽ Participate in ACF monthly review meetings.

c) Laboratory personnel:

ƽ Receive the patient at the laboratory and explain the process of quality sputum
collection and turnaround time for results

ƽ Carry out laboratory tests and relay results back to the referring clinicians. Where
applicable, use the linkage assistant to relay the results back to the clinician.

ƽ +SPPS[ YT EPP GSRǻVQIH 8' TEXMIRXW JVSQ XLI PEFSVEXSV] VIKMWXIV XS VIXYVR JSV
treatment initiation.

ƽ Review the monthly TB laboratory data and present during the monthly ACF data
review meetings.

ƽ Participate in ACF monthly review meetings.

d) Roles of Clinicians in the TB clinic

ƽ Evaluate all patients referred to TB clinic for treatment initiation (history &
physical examination) and provide health education to the patient. Capture
the demographic and clinical details in the patient record cards and attach the
laboratory results where applicable.

ƽ Document the patient in the TB register and initiate treatment.

 Ensure the appointment card in populated and issued to the patient.

ƽ 1MRI PMWX EPP GSRXEGXW SJ TYPQSREV] FEGXIVMSPSKMGEPP] GSRǻVQIH8' TEXMIRXW ERH
children <5 with TB in the TPT/Contact management register. The contacts
should then be invited to the facility for assessment and further evaluation for TB.

ƽ Inform CHVs of any contacts who have not been screened for follow up in the
community

ƽ *RWYVIXLITEXMIRXWEVIRSXMǻIHXLVSYKLXLI(81(

ƽ Analyze the data and present during monthly ACF meetings at the health facility.

e) Roles of HRIOs

ƽ Compile the data along the cascade of care for patients who undergo TB
screening at the health facility.

ƽ 7ITSVXMRK8' WGVIIRMRK ERH GEWI ǻRHMRK HEXE SR REXMSREP VITSVXMRK HEXEFEWIW
(DHIS)

ƽ Analyze the ACF care cascade data from the departments starting from the
workload and respiratory conditions reported within the month – OPD, In-patients,
Maternity, MCH/Child Wellness clinics, special clinics etc.

14 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ Participate in monthly ACF meetings and present the progress against facility
target.

B. Role of county and hospital managers

a) Hospital Management Team (HMT)

ƽ Provide leadership at facility level on ACF target setting, improving diagnosis,

IPC, TB treatment and follow up

ƽ Provide leadership on the use of data for planning and decision making in their
facilities

b) County & Sub-County Health Management Teams (CHMT/ SCHMT)

ƽ Provide leadership of TB control services in the County/ Sub-County (Champion

ACF agenda and target setting)

ƽ Provide leadership on ACF data use for planning and decision making in their
Counties/ Sub-Counties

c) County TB and Leprosy coordinator (CTLC)

ƽ Provide oversight of TB programming in the county

ƽ Build capacity of SCTLCs and HCWs on TB through micro-teachings, on-job

mentorship, facility CMEs and by availing job aids, SOPs and guidelines

ƽ Conduct support supervision

d) Sub-county TB and Leprosy coordinator (SCTLC)

ƽ Avail TB recording and reporting tools

ƽ Provide oversight of TB programming in the sub-county

ƽ Build capacity of HCW on TB through micro-teachings, on-job mentorship, facility

CMEs, and by availing job aids, SOPs and guidelines

ƽ Conduct support supervision to healthcare workers

ƽ *RWYVIXMQIP]RSXMǻGEXMSRSJ8'TEXMIRXWMR8.'9

ƽ Participate in the ACF monthly meetings

e) County Medical and Laboratory Technologist (CMLT)

ƽ Provide oversight on TB laboratory procedures in the county

ƽ Ensure reporting on TB laboratory consumables in the county

ƽ Build capacity of SCMLTs and HCWs on laboratory procedures for TB through

micro-teachings, on-job mentorship, facility CMEs and by availing job aids, SOPs
and guidelines

ƽ Conduct support supervision

Integrated Guideline for Tuberculosis, 15

Leprosy and Lung Disease | 2021
 f) Sub-county Medical and Laboratory Technologist (SCMLT)

ƽ 5VSZMHISZIVWMKLXSR8'PEFSVEXSV]TVSGIHYVIWMRXLIWYFGSYRX]

ƽ Ensure reporting on TB laboratory consumables in the sub county

ƽ Build capacity of HCWs on laboratory procedures for TB through micro-teachings,

on-job mentorship, facility CMEs and by availing job aids, SOPs and guidelines

ƽ Conduct support supervision

C. Role of community members and other players

Community health workers/ volunteers and other community players e.g. Civil Society
Organizations

ƽ Sensitize communities on TB

ƽ Screen community members for TB including contacts who are not able to go to
the health facilities

ƽ Refer and link community members who require further evaluation to health
facilities

ƽ Liaise with health facilities to trace and return TB treatment interrupters back to
treatment

2.4 Contact Management

During enrolment to TB treatment, health care workers should line list contacts of all
TYPQSREV] FEGXIVMSPSKMGEPP] GSRǻVQIH 8' TEXMIRXW MRHI\ GEWI ERH GLMPHVIR YRHIV 
with TB (reverse contact tracing). The contacts can be drawn from the household, social
and work places. All listed contacts should be screened for TB at the health facility or in
the community i.e. households, schools and workplaces. Contacts who are presumptive
TB cases should be managed in line with the TB diagnostic algorithm (Annex 2 & 3). Index
cases should be advised to bring their contacts to the health facility for TB screening.

)IǻRMXMSRWJSV(SRXEGX.RZIWXMKEXMSR
a) Index case/ Index patient
8LIMRMXMEPP]MHIRXMǻIHGEWISJRI[SVVIGYVVIRX8'MRETIVWSRSJER]EKIMREWTIGMǻG
household or other comparable setting in which others may have been exposed.

Priority should be given to index patients who have any of the following characteristics:

ƽ -EWFEGXIVMSPSKMGEPP]GSRǻVQIHTYPQSREV]8'

ƽ .WEGLMPH!]IEVW[MXL8' XSǻRHXLIWSYVGISJMRJIGXMSR

ƽ DRTB cases (proven or suspected)

Note:Ɛ FüƐ ŹåžŇƣŹÏåžƐ ±ŹåƐ ±ƽ±ĞĮ±ÆĮåØƐ ÏŇĻƒ±ÏƒƐ ĞĻƽ垃Ğď±ƒĞŇĻƐ ķ±DžƐ ÆåƐ ÏŇĻÚƣσåÚƐ üŇŹƐ ĞĻÚåDŽƐ
Ť±ƒĞåĻƒžƐŇüƐĮŇƾåŹƐŤŹĞŇŹĞƒDžƐžƣÏĚƐ±žƐƒĚŇžåƐƾЃĚƐÏĮĞĻĞϱĮĮDžƐÚбďĻŇžåÚƐŤƣĮķŇĻ±ŹDžƐ‰

16 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
b) Contact
Any person who has been exposed to an index case. There are two types of contacts:

i) Household contact

A person who shared the same enclosed living space for one or more nights or for
frequent or extended periods during the day with the index case during the 3 months
before commencement of the current treatment episode

Note: %åĀĻЃĞŇĻžƐŇüƐŵĚŇƣžåĚŇĮÚŷƐƽ±ŹDžƐÏŇĻžĞÚåŹ±ÆĮDžƐ±ĻÚƐķƣžƒƐÆåƐ±Ú±ŤƒåÚƐƒŇƐƒĚåƐĮŇϱĮƐÏŇĻƒåDŽƒũƐ
œĞƒĚĞĻƐĚŇƣžåĚŇĮÚžØƐƒĚåŹåƐĞžƐ±ƐڱƒĞŇĻƐŇüƐåDŽŤŇžƣŹåØƐŹ±ĻďĞĻďƐüŹŇķƐžĚ±ŹĞĻďƐƒĚåƐž±ķåƐÆåÚƐ±žƐ
ƒĚåƐĞĻÚåDŽƐϱžåƐƒŇƐĮĞƽĞĻďƐĞĻƐƒĚåƐž±ķåƐÏŇķŤŇƣĻÚƐÆƣƒƐĻŇƒƐĞĻƐƒĚåƐž±ķåƐåĻÏĮŇžåÚƐžŤ±Ïåũ

ii) Close contact

A person who is not in the household but shared an enclosed space, such as a social
gathering place, workplace or facility, for extended periods during the day with the index
case during the 3 months before commencement of the current treatment episode.

2.4.2. Contact Investigation

A systematic process intended to identify previously undiagnosed cases of TB among
the contacts of an index case.

Contact investigation consists of two components:

(SRXEGX.HIRXMǻGEXMSRERH5VMSVMXM^EXMSR

A systematic process to identify contacts with or at increased risk for development of

TB. This includes:

ƽ An interview with the index case to obtain the names and ages of contacts

ƽ Line listing of all contacts in the contact management register

ƽ An assessment of contacts’ risk for having or developing TB, based on the

presence of TB signs and symptoms, to determine those for whom clinical
evaluation is indicated.

2.4.2.2. Clinical Evaluation

A systematic process for the diagnosis or exclusion of active TB among contacts who
have signs and symptoms of TB. Clinical evaluation should be done in accordance with
the TB diagnostic algorithm (Annex 2 & 3).

Priority should be given to the following contacts:

ƽ People of all ages with signs and symptoms suggestive of TB
ƽ Children <5 years of age
ƽ People with known or suspected immunocompromising conditions
(especially PLHIV)
ƽ Contacts of index cases with DRTB (proven or suspected)

Integrated Guideline for Tuberculosis, 17

Leprosy and Lung Disease | 2021
 2.4.3. Reverse Contact Tracing
A source case investigation (also known as a ‘reverse contact investigation’) is a type of
contact investigation done to identify the source case of someone recently diagnosed
with active TB disease. Source case investigations are recommended when children
less than 5 years old are diagnosed with active TB disease and in the event of pleural TB
(primary TB) in a younger person.

Source case investigations focus on identifying and screening those most likely to have
TB disease among the people that spent the most time with the index case.

For index cases that are children, source cases are most likely to be found among
adolescents or adults from:

ƽ Within the household (persons living in the home, frequent visitors, babysitters)

ƽ School

ƽ Daycare

ƽ Carpools or school buses

ƽ Playgroups

ƽ Places of recent travel

2.4.4. TB Screening and Care Cascade

Screening of contacts should be addressed based on whether the contact was invited
(contact invitation) or traced (contact tracing).

2.4.4.1. Contact Invitation

Contact invitation is when the index patients brings his/her contacts to the hospital for
TB screening. All invited contacts should undergo the following;

1. Vital signs should be taken (fever as a key sign will be elicited at this point)

2. TB symptomatic screening, the cardinal signs and symptoms of TB are:

ƽ Cough of any duration
ƽ Unintended weight loss
ƽ Drenching night sweats
ƽ Hotness of body
ƽ Chest Pain
ƽ '2.PIWWXLERSJ^WGSVIǷ

For children, in addition to the above, the following should be considered;

ƽ History of frequent respiratory tract infections
ƽ Failure to Thrive
ƽ Reduced Playfulness

18 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ Lethargy and irritability

ƽ History of contact with a known TB case

3. The clinician performs detailed history taking and physical examination to determine
true presumptive TB cases who are then documented in the presumptive TB register
and generates a sputum request form.

4. Presumptive TB cases should be sent to the laboratory/designated area for

collection of samples after which the patient is advised on how to collect their
results, then exited through normal facility procedures. In some facilities, clinicians
can be sensitized on procedure for sample collection and a designated cough area
MHIRXMǻIHXLMW[MPPQMRMQM^ISR[SVOPSEHWIRXXSXLIPEFSVEXSV]

 5EXMIRXW[LS EVI GSRǻVQIH8' TSWMXMZI JVSQ XLI PEFSVEXSV] WLSYPH FI XVEGIH ERH
MRMXMEXIH SR XVIEXQIRX  [LMPI XLSWI [LS VIGIMZI RIKEXMZI PEFSVEXSV] GSRǻVQEXMSR
should be followed up closely and in the event that symptoms persist, further
investigations need to be done to confer a clinical diagnosis.

6. Contacts who screen negative for all the symptoms and are eligible for preventive
therapy, should be initiated on TPT (refer to Chapter 11 on LTBI), otherwise they
are discharged in line with hospital policies and advised to come for follow up TB
screening every six months.

2.4.4.2. Contact Tracing

Contact tracing is initiated when an index case fails to bring his/her contacts to the
hospital for TB screening. The CHV/CHW is then given a list of all the listed contacts to
trace from the community.

All traced contacts should undergo the following;

1. Vital signs should be taken (fever as a key sign will be elicited at this point)

2. TB symptomatic screening, the cardinal signs and symptoms of TB are:

ƽ Cough of any duration
ƽ Unintended weight loss
ƽ Drenching night sweats
ƽ Hotness of body
ƽ Chest Pain
ƽ '2.PIWWXLERSJ^WGSVIǷ

For children, in addition to the above, the following should be considered;

ƽ History of frequent respiratory tract infections
ƽ Failure to Thrive
ƽ Reduced Playfulness
ƽ Lethargy and irritability
ƽ History of contact with a known TB case

Integrated Guideline for Tuberculosis, 19

Leprosy and Lung Disease | 2021
 3. The clinician performs detailed history taking and physical examination to determine
true presumptive TB cases who are then documented in the presumptive TB register
and generates a sputum request form.

4. Presumptive TB cases should be sent to the laboratory/designated area for

collection of samples after which the patient is advised on how to collect their
results, then exited through normal facility procedures. In some facilities, clinicians
can be sensitized on procedure for sample collection and a designated cough area
MHIRXMǻIHXLMW[MPPQMRMQM^ISR[SVOPSEHWIRXXSXLIPEFSVEXSV]

 5EXMIRXW[LS EVI GSRǻVQIH8' TSWMXMZI JVSQ XLI PEFSVEXSV] WLSYPH FI XVEGIH ERH
MRMXMEXIH SR XVIEXQIRX  [LMPI XLSWI [LS VIGIMZI RIKEXMZI PEFSVEXSV] GSRǻVQEXMSR
should be followed up closely and in the event that symptoms persist, further
investigations need to be done to confer a clinical diagnosis.

6. Contacts who screen negative for all the symptoms and are eligible for preventive
therapy, should be initiated on TPT (refer to Chapter 11 on LTBI), otherwise they
are discharged in line with hospital policies and advised to come for follow up TB
screening every six months.

2.4.5. Recording and Reporting

Adequate contact management helps to curtail the TB transmission process and as
such monitoring the yield of contact investigation can only be attained through proper
documentation in the following tools:

ƽ TPT/Contact management register - during enrolment of an index case, the HCW

should line list all their household and close contacts (household, work, social).
Further, these contacts should be invited for TB screening and their screening
status documented in the same register.

ƽ Contact tracing log - for those patients who are traced in the community; both
phone and home tracing should be documented

2.4.5.1 Contact Investigation Data Flow

Identify index cases during initiation to TB Treatment

ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

Line listing contacts of the index cases in TPT/Contact Management register

ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

Contact invitation and screening for TB by health care worker

ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

Health care worker at the clinic forwards to the CHV the list of contacts that did not come following
contact invitation

ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

20 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 CHVs use the TB screening/community contact tracing form to screen contacts of the index
cases and refer those contacts with TB symptoms to the health facility. All contacts <5, PLHIV and
contacts of MDR and XDR TB patients should be referred using the Community Referral form
MOH 100.

CHV returns the forms to the health facility. Each form represents an index patient and their
contacts
ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

8LILIEPXLGEVI[SVOIVZIVMǻIWXLIJSVQWYTHEXIWXLIGSRXEGXQEREKIQIRX858VIKMWXIVERH
begins investigations for those who are presumptive TB cases as guided in the TB diagnostic
algorithm (Annex 1 & 2).

Ã
ĮĮƐĚŇƣžåĚŇĮÚƐ±ĻÚƐÏĮŇžåƐÏŇĻƒ±ÏƒžƐžĚŇƣĮÚƐÆåƐÏŇƣĻžåĮåÚƐ±ĻÚƐƒåžƒåÚƐüŇŹƐBFš

2.4.5.2. Monitoring

Monitoring should be both internal and external and should be done continuously in
order to detect underperformance early and plan for corrective action. Internally, during
the monthly meetings, performance/progress against targets should be reviewed.
Periodic county and sub county supervisions should incorporate key indicators on
GSRXEGXQEREKIQIRXXSEWWIWWXLITVSKVIWWSRGEWIǻRHMRKERH858YTXEOI8LMWWLSYPH
provide an opportunity for continuous mentorship and sensitization.

2.5. Community Outreaches

2.5.1. Advocacy and Social Mobilization
CHWs/CHVs/peer educators, opinion leaders, local administration, religious leaders
ERHPSGEPTSPMG]TSPMXMGEPPIEHIVWWLSYPHFIWIRWMXM^IHSRXLIMVVSPIMR8'GSRXVSPIǺSVXW
in the community. Community outreach interventions should be guided by disease
burden, health seeking behaviour and/or linkage to availability of TB services.

A multi-sectoral approach through engagement of key stakeholders to reach their

populations e.g. education (schools, colleges,) transport (matatu industry, association
of long distance truck drivers), should be used. These interventions should include
appropriate linkage to health facilities for further management.

2.5.2. Client Flow

ƽ Initial screening should be done using TB signs and symptoms
- Cough of any duration
- Unintended weight loss
- Drenching night sweats
- Hotness of body
- Chest Pain
- '2.PIWWXLERSJ^WGSVIǷ

Integrated Guideline for Tuberculosis, 21

Leprosy and Lung Disease | 2021
 ƽ (PMIRXW[LSWGVIIRW]QTXSQTSWMXMZIWLSYPHFISǺIVIHGLIWX<7E].XMWSRP]
those clients with radiographs interpreted as Ŵ
ÆĻŇŹķ±ĮƐ„ƣďď垃ĞƽåƐŇüƐ‰Ŷ who
should provide samples for laboratory diagnosis.

ƽ After TB screening and determination of a true presumptive TB case, the

client should produce a sputum sample for TB screening and other necessary
tests.

ƽ 8LSWI[LSEVIGSRǻVQIH[MXL8'WLSYPHFIPMROIHXSXLIRIEVIWX8'XVIEXQIRX
site and/or CHV of their community unit.

ƽ The outreach team should always comprise of clinicians who will determine
the true presumptive TB cases and assess the need of initiating severely ill
patients on TB treatment during an outreach activity, however, they should
ensure adequate linkage mechanisms for follow up visits.

ƽ Clients with negative laboratory results should be evaluated further, treated

for the other lung diseases and closely monitored for possibility of a clinical
diagnosis should the symptoms recur.

During targeted outreaches, chest X-ray should be used as a screening tool. It is only those
with radiographs “Abnormal Suggestive of TB” who should be eligible to provide samples
for laboratory diagnosis.

ƽ (SRXEGXWSJXLSWI[LSEVIGSRǻVQIH[MXL8'WLSYPHEPWSFIWGVIIRIH

ƽ Contacts who are asymptomatic should be assessed for TPT eligibility.

For those eligible; TPT should be initiated, the rest should be discharged
according to the hospital policy and advised to come for follow up screening
every six months.

(SRWMHIVEXMSRWJSVGEWIǻRHMRKEQSRKWTIGMEPTSTYPEXMSRW
ƽ Health care workers: Screen biannually using the TB screening questions. A contact
management / TPT register should be introduced at all health facilities to capture data
on health care workers screening (Name, department, cadre, screened for TB - yes/no,
presumptive - yes/no). Further management should be documented in the presumptive
register. This will also include students for practicals, interns and volunteers working in
health institutions.
ƽ Residential institutions 5VMWSRIVWERHTVMWSRWXEǺ5ISTPIVIWMHMRKMRWLIPXIVWERH
other congregate settings such as the military): Screen at entry and every six months.
Continuous surveillance should be conducted routinely in the prisons.
ƽ Detainees (in police cells) and remandees: There is a need to ensure that detainees
and remandees are screened and investigated as appropriate. Ensure comprehensive
contact information is provided to support linkage with the health facilities for those
who are presumptive.

22 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ Students in learning institutions: The medical examination at entry requires a chest
x-ray done. Ensure the chest x-ray is interpreted and reported. A GeneXpert test to be
requested for any abnormal chest x-ray report. School clinics should liaise with nearby
health facilities for reporting and linkage to diagnostic facilities.
ƽ Community: Geographical areas with a high prevalence and subpopulations with poor
access (poor populations, urban slums, remote areas, refugees, homeless)
ƽ Hospital outpatient and inpatient departments, and primary health-care centres:
5ISTPITVIZMSYWP]XVIEXIHJSV8'5ISTPI[MXLERYRXVIEXIHǻFVSXMGPIWMSR5ISTPIPMZMRK
with HIV and people attending HIV testing, People with diabetes mellitus, People with
chronic respiratory disease and smokers, Undernourished People with gastrectomy or
jejuno-ileal bypass, People with an alcohol or drug-use disorder, People with chronic
renal failure, People on immunocompromising treatments, Elderly people, People in
mental health clinics or institutions
ƽ Immigration and refugee services: Immigrants from settings with a high prevalence of
TB, People in refugee camps
ƽ Workplaces: Miners or others who are exposed to silica, Other workplaces with a high
prevalence of TB

2.5.3. Community Outreach Data Flow

-IEPXLGEVI[SVOIVWWGVIIRGSQQYRMX]QIQFIVWERHǻPPXLIGSQQYRMX]8'WGVIIRMRKJSVQ

ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

Health care workers list presumptive TB cases in a designated presumptive register for outreaches
which should be kept at the TB clinic
ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

People presumed to have TB are linked to the health facility and managed according to the TB
diagnostic algorithm (Annex 1 & 2)
ƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉƉ

Discharge from the health facility should be through the CHVs/CHWs in their respective
community units for adequate follow up

Quality Assurance

8LIJSPPS[MRKEVIWXITWXSIRWYVIUYEPMX]MR8'GEWIǻRHMRK

ƽ 8VEMRMRKSJLIEPXLGEVI[SVOIVWMR8'MRGPYHMRKMR8'GEWIǻRHMRK

ƽ Provision of guidelines, job aids and SOPs to healthcare workers

ƽ Ensuring clinician review for all patients screened by non-clinicians and labelled as
presumptive

ƽ Use of and adherence to standard MOH tools for recording and reporting and diagnostic
algorithm (Annex 1 & 2)

Integrated Guideline for Tuberculosis, 23

Leprosy and Lung Disease | 2021
 ƽ Following up patients along the entire cascade of care to minimize leakages and ensure
those with TB receive prompt treatment and the rest get appropriate care.

ƽ Correct and complete documentation and timely reporting

ƽ Regular data review

ƽ Mentorship and supervision by facility, sub-county and county leadership teams

24 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
MANAGEMENT OF
DRUG SUSCEPTIBLE
TUBERCULOSIS (DSTB)
3
IN ADULTS

3.1 Introduction KEY HIGHLIGHTS:

)IǻRMXMSR 1. Chest x-ray has a role in TB

Tuberculosis (TB) is an airborne chronic infectious screening and diagnosis
disease caused by aDžÏŇƱσåŹĞƣķƐƒƣÆåŹÏƣĮŇžĞž. It usually 2. New diagnostic techniques
infects the lungs, but it can infect any part of the body have been introduced,
such as the kidney, spine, and brain except the nails, hair including Gene Xpert Ultra
and teeth. If not treated properly, TB disease can be fatal. and TB-LAM

3. Algorithm for TB diagnosis

has been revised and
3.1.2 Aetiology includes TB screening and
guidance on interpretation
TB disease is caused by a pathogenic bacteria called of results and follow up of
aDžÏŇƱσåŹĞƣķƐ ƒƣÆåŹÏƣĮŇžĞž (M. tuberculosis) from the persons with TB
family Mycobacteriaceae. aũƐ ƒƣÆåŹÏƣĮŇžĞž is one of the
4. Dosage of anti-TB medicines
very closely related aũƐ ƒƣÆåŹÏƣĮŇžĞžƐ ÏŇķŤĮåDŽ species is weight based and now
which include aũƐÆŇƽĞž, aũƐ±üŹĞϱĻƣķ, aũƐķĞÏŹŇƒĞ, M. caprae, accommodates dosing for
aũƐ ŤĞĻĻĞŤåÚĞĞ, aũƐ ϱĻ僃Рand aũƐ ķƣĻďĞ. Most, but not all, those > 70kg
of these species have been found to cause disease in 5. In Kenya, DSTB is treated
humans. using four medicines in
ǻ\IHHSWIGSQFMREXMSR
The majority of TB cases are caused by aũƐƒƣÆåŹÏƣĮŇžĞž. formulation
aũƐƒƣÆåŹÏƣĮŇžĞž organisms are also called tubercle bacilli.
In rare situations Non-tuberculous Mycobacteria (NTM)
may cause a disease similar to typical TB infection with
aũƐƒƣÆåŹÏƣĮŇžĞž.

Integrated Guideline for Tuberculosis, 25

Leprosy and Lung Disease | 2021
  (PEWWMǻGEXMSRSJ8YFIVGYPSWMW
8'(EWI)IǻRMXMSRW
8LIJSPPS[MRKEVIGEWIHIǻRMXMSRWYWIHXSGPEWWMJ]8'GEWIWMRMXMEPP]

a) A presumptive TB case: one who presents with symptoms or signs suggestive of TB

b) 'EGXIVMSPSKMGEPP] GSRǻVQIH 8' GEWI one from whom a biological specimen is

positive by smear microscopy, culture or WHO-approved rapid diagnostics (WRD)
WYGLEW,IRI<TIVX28'7.+&PPWYGLGEWIWWLSYPHFIRSXMǻIHVIKEVHPIWWSJ[LIXLIV
TB treatment was started or not.

c) A clinically diagnosed TB case; A clinically diagnosed TB case is one who does

RSX JYPǻPP XLI GVMXIVME JSV FEGXIVMSPSKMGEP GSRǻVQEXMSR FYX LEW FIIR HMEKRSWIH[MXL
active TB by a clinician or other medical practitioner who has decided to give the
TEXMIRX E JYPP GSYVWI SJ 8' XVIEXQIRX 8LMW HIǻRMXMSR MRGPYHIW GEWIW HMEKRSWIH
on the basis of X-ray abnormalities or suggestive histology and extra-pulmonary
GEWIW [MXLSYX PEFSVEXSV] GSRǻVQEXMSR Clinically diagnosed cases subsequently
found to be bacteriologically positive (before or after starting treatment) should
FI VIGPEWWMǻIH EW FEGXIVMSPSKMGEPP] GSRǻVQIH&PP WYGL GEWIW WLSYPH FI RSXMǻIH
regardless of whether TB treatment was started or not.

&PP FEGXIVMSPSKMGEPP] GSRǻVQIH SV GPMRMGEPP] HMEKRSWIH GEWIW SJ 8' EVI EPWS GPEWWMǻIH
according to the following:

1. Anatomical site of disease

2. History of previous treatment

3. HIV status

4. Drug resistance

8LMWGPEWWMǻGEXMSRMWWYQQEVM^IHMRXLIXEFPIFIPS[

8EFPI(PEWWMǻGEXMSRSJ8'

(PEWWMǻGEXMSRFEWIHSREREXSQMGEPWMXIW

Pulmonary TB (PTB) &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'MRZSPZ-

ing the lung parenchyma or the tracheobronchial tree. This exclude pleural
IǺYWMSR
Extra pulmonary TB &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'MRZSPZ-
(EPTB) ing organs other than the lung parenchyma, e.g. pleura, lymph nodes, ab-
domen, genitourinary tract, skin, joints and bones, meninges.
(PEWWMǻGEXMSRFEWIHSRLMWXSV]SJTVIZMSYW8'XVIEXQIRX TEXMIRXVIKMWXVEXMSRKVSYT

New patients Patient who has never been treated for TB or has taken anti-TB drugs for
less than 1 month.

26 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Previously treated Patient who has received 1 month or more of anti-TB drugs in the past.
patients 8LI]EVIJYVXLIVGPEWWMǻIHF]XLISYXGSQISJXLIMVQSWXVIGIRXGSYVWISJ
treatment as follows:
a) Relapse patients; previously treated for TB, declared cured or treatment
completed at the end of their most recent course of treatment, and are
now diagnosed with a recurrent episode of TB (either a true relapse or a
new episode of TB caused by reinfection).
b) Treatment after failure patients; previously treated for TB and whose
treatment failed at the end of their most recent course of treatment.
c) Treatment after loss to follow-up patients; previously treated for TB,
and declared lost to follow-up at the end of their most recent course
of treatment. (These were previously known as return after default pa-
tients).
Patients with Manage as a previously treated patient
unknown previous
TB treatment history
(PEWWMǻGEXMSRFEWIHSR-.:WXEXYW

HIV-positive TB &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'[LSLEW
patient a positive result from HIV testing conducted at the time of TB diagnosis or
other documented evidence of enrolment in HIV care, such as enrolment
in the pre-ART register or in the ART register once ART has been started.

HIV-negative TB &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'[LSLEW
patient a negative result from HIV testing conducted at the time of TB diagnosis.
Any HIV-negative TB patient subsequently found to be HIV-positive should
FIVIGPEWWMǻIHEGGSVHMRKP]
HIV status unknown &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'[LSLEW
TB patient no result of HIV testing and no other documented evidence of enrolment
in HIV care. If the patient’s HIV status is subsequently determined, he or she
WLSYPHFIVIGPEWWMǻIHEGGSVHMRKP]

(PEWWMǻGEXMSRFEWIHSRHVYKVIWMWXERGI VIJIVXS)78'GLETXIV

Drug Susceptible TB &R]FEGXIVMSPSKMGEPP]GSRǻVQIHGEWISJ8'[MXLRSIZMHIRGISJVIWMWXERGI

XSER]SJXLIǻVWXPMRIERXM8'QIHMGMRIW
Drug Resistant TB &R]FEGXIVMSPSKMGEPP]GSRǻVQIHGEWISJ8'[MXLGSRǻVQIHVIWMWXERGIXSER]
SJXLIǻVWXPMRIQIHMGMRIW.XEPWSMRGPYHIWGEWIW[MXLGSRǻVQIHVIWMWXERGI
to second line anti-TB medicine.

 )MEKRSWMWSJ8YFIVGYPSWMW
&GXMZI8'GEWIǻRHMRKMWOI]MRHMEKRSWMWSJ8'MREHYPXWERHEHSPIWGIRXW8LMWMRZSPZIW
screening all persons visiting health facilities using key screening questions which
include presence of:
1. Cough (of any duration)
2. Hotn;ess of body/ body temperature > 37.50 C
3. Drenching night sweats
4. Unintended weight loss/ BMI less than 18.5
5. Chest pain

Integrated Guideline for Tuberculosis, 27

Leprosy and Lung Disease | 2021
 Persons who screen positive for any of the signs and symptoms listed above should
YRHIVKSEXLSVSYKLGPMRMGEPIZEPYEXMSRFIJSVIGPEWWMǻGEXMSREWETVIWYQTXMZI8'GEWI
Presumptive TB cases should undergo diagnostic evaluation as per the TB screening
and diagnostic algorithm for adults and adolescents >10years shown below:

Figure 3.1: TB Screening and Diagnostic Algorithm for Adults/ Children > 10years

TB SCREENING AND DIAGNOSTIC ALGORITHM

+47(-.1)7*3Ǹ10yrs AND ADULTS
GeneXpert is the recommended initial test for TB diagnosis. However, where a facility has no GeneXpert, smear microscopy
SHOULD BE USED as another sample is collected & referred for GeneXpert.
TB LAM should be used where indicated among PLHIV as per guidelines. TB LAM SHOULD NOT be used as an alternative to GeneXpert testing.

Does the client have any of the following signs & symptoms?

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MOH/DNTLDP/TBSDXALG/01
September 2020

28 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
To make a diagnosis of Tuberculosis disease, the following steps should be followed:

A) History Taking

TB diagnosis begins with taking a thorough medical history. TB should be ruled out in
any person presenting with any of the signs and symptoms of TB, and history of contact
[MXLE8'TEXMIRX8LIEMQSJLMWXSV]XEOMRKMWXSVYPISYXSXLIVHMǺIVIRXMEPHMEKRSWIWSJ
TB disease which are shown below:

8EFPI)MǺIVIRXMEP)MEKRSWMWSJ5YPQSREV]8YFIVGYPSWMW

Disease Presentation Distinguishing From PTB

Chronic Obstructive Exertional dyspnea, Lung function tests (spirometry),
Pulmonary Disease (chronic chronic cough and sputum imaging
bronchitis /emphysema) production
Heart failure Exertional dyspnea, chronic Imaging (CXR, echocardiogram)
cough, orthopnea, edema shows cardiomegaly, ECG,
laboratory tests
Bronchiectasis Chronic cough, daily Lung function tests (spirometry),
mucopurulent sputum CT scan imaging
production
Lung abscess Fever, cough and sputum Culture results, imaging usually
production WLS[WMRǻPXVEXIW[MXLEGEZMX]
Lymphoma Rapidly growing mass with CXR CT
fever, night sweats and
Histopathology
weight loss
Lung cancer Cough, hemoptysis, chest Histopathology
pain and dyspnea
Sarcoidosis Chronic cough, dyspnea, Histopathologic detection of
chest pain noncaseating granulomas
Fungal pneumonia e.g. Fever, chest pain, shortness Exposure history and culture

žŤåŹďĞĮĮƣž,ƐBĞžƒŇŤĮ±žķ± of breath, cough, and/or results
hemoptysis

B) Physical Examination

Physical signs of TB on respiratory examination may include tachypnea, bronchial breath

sounds, dullness on percussion, reduced air entry, fever > 37.50 C, wasting, haemoptysis
and pallor.

If the patient does not have any of the signs/ symptoms above or is not found to be a
presumptive TB case on further clinical review, evaluate the patient for TB preventive
therapy (refer to Chapter 11: Latent TB infection management)

Integrated Guideline for Tuberculosis, 29

Leprosy and Lung Disease | 2021
 C) Investigations for Diagnosis of PTB

,IRI<TIVX28F7MJMWXLITVIJIVVIHǻVWXXIWXSJGLSMGIJSV8'HMEKRSWMWERHHIXIGXMSR
of rifampicin resistance. All persons with Presumptive TB should undergo microbiologic
XIWXMRKXSGSRǻVQXLIHMEKRSWMW0I]GSRWMHIVEXMSRWMRXLIGLSMGISJ8'HMEKRSWXMGXIWX
to be used include:

ƽ When GeneXpert testing is available on site, a sputum sample should be collected

and sent for GeneXpert testing.

ƽ When only smear microscopy is available on site, 2 sputum samples should

be collected, one for smear microscopy, and the other to be transported to the
nearest GeneXpert testing laboratory. If smear microscopy is positive, the patients
should be started on DS TB treatment and reviewed once GeneXpert results are
received. A negative smear microscopy result does not rule out TB.

ƽ If both GeneXpert and smear microscopy are not available on site, a sputum
sample should be referred to the nearest GeneXpert testing laboratory.

ƽ TB LAM should be considered for eligible PLHIV as per the diagnostic algorithm.
If positive, initiate DS TB treatment and review once GeneXpert results are
received. A negative TB LAM result does not rule out TB.

ƽ All adult patients newly diagnosed with TB should undergo HIV testing as per the
HTS algorithm and Diabetes testing as per the Kenya Diabetes guidelines.

Table 3.3: Tuberculosis Investigations

Investigation Target Purpose

1.GeneXpert and Preferred test of choice for all For diagnosis of TB and detection RR TB
GeneXpert ultra presumptive TB cases

2.Smear All presumptive Pulmonary Detect TB disease.

microscopy TB where GeneXpert is not
available
(Fluorescent and
Monitoring of bacteriologically
All DSTB patients for treatment
Light microscopy) GSRǻVQIH8'TEXMIRXWSRXVIEXQIRXEX
follow up.
months 2/3, 5 and 6
3. Chest X-ray Preferred for all presumptive A screening tool to identify those at high
pulmonary and some risk of TB disease.
extra pulmonary TB where
Supports TB diagnosis especially in
EGGIWWMFPIERHEǺSVHEFPI
children and when sputum for AFB/
GeneXpert is negative or not applicable
4. Histology All presumptive EPTB Tissue diagnosis in suspected EPTB e.g.
TB adenitis
Other supportive tests
Tuberculin skin test For detection of TB infection Used in detection of latent TB infection
and IGRA

30 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
1EXIVEPǼS[YVMRI HIV infected patients with For diagnosis of TB as an add-on test to
lipoarabinomannan severe illness or advanced GeneXpert/ GeneXpert ultra
assay (LF-LAM) disease
It is an add-on test to GeneXpert testing
All hospitalized PLHA to increase diagnostic yield of TB testing
in severely immunocompromised PLHA.
All attempts must be made to make a bacteriological diagnosis of PTB in adults.

 'EWIPMRI;SVO9TJSV3I[P])MEKRSWIH8YFIVGYPSWMW
Adult patients newly diagnosed with TB should receive the following care once they are
received at the TB clinic:

1. Detailed clinical evaluation including history of previous treatment and co-morbid

conditions

2. Patient education, counselling (including adherence counselling, substance

abuse counselling and mental health assessment)

3. Nutritional assessment, diagnosis and management

4. Where accessible, a baseline chest X-ray should be done for persons with
pulmonary TB

5. Line listing of all contacts, contact invitation/ tracing and management.

6. Initiation of treatment and follow up during treatment

 7SPISJ(LIWX<VE] (<7MR8YFIVGYPSWMWGVIIRMRK

and Diagnosis
1. Screening tool for tuberculosis in those at risk (used to stratify for risk of TB and to
assess for asymptomatic active disease) or during targeted outreaches to screen
those eligible for testing.

2. As an aid in diagnosis of active Pulmonary TB and some EPTB (pleural, pericardial,

nodal, spine).

3. 9WIHXSHMǺIVIRXMEXIPEXIRX8'ZWEGXMZI8'FEWIHSRXLIVEHMSKVETLMGǻRHMRKW

4. 8SGLEVEGXIVM^IVEHMSKVETLMGEFRSVQEPMXMIWWSEWXSI\GPYHISXLIVHMǺIVIRXMEPJSV
appropriate referral and management.

5. Useful in the follow up treatment response based on clinical status (for patients
[LSEVIRSXMQTVSZMRKMRXLIǻVWXQSRXLSJXVIEXQIRXSVTEXMIRXW[LSKIX[SVWI
after initially improving clinicaly.

6. Detection of complications of active TB disease and post TB sequelae.

7. Baseline CXR examination to support comparative evaluation during treatment

and follow up of patients.

Integrated Guideline for Tuberculosis, 31

Leprosy and Lung Disease | 2021
 Where accessible, pulmonary TB patients should have a CXR at the beginning of
treatment and at the end of treatment at 6 months

All patients with chest X-ray features suggestive of TB at baseline should have
sputum specimens submitted for microbiological examination. It is a major
omission to diagnose pulmonary TB on the basis of a chest X-ray ONLY.

The algorithm below should be used in the diagnosis of TB.

Figure 3.2: Chest X-ray Algorithm for TB diagnosis

3.5.1 Recommended Radiographic Views and Utility

Standard Views

View Indication
Postero-anterior (PA) Standard View for All adults
Antero-posterior (AP) For patients unable to stand including the very sick, elderly and
children
Additional Views (to be recommended by the radiologist)

Lateral As an aid to PA and AP view to evaluate the mediastinum, hilar

regions, the posterior lung and spine
Lordotic To evaluate subtle changes in the lung to provide better
visualization.

32 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Apical To evaluate subtle changes in the Apical segments of the upper
lobes to provide better visualization
Lateral decubitus 8SVYPISYXWQEPPTPIYVEPǼYMHMRXLITVIWIRGISJFPYRXMRKSJXLI
costophrenic angles

3.5.2 Image Reporting

(LIWX<VE]WWLSYPHFIVIZMI[IHF]EGPMRMGMERJSVHIǻRMXMZIQEREKIQIRXERHVIJIVVEPEW
ETTVSTVMEXI&FRSVQEPGLIWX\VE]WWLSYPHFIVITSVXIHF]EVEHMSPSKMWXJSVGSRǻVQEXMSR
of the diagnosis.

3.5.3 Radiographic Findings in Pulmonary Tuberculosis

Tuberculosis disease exhibits a varied range of radiographic patterns in the lung
depending on the patient immunological status, exposure whether recent or past and
duration of infection. It can be primary or post primary, typical or atypical.

Type of TB 5SWWMFPIVEHMSKVETLMGǻRHMRKW

Primary TB 1]QTLEHIRSTEXL]GSRWSPMHEXMSRTPIYVEPIǺYWMSR2MPPMEV]RSHYPIW

Post primary TB (SRWSPMHEXMSRERHSVJSGEPMRǻPXVEXMSRQEMRP]MRZSPZMRKXLIETMGEPSVTSWXIVMSV

segments of the upper lobes and superior segments of the lower lobes,
GEZMXEXMSRRSHYPIWSVǻFVSWMW

In HIV infected persons, with intact immunity, the radiographic picture is often typical. In
advanced HIV with severe immunosuppression, the radiographic picture is more often
atypical with lower or mid-zone shadows and the presence of hilar or mediastinal lymph
RSHIIRPEVKIQIRXSVTPIYVEPIǺYWMSRWFIMRKVIPEXMZIP]GSQQSR

8LI VEHMSKVETLMG ǻRHMRKW GSYPH EPWS FI RSVQEP IWTIGMEPP] MR EHZERGIH -.:
MQQYRSWYTTVIWWMSR8EFPISYXPMRIWWSQIGSQQSRGLIWX\VE]ǻRHMRKWWYKKIWXMZI
of pulmonary TB.

Integrated Guideline for Tuberculosis, 33

Leprosy and Lung Disease | 2021
 Table 3.4: Examples of Pulmonary Tuberculosis Radiographic Findings (Figures
sourced from Ě垃Ɛ£ĝŹ±DžžƐķ±ÚåƐ属Dž×ƐĚŹĞžƒŇŤĚåŹƐĮ±ŹīåƅƐƞǑƞǑ)

Radiograph

Findings Right apical consolidation, cavitation

ERHǻFVSXMGGLERKIW[MXLIPIZEXMSRSJXLIQMRSV
ǻWWYVI

Left lingula segment consolidation and

cavitation. Intracavitary aspergillosis is also
a possibility. Right mid zone parenchymal
MRǻPXVEXIWERHRSHYPIWEVIEPWSHIQSRWXVEXIH

7MKLXWMHIHǻFVSWMW[MXLQEVOIHZSPYQIPSWW
retraction of the upper lobe. Right apical thick
irregular pleural capping. Left upper lobe
nodular lesions and a cavitary lesion.

34 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Right upper lobe consolidation, cavitary lesions
ERHǻFVSWMW

)MǺYWITEVIRGL]QEPMRǻPXVEXIWERHRSHYPEV
PIWMSRW7MKLXTPIYVEPIǺYWMSR(EVHMSQIKEP]

7MKLXTPIYVEPIǺYWMSR5EVIRGL]QEPMRǻPXVEXIW
Cardiac patient.

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Leprosy and Lung Disease | 2021
 Miliary TB ƽ 2MPMEV]8'[MXL2MPMEV]PIWMSRWSRGLIWX
X-ray.

3.6 Diagnosis of Extrapulmonary TB

8'GEREǺIGXEPPFSH]XMWWYIWI\GITXXLILEMVREMPWERHXLIXIIXL IREQIP8LIHMEKRSWMW
of extra-pulmonary TB largely depends on the health worker index of suspicion as well
as the ability of the health worker to conduct appropriate investigations to rule out other
HMǺIVIRXMEPHMEKRSWIW8LIXEFIFIPS[MWEWYQQEV]SJWSQISJXLIGSQQSRJSVQWSJ
*58'ERHXLIHMEKRSWXMGETTVSEGLIWXSGSRǻVQ8'HMEKRSWMW

Table 3.6: Common Forms of Extrapulmonary TB and Diagnostic Approach

Form of Extra Signs and Symptoms Diagnosis

Pulmonary TB
Pleural TB with Pleural 8YFIVGYPSYWTPIYVEPIǺYWMSR ƽ (LIWX\VE]MWSJXIRVIUYMVIH
*ǺYWMSR usually presents with: XSGSRǻVQXLITVIWIRGISJXLI
ƽ 1SGEPGLIWXW]QTXSQW IǺYWMSR;LIRIǺYWMSRMWWQEPPE
that include chest pain, supplemental lateral decubitus view
Shortness of breath. or ultrasound on the suspected side
SJIǺYWMSRQE]FITIVJSVQIH
ƽ (SYKLERHW]WXIQMG
symptoms including ƽ .XMWEPWSEHZMWEFPIMJXLII\TIVXMWI
fever and night sweats. exists, to always perform a
diagnostic pleural aspiration at
ƽ ƸWXSR]ƹHYPPRIWWSR the minimum to distinguish pus
percussion IQT]IQEJVSQƸYWYEPƹIǺYWMSR
ƽ 7IHYGIHFVIEXL &WTMVEXIHǼYMHWLSYPHFIWIRXXS
sounds on the side of the laboratory for cytology and
XLIIǺYWMSR microbiological tests including
GeneXpert and TB Culture.
ƽ &TPIYVEPFMSTW]MWVEVIP]VIUYMVIHMR
young patients below the age of 40
years.
ƽ 4PHIVTEXMIRXWERHIWTIGMEPP]XLSWI
[MXLEWMKRMǻGERXWQSOMRKLMWXSV]QE]
have other diagnoses and in these
patients it is advisable to perform
a pleural biopsy using an Abrahm’s
needle.

36 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Tuberculous Tuberculous Peritonitis and ƽ 9PXVEWSRSKVETL]QE]WLS[QEXXIH
Peritonitis and Ascites usually presents PSSTWSJFS[IP[MXLJVIIǼYMH
with: ƽ 5IVMXSRIEPFMSTW]VEVIP]HSRIQER]
Ascites
ƽ EFHSQMREPTEMRERH of these end up with a surgical
swelling biopsies during laparotomy.

ƽ HMWXYVFERGISJFS[IP
motion i.e., constipation
or diarrhea

ƽ JIZIV

Tuberculous Meningitis This disease is often very The diagnosis of tuberculous meningitis
HMǽGYPXXSHMEKRSWIERH is made by:
requires a very high index ƽ *\EQMREXMSRSJGIVIFVSWTMREPǼYMH
of clinical suspicion. This (CSF) obtained following a lumbar
disease presents with: puncture:
1. Prodromal phase - ƽ (+WXEMRTSWMXMZIJSV
mild headache, fever, mycobacterium or CSF GeneXpert
malaise positive.
2. Meningitic phase ƽ (8GERSJXLIFVEMR[LMGLWLS[W
- headache, basal meningitis, tuberculomas and
vomiting, confusion, development of hydrocephalus.
meningismus
3. Paralytic phase -
stupor, coma, seizures,
hemiparesis
Tuberculous Pericarditis Tuberculous pericarditis ƽ &GLIWX\VE]MWEP[E]W
is increasingly becoming required and usually
common in the HIV era and it shows a large globular
may present with a variety of heart.
symptoms including: ƽ ;LIVIJIEWMFPITEXMIRXW
ƽ LSVXRIWWSJFVIEXL XLI suspected to have a
most common symptom). TIVMGEVHMEPIǺYWMSR
ƽ (LIWXTEMR should be referred
to a heart specialist
ƽ (SYKL JSVGSRǻVQEXMSRSJ
ƽ 1IKW[IPPMRK the diagnosis using
ƽ +IZIV echocardiography.

ƽ 9WYEPP]LEWELMKLTYPWI ƽ &TIVMGEVHMEPXETJSV
rate (tachycardia). diagnostic purpose
is rarely required but
ƽ 2E]LEZIEPS[FPSSH may be life saving
pressure, impalpable apex if there are signs of
beat, quiet heart sounds cardiac compression
and signs of heart failure (tamponade). This
like a large liver, ascites procedure must be
and leg edema. done by experienced
health care workers
(cardiologists) only.

Integrated Guideline for Tuberculosis, 37

Leprosy and Lung Disease | 2021
 TB adenitis ƽ 8YFIVGYPSYWEHIRMXMWMWSRI ƽ 3SHIEWTMVEXI
of the common types of ƽ 3SHIFMSTW]JSVFSXL
extra-pulmonary TB histology and culture
ƽ 9WYEPP]YRMPEXIVEP
ƽ 2SWXGSQQSRWMXIMWXLI
cervical area
ƽ 5EMRPIWWW[IPPMRKƳMRMXMEPP]
discrete then matted
ƽ +MWXYPEERHWMRYWJSVQEXMSR

TB encephalitis including The clinical presentation is ƽ Brain CT scans are useful

Tuberculoma similar to that of other space in demonstrating lesions
occupying brain lesions and such as tuberculomas or
includes: cerebral infarcts.
ƽ -IEHEGLIW ƽ MRI with contrast
ƽ :SQMXMRK and spectroscopy is
superior in the diagnosis
ƽ (SRZYPWMSRW of encephalitis,
ƽ 1MQF[IEORIWW tuberculoma and spinal
ƽ (VERMEPRIVZITEPWMIW TB .
ƽ 4JXIRMXMWHMǽGYPXXS
GSRǻVQXLIHMEKRSWMW
of brain TB and most
patients are treated on
an empiric basis.
TB of the skin ƽ XƣŤƣžƐƽƣĮď±ŹĞž×ƐPersistent ƽ 8LIHMEKRSWMWMWYWYEPP]
and progressive form of QEHISVGSRǻVQIHF]
cutaneous TB. It occurs a skin biopsy. Typical
EWWQEPPWLEVTP]HIǻRIH tubercles are caseating
reddish-brown lesions with epithelioid granulomas
a gelatinous consistency that contain acid-
(called apple jelly nodules). fast bacilli. These are
ƽ 9RXVIEXIHPIWMSRWTIVWMWX detected by tissue
for years, leading to staining, culture and
HMWǻKYVIQIRX polymerase chain
reaction (PCR)
ƽ „ÏŹŇüƣĮŇÚåŹķ±× Skin lesions
result from direct extension
of underlying TB infection of
lymph nodes, bone or joints.
ƽ 4JXIREWWSGMEXIH[MXL8'
of the lungs. Firm, painless
lesions that eventually
ulcerate with a granular
base. May heal even
without treatment but this
takes years and leaves
unsightly scars.

38 Integrated Guideline for Tuberculosis,

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TB of the bones and Joints ƽ 8'GEREǺIGXER]FSRIWSV ƽ )MEKRSWMWQE]
joints, primarily the large FIGSRǻVQIHF]
bones/ joints e.g hip (see bone biopsy for
pic on the left) and spine culture. However,
ƽ 8LIWTMRIMWEǺIGXIHMR in most instances,
many instances with a the characteristic
characteristic ‘gibbus’ VEHMSKVETLMGǻRHMRKW
deformity of the spine. with bone destruction
while soft tissues are
spared.

NOTE: When patients present with symptoms of TB disease and the health care worker is
not able to make a diagnosis or when there are signs of severe disease, a rapid referral to
the next appropriate level is highly recommended.

 8VIEXQIRXSJ)VYKYWGITXMFPI8YFIVGYPSWMW
8VIEXQIRXSJ8YFIVGYPSWMWFIRIǻXWFSXLXLIMRHMZMHYEPTEXMIRXERHXLIGSQQYRMX]EWE
whole. Any health provider undertaking to treat a patient for Tuberculosis is assuming
an important public health function that includes not only prescribing an appropriate
treatment regimen but also ensuring adherence to the regimen until treatment is
completed.

3.7.1 Goals of TB Treatment

The overall goals of TB therapy include:

1) (YVITEXMIRXWERHXLIVIJSVITVIZIRXWYǺIVMRK

2) Prevent transmission of the infection.

3) Prevent death.

4) Prevent long-term complications or sequelae of TB.

5) Prevent relapse of the disease.

6) Prevent the development of drug resistant TB.

Integrated Guideline for Tuberculosis, 39

Leprosy and Lung Disease | 2021
 3.7.2 Principles of TB treatment
The principles of TB treatment include the following:

1) Never use single drugs - this increases the likelihood of selection of naturally
occurring resistant mutants to aũƐƒƣÆåŹÏƣĮŇžĞž

2) Always use drugs in combinations - using Fixed Dose Combinations (FDCs) to

avoid selection of naturally occurring resistant mutants to aũƐƒƣÆåŹÏƣĮŇžĞž

3) Drug dosage is based on weight - to achieve therapeutic drug levels in the body
ERHTVIZIRXQIHMGEXMSRWMHIIǺIGXW

4) Drug intake should be directly observed for all patients - to ensure adherence,
TVIZIRXIQIVKIRGISJHVYKVIWMWXERGIEWWIWWJSVQIHMGEXMSRWMHIIǺIGXWERHXS
follow clinical response closely

5) Ensure the entire treatment is taken as recommended.

3.7.3 First line Anti-Tuberculosis Drugs

Anti-TB drugs should have one of the following properties:

A. Bactericidal - the ability to kill the rapidly dividing, metabolically active bacilli
found in the walls of cavities and in the sputum of patients with microscopy smear-
positive pulmonary tuberculosis. Drugs with high early bactericidal activity such
as Isoniazid will make the patient non-infectious as early as possible.

B. Sterilization - the ability to kill the persisting, dormant or intermittently active

bacilli, responsible for relapses. Drugs with rapid sterilization ability such as
Rifampicin and Pyrazinamide will lead to the shortening of treatment.

8LIVIEVIJSYVHVYKWYWIHMRXLIǻVWXPMRIXVIEXQIRXSJ8'ERHXLI]MRGPYHI

ƽ Rifampicin

ƽ Isoniazid

ƽ Pyrazinamide

ƽ Ethambutol

These drugs are given in two phases of treatment:

1. Intensive phase - lasts two months and usually consists of four drugs. Aim is to
achieve a rapid killing of actively dividing bacteria, resulting in the reduction of
bacillary load, negativization of sputum (within two weeks) and eradication of
clinical symptoms.

2. Continuation phase - lasts four months to ten months and usually consists of two
drugs. Aim is to kill any remaining or dormant bacilli and preventing subsequent
relapse

40 Integrated Guideline for Tuberculosis,

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8LIJSYVHVYKWLEZIHMǺIVMRKKVEHMRKSJEGXMZMX]EKEMRWX2XYFIVGYPSWMWEWWLS[RFIPS[

Table 3.7: Grading of Activity of Anti-Tuberculosis Drugs

Activity Prevention of Early Bactericidal Sterilising Activity

Resistance Activity
High Isoniazid Isoniazid Rifampicin

Rifampicin Pyrazinamide

Ethambutol

Ethambutol Rifampicin Isoniazid

Low Pyrazinamide Pyrazinamide Ethambutol

8LI JSYV ǻVWX PMRI ERXM 8' HVYKW LEZI WTIGMǻG MRHMZMHYEP TVSTIVXMIW XLEX EVI YWIJYP MR
XVIEXMRKXLIHMǺIVIRX8'FEGMPPMTSTYPEXMSRWTVIWIRXMRER]TEXMIRXW8LIWIEVIWYQQEVM^IH
in the table below.

Table 3.8: Properties of Individual TB drugs

Drug Mechanism of action Target bacilli Media Compartment

it works in

Isoniazid (H) Bactericidal action with Rapid and Alkaline Intracellular

highest potency. Has intermediate and acid and
highest early bactericidal growing bacilli media. extracellular
activity and kills > 90%
FEGMPPMMRXLIǻVWXJI[HE]WSJ
treatment.

Rifampicin (R) Bactericidal action with All Alkaline Intracellular

LMKLTSXIRG]2SWXIǺIGXMZI populations and acid and
sterilizing agent. including media. extracellular
dormant
bacilli.

Pyrazinamide Bactericidal with a low Slowly Acid Intracellular

(Z) potency. Highly potent multiplying bacilli only
sterilizing action and highly medium (macrophages)
bacilli
IǺIGXMZIHYVMRKXLIǻVWX
months of treatment.

Ethambutol Bacteriostatic. Low potency. All bacterial Alkaline Intracellular

(E) Minimizes the emergence of populations. and acid and
possible initial resistance to media. extracellular
Isoniazid.

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 Tuberculosis treatment involves the use of multiple drugs taken in combination. These
are often combined into Fixed Dose Combinations (FDC) tablets which contain two or
more medicines within the same tablet or capsule.

Advantages of using FDCs include:

1) Reduced risk of resistance developing to the drugs in the event of missed doses.

2) Reduction of pill burden.

3) Fewer medication errors.

4) Fewer prescription errors.

5) Easier for treatment supporter to monitor treatment via DOT

Disadvantages of using FDCs include:

1) Reduced bioavailability of some drugs.

2) Flexibility in obtaining an optimal dose of some agents.

3) )MǽGYPX]MREWGIVXEMRMRKGEYWISJEHZIVWIHVYKIǺIGX[LIRYWMRK+)(W

3.7.4 Direct Observation of Therapy

The WHO in 1993 recommended the Directly Observed Therapy Short-course (DOTS)
strategy to treat TB.

DOTs helps patients to improve adherence to treatment and treatment completion,

thus achieving cure and preventing the development of drug resistance. Depending
on the local conditions, DOT may be undertaken at a health facility, in the workplace,
in the community or at home. DOT should be provided by a treatment supporter who
is acceptable and accountable to the patient and is trained and supervised by a health
worker.

3.7.5 Adult TB First Line Treatment Regimens

First line anti-TB treatment regimens for use in adult patients are shown in the table
below.

Table 3.9: First Line Anti-tuberculous regimen for Adult Patients

TB type Intensive phase Continuation phase

All forms of TB except TB Meningitis and 2 RHZE 4 RH

osteoarticular TB.

TB Meningitis and osteo-articular TB 2 RHZE 10 RH

42 Integrated Guideline for Tuberculosis,

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8LI JSPPS[MRK XEFPI WLS[W [IMKLXFEWIH HSWEKI JSV ǻVWX PMRI +)( ERXM8' XVIEXQIRX
regimens.

Table 3.10: FDC treatment dosage for adults

FDC Dosages Formulation 30-39kg 40-54 kg 55 - 69 kg Over 70 Kg

Rifampicin 150 mg + 4-FDC tablet RHZE 2 3 4 5

Isoniazid 75 mg +

Pyrazinamide 400
mg + Ethambutol
275 mg

Rifampicin 150 mg + 2-FDC tablet RH 2 3 4 5

Isoniazid 75mg

NOTE:

1) Monthly monitoring of weight should be done and recorded in the patients

TB record card and doses adjusted accordingly.

2) No trial of therapy should be done to minimize the emergence of drug

resistance.

3) For children or adolescents above 30kg do not give RH 60/60 but treat as
adults

4) All patients taking anti-TBs should also receive daily pyridoxine as shown
in the table below to reduce the risk of developing peripheral neuropathy.
However, lack of pyridoxine should not stop TB therapy.

Table 3.11: Dosages for Pyridoxine

Weight (kg) Dose of pyridoxine (available in both 25mg and 50mg tablets)

1-13.9 kg 12.5mg

14-25 kg 25mg

>25 kg 50mg

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 3.8 Special Considerations in the Management of TB
a) Hospitalization:
Patients with TB may require hospitalization in certain circumstances as outlined below:

1) IZIVIJSVQWSJ58'ERH*58' IK8'QIRMRKMXMWERHTPIYVEPIǺYWMSR

2) Severe malnutrition

3) Severe pneumonia

4) Other comorbidities e.g. severe anemia, severe diarrhea, etc

5) Court ordered patients to ensure adherence

6) Severe adverse reactions such as hepatotoxicity, severe cutaneous reactions

b) Steroid Therapy:
Corticosteroids have been proven in clinical trials to improve the morbidity and mortality
outcomes in patients with the following conditions:

1) TB meningitis

2) TB pericarditis

3) 8'.QQYRI7IGSRWXMXYXMSR.RǼEQQEXSV]]RHVSQIMR51-.:

For TB meningitis, dexamethasone in the dose of 0.4 mg/kg/day is recommended in

adults (>14 years) in conjugation with antitubercular drugs. The dose should be reduced
over 6–8 weeks. In other conditions, Prednisolone is the preferred corticosteroid used.

The following table summarizes the dose of Prednisolone for adults and children which
are given in a tapering dosage over 7 weeks.

Table 3.12: Dosage of prednisone for adults and children

DOSAGE Weeks 1-4 Weeks 5-6 Week 7

Adult and 1mg/kg (max 60mg) 0.5mg/kg 0.25mg/kg

Children>30kg

Children < 30kg 1-2mg/kg (max 60mg) 0.5-1mg/kg 0.25-0.5 mg/kg

44 Integrated Guideline for Tuberculosis,

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 8'8VIEXQIRX4YXGSQI)IǻRMXMSRW
Upon treatment, persons with drug susceptible TB should be assigned a treatment
outcome from the following list.

Table 3.13: Treatment Outcomes for Drug Susceptible TB Patients

Outcome )IǻRMXMSR

Cured &TYPQSREV]8'TEXMIRX[MXLFEGXIVMSPSKMGEPP]GSRǻVQIH8'EXXLIFIKMRRMRK
of treatment who was smear or culture negative in the last month of treatment
and on at least one previous occasion.

Treatment A TB patient who completed treatment without evidence of failure BUT with
completed no record to show that sputum smear or culture results in the last month of
treatment and on at least one previous occasion were negative, either because
tests were not done or because results are unavailable.

Treatment The sum of cured and treatment completed. This is calculated based on
success FEGXIVMSPSKMGEPP]GSRǻVQIHGEWIW

Treatment A TB patient whose sputum smear or culture is positive at month 5 or later

failed during treatment.

Died A TB patient who dies for any reason before starting or during the course of
treatment.

Moved to Cat. &TEXMIRX[LSMWGSRǻVQIHXSLEZI)VYKVIWMWXERX8'[LMPISRǻVWXPMRI8'

4 (MT4) treatment regimen.

Lost to A TB patient who did not start treatment or whose treatment was interrupted
follow-up for 2 consecutive months or more.

Not A TB patient for whom no treatment outcome is assigned. This includes cases
evaluated “transferred out” to another treatment unit as well as cases for whom the
treatment outcome is unknown to the reporting unit.

(SQTPMGEXMSRWSJ5YPQSREV]8YFIVGYPSWMW
If TB is not diagnosed early and treated accordingly, a number of complications may
occur. Some of the possible complications are summarized in the table below:

Table 3.13: Common Complications of Pulmonary Tuberculosis

Disease Presentation Management

Spontaneous Pneumothorax
Presence of air in the pleural Acute onset of shortness of The patient should be admitted
cavity resulting in impairment breath to hospital for appropriate
of oxygenation and ventilation. management.
Chest pain
It is a medical emergency and
Chest tube with underwater
results from rupture of a TB
seal drainage should be
cavity adjacent to the pleura.
performed.

Integrated Guideline for Tuberculosis, 45

Leprosy and Lung Disease | 2021
 Disease Presentation Management
It may be associated with Give anti-TB therapy
formation of pus in the pleural
space (empyema) leading to a
pyopneumothorax.

Bronchiectasis
Chronic lung disease often Cough Chest physiotherapy mainstay
secondary to an infectious with postural drainage and
Copious amounts of sputum
process that results in the other manoeuvers to improve
which is mainly greenish,
abnormal and permanent drainage of respiratory
blood stained and foul
distortion of one or more of the secretions
smelling
conducting bronchi or airways.
Infective exacerbations require
Hemoptysis
Extrinsic compression of a antibiotics. Broad spectrum
bronchus by enlarged nodes antibiotics like amoxicillin-
may cause bronchial dilation clavulanate, metronidazole
distal to the obstruction. or clindamycin for anaerobic
infection. Antipseudomonal
Progressive destruction and
ERXMFMSXMGWPMOIGMTVSǼS\EGMR
ǻFVSWMWSJPYRKTEVIRGL]QE
3rd generation cephalosporin
may lead to localized bronchial
(Ceftazidime) should be
dilation.
used when colonization with
{žåƣÚŇķŇĻ±žƐis suspected.
Lung Fibrosis
Sequelae of extensive Shortness of breath, Long term oxygen therapy in
tuberculous disease with particularly with exertion severe terminal cases
long-term lung tissue injury.
Chronic dry cough Need referral to chest
Replacement of normal lung
physicians
parenchyma with collagenous Fatigue
tissue results in changes in the Lung transplantation in some
Chest pain
lung, such as thickening and cases
WXMǺIRMRKSJXLIPYRK[EPPW Loss of appetite

Lung Abscess
Necrosis of the pulmonary Fever, productive cough Empiric antibiotics given, aided
parenchyma caused by with putrid or sour-tasting by Gram stain and culture of
microbial infection. Seen in sputum sputum
extensive lung damage after
Night sweats, weight loss, Broad cover for strict
tuberculosis.
and anemia anaerobes and facultatively
anaerobic species with any
Chest pain and hemoptysis
combination of a beta-lactam–
beta-lactamase inhibitor eg
ampicillin-sulbactam
Massive Hemoptysis
Usually seen in cavitary disease Coughing up massive Ensure ABCs followed ie
and sources include the amounts of blood and adequate oxygenation and
pulmonary artery, bronchial considered to be life- ventilation, secure the airway
arteries, intercostal arteries, threatening when there has with endotracheal tube,
and other vessels supplying been approximately 150 mL position the patient in lateral
the lung. Tuberculous vascular of blood expectorated in a decubitus with bleeding side
lesions include pulmonary 24-hour period HS[RKMZIǼYMHWSVFPSSHERH

46 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Disease Presentation Management

or bronchial arteritis and (or 100ml/hour) or give sylate to control bleeding.

thrombosis, bronchial artery associated with airway
Refer for bronchoscopy by
dilatation, and Rasmussen SFWXVYGXMSRWMKRMǻGERXP]
chest physician
aneurysm. hypoxemia or hypotension

Chronic pulmonary
aspergillosis
Weight loss, chronic (SRǻVQIHF]LMKLPIZIPWSJ
Result of colonization of productive cough and WIVYQWTIGMǻG.QQYRSKPSFYPMR
tuberculous cavities or recurrent or persistent G against
žŤåŹďĞĮĮƣž
bronchiectatic lesions with the hemoptysis in patient
Surgical resection is only
fungus AžŤåŹďĞĮƣžũ previously treated for PTB
IǺIGXMZIXVIEXQIRX
Fatigue
Shortness of breath
Chest pain

3.11 Treatment Preparation, Initiation and Follow Up

3.11.1 Patient Education and Counselling
Adherence to TB treatment is essential in preventing emergence of resistance and
to increase the chance of cure. This guideline provides practical steps to be used
by healthcare workers to provide patient education/ counselling to patients on TB
treatment.

Counselling explores and assesses psychological and emotional issues that could be
pre-existing, drug induced and/or emerging in the course of the treatment due to social
pressures. The approach needs to be patient-centred and geared towards helping
TEXMIRXW ǻRH XLIMV S[R WSPYXMSRW XS HEMP] PMJI TVSFPIQW XLEX QE] MQTEGX RIKEXMZIP] SR
adherence.

Counselling/Education will aim to achieve the following:

a) Inform and educate patients and their caregivers on TB.

b) Increase patient understanding of TB disease and treatment to enhance

adherence.

c) Empower the patient to take responsibility for their treatment.

d) Identify psychological issues arising from treatment or disease presence and

provide psychological support

e) Create a harmonised patient education for enhanced holistic care.

f) Improve patient/health care worker relationship

This relies on the quality of the therapeutic relationship established between the
educator, the clinic team and the patient.

Integrated Guideline for Tuberculosis, 47

Leprosy and Lung Disease | 2021
 3.11.2 Patient Counselling and Education Before Treatment
TB patients MUST be provided with counselling and education sessions before
initiation of treatment and subsequently provided during follow-up visits. The
counselling will be provided by the health care workers at the TB treatment centre.
The process of counselling and education will follow the steps below:

1. (VIEXIVETTSVXERHEWWYVIGSRǻHIRXMEPMX]

2. Use of simple and appropriate language that the patient can understand.

3. Listen to feedback from the patient and address any questions.

4. Clarify information.

5. Explore barriers to treatment adherence.

6. Provide information on TB treatment and adherence.

7. Provide information about treatment services which include duration of treatment,

TSWWMFPIWMHIIǺIGXWMQTSVXERGISJ)48JSPPS[YTZMWMXW

8. Roles and responsibilities for the patients, family, patient supporters and health
care worker

3.11.3 Patient Counselling and Education During Treatment

The counselling/ education sessions will aim to develop a TB treatment plan in line with
a patient-centred approach. The plan will include a schedule of clinic visits for treatment
follow up and counselling/education sessions. The frequency of the visits will be weekly
during intensive phase and two weekly in the continuation phase.

However, the frequency of visits for counselling/education may be increased during any
TLEWI SJ XVIEXQIRX MJ MWWYIW XLEX[SYPH EǺIGX EHLIVIRGI EVI MHIRXMǻIH8LI JSPPS[MRK
will be conducted during the follow up counselling and education sessions as further
described in Table 3.14:

ƽ Adherence assessment, supportive education

ƽ Psychosocial review and support

ƽ MHIIǺIGXQSRMXSVMRK

Table 3.14: Counselling and Education Schedule for Tuberculosis patients

Phase Session Content

Baseline First contact with patient ƽ Establish rapport and assuring
(Provide a session at the time GSRǻHIRXMEPMX]
of giving results) ƽ Educate patients on TB treatment and
prevention; transmission, common drugs
WMHIIǺIGXW
ƽ Educate on importance of referral of
contacts for TB screening

48 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Phase Session Content
ƽ Clarify information and myths
ƽ Explore barriers to treatment adherence
ƽ Provide information on TB treatment and
adherence
ƽ Roles and responsibilities for the patients,
family, patient supporter and health care
worker
Intensive phase At every visit (weekly) ƽ Adherence assessment and support
.JQENSVMWWYIWEVIMHIRXMǻIH ƽ Supportive education
arrange for frequent ƽ Psychosocial review and support
adherence sessions
ƽ MHIIǺIGXWQSRMXSVMRK
Continuation Every two weeks, until ƽ Adherence assessment, support and
phase and completion of treatment education
follow-up ƽ MHIIǺIGXWQSRMXSVMRK
ƽ Emotional validation, reassurance

8VIEXQIRX7IWTSRWI+SPPS[YTJSVFEGXIVMSPSKMGEPP]
GSRǻVQIH8'
All patients should be regularly monitored to assess their response to therapy. Regular
QSRMXSVMRKSJTEXMIRXWEPWSJEGMPMXEXIWXVIEXQIRXGSQTPIXMSRERHEPPS[WXLIMHIRXMǻGEXMSR
and management of adverse drug reactions. All patients, their treatment supporters
and health workers should be instructed to report the persistence or reappearance
of symptoms of TB (including weight loss), symptoms of adverse drug reactions, or
treatment interruptions.

7IWTSRWI XS XVIEXQIRX MR TYPQSREV] FEGXIVMSPSKMGEPP] GSRǻVQIH 8' TEXMIRXW MW
monitored by sputum smear examination as shown in the table below. Clinical visits
for the patient should be booked weekly during the intensive phase and twice weekly
during the continuation phase of anti-tuberculous therapy.

Table 3.15: Treatment Response Assessment for Smear positive or GeneXpert

Positive Patients

Months of Specimen Test Result Comment/action

treatment
2 or 3 Sputum Microscopy Negative Transit to continuation phase
Positive ƽ For patients who remain positive at 2 or
3 months: Evaluate for adherence, and
other causes of delayed conversion and
continue RHZE for 1 more months.

Integrated Guideline for Tuberculosis, 49

Leprosy and Lung Disease | 2021
 Months of Specimen Test Result Comment/action
treatment
ƽ Request for all the following drug
susceptibility tests (DST); GeneXpert,
FL* LPA and SL** LPA, Culture, FL DST
and SL DST.
ƽ If DST results is received by then adjust
treatment regimen based on DST results
accordingly
5 Sputum Microscopy Negative Continue treatment until end of month
Positive ƽ For patients who remain positive at 5 or
6 months - declare treatment failure
and stop anti-TB treatment
ƽ Patient must be reviewed by the sub
county and county TB clinical review
teams (PMDT teams)
ƽ Evaluate for adherence, other causes
of delayed sputum conversion and
treatment failure
ƽ Request for GeneXpert, FL LPA and SL
LPA, Culture, FL DST and SL DST
ƽ Review DST results and re-initiate
treatment based on DST results and
SXLIVGPMRMGEPǻRHMRKW
6 Sputum Microscopy Negative Declare patients cured and enrol for the
with one post TB lung disease care follow up clinic
previous
sputum
negative

ÃƐ8XƐƐĝƐ8ĞŹžƒƐXĞĻå

ÃÄXƐĝƐ„åÏŇĻÚƐXĞĻå

3.12.1 Causes of Delayed Sputum Conversion

Smear status at the end of the intensive phase is a poor predictor of which new patients
will relapse. However, detection of a positive sputum smear remains important as a trigger
for the patient assessment as well as for additional drug susceptibility tests as outlined
in Table 3.15. The proportion of smear-positive patients with sputum smear conversion
at the end of the intensive phase is also an indicator of TB programme performance.
Causes of delayed sputum conversion are summarized below in Table 3.16.

50 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Table 3.16: Causes of Delayed Sputum Conversion

Patient Factors Bacillary Factors Drugs HCW and Health system

Factors factors
Extensive High pre-treatment bacillary Poor quality Delayed diagnosis
cavitations loads - smears 2+ to 3+

Poor adherence 7IWMWXERGIǻVWXPMRI Expired Inadequate knowledge

treatment failure with positive drugs among HCWs
culture
Under dosage Dead / Non-viable bacilli with Poor storage Unavailability of guidelines
negative culture - possible
even up to 4th to 5th month of
treatment due to bactericidal
action of Rifampicin and
Isoniazid
Malabsorption Non tuberculous Lab error
mycobacteria
HIV Poor supervision of intensive
phase
Chronic diarrhea

Diabetes mellitus

Older age > 50

years
Smokers
Males
Delayed High pre-treatment bacillary Poor health seeking
consultation loads - smears 2+ to 3+ behavior in the community

3.13 Treatment Interruption

If a patient misses an arranged appointment to receive treatment, the TB clinic should
ensure that the patient is contacted within a day after missing treatment during the initial
phase, and within a week during the continuation phase. The patient can be traced using
the locating information previously obtained on enrolment.

.XMWMQTSVXERXXSǻRHSYXXLIGEYWISJXLITEXMIRXƶWEFWIRGIWSXLEXETTVSTVMEXIEGXMSR
can be taken and treatment can continue.

Steps to take for treatment interruption include:

1. Actively trace patients back from locator information in register

(phone call, home visit)

Integrated Guideline for Tuberculosis, 51

Leprosy and Lung Disease | 2021
 2. Establish the causes for interruption of treatment

3. Address the problem or concerns of the patients

4. Educate and counsel the patients

5. Collect sputum for GenXpert

NOTE:

;LIR E TEXMIRX VIJYWIW XS GSRXMRYI XVIEXQIRX IZIV] IǺSVX WLSYPH FI QEHI XS
convince the patient to continue. When all measures fail and patients insist on
stopping treatment, the patient should sign a refusal form so that other options
are considered such as legal action since TB is a communicable disease of public
health concern.

The following table shows the management of treatment interruption once the patient
returns.

Table 3.17: Management of Treatment Interruption in Tuberculosis Treatment

Treatment Length of Action to be taken
Phase interruption
Intensive Less than 2 1. Perform adherence counselling to address causes of treatment
Phase weeks interruption
2. Continue treatment at the point it was stopped and add the
missed doses to the intensive phase.
More than 2 1. Perform adherence counselling to address causes of treatment
weeks interruption
2. Request for smear microscopy
- If positive, restart treatment and give the full course of anti-TB
treatment
- If negative, continue treatment and add the missed doses to
the intensive phase
3. Perform DST (GeneXpert, Culture, LPA DST) upon return for all.

If treatment is interrupted for more than 2 months

1. Assign outcome as Lost to Follow-Up
2. Upon return, register the patient as Treatment after Loss to
Follow-up (TLF)
3. Re-start anti-TB treatment
Continuation Less than a 1. Perform adherence counselling to address causes of treatment
Phase month interruption
2. Continue treatment at the point it was stopped and add the
missed doses to the continuation phase.

52 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 More than a 1. Perform adherence counselling to address causes of treatment
month interruption
2. Request for smear microscopy
- If negative, continue treatment and add the missed doses to
the continuation phase.
- If positive, declare treatment failure and re-start anti-TB
treatment
3. Perform DST (GeneXpert, Culture, LPA DST) for all treatment
interrupters

If treatment is interrupted for more than 2 months

1. Assign outcome as Lost to Follow-Up
2. Register the patient as Treatment after Loss to Follow-up (TLF)
and Perform DST as above
3. Restart anti-TB treatment

(SQQSR&HZIVWI*ǺIGXWSJ+MVWX1MRI&RXM
8YFIVGYPSYW)VYKW
2SWX8'TEXMIRXWGSQTPIXIXLIMVXVIEXQIRX[MXLSYXER]WMKRMǻGERXEHZIVWIHVYKIǺIGXW
-S[IZIV E JI[ TEXMIRXW HS I\TIVMIRGI EHZIVWI IǺIGXW .X MW XLIVIJSVI MQTSVXERX XLEX
TEXMIRXWFIGPMRMGEPP]QSRMXSVIHHYVMRKXVIEXQIRXWSXLEXEHZIVWIIǺIGXWGERFIHIXIGXIH
promptly and managed properly. Routine laboratory monitoring is not necessary.

-IEPXL TIVWSRRIP GER QSRMXSV EHZIVWI HVYK IǺIGXW F] IHYGEXMRK TEXMIRXW LS[ XS
VIGSKRM^IXLIW]QTXSQWSJGSQQSRIǺIGXWYVKMRKXLIQXSVITSVXMJXLI]HIZIPSTWYGL
symptoms, and by asking about symptoms when patients come to collect drugs.

8LIJSPPS[MRKMWXLIETTVSEGLXSXLIQEREKIQIRXSJXLIQSWXGSQQSREHZIVWIIǺIGXW
XSǻVWXPMRIERXM8'QIHMGMRIW

E &HZIVWI*ǺIGXAcute Hepatotoxicity

Causative agent: (in decreasing order of likelihood): Pyrazinamide, Rifampicin, Isoniazid

Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life

threatening

ALT (SGPT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

AST (SGOT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

Continue treatment Continue treat- Stop all drugs, Stop all drugs,
regimen. Patients ment regimen. including anti-TB including anti-TB
should be followed Patients should drugs; measure drugs; measure
until resolution (re- be followed until LFTs weekly. LFTs weekly.
turn to baseline) or resolution (return Treatment may Treatment may
ACTION stabilization of AST/ to baseline) or sta- be reintroduced be reintroduced
ALT elevation. bilization of AST/ after toxicity is after toxicity is
ALT elevation. resolved. resolved.

Integrated Guideline for Tuberculosis, 53

Leprosy and Lung Disease | 2021
 Suggested management strategy

Reintroduce anti-TB drugs once liver enzymes return to normal level. Anti-TB drugs
should be reintroduced in a serial fashion by adding a new medicine every three to four
days. The least hepatotoxic drugs while monitoring liver function tests after each new
exposure. (E, H,R,Z).

(SRWMHIV WYWTIRHMRK XLI QSWX PMOIP] SǺIRHMRK HVYK TIVQERIRXP] MJ MX MW RSX
essential to the regimen. This is often the case for pyrazinamide if it is less likely
XSFIIǺIGXMZIF]GPMRMGEPLMWXSV]

F &HZIVWI*ǺIGXPeripheral Neuropathy

Causative agent: Isoniazid

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life-

Moderate threatening

Neurosensory
žDžķŤƒŇķ±ƒĞÏƐ „åĻžŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ „åĻžŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ %Ğž±ÆĮĞĻďƐžåĻžŇŹDžƐ

alteration ƾЃĚƐžåĻžŇŹDžƐ ŇŹƐŤ±Ź±åžƒĚåžĞ±Ɛ ŇŹƐŤ±Ź±åžƒĚåžĞ±Ɛ ±ĮƒåŹ±ƒĞŇĻƐŇŹƐ
(including ±ĮƒåŹ±ƒĞŇĻƐŇĻƐ ϱƣžĞĻďƐďŹå±ƒåŹƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐ Ť±Ź±åžƒĚåžĞ±Ɛ
paraesthesia åDŽ±ķƐŇŹƐķĞĻĞķ±ĮƐ ƒĚ±ĻƐķĞĻĞķ±ĮƐ ƒŇƐŤåŹüŇŹķƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐƒŇƐ
and painful Ť±Ź±åžƒĚåžĞ±Ɛ ĞĻƒåŹüåŹåĻÏåƐƾЃĚƐ ƣžƣ±ĮƐžŇÏбĮƐ ŤåŹüŇŹķƐƱžĞÏƐžåĮüĝ
neuropathy) ϱƣžĞĻďƐĻŇƐ ƣžƣ±ĮƐžŇÏбĮƐ ±ĻÚƐüƣĻσĞŇĻ±ĮƐ ϱŹåƐüƣĻσĞŇĻž
ŇŹƐķĞĻĞķ±ĮƐ ±ĻÚƐüƣĻσĞŇĻ±ĮƐ ±ÏƒĞƽЃĞåž
ĞĻƒåŹüåŹåĻÏåƐƾЃĚƐ ±ÏƒĞƽЃĞåž
ƣžƣ±ĮƐžŇÏбĮƐ±ĻÚƐ
üƣĻσĞŇĻ±ĮƐ±ÏƒĞƽЃĞåž
Monitor. If Stop Cs and Stop Cs and Lzd. Stop Cs and Lzd.
symptoms Lzd (high dose If symptoms If symptoms
improve after 2 H). If symptoms improve after 2 improve after 2
weeks, consider resolve after 2 weeks consider weeks consider
Action restarting these weeks, consider restarting restarting
drugs. Consider restarting cycloserine. cycloserine.
restarting Lzd at cycloserine.
a lower dose. Do not Do not
Do not reintroduce Lzd. reintroduce Lzd.
reintroduce Lzd.

Symptomatic relief for peripheral neuropathy:

ƽ 3SRWXIVSMHEPERXMMRǼEQQEXSV]HVYKW or acetaminophen helps alleviate

symptoms.

ƽ Tricyclic antidepressants have also been used successfully. Start amitriptyline

25 mg at bedtime. The dose should be increased to a maximum of 150 mg daily
for refractory symptoms.

ƽ CarbamazepineMWIǺIGXMZIMRVIPMIZMRKTEMRERHSXLIVW]QTXSQWSJTIVMTLIVEP
neuropathy.

54 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
G &HZIVWI*ǺIGXOptic Neuritis
Causative agent: Ethambutol

Grade 1 Mild Grade 2 Grade 3 severe Grade 4 life-

Moderate threatening
Visual changes šĞžƣ±ĮƐÏ̱ĻďåžƐ šĞžƣ±ĮƐÏ̱ĻďåžƐ šĞžƣ±ĮƐÏ̱ĻďåžƐ %Ğž±ÆĮĞĻďƐƽĞžƣ±ĮƐ
(from baseline) ϱƣžĞĻďƐķĞĻĞķ±ĮƐ ϱƣžĞĻďƐďŹå±ƒåŹƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐ ĮŇžž
ŇŹƐĻŇƐĞĻƒåŹüåŹåĻÏåƐ ƒĚ±ĻƐķĞĻĞķ±ĮƐ ƒŇƐŤåŹüŇŹķƐ
ƾЃĚƐƣžƣ±ĮƐžŇÏбĮƐ ĞĻƒåŹüåŹåĻÏåƐƾЃĚƐ ƣžƣ±ĮƐžŇÏбĮƐ
±ĻÚƐüƣĻσĞŇĻ±ĮƐ ƣžƣ±ĮƐžŇÏбĮƐ ±ĻÚƐüƣĻσĞŇĻ±ĮƐ
±ÏƒĞƽЃĞåž ±ĻÚƐüƣĻσĞŇĻ±ĮƐ ±ÏƒĞƽЃĞåž
±ÏƒĞƽЃĞåž
Action Stop LZD Stop LZD Stop LZD Stop LZD
immediately if immediately if immediately if immediately if
there are any there are any there are any there are any
suspicion of optic suspicion of optic suspicion of optic suspicion of optic
neuritis. Do not neuritis. Do not neuritis. Do not neuritis. Do not
restart. restart. restart. restart.

Suggested management strategy

ƽ )SRSXVIWXEVXXLIWYWTIGXIHGEYWEXMZIHVYK 1MRI^SPMHSV*XLEQFYXSP

ƽ 7IJIVTEXMIRXWXSERSTLXLEPQSPSKMWXJSVJYVXLIVIZEPYEXMSRERHQEREKIQIRX

ƽ 4TXMGRIYVMXMWKIRIVEPP]MQTVSZIWJSPPS[MRKGIWWEXMSRSJSǺIRHMRKHVYKMJMXGER
be stopped early enough.

3.15 Dietary Considerations for Persons on First Line

Anti-TB Medicines
Drug Name Dietary Restriction 5SWWMFPIWMHIIǺIGX

Rifampicin To be taken 1 hr before or Nausea, Vomiting, Appetite loss

2 hrs after food.1 hr before
Antacids. Avoid Alcohol

Isoniazid Taken 1 hr before or 2 hrs Hepatotoxicity, Cutaneous

after food. Give 50mg of hypersensitivity, Peripheral
Pyridoxine daily. Avoid Neuropathy
alcohol

Ethambutol May be taken with food. Anthralgia,Retrobulbar neuritis.

Avoid Alcohol

Pyrazinamide May be taken with food Hepatotoxicity, Anthralgia, Nausea,

Vomiting

Integrated Guideline for Tuberculosis, 55

Leprosy and Lung Disease | 2021
56 Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
TUBERCULOSIS IN
CHILDREN 4

KEY HIGHLIGHTS:

'EGOKVSYRH
ƽ 1.2 million children became ill with TB in 2019 Î ‰ųå±ƋĵåĹƋƵĜƋʱĹƋĜě‰ÚųƚčŸ
Î ĘĜĬÚųåĹųåŞųåŸåĹƋ10-15% of all TB cases and this could ±ŸޱųƋŅüÚĜ±čĹŅŸĜŸŠƋųĜ±ĬěŅüě
be higher in high burden countries ƋĘåų±ŞƼšĜŸĹŅƋųåÏŅĵĵåĹÚåÚ

Î ‰ĜĹƼŅƚĹčÏĘĜĬÚųåĹĜŸŅüƋåĹÚĜŸŸåĵĜűƋåÚ±ĹÚų±ŞĜÚĬƼ
progressive
ĻƐ±ƒƒåķŤƒƐžĚŇƣĮÚƐÆåƐķ±ÚåƐ
ƒŇƾ±ŹÚžƐŇƃ±ĞĻĞĻďƐ±Ɛž±ķŤĮåƐüŇŹƐ
:åĻå£ŤåŹƒƐƒåžƒĞĻďØƐĚŇƾåƽåŹØƐa
MKRWERH]QTXSQWSJ8' negative Xpert MTB/RIF test
The most common symptoms associated with TB include result doesn’t indicate the
the following: child has no TB; üƣŹƒĚåŹƐÏĮĞĻĞϱĮƐ
Î ŅƚčĘ åƽ±Įƣ±ƒĞŇĻƐĞžƐĻååÚåÚƐƒŇƐķ±īåƐ±Ɛ
ÏĮĞĻĞϱĮƐÚбďĻŇžĞžƐŇüƐ‰ƐĞĻƐžƣÏĚƐ
Î 8åƴåų±ĹÚxŅųĹĜčĘƋŸƵå±ƋŸ ÏĚĞĮÚŹåĻ
Î œåĜčĘƋĬŅŸŸŅų{ŅŅųƵåĜčĘƋŠ8±ĜĬƚųåƋŅƋĘųĜƴåš
Î XåƋʱųčƼxųåÚƚÏåÚŞĬ±ƼxĬ域±ÏƋĜƴå 8VIEXQIRXSJ8'MRGLMPHVIR
Î ŽŸåÏĘĜĬÚěüųĜåĹÚĬƼ
)MEKRSWMWSJ8'MRGLMPHVIR formulations
Î ‰ĘåÚĜ±čĹŅŸĜŸŅü‰ĜĹÏĘĜĬÚųåĹųåĬĜåŸŅűčŅŅÚĘĜŸƋŅųƼ Î eĬĬÏĘĜĬÚųåĹŅʼnƋųå±ƋĵåĹƋ
and a careful physical examination aŽ„‰ÆåŅĹŞƼųĜÚŅƻĜĹå
Î FƋĜŸÏųĜƋĜϱĬƋŅåŸƋ±ÆĬĜŸĘ±ĘĜŸƋŅųƼŅüÏŅĹƋ±ÏƋƵĜƋʱŠΠ%ŅŸĜĹčüŅųÏĘĜĬÚųåĹĵƚŸƋÆå
±ÚŅĬåŸÏåĹƋŅų±ÚƚĬƋƵĜƋĘÏŅĹĀųĵåÚŅųŞųåŸƚĵŞƋĜƴå‰ weight-based and regularly
within the last two years adjusted to weight.
Î ‰ĘåÚĜ±čĹŅŸĜŸŅü‰ϱĹÆåĵ±ÚåƵĜƋĘÏŅĹĀÚåĹÏåĜĹƋĘå
ĵ±ģŅųĜƋƼŅüÏĘĜĬÚųåĹƚŸĜĹčÏĬĜĹĜϱĬ±ŸŸåŸŸĵåĹƋx±ĬčŅųĜƋĘĵ
for diagnosing TB in children.

Integrated Guideline for Tuberculosis, 57

Leprosy and Lung Disease | 2021
 4.1 Introduction
4.1.1 Epidemiology of TB in Children
In 2019, 1.2 million children below the age of 15 years became ill with tuberculosis
(WHO). Children represent 10-15% of all TB cases and this could be higher in high burden
countries. Children below 5 years are more vulnerable to developing TB disease. They
LEZI TEYGMFEGMPPEV] HMWIEWI ERH SJXIR TVIWIRX [MXL RSRWTIGMǻG W]QTXSQW (LMPH
contacts with household exposure are 17 times more likely to be infected with TB than
non-contacts.

.RGLMPHVIREGGSYRXIHJSV  SJXSXEP8'GEWIWRSXMǻIHMR0IR]E&FSYX
half of these were below 5 years. Approximately 21% of patients 5-14 years were co-
infected with HIV. About 65% of children seeking care with symptoms are missed.
Health workers need to have a high index of suspicion to improve the diagnosis of TB
in children.

In the context of this guideline, a child refers to a person aged 0 to 14 years. This may
HMǺIVJVSQXLIHIǻRMXMSRSJGLMPHVIRMRSXLIVGSRXI\XW

4.1.2 Risk of Latent TB Infection Progressing to TB disease

Children with latent TB infection can progress to active TB disease. Risk factors for this
progression include:

ƽ -.:MRJIGXMSR

ƽ &KIIWTIGMEPP]XLSWIYRHIVXLIEKISJX[S]IEVW

ƽ 7IGIRXMRJIGXMSR[MXL2XYFIVGYPSWMW [MXLMRXLIPEWXX[S]IEVW

ƽ -MWXSV]SJTVIZMSYWP]TSSVP]XVIEXIH8'

ƽ .QQYRSWYTTVIWWMZIXLIVET]

ƽ 4XLIVMQQYRIWYTTVIWWMZIGSRHMXMSRWIKHMEFIXIWWMPMGSWMWQEPMKRERGMIW

Progression of the primary complex may lead to enlargement of hilar and mediastinal
nodes with resultant bronchial collapse. Progressive primary TB disease may develop
when the primary focus cavitates and organisms spread through contiguous bronchi.
Lympho-haematogenous dissemination, especially in children, may lead to milliary TB
when caseous material reaches the bloodstream from a primary focus or a caseating
metastatic focus in the wall of a pulmonary vein. TB meningitis may result from
hematogenous dissemination.

The bacilli may remain dormant in the lungs for several months or years. A positive
tuberculin skin test (TST) or Interferon Gamma Release Assay (IGRA) where available
would be the only evidence of infection.

58 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 TB in young children is often disseminated and rapidly progressive

4.2 Diagnosis of TB in children

The diagnosis of TB in children relies on a good history, a careful physical examination
EW [IPP EW VIPIZERX MRZIWXMKEXMSRW &PP IǺSVXW WLSYPH FI QEHI XS KIX E WTIGMQIR JSV
FEGXIVMSPSKMGEPGSRǻVQEXMSRSJ8'MRGLMPHVIRIn cases where it is not possible to obtain
a specimen in a timely way, this should not be a barrier to making the diagnosis, a
clinical diagnosis can be made using the pediatric diagnostic algorithm.

A trial treatment with anti-TB drugs is not recommended as a method of diagnosing

TB in children. Most children with TB have Pulmonary TB. However, approximately 30
– 40% of children with TB have TB in organs outside of the chest – also called extra-
pulmonary TB.

4.2.1 Diagnosis of Pulmonary TB

History
The key elements of history are:

E -MWXSV]SJGSRXEGX[MXLEREHSPIWGIRXSVEHYPX[MXLGSRǻVQIHSVTVIWYQTXMZI
TB within the last two years
Close contact MWHIǻRIHEWETIVWSR[LSLEWGSRǻVQIHSVTVIWYQTXMZI8'PMZMRKMRXLI
WEQILSYWILSPHSVMRJVIUYIRXGSRXEGX[MXLXLIGLMPH IKGEVIXEOIVWWGLSSPWXEǺ

.J RS MRHI\ GEWI MW MHIRXMǻIH EP[E]W EWO EFSYX ER]SRI MR XLI LSYWILSPHHSVQMXSV]
classroom/school transport with chronic cough- if present request assessment of that
person for possible TB.

Most children who develop TB, do so within two years of exposure.

b) History of symptoms suggestive of TB

The most common symptoms associated with TB include the following:

ƽ (SYKL

ƽ +IZIVERHSVRMKLXW[IEXW

ƽ ;IMKLXPSWW5SSV[IMKLXKEMR +EMPYVIXSXLVMZI

ƽ 1IXLEVK]VIHYGIHTPE]PIWWEGXMZI

The diagnosis of TB in children relies on a careful history and physical examination

Integrated Guideline for Tuberculosis, 59

Leprosy and Lung Disease | 2021
 Physical examination
a) General examination

Examine the child and check for:

ƽ 8IQTIVEXYVI# JIZIV
ƽ ;IMKLX XSGSRǻVQTSSV[IMKLXKEMR[IMKLXPSWW
ƽ 7IWTMVEXSV]VEXI JEWXFVIEXLMRK

b) Examination of the Respiratory System

In the early stages of pulmonary TB, the respiratory exam may show few abnormal signs.
As the disease progresses respiratory signs become more obvious as follows:
ƽ (SYKL
ƽ .RGVIEWIHVIWTMVEXSV]VEXI JEWXFVIEXLMRK
ƽ 7IWTMVEXSV] HMWXVIWW IK PEFSYVIH FVIEXLMRK GLIWX MRHVE[MRK XLMW WLS[W
severe disease)
ƽ 5IVGYWWMSRRSXIHYPP[LIRPSFEVGSRWSPMHEXMSRMWTVIWIRX RSVQEPVIWSRERGI
may be found in many children with PTB).

Auscultation may be normal in early disease and abnormal in more advanced disease
(crackles, bronchial breathing).

The classic symptoms of PTB are cough, fever, poor weight gain, and lethargy/
reduced playfulness

The following is a summary of the algorithm for the diagnosis of TB in children

Table 4.1: Algorithm for the diagnosis of pulmonary TB in children

History of For all children presenting to a health facility ask for the following suggestive
Presenting symptoms:
illness
(Cough, fever, poor weight gain, lethargy or reduced playfulness)
Suspect TB if a child has two or more of these suggestive symptoms
Ask for history of contact with adult/adolescent with chronic cough or TB
within the last 2 years

Physical Examine the child and check for:

Examination
ƽ 8IQTIVEXYVI# JIZIV
ƽ ;IMKLX XSGSRǻVQTSSV[IMKLXKEMR[IMKLXPSWWGLIGOKVS[XL
monitoring curve
ƽ 7IWTMVEXSV]VEXI JEWXFVIEXLMRK
ƽ 7IWTMVEXSV]W]WXIQI\EQMREXMSRER]EFRSVQEPǻRHMRKW#
Examine other systems for abnormal signs suggestive of extra-pulmonary TB+

60 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Investigations Obtain specimen* for Xpert MTB/RIF (and culture when
indicated**)

Do a chest X-ray (where available)

Do a Mantoux test*** (where available)
Do an HIV test
Do other tests to diagnose extra-pulmonary TB where suspected+

Diagnosis Bacteriologically Clinically diagnosed TB:

GSRǻVQIH8'
ĚĞĮÚƐ̱žƐtwo or more ŇüƐƒĚåƐüŇĮĮŇƾĞĻďƐžƣďď垃ĞƽåƐ
Diagnose if specimen
žDžķŤƒŇķž×
is positive for MTB
ƽ 5IVWMWXIRXGSYKLJIZIVTSSV[IMKLXKEMR
lethargy PLUS two or more of the following:
ƽ 5SWMXMZIGSRXEGXEFRSVQEPVIWTMVEXSV]WMKRW
abnormal CXR, positive Mantoux
Note: If the child has clinical signs suggestive of
EPTB, refer to EPTB diagnostic table+

Treatment Treat for TB as follows:

ƽ &PPGLMPHVIR[MXLFEGXIVMSPSKMGEPP]GSRǻVQIH8'
ƽ &PPGLMPHVIR[MXLEclinical diagnosis of TB
NB: In children who do not have an Xpert result, or their Xpert result is
negative, but they have clinical signs and symptoms suggestive of TB they
should be treated for TB. All forms of TB (Except TB meningitis, bone, and
joint TB): Treat for 6 months (2 RHZE / 4 RH)
TB meningitis, bone, and joint TB: Treat for 12 months (2 RHZE/ 10 RH)

ÄŤåÏĞķåĻƐķ±DžƐĞĻÏĮƣÚåƐåDŽŤåÏƒŇŹ±ƒåÚƐžŤƣƒƣķƐŦÏĚĞĮÚƐĕƐĂƐDžå±ŹžŧØƐĞĻÚƣÏåÚƐžŤƣƒƣķØƐ
Ļ±žŇŤĚ±ŹDžĻďå±ĮƐ±žŤĞŹ±ƒåØƐﱞƒŹĞÏƐ±žŤĞŹ±ƒåØƐ±ĻÚƐžƒŇŇĮũƐ
ƒƒåķŤƒƐƒŇƐŇƃ±ĞĻƐžŤåÏĞķåĻƐĞĻƐåƽåŹDžƐ
ÏĚĞĮÚ

ÃÃ%ŇƐÏƣĮƒƣŹåƐ±ĻÚƐ%„‰ƐüŇŹƐƒĚåƐüŇĮĮŇƾĞĻďƐÏĚĞĮÚŹåĻ×

1. Ğü±ķŤĞÏĞĻƐŹåžĞžƒ±ĻÏåƐÚåƒåσåÚƐÆDžƐƒĚåƐ£ŤåŹƒƐƒåžƒ

2. åüƣďååžƐ±ĻÚƐÏĚĞĮÚŹåĻƐĞĻƐÏŇĻƒ±ÏƒƐƾЃĚƐ±ĻDžŇĻåƐƾĚŇƐ̱žƐ%ŹƣďĝåžĞžƒ±ĻƒƐ‰

3. ‰ĚŇžåƐĻŇƒƐŹåžŤŇĻÚĞĻďƐƒŇƐ‰ƐƒŹå±ƒķåĻƒ

4. ‰ĚŇžåƐƾЃĚƐFĻÚåƒåŹķĞĻ±ƒåƐ£ŤåŹƒƐŹåžƣĮƒž

ÃÃÃƐ‰ĚĞžƐķ±DžƐĞĻÏĮƣÚåƐF:
ƐĞĻƐü±ÏĞĮЃĞåžƐƾĚåŹåƐЃƐĞžƐ±ƽ±ĞĮ±ÆĮå

ņƐŽžåƐFaFƐďƣĞÚåĮĞĻåžƐƒŇƐÏĮ±žžĞüDžƐžåƽåŹĞƒDžƐŇüƐÚĞžå±žå

ūåüåŹƐƒŇƐ‰±ÆĮåƐċũƗƐŇĻƐÚбďĻŇžĞžƐŇüƐ)DŽƒŹ±ĝŤƣĮķŇĻ±ŹDžƐ‰Ɛ

Integrated Guideline for Tuberculosis, 61

Leprosy and Lung Disease | 2021
 ‰ĚåƐÚбďĻŇžĞžƐŇüƐ‰ƐϱĻƐÆåƐķ±ÚåƐƾЃĚƐÏŇĻĀÚåĻÏåƐĞĻƐƒĚåƐķ±ĥŇŹĞƒDžƐŇüƐÏĚĞĮÚŹåĻƐƣžĞĻďƐ
clinical assessment

A negative Xpert MTB/RIF test result does not rule out TB.

Some children may present with an atypical clinical presentation of pulmonary TB.
Some of the atypical presentations include,

a) Acute severe pneumonia

ƽ Presents with fast breathing and chest in-drawing

ƽ Occurs especially in infants and HIV-infected children

In this case, presume Pulmonary TB if the child does not respond to antibiotics. For
a child who is HIV infected, rule out other HIV-related lung diseases e.g. PCP before
considering TB treatment

b) Wheeze
Asymmetrical and persistent wheeze can be caused by airway compression due to
enlarged tuberculous hilar lymph nodes. Presume PTB when wheeze is asymmetrical,
persistent, and non-responsive to bronchodilator therapy.

PTB can also present acutely as bronchopneumonia in children with tachypnea

(fast breathing), respiratory distress, and crackles.

cŇŹķ±ĮƐŹåžŤĞŹ±ƒŇŹDžƐÏĮĞĻĞϱĮƐĀĻÚĞĻďžƐÚŇƐĻŇƒƐŹƣĮåƐŇƣƒƐ{‰ũ

)MǺIVIRXMEP)MEKRSWMWJSV(LMPH[MXL(LVSRMG(SYKL7IWTMVEXSV]]QTXSQW
Other conditions to consider in a child with chronic cough/chronic respiratory symptoms
[LSHSIWRSXJYPǻPPXLIGPEWWMGEPGPMRMGEPTMGXYVISJ58'MRGPYHIXLSWIMRXLIXEFPIFIPS[

8EFPI)MǺIVIRXMEPHMEKRSWMWJSVGLVSRMGGSYKLVIWTMVEXSV]W]QTXSQW

)MǺIVIRXMEPHMEKRSWMW Clinical Presentation

Asthma Recurrent wheeze/cough – responds to bronchodilators
Usually associated with other allergies such as eczema, rhinitis.
Upper airway Recurrent/persistent runny nose and /or nasal blockage and snoring
conditions
Seasonal pattern Triggers
Allergic rhinitis
Adenoid hypertrophy

62 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Foreign Body Usually, sudden onset in previously well child May have history of
Inhalation choking
Persistent cough
One-sided respiratory signs–inspiratory stridor, wheeze
Gastroesophageal
VIǼY\HMWIEWI
Recurrent cough/wheeze Onset in early infancy
+/- Hoarse voice
Bronchiectasis Severe persistent c o u g h, much sputum (often infected green or
yellow in color) Finger clubbing
CXR shows a reticular or honey-comb pattern
Congenital Heart Easily fatigability, breathlessness, Onset early infancy
Disease
Acquired heart Older children, palpitations, easy fatigability, dyspnea on exertion
disease
+/- edema
Congenital Onset early infancy Commonly premature baby
respiratory disorders
Noisy breathing during inspiration not responding to bronchodilators

4.2.2 Diagnosis of Extra Pulmonary Tuberculosis (EPTB)

Approximately 30-40% of children with TB have TB in organs outside of the chest – also
called extra-pulmonary TB. Younger children and children with HIV disease are more
likely to have EPTB than older children and adults.

EPTB disease is TB outside the lung parenchyma. It can be:

ƽ Intra-thoracic (inside the chest, but outside of the lung tissue) – pleural
IǺYWMSR MRXVEXLSVEGMG P]QTLEHIRSTEXL] QIHMEWXMREP TEVEXVEGLIEP SV LMPEV
lymphadenopathy)

ƽ Extra-thoracic (outside the chest) – peripheral lymph nodes, abdomen,

genitourinary tract, skin, joints and bones, meninges.

The most common site for EPTB is the lymph nodes (hilar or cervical), followed by
TB meningitis. Frequently, a child will have a combination of both pulmonary and
extrapulmonary TB, with infection starting in the lungs and disseminating to other parts
of the body.

History
For children suspected to have EPTB, two elements of history are important:

ƽ -MWXSV] GSRXEGX [MXL ER EHSPIWGIRX SV EHYPX [MXL GSRǻVQIH SV TVIWYQTXMZI 8'
within the last two years

ƽ -MWXSV]SJW]QTXSQWWYKKIWXMZISJ*58'

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Leprosy and Lung Disease | 2021
 Children with EPTB may have the classic symptoms suggestive of TB:

ƽ +IZIVERHSVRMKLXW[IEXW

ƽ 5SSV[IMKLXKEMRSV[IMKLXPSWW

ƽ 1IXLEVK]PIWWEGXMZIVIHYGIHTPE]

ƽ (SYKL

.REHHMXMSRXLI]QE]LEZIW]QTXSQWWTIGMǻGXSXLIWMXISJ*58'JSVI\EQTPI

ƽ [SPPIRRIGOP]QTLRSHIWQE]FIHMWGLEVKMRKGEWISYWQEXIVMEP

ƽ ]QTXSQW SJ QIRMRKMXMW Ƴ TVSKVIWWMZI YRVIPIRXMRK LIEHEGLI MVVMXEFMPMX]

confusion, focal neurologic weakness, convulsions, reduced consciousness

ƽ ]QTXSQWSJLMPEVP]QTLEHIRSTEXL]GSQTVIWWMRKXLIEMV[E]WƳ;LII^IVETMH
breathing, and worsening breathlessness (may or may not have cough)

8EFPISQISJXLIWMXIW*58'QE]EǺIGXXLIMVTVIWIRXEXMSRERHMRZIWXMKEXMSRW

Site of EPTB History Clinical signs Investigation

Cervical ƽ Progressive swelling ƽ Enlarged cervical LN 1. Fine needle

Lymphadenitis in the neck >2cm diameter Not hot aspiration when
(TB adenitis) ƽ Usually on one side, or tender+/- possible
but may occur on ƽ Discharging sinus
both sides (caseous discharge) 2. Mantoux
ƽ Several swellings ƽ Most common in the
that are not painful neck area
with or without thick ƽ Tachypnea
yellow discharge
ƽ +/- respiratory distress
ƽ May or may not have
cough ƽ Normal percussion note

Hilar ƽ Noisy breathing ƽ 'VIEXLWSYRHWQE]FI 1. CXR

lymphadenopathy (parent may louder on one side of the 2. Mantoux
describe as a chest than on the other
wheeze) ƽ Wheeze/rhonchi which
ƽ Fast breathing, are often asymmetric,
progressive low pitched, with
breathlessness poor response to
bronchodilators

Pleural TB ƽ Chest pain on the ƽ Dullness on percussion 1. CXR

EǺIGXIHWMHI ƽ Reduced breath sounds 2. Pleural tap
ƽ Progressive SRXLIEǺIGXIHWMHI 3. Mantoux test
breathlessness
ƽ May or may not have
cough

64 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Site of EPTB History Clinical signs Investigation

TB meningitis ƽ Unremitting ƽ Irritability/abnormal 1. Lumbar puncture

headache behavior to obtain CSF
progressing to ƽ Lethargic/reduced level 2. Infants-cranial
Irritability/abnormal of consciousness, with ultrasound
behavior or without convulsions 3. Older child do CT
ƽ Lethargic/ ƽ 3IGOWXMǺRIWW scan head
reduced level of
consciousness ƽ Bulging fontanel 4. Mantoux test
with or without ƽ Cranial nerve palsies
Convulsions
Miliary TB ƽ 3SRWTIGMǻG ƽ +IZIV 1. CXR
ƽ Lethargic ƽ ;EWXMRK 2. Mantoux test
ƽ With or without ƽ ;MXLSV[MXLSYX
cough respiratory signs
ƽ ;MXLSV[MXLSYX
hepatosplenomegaly
Abdominal TB ƽ Painless abdominal ƽ &WGMXIW 1. Ascitic tap
swelling ƽ ;MXLSV[MXLSYX 2. Abdominal
ƽ With or without GIT hepatosplenomegaly ultrasound
disturbances 3. Mantoux test
Spinal TB ƽ Painless deformity of ƽ ,MFFYWHIJSVQMX] 1. Lateral X-ray
the spine ƽ <VE]WLS[WERXIVMSV spine
ƽ May have lower limb vertebral collapse 2. Mantoux test
weakness/paralysis
Pericardial TB ƽ Cardiac failure: ƽ &TI\FIEXHMǽGYPXXS 1. CXR
(SYKLHMǽGYPX]MR palpate 2. Echocardiogram
breathing, swelling ƽ 2YǾIHLIEVXWSYRHW
of legs and/or 3. Mantoux test
abdomen
TB bone and joint ƽ Painless swelling ƽ *ǺYWMSRSJPEVKINSMRXW 1. X-ray
(excluding spine) end of long bones (usually knee or hip) 2. CT scan
with limitation of ƽ 1MQMXEXMSRSJQSZIQIRX
movement 3. MRI
in long bones
 Painless unilateral
joint swelling

The most common form of extra-pulmonary TB in children is lymphadenopathy.

This can be cervical or hilar

Integrated Guideline for Tuberculosis, 65

Leprosy and Lung Disease | 2021
 Investigations
Having taken a comprehensive history and conducted a thorough physical examination,
a Mantoux test/IGRA may be done where applicable to determine exposure. A chest
x-ray should also be done where accessible to aid diagnosis. Samples should be
collected for GeneXpert testing (where applicable). Sputum induction and gastric
lavage are encouraged for younger children who cannot produce sputum.

Table 4.4: Laboratory Tests, Targets, and Purpose

Laboratory test Target Purpose

Immunologic Tests
ƽ (LMPHVIR ƽ 9WIJYPXIWXXSHIXIGX8'I\TSWYVIMR
children and support presumptive
clinical diagnosis in situations where
Tuberculin skin there is no obvious close TB contact
test to the child

Interferon- ƽ (LMPHVIR ƽ MQMPEVVSPIXS88FYXQSVI

gamma release expensive
assay (IGRA)
Radiological investigations
ƽ (LIWX<VE]JSVEPPMRJERXW ƽ )MEKRSWMWSJ8'ERH*58'MREPP
children, and adolescents children where x-ray services are
X-ray with presumptive TB available.

ƽ <VE]WSJXLIEǺIGXIHFSRI ƽ For children obtain Anteroposterior

joint, spine as appropriate and lateral CXR views
ƽ &FHSQMREPYPXVEWSYRH ƽ )MEKRSWMWSJEFHSQMREP8'
Chest ultrasound )IXIGXMSRSJTPIYVEPIǺYWMSR
Ultrasound
ƽ -IEH(8(LIWX(8EW
needed
CT Scan or MRI ƽ *ZEPYEXMSRSJWIZIVISVGSQTPMGEXIH
ƽ 27.SJXLIEFHSQIRLIEH cases
chest, or spine

ƽ EWRIIHIH
Bacteriological Investigations
MTB/RIF ƽ 8LIǻVWXPMRIXIWXJSVEPP ƽ +SVHMEKRSWMWSJ8'
GeneXpert presumptive or suspected
TB in Infants, children, and ƽ 8SHIXIVQMRIVMJEQTMGMR
adolescents susceptibility

ƽ YVZIMPPERGIJSV)VYK ƽ )SRIJSVGLMPHWTIGMQIRWSJ
Resistant TB among sputum, CSF, Gastric aspirate,
children previously treated 5PIYVEPǼYMHTIVMGEVHMEPǼYMH&WGMXMG
for TB, child contacts of ǼYMHWXSSP
DRTB patients, refugees,
prisoners, children not
MQTVSZMRKSRǻVWXPMRI8'
treatment

66 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Smear ƽ .RJERXWGLMPHVIRERH ƽ 4RP]YWIHMRWMXYEXMSRW[LIVI<TIVX
microscopy adolescents with is not accessible
(Fluorescent presumptive Pulmonary TB
and Light ƽ 2SRMXSVMRKWQIEVTSWMXMZIERHSV
microscopy) GeneXpert positive TB patients on
treatment at months 2, 5 and 6

Whenever possible try to make a bacteriological diagnosis of TB in infants and older children by
Ňƃ±ĞĻĞĻďƐžŤåÏĞķåĻžƐ±ĻÚƐžåĻÚĞĻďƐƒĚåķƐüŇŹƐ:åĻåƐ£ŤåŹƒƐŦŤŹåüåŹŹåÚƐĀŹžƒĝĮĞĻåƐƒåžƒŧØƐ
8ƐķĞÏŹŇžÏŇŤDžØƐ
or TB culture.

Immunologic Tests
Tuberculin Skin Test (Mantoux test)

A positive Mantoux test is evidence that one is infected with M. Tuberculosis, but
doesn’t necessarily indicate disease. Correct technique of administering, reading, and
interpretation of a Mantoux test is very important. ŦåüåŹƐƒŇƐ±ŤŤŹŇŤŹĞ±ƒåƐ„k{ŧ

Mantoux is positive if induration is:

ƽ ǸQQMRE[IPPRSYVMWLIH-.:RIKEXMZIGLMPH

ƽ ǸQQMREQEPRSYVMWLIHSV-.:MRJIGXIHGLMPH

A negative Mantoux does not rule out TB (especially in the HIV positive or malnourished
child).

Interferon-Gamma Release Assays (IGRAs)

Haematological tests that can aid in diagnosing Mycobacterium tuberculosis infection

e.g. QuantiFERON®-TB Gold In-Tube test (QFT-GIT) and T-SPOT®.TB test (T-Spot). It is
an antibody-antigen test that - like the Mantoux test - measures the presence of an
immune response to TB bacilli. There is limited data on its use in:

ƽ (LMPHVIR]SYRKIVXLER]IEVWSJEKI

ƽ 5IVWSRWVIGIRXP]I\TSWIHXS2XYFIVGYPSWMW

ƽ .QQYRSWYTTVIWWIHTIVWSRWERH

ƽ IVMEPXIWXMRK

Integrated Guideline for Tuberculosis, 67

Leprosy and Lung Disease | 2021
 NOTE:
ÎƐ ŇŹŹåσƐ ƒåÏĚĻĞŭƣåƐ ŇüƐ ±ÚķĞĻĞžƒåŹĞĻďØƐ Źå±ÚĞĻďØƐ ±ĻÚƐ ĞĻƒåŹŤŹåƒ±ƒĞŇĻƐ ŇüƐ ƒĚåƐ
Mantoux test is very important (Refer to appropriate SOP)

ÎƐ
ƐĻåď±ƒĞƽåƐa±ĻƒŇƣDŽƐÚŇåžƐĻŇƒƐŹƣĮåƐŇƣƒƐ‰ƐŦåžŤåÏбĮĮDžƐĞĻƐƒĚåƐBFšƐŤŇžĞƒĞƽåƐŇŹƐ
malnourished child)

ÎƐ a±ĻƒŇƣDŽƐƒåžƒƐķ±DžƐÆåƐĻåď±ƒĞƽåƐÚåžŤĞƒåƐƒĚåƐÏĚĞĮÚƐ̱ƽĞĻďƐ‰ƐåžŤåÏбĮĮDžƐĞĻƐ
žåƽåŹåƐÚĞžžåķĞĻ±ƒåÚƐ‰ØƐķ±ĮĻƣƒŹĞƒĞŇĻØƐ±ĻÚƐBFšƐÚĞžå±žå

A child in close contact with a smear-positive household member should be

considered TB infected and TST/IGRA may not be necessary

Chest Radiograph (Chest X-ray)

The chest radiograph (chest x-ray) is an important investigation for the diagnosis of
TB in children. A clinical diagnosis of PTB may be made by combining suggestive
LMWXSV]TL]WMGEPI\EQMREXMSRǻRHMRKWERHEREFRSVQEP(<75VMQEV]8'XIRHWXSFI
predominantly enclosed in hilar lymph nodes and therefore the bacilli are absent in
sputum. In this case, the CXR provides important support for making a clinical diagnosis
of PTB in children.

For children with history and physical signs suggestive of TB, it is important
to do a chest x-ray.

An abnormal CXR provides additional evidence to support the clinical

diagnosis of PTB in children.

The radiological features that may be suggestive of PTB include:

ƽ Enlarged hilar or subcarinal lymph nodes (check for these on AP and lateral views
of the chest x-ray)

ƽ 1YRKSTEGMǻGEXMSRƳIWTIGMEPP]MJJSGEP WIKQIRXEPSVPSFEVSTEGMǻGEXMSRGSQQSR
FYX MR MRJERXW QE] FI TEXGL] STEGMǻGEXMSR MR QER] PSFIW EW WIIR MR FVSRGLS
pneumonia)

ƽ )MǺYWIQMGVSRSHYPEVMRǻPXVEXIWXLVSYKLSYXFSXLPYRKW QMPPMEV]TEXXIVR

ƽ 4PHIVGLMPHVIRERHEHSPIWGIRXWƳYTTIVPSFISTEGMǻGEXMSR[MXLSV[MXLSYXGEZMXMIW

68 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Other radiological features may be suggestive of EPTB:

E .RXLIXLSVEGMGGEZMX]IK5PIYVEPIǺYWMSR YWYEPP]SRIWMHIH

b) Other sites in the body e.g. bone and joint disease, spinal TB

The images below show some of the radiological changes that may occur with PTB.

Figure 4.1 Pictures suggestive of Pulmonary TB

±ŧƐĞďĚƒƐŤåŹĞĚĞĮ±ŹƐĮDžķŤĚƐĻŇÚåƐåĻĮ±ŹďåķåĻƒ Æŧ XåüƒƐƣŤŤåŹƐĮŇÆåƐŇŤ±ÏĞĀϱƒĞŇĻƐƾЃĚƐĻ±ŹŹŇƾĞĻďƐ
±ĻÚƐžĚĞüƒƐŇüƐĮåüƒƐķ±ĞĻƐÆŹŇĻÏĚƣž
œĞƒĚƐŇŤ±ÏЃDžƐĞĻƐƒĚåƐŹĞďĚƒƐķĞÚĝǍŇĻå

ÏŧƐaĞĮбŹDžƐ‰×Ɛ‰DžŤĞϱĮƐÆĞĮ±ƒåŹ±ĮƐÚĞýƣžåƐķĞÏŹŇƐĻŇÚƣĮ±ŹƐŤ±ƒƒåŹĻũ

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Leprosy and Lung Disease | 2021
 Figure 4.1 Pictures suggestive of Pulmonary TB

ÚĝŐŧƐFĻƐžƣžŤåσåÚƐĚĞĮ±ŹƐ±ĻÚƐŤ±Ź±ƒŹ±ÏĚå±ĮƐĮDžķŤĚƐ ÚĝƞŧƐa±žžĞƽåƐĚĞĮ±ŹƐĮDžķŤĚƐďĮ±ĻÚƐåĻĮ±ŹďåķåĻƒƐ
ŦĻŇÚåŧƐďĮ±ĻÚƐåĻĮ±ŹďåķåĻƒØƐƒĚåƐÚбďĻŇžĞžƐϱĻƐÆåƐ ƽĞžĞÆĮåƐŇĻƐƒĚåƐĮ±ƒåŹ±ĮƐÏĚ垃ƐŹ±ÚĞŇŤĚũƐ‰ĚåƐ
ķ±ÚåƐƾЃĚƐķŇŹåƐÏåŹƒ±ĞĻƒDžƐƾĚåĻƐ±ƐĮ±ƒåŹ±ĮƐÏĚ垃Ɛ ±ŹŹŇƾƐĞĻÚĞϱƒåžƐƒĚåƐƐĚĞĮ±ŹƐĮDžķŤĚƐďĮ±ĻÚž
Ź±ÚĞŇŤĚƐĞžƐåDŽ±ķĞĻåÚƐ±žƐƾåĮĮũƐ‰ĚĞžƐžĚŇƣĮÚƐĻŇƒƐÆåƐ
ÏŇĻüƣžåÚƐƾЃĚƐķåÚбžƒĞĻ±ĮƐƾĞÚåĻĞĻďƐÚƣåƐƒŇƐ±ƐĮ±ŹďåƐ
ƒĚDžķƣžƐŦžååƐĀďƣŹåƐċũŐĝåŧ

åŧƐŇķķŇĻƐϱƣžåƐüŇŹƐ±ƐƾĞÚåĻåÚƐķåÚбžƒĞĻƣķƐĞĻƐ±ƐDžŇƣĻďƐÏĚĞĮÚƐĞžƐ±ƐĮ±ŹďåƐƒĚDžķƣžƐƾĚĞÏĚƐƐϱƣžåžƐƒĚåƐƐ
ž±ĞĮƐžĞďĻƐŇĻƐƒĚåƐÏĚ垃ƐŹ±ÚĞŇŤĚƐŦžååƐ±ŹŹŇƾĚå±Úž)

70 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
7EHMSPSKMGEPJIEXYVIWXLEXQE]WYKKIWXI\XVETYPQSREV]8'ZEV]EGGSVHMRKXSXLIEǺIGXIH
site. Examples include these below:

Figure 4.2 X-rays suggestive of extrapulmonary TB

a-c) Spinal TB: collapse of thoracic vertebra causing angulation in a 6-year old boy

ÚŧƐX±ƒåŹ±ĮƐ£ƐžĚŇƾĞĻďƐåĻĮ±ŹďåÚƐ åŧƐ‰ƐŤĮåƣŹ±ĮƐåýƣžĞŇĻ×ƐĮ±ŹďåƐ üŧƐ{åŹĞϱŹÚбĮƐ‰×ƐåĻĮ±ŹďåÚ

ĚĞĮ±ŹƐĮDžķŤĚƐĻŇÚåžƐŦŴÚŇƣďĚĻƣƒƐ ĮåüƒĝžĞÚåÚƐåýƣžĞŇĻũƐ{ĮåƣŹ±ĮƐ
žĞďĻŶŧ ƒ±ŤƐƒŇƐÚĞýåŹåĻƒĞ±ƒåƐüŹŇķƐ ϱŹÚбÏƐžĚ±ÚŇƾũƐ)ÏĚŇĝ
åķŤĚDžžåķ± ϱŹÚĞŇķƐƒŇƐÚĞýåŹåĻƒĞĝ
±ƒåƐüŹŇķƐŇƒĚåŹƐϱƣžåžƐŇüƐ
ϱŹÚбÏƐü±ĞĮƣŹå

Other Tests for TB diagnosis

1. Radiologic tests include:

ƽ (8 WGER Ƴ .R GSQTPMGEXIH MRXVEGVERMEP 8' XYFIVGYPSQE L]HVSGITLEPYW

comatose child)

ƽ 9PXVEWSYRHƳYWIJYPJSVEFHSQMREP8'ERHTPIYVEPIǺYWMSR

2. Laboratory tests: These are mainly used in research settings

ƽ 3YGPIMGEGMHEQTPMǻGEXMSRXIWXW 3&&8

 3SRWTIGMǻGXIWXWPMOI*7ERH(VIEGXMZITVSXIMRXIWXWWYKKIWXXLITVIWIRGISJ
MRǼEQQEXMSRMJMRGVIEWIH

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 4. Biochemical tests – Elevated protein and low glucose levels in cerebrospinal
ǼYMH (+TPIYVEPEWTMVEXIWSVEWGMXMGEWTMVEXIWWYKKIWXERI\YHEXI.

GeneXpert MTB/Rif/Ultra: Where accessible, this is the preferred test for diagnosis
of TB among children. The GeneXpert test can be performed for Sputum, gastric/
REWSTLEV]RKIEPEWTMVEXIFVSRGLMEPWIGVIXMSRWTIGMQIRW(+EWGMXMGǼYMHTPIYVEPǼYMH
and stool. Specimens from children who cannot expectorate can be obtained through a
gastric aspirate or sputum induction ŦåüåŹƐƒŇƐ±ŤŤŹŇŤŹĞ±ƒåƐ„k{ŧũ

A negative Xpert MTB/RIF test result however doesn’t indicate the child has
no TB; further clinical evaluation is needed to make a clinical diagnosis of TB
in such children.

Other tests may be used together with those above to further support a diagnosis of TB.
These are shown in the table below:

Table 4.5: Adjunct test for use in selected situations

Laboratory Target Purpose

Test
Line Probe Children who are: To determine if Isoniazid
Assay (LPA) resistance is present
ƽ 28'TSWMXMZIVMJEQTMGMRWIRWMXMZIERH
are at high risk for DRTB

ƽ 28'TSWMXMZIVMJEQTMGMRVIWMWXERX
VIKEVHPIWWSJ)78'VMWOTVSǻPI

Culture and Children who are: To diagnose TB

DST
ƽ *PMKMFPIJSV15&WLSYPHEPWSLEZIE
culture and DST requested
To determine the drug sensitivity
ƽ (LMPHVIR[MXLGPMRMGEPP]WYWTIGXIH8' pattern
whose Xpert is negative

ƽ (LMPHVIR[LSEVISRXVIEXQIRXJSV8'
who are failing to respond to therapy To diagnose infections with non-
tuberculous mycobacteria
Histology All presumptive extra-pulmonary TB where Tissue diagnosis in suspected
FNA is indeterminate EPTB e.g. TB adenitis

HIV test
Making a diagnosis of HIV infection has obvious implications for the management of
TB and HIV. All children with suspected TB should be tested for HIV.

72 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 8VIEXQIRXSJ)VYKIRWMXMZI8YFIVGYPSWMWMR(LMPHVIR
Treatment outcomes in all children are generally good provided treatment is started as
soon as a diagnosis is made. However, response to treatment in HIV positive children
may be slow. Children generally tolerate anti-TB medicine better than adults and
their dosages are calculated according to weight (not age). Weight is important for
monitoring treatment response.

The goals of anti- TB treatment in children are to:

ƽ (YVIXLIGLMPHSJ8'

ƽ 5VIZIRXHIEXLJVSQ8'

ƽ 5VIZIRXGSQTPMGEXMSRWEVMWMRKJVSQ8'HMWIEWI

ƽ 5VIZIRX8'VIPETWIVIGYVVIRGIF]IPMQMREXMRKXLIHSVQERXFEGMPPM

ƽ 5VIZIRXXLIHIZIPSTQIRXSJHVYKVIWMWXERGIF]YWMRKEGSQFMREXMSRSJHVYKW

ƽ 7IHYGI8'XVERWQMWWMSRXSSXLIVW

4.3.1 Standard Operating Procedures for Treatment

ƽ 8VIEXQIRXWLSYPHWXEVXEWWSSREWHMEKRSWMWMWQEHI FEGXIVMSPSKMGEPGSRǻVQEXMSR
or clinical diagnosis).

ƽ (PEWWMJ] XLI TEXMIRX FEWIH SR XLI WMXI SJ 8' HMWIEWI FIJSVI WXEVXMRK XVIEXQIRX
(Pulmonary TB or extrapulmonary TB).

ƽ .HIRXMJ]EXVIEXQIRXWYTTSVXIV (EVIKMZIVJSVEPPEKIWMRGPYHMRKSPHIVGLMPHVIR

ƽ &HLIVIRGIXSXLIJYPPGSYVWISJXVIEXQIRXWLSYPHFIIQTLEWM^IHERHVIMRJSVGIH

ƽ 'VIEWXJIIHMRKMRJERXWERHGLMPHVIRWLSYPHGSRXMRYI[LMPIVIGIMZMRK8'XVIEXQIRX

ƽ 8VIEXQIRX SYXGSQIW MR GLMPHVIR EVI KIRIVEPP] KSSH IZIR MR XLI -.: MRJIGXIH
provided treatment is started promptly. However, response to treatment in HIV
co-infected children may be slow.

ƽ (LMPHVIRKIRIVEPP]XSPIVEXIERXM8'HVYKWFIXXIVXLEREHYPXW

ƽ ;IMKLXMWMQTSVXERXJSVQSRMXSVMRKXVIEXQIRXVIWTSRWIXLIVIJSVIQYWXFIXEOIR
and recorded at every visit.

ƽ 7IGSVHXLI8'HMEKRSWXMGGEXIKSV]XVIEXQIRXVIKMQIRERHHEXIERXM8'XVIEXQIRX
was started on the road-to-health book as well as on TB record card and facility
TB register.

ƽ (EPGYPEXI HVYK HSWEKIW EX every visit according to the child’s current weight
(note that children gain weight while receiving anti-TB treatment). Doses should
be adjusted according to weight. In case of weight increase then the dose
should be increased according to the weight band and reduced accordingly
when weight decreases. In instances of weight loss evaluate the child further
to establish the cause and manage accordingly.

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 ƽ 4RGIXVIEXQIRXMWWXEVXIHMXQYWXFIGSQTPIXIH “trial of TB treatment” should
never be used as a diagnostic tool.

4.3.2 Recommended Treatment Regimen

Dosages for paediatric TB treatment (child-friendly formulations)

ƽ )YVMRKXLIMRXIRWMZITLEWIKMZITEIHMEXVMG+)(SJ7->HMWTIVWMFPIXEFPIXWTPYW*
tablets.

ƽ )YVMRKXLIGSRXMRYEXMSRTLEWIKMZITEIHMEXVMG+)(SJ7-HMWTIVWMFPIXEFPIXW

The table below shows the current recommended TB treatment regimen in children

Table 4.6: WHO Recommended TB Treatment Regimen for Children

TB disease category Recommended regimen

Intensive phase Continuation
phase
All forms of TB EXCEPT TB meningitis, bone and 2 RHZE* 4 RH
joint TB (osteoarticular TB)
TB meningitis and kžƒåұŹƒĞÏƣĮ±ŹƐ‰ 2 RHZE 10 RH
Drug-resistant TB Refer to a DR TB specialist and inform CTLC

ÃB÷FžŇĻбǍĞÚØƐ÷ƐĞü±ķŤĞÏĞĻØƐ¬÷{DžŹ±ǍĞĻ±ķĞÚåØƐ)÷Ɛ)ƒĚ±ķÆƣƒŇĮ

8EFPI)SWEKISJMRHMZMHYEPǻVWXPMRIERXM8'HVYKWEGGSVHMRKXSFSH][IMKLX

Drug Recommendations Average Range in mg/kg Maximum Dose

dose in mg/kg

Isoniazid 10 7–15 300mg

Rifampicin 15 10–20 600mg

Pyrazinamide 35 30–40 2.0g

Ethambutol 20 15–25 1.0g

8LI ǻVWX  HVYKW .WSRME^MH 7MJEQTMGMR ERH 5]VE^MREQMHI LEZI FIIR GSQFMRIH
MRXS TEIHMEXVMG GLMPHJVMIRHP] ǻ\IHHSWI GSQFMREXMSRW +)(W [LMGL EVI HMWTIVWMFPI
in liquid, have a pleasant taste, and are therefore easier for children to take. The
improved paediatric TB FDCs provide the correct dosing ratio of Rifampicin: Isoniazid:
Pyrazinamide as follows:

Rifampicin 75mg: isoniazid 50mg: pyrazinamide 150mg (RHZ 75:50:150) tablet

Rifampicin 75mg: isoniazid 50mg (RH 75:50) tablet

74 Integrated Guideline for Tuberculosis,

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Ethambutol is available as a single drug paediatric tablet of 100mg (E 100). Young age
MRǼYIRGIW HVYK QIXEFSPMWQ E TEVXMGYPEV HSWI SJ E HVYK MR QKOK [LIR KMZIR XS E
young child (under 5 years) may not reach the same level in the blood as when given to
an older child or adult. Higher mg/kg dosages are therefore required in young children
to achieve bactericidal levels.

Ethambutol can be safely used in all children at the recommended dosage of

20mg/kg

Table 4.8: Dosages for a child weighing up to 3.9 kg

Weight Number of tablets

band (Kg) Intensive Phase Continuation Phase
RHZ E (100mg) How to reconstitute RH How to reconstitute
(75/50/ the medicines (75/ the medicines

150mg) 50mg)

Dissolve one (1) tablet Dissolve one (1) tablet

of RHZ of RH in 20 ml of safe
in 20 ml of safe drinking water.
drinking water.
Less than
¼ ¼ ¼ Once fully
2 Kg dissolved, give
Once fully dissolved,
add the completely 5ml (1/4) of this
crushed one (1) tablet solution measured
of Ethambutol and with a
give 5ml (1/4) of this syringe.
solution measured
with a syringe.
Dissolve one (1) tablet Dissolve one (1) tablet
of RHZ of RH in 20 ml of safe
in 20ml of safe drinking water.
drinking water.
2 – 2.9 ½ ½ ½ Once fully
Once fully dissolved, dissolved, give
add the completely 10ml (1/2) of this
crushed one (1) tablet solution measured
of Ethambutol and with a
give10ml (1/2) Syringe.
of this solution
measured with a
Syringe.

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 Weight Number of tablets
band (Kg) Intensive Phase Continuation Phase
RHZ E (100mg) How to reconstitute RH How to reconstitute
(75/50/ the medicines (75/ the medicines

150mg) 50mg)

Dissolve one (1) tablet Dissolve one (1) tablet

of RHZ of RH in 20 ml of safe
in 20 ml of safe drinking water.
drinking water.
3 – 3.9 ¾ ¾ ¾ Once fully
Once fully dissolved, dissolved, give
add the completely 15ml (3/4) of this
crushed one (1) tablet solution measured
of Ethambutol and with a
give 15ml (3/4) of this syringe.
solution measured
with a syringe.

Ethambutol is not dispersible. Crush it completely before adding it to the prepared

solution of RHZ during the intensive phase.

After giving the child their dose for that day, discard the rest of the solution.
Prepare a fresh solution every day.

Table 4.9: Dosages for a child weighing 4-25 kg

Number of tablets

Weight Intensive Phase Continuation Phase

band
RHZ E How to reconstitute RH How to
(Kg)
(75/50 (100mg) the medicines (75/ reconstitute the
/150mg) 50mg) medicines

4 - 7.9 1 1 Dissolve the tablet(s) 1

of RHZ in 20 ml of
safe drinking water.

8 - 11.9 2 2 Once fully 2 Dissolve the

dissolved, add tablet(s) of RH in 20
the completely ml of safe drinking
12 - 15.9 3 3 crushed tablet(s) 3 water.
of Ethambutol
and give ALL this Once fully dissolved
16 - 24.9 4 4 solution to the 4
give ALL this
child. solution to the child.
25 kg and Use adult dosages and preparations
above

76 Integrated Guideline for Tuberculosis,

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Table 4.10: Dosages for a child weighing 25kgs and above
(adult formulation dosage table)

Number of tablets

Weight band (Kg) Intensive Phase Continuation Phase

RHZE (150/75/400/275mg) RH(150/75mg)

25 – 39.9 2 2

40 – 54.9 3 3

55kg and above 4 4

Use of Ethambutol in children

The risk of toxicity is negligible when Ethambutol is used at recommended dosages of
20(15-25) mg/kg/day.

The risk of toxicity is related to the dose and duration of therapy. The main potential side
IǺIGXMWSTXMGRIYVMXMWXLEXGERPIEHXSFPMRHRIWW-S[IZIVHEXESRXLIVMWOSJXS\MGMX]MR
children has been extensively reviewed and there is now a lot of clinical experience of
its use in young children.

Pyridoxine supplementation for children on TB treatment

.WSRME^MHMWEWWSGMEXIH[MXLETSXIRXMEPEHZIVWIIǺIGXSJTIVMTLIVEPRIYVSTEXL](LMPHVIR
who are malnourished or who have borderline to low levels of pyridoxine (vitamin B6)
are most at risk of developing this adverse reaction to INH.

ALL children who are on an Isoniazid-containing regimen should be given

pyridoxine throughout treatment, to prevent/minimize the risk of Isoniazid
toxicity.

The recommended doses of pyridoxine are given in the table below:

Table 4.11: Pyridoxine (vitamin B6) dosing for children on TB treatment

Weight band Dose in mg Number of 25mg tablets Number of 50mg tablets

(Kgs)

Less than 5 6.25 mg Half a tablet 3 TIMES PER Not suitable for the young infant
WEEK

5.0 – 7.9 12.5 mg Half a tablet daily Half of 50mg tablet 3 TIMES PER
WEEK

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 Weight band Dose in mg Number of 25mg tablets Number of 50mg tablets
(Kgs)

8.0 – 14.9 25 mg One tablet daily Half of 50mg tablet daily

15 kg and above 50 mg Two tablets daily One 50mg tablet daily

All children on TB treatment MUST be on pyridoxine throughout their

treatment, to prevent/minimize the risk of Isoniazid toxicity

Other important observations to note include:

ƽ 7ITSVXEPPGLMPHVIRVIGIMZMRKERXM8'XVIEXQIRXXSXLI3EXMSREP8'5VSKVEQ

ƽ MHI IǺIGXW QE] SGGYV FYX EVI RSX GSQQSR8LI QSWX MQTSVXERX WMHI IǺIGX MW
hepatotoxicity

4.3.3 Additional Management Decisions

a) Hospitalization
The following categories of children with TB should be treated as in-patients:

ƽ Severe forms of PTB and EPTB (e.g. Spinal TB) for further investigation and initial
management.

ƽ TB meningitis.

ƽ Severe malnutrition for nutritional rehabilitation.

ƽ Signs of severe pneumonia (i.e. chest in-drawing).

ƽ Other comorbidities e.g. severe anaemia

ƽ Social or logistic reasons to ensure adherence.

ƽ Severe adverse reactions such as hepatotoxicity.

b) Steroid Therapy
Steroid therapy should be given in the following situations:

ƽ TB meningitis and other forms of intracranial TB

ƽ PTB with respiratory distress

ƽ PTB with airway obstruction by hilar lymph nodes (asymmetrical wheeze)

ƽ Severe Milliary TB

ƽ 5IVMGEVHMEPIǺYWMSR

78 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Give prednisone at 2mg/kg once daily for 4 weeks, and then taper down over
2 weeks (1mg/kg for 7 days, then 0.5mg/kg for 7 days)

c) Referral of children with TB should be considered if:

ƽ The child has severe disease

ƽ Diagnosis is uncertain

ƽ Need for HIV-related care to commence ART

ƽ Failure to respond to treatment despite good adherence

4.3.4 When to Stop TB treatment

Treatment should stop when:

1. There is an adverse drug reaction

2. The child develops DR-TB while on DS-TB treatment

3. The child’s condition deteriorates

4.3.5 Follow-up of a Child on Anti-TB Therapy

8LMWMWEGVMXMGEPGSQTSRIRXJSVIǺIGXMZI8'XVIEXQIRX5EXMIRXWWLSYPHZMWMXXLILIEPXL
facility weekly during the intensive phase and every two weeks during the continuation
phase. During the visit, the child should be assessed as shown below:

Table 4.12: Follow-up assessment

Month Baseline 1 2 3 4 5 6 7 8 9 10 11 12
Clinical review
for both PTB
and EPTB Every
(symptom as- week
Every two weeks
sessment, drug
toxicity, and
adherence)

Weight (dose Every Every two weeks

adjustment) week

Height/Weight
for Height
Z-score/BMI
for age

Integrated Guideline for Tuberculosis, 79

Leprosy and Lung Disease | 2021
 Month Baseline 1 2 3 4 5 6 7 8 9 10 11 12
Xpert MTB/
RIF (Done for
diagnosis. May
repeat at any
other point if
drug resistance
is suspected)
Smear for follow
up in bacteriolog-
MGEPP]GSRǻVQIH
TB
Culture and DST
(if not improving/
suspected resis- See algorithm
tance)
Viral load (for HIV
infected)
CXR Repeat if not responding to treatment at any point

4.3.6 Poor Response to Treatment

Most children with TB will start to show signs of improvement within a month of anti-TB
treatment. Weight gain is a sensitive indicator of good response to treatment. Children
not responding to TB treatment after one month should be reassessed for causes of
the poor response and possible drug resistance.

Potential causes of poor response to treatment include:

ƽ Poor adherence is the commonest cause of poor response to treatment. If

uncertain, a child can have a healthcare worker DOT at the health facility.

ƽ HIV infection.

ƽ Wrong diagnosis.

ƽ Other concurrent chronic lung diseases

ƽ Under-dosage of drugs

ƽ Resistant form of TB

ƽ Complications e.g. neurological complications, bronchiectasis, etc.

Consider treatment failure if a child is receiving anti-TB treatment and:

a) If smear-positive at baseline and remains so up to 5 months

b) There is no symptom resolution or symptoms are getting worse. In this case,

EP[E]W GSRǻVQ XLEX EHLIVIRGI MW KSSH .J YRGIVXEMR E GLMPH GER LEZI E LIEPXL
care worker DOT at the health facility.

c) There is continued loss of weight.

80 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Refer children with suspected treatment failure for further assessment.

Most children with TB will start to show signs of improvement within 4 – 8 weeks
of anti-TB treatment. Weight gain is a sensitive indicator of good response to
treatment. Children not responding to TB treatment after one month should be
reassessed for causes of the poor response and possible drug resistance. TB
treatment should however not be stopped.

4.3.7 Ways to Improve Adherence

ƽ Explain and emphasize to care-givers and children why they must take the full
course of treatment even if they are feeling better.

ƽ Note risk factors for poor adherence and address them accordingly. These
include distance/ transport; being an orphan (especially if the mother has died)
or primary care-giver is unwell; and adolescents.

ƽ Ensure education and adherence support especially for TB/HIV co-infected

patients.

Treatment Interruptions
To be managed as per the treatment interruptions guidelines in the adult TB chapter 3.

4.3.8 Adverse Drug Reactions of Anti TB Drugs in Children

Adverse events caused by anti-TB drugs are much less common in children than in adults.
&RXM8'HVYKWMRGLMPHVIREVIKIRIVEPP][IPPXSPIVEXIHERHWEJIMHIIǺIGXWSGGYVERH
are managed žĞķĞĮ±ŹƐƒŇƐƒĚåƐ±ÚƣĮƒžƅƐŹåüåŹƐƒŇƐÏ̱ŤƒåŹƐüŇŹƐƒĚåƐķ±Ļ±ďåķåĻƒƐŇüƐÏŇķķŇĻƐ
%žũƐ

.3-QE]GEYWIW]QTXSQEXMGT]VMHS\MRIHIǻGMIRG] TEVXMGYPEVP]MRWIZIVIP]QEPRSYVMWLIH
children and HIV-infected children on highly active antiretroviral therapy (HAART). It
manifests as tingling, numbness, and weakness. A child may also present with reduced
playfulness. Supplemental pyridoxine is recommended for all children on TB treatment
or Isoniazid.

4.4 DR TB in Children
Diagnosis of DR-TB in children
In children, DR-TB is mainly the result of the transmission of DR-TB bacilli from an
infected adult source. It should be highly suspected in a child with a history of exposure
to a known DR-TB case or a person with a chronic cough.

Integrated Guideline for Tuberculosis, 81

Leprosy and Lung Disease | 2021
 DR-TB should be suspected when:
1. There is contact with known DR-TB
2. There is contact with suspected DR-TB, i.e. source case had treatment failure or
was previously treated
 &GLMPH[MXL8'MWRSXVIWTSRHMRKXSǻVWXPMRIXLIVET]HIWTMXIEHLIVIRGI
4. A child previously treated for TB presents with recurrence of disease.

;LIR )78' MW WYWTIGXIH IZIV] IǺSVX WLSYPH FI QEHI XS GSRǻVQ XLI HMEKRSWMW F]
obtaining specimens for culture and drug susceptibility testing (DST). Rapid DST of
Isoniazid and Rifampicin or Rifampicin alone is recommended over conventional testing
SVRSXIWXMRKEXXLIXMQISJHMEKRSWMW(LMPHVIR[MXLSYXFEGXIVMSPSKMGEPGSRǻVQEXMSRFYX
are highly suspected to have drug-resistant TB should be initiated on DR TB treatment.

4.4.1 Treatment of DR-TB in Children

Treatment of DR-TB in children should be guided by the DST results. In children for
whom DST results are not available, the DST pattern may be assumed to be similar to
that of the contact.

ĚĞĮÚŹåĻƐƾЃĚƐ±ÏƒĞƽåƐ‰ƐƾĚŇƐ±ŹåƐĚŇƣžåĚŇĮÚƐÏŇĻƒ±ÏƒžƐŇüƐ±ƐÏŇĻĀŹķåÚƐa%ĝ‰ƐŇŹƐ
XDR-TB patient should be considered to have DR-TB, even if smear and culture
±ŹåƐĻåď±ƒĞƽåũƐ‰ĚåžåƐÏĚĞĮÚŹåĻƐžĚŇƣĮÚƐÆåƐŇýåŹåÚƐåķŤĞŹĞϱĮƐƒŹå±ƒķåĻƒƐƱžåÚƐŇĻƐƒĚåƐ
contact`s DST pattern.

Drugs used for the treatment of children with MDR-TB

ƽ 8LIVIKMQIRYWIHXSXVIEXGLMPHLSSHHVYKVIWMWXERX8'QE]FIHMǺIVIRXJVSQXLEX
used in adults. Pediatric friendly formulations are recommended where available.

ƽ 8LIFIRIǻXSJǼYSVSUYMRSPSRIWJEVSYX[IMKLWXLIVMWOERHWLSYPHFITEVXSJIZIV]
DR-TB regimen.

ƽ Bedaquiline is recommended for use in children above 6 years of age. Bedaquiline

can be dissolved in water without altering the bioavailability; which makes it easier
for use in young children until the paediatric friendly formulation becomes available.

ƽ Delamanid is recommended for use above 3 years of age but it could be considered
in children <3 years once safety and dosing data is available. There is no current
recommendation for its routine use in this age group. Delamanid should not be
crushed or dissolved as this will alter the drug’s bioavailability.

ƽ Both bedaquiline and delamanid should be used for six months of treatment,
though there are no known safety concerns with using these drugs for longer than
WM\QSRXLWSQIGLMPHVIRQE]FIRIǻXJVSQYWMRKXLIWIHVYKWJSVXLIJYPPHYVEXMSR
of their therapy.

82 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ‰ĚåŹåƐĞžƐĮĞķЃåÚƐÚ±ƒ±ƐŇĻƐƒĚåƐƣžåƐŇüƐÆåÚ±ŭƣĞĮĞĻåƐ±ĻÚƐÚåĮ±ķ±ĻĞÚƐĞĻƐÏŇķÆĞĻ±ƒĞŇĻó
although existing data suggest the combination of the two medications does not
ĞĻÏŹå±žåƐ±ÚƽåŹžåƐåƽåĻƒžũƐFĻƐÏĚĞĮÚŹåĻƐƾЃĚƐāƣŇŹŇŭƣĞĻŇĮŇĻåƐŹåžĞžƒ±ĻÏåƐŇŹƐĞĻƐƾĚŇķƐ
ƒĚåŹåƐ±ŹåƐĮĞķЃåÚƐƒŹå±ƒķåĻƒƐŇŤƒĞŇĻžØƐåDŽƒåĻžĞŇĻƐ±ĻÚƐÏŇķÆĞĻ±ƒĞŇĻƐŇüƐÆåÚ±ŭƣĞĮĞĻåƐ
and/or delamanid could be considered on a patient-by-patient basis with
careful monitoring.

ƽ *QTMVMGXVIEXQIRXJSV)78'WLSYPHFIMRMXMEXIHTVSQTXP]YWMRKERETTVSTVMEXI
regimen based on the resistance pattern of the source case.

ƽ Drug dosages should be based on body weight and the higher end of the
recommended range5.

Recommended regimen for treatment of DR-TB in children

Treatment is provided for 18 months: 6 months of intensive phase and 12 months of the
continuation phase

Table 4.13: Recommended regimen for treatment of DR-TB in children

PAEDIATRIC MDR/RR TB (<6 YRS AND < 25KG) STANDARD PAEDIATRIC INJECTABLE FREE
REGIMEN)

Use at least 4 New Medicines or with proven susceptibility

ƽ Intensive phase: 6 Lzd/Mfx/Cfz/Cs

ƽ Continuation phase: 12 Mfx/Cfz/Cs

3SXIJSVGLMPHVIRǸ]IEVWSVǸOKYWIEHYPXVIKMQIR7IJIVXS2)78'QEREKIQIRXMR
section 8

PRE - XDR PAEDIATRICS - Fluoroquinolone Resistance

ƽ Intensive phase: 6 Bdq**/*Dlm/Lzd/Cfz/Cs/Z

ƽ Continuation phase: 14 Dlm/Cfz/Cs/Z

*Delamanid should only be prescribed in children under 3 years after consultation with the
National Clinical team
ÃÃåÚ±ŭƣĞĮĞĻåƐƣžåƐĞĻƐ{±åÚбƒŹĞÏžƐŹåŭƣĞŹåžƐÚĞžžŇĮƣƒĞŇĻƐĞĻƐƾ±ƒåŹ

%}÷åÚ±ŭƣĞĮĞĻåØƐ8¬÷ĮŇü±ǍĞķĞĻåØƐ„÷DžÏĮŇžåŹĞĻåØƐ%Xa÷Ɛ%åĮ±ķ±ĻĞÚØƐX¬%÷XĞĻåǍŇĮĞÚØƐ
a8£÷aŇDŽĞāŇDŽ±ÏĞĻØƐ¬÷{DžŹ±ǍĞĻ±ķĞÚå

Integrated Guideline for Tuberculosis, 83

Leprosy and Lung Disease | 2021
 Follow up of children on DR-TB treatment
ƽ Weights and Z-score should be measured monthly and dose adjustments made
as the child’s weight changes.

ƽ In culture-negative children with DR-TB, clinical criteria can be used to determine

response to therapy and the duration of the intensive and continuation phases.

ƽ The DR-TB clinical teams should review and follow the progress of all paediatric
cases.

Refer to chapter 8 for monitoring schedule for patients with DR-TB and for management
SJGSQQSRWMHIIǺIGXWSJWIGSRHPMRIXVIEXQIRX

4.5 TB and HIV Co-infection in Children

Most paediatric HIV infection occurs prenatally through vertical transmission. HIV
disease progresses rapidly in children with ~50% of them developing severe immune-
suppression and dying before 2 years of age if they do not access antiretroviral therapy. In
this setting, when these children are infected with TB, TB progresses even more rapidly
to severe disease with high mortality. These children are at high risk of TB infection as
they live in households where a parent is also likely to have HIV disease and have a
higher probability of developing active TB. Similarly, TB co-infection itself causes a more
rapid progression of HIV disease.

HIV-infected children may have multiple and concurrent opportunistic lung infections
that clinically present like TB, thus making the diagnosis of TB in an HIV-infected
GLMPHQSVIHMǽGYPX8LI&7:WERHERXM8'HVYKWLEZITSXIRXMEPP]WMKRMǻGERXHVYKHVYK
interactions as well as overlapping toxicities that pose additional challenges in treating
co-infections. Therefore, a comprehensive approach to the management of both TB and
HIV is critical.

4.5.1 Diagnosis of TB in HIV

The approach to diagnosis of TB in HIV-infected children is similar to HIV uninfected
children. History of contact with TB is extremely important in pointing to the possibility
of TB disease in a younger, HIV infected child.

]QTXSQFEWIH8'WGVIIRMRKYWMRKXLI.RXIRWMǻIH(EWI+MRHMRKXSSPŦåüåŹƐƒŇƐ±ŤŤŹŇŤŹĞ±ƒåƐ
„k{) MUST be performed for all children living with HIV at every clinic visit to rule out
active TB; patients who screen positive (presumptive TB cases) must be evaluated
according to the algorithm for TB diagnosis. Patients who screen negative should be
initiated on Isoniazid Preventive Therapy (IPT) according to the guidelines.

Together with TB symptoms, a positive Mantoux test is suggestive of TB disease. A

positive Mantoux test without symptoms or features suggestive of TB should not be used
to diagnose TB in children (see algorithm for TB diagnosis in children). Any child with a
positive Xpert MTB/RIF test result should be started on anti TB treatment. A negative
Xpert MTB/RIF test result however doesn’t indicate the child has no TB; further
clinical evaluation is needed to make a clinical diagnosis of TB in such children.

84 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
4.5.2 Diagnosis of HIV in TB
HIV testing should be voluntary and conducted ethically in an environment where the
ǻZI(W(SRWIRX(SRǻHIRXMEPMX](SYRWIPMRK(SVVIGXVIWYPXWERH(SRRIGXMSR PMROEKI
- can be assured.

For all children and adolescents with TB under the age of 15 years, conduct HIV testing
and counselling (with parental consent). Adolescents 15 years and above can give
consent for HIV testing and counselling. Infants should be tested according to the
available guidelines for HIV diagnosis in infants aged <18 months. A positive HIV antibody
XIWXMREGLMPH]SYRKIVXLERQSRXLWSJEKIGSRǻVQW-.:I\TSWYVI

All HIV Exposed Infants (HEI) should be tested with DNA PCR within 6 weeks of age or 1st
contact thereafter, and if negative then another DNA PCR at 6 months, and if negative
then another DNA PCR at 12 months. This replaces previous guidelines to perform
antibody testing for infants at 9 months.

An antibody test should be performed for all HEI at 18 months, and 6 weeks after
complete cessation of breastfeeding.

)MǺIVIRXMEP)MEKRSWMWMR-.:.RJIGXIH(LMPH[MXL(LVSRMG
Respiratory symptoms
The diagnosis of PTB can be particularly challenging in an HIV-infected child because
of clinical and radiological overlap with other HIV-related lung diseases. The respiratory
system is a common site for many opportunistic infections in HIV infected children. Often
there is co-infection as well, which further complicates the diagnosis, other possible
causes of chronic lung disease in HIV infected children are shown in the table below:

8EFPI)MǺIVIRXMEPHMEKRSWMWSJGLVSRMGVIWTMVEXSV]W]QTXSQWMR-.:MRJIGXIH
children

)MǺIVIRXMEP)MEKRSWMW Clinical features

Recurrent pneumonia Recurrent episodes of cough, fever, and fast breathing that usually
respond to antibiotics
Lymphoid Interstitial Slow onset cough associated with generalized symmetrical
P]QTLEHIRSTEXL]ǻRKIVGPYFFMRKTEVSXMHIRPEVKIQIRX3YXVMXMSREP
Pneumonitis
status variable, mild hypoxia

(<7HMǺYWIVIXMGYPSRSHYPEVTEXXIVRERHFMPEXIVEPTIVMLMPEV
adenopathy
Pneumocystis jirovecii A common cause of acute severe pneumonia, severe hypoxia
especially in infants.
Pneumonia
(<7HMǺYWIMRXIVWXMXMEPMRǻPXVEXMSRERHL]TIVMRǼEXMSR
Tuberculosis Persistent respiratory symptoms not responding to antibiotics.
Often poor nutritional status. Positive TB contact especially in
younger children

CXR: focal abnormalities and perihilar adenopathy

Integrated Guideline for Tuberculosis, 85

Leprosy and Lung Disease | 2021
 )MǺIVIRXMEP)MEKRSWMW Clinical features
Bronchiectasis (SYKLTVSHYGXMZISJTYVYPIRXWTYXYQLEPMXSWMWǻRKIVGPYFFMRKWIIR
in older children.

CXR: honeycombing usually of lower lobes

Complicates recurrent bacterial pneumonia, LIP, or TB

Mixed infection Common problem: LIP, bacterial pneumonia, Consider TB when there is
TSSVVIWTSRWIXSǻVWXPMRIIQTMVMGQEREKIQIRX
Kaposi’s Sarcoma Uncommon Characteristic lesions on skin or palate

4.5.4 Treatment of TB in HIV in Children

All Children and adolescents living with HIV (CALHIV) qualify for ART irrespective of
WHO Clinical Stage, CD4 count, age, gender, pregnancy status or co-infection status,
etc. Any child with active tuberculosis should begin TB treatment immediately, and
begin ART as soon as the TB treatment is tolerated; i.e. no nausea or vomiting and no
on-going or evolving adverse drug events, usually 2 to 8 weeks of TB therapy.

kĻÏåƐ±ƐÚбďĻŇžĞžƐŇüƐ‰ƐĞžƐķ±ÚåƐĞĻƐ±ĻƐBFšƐĞĻüåσåÚƐÏĚĞĮÚØƐ‰ƐƒŹå±ƒķåĻƒƐžĚŇƣĮÚƐÆåƐ
initiated as a matter of urgency, regardless of whether the child is on ART or not.

The principles of treatment of tuberculosis in HIV-infected children are similar to those

in HIV-negative children, and the same regimens should be used as those used in HIV
negative children. However, response to TB treatment may be slow in children living
with HIV.

All children with TB/HIV should receive Cotrimoxazole prophylaxis as well as

antiretroviral therapy. Nutritional support is often needed for children with TB/HIV.

Recommended ART Regimen for TB HIV Co-infection in Children Living with

HIV (CALHIV)
The preferred ART Regimens for children with TB/HIV Co-infection are as shown in the
Table 4.15:

86 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Table 4.15: Recommended ART Regimen for TB HIV Co-infection in Children Living
with HIV (CALHIV)

Age Scenario Recommendation

a c
<20kgs ABC/3TC/LPV/r Super Boost LPV/r

20kgs-35kgs ABC/3TC/DTG RAL at x2 standard weight-

based BD dosing until 2 weeks
after completion of Anti-TBs
b
>35kg TDF/3TC/DTG DTG x2 standard dose BD
dosing

a. For children who cannot tolerate

LPV/r + RTV (usually because of GI
WMHIIǺIGXWXLIEPXIVREXMZIVIKMQIR
MW7&1 HSYFPIHSWIMJǸ]IEVWSPH
if < 2 years old use a triple-NRTI
regimen of ABC + 3TC + AZT for
the duration of TB treatment, then
return to ABC + 3TC + LPV/r upon
completion of TB.

b. For children >35kgs HIV-TB co-

infected to use DTG x2 standard dose
BD dosing. Those who cannot tolerate
DTG, the alternative is RAL at X2
standard weight-based BD dosing

c. For patients on these regimens who

become viremic consult Regional or
National HIV Clinical Support Center
([email protected]) or call Uliza
Toll-free Hotline 0800 72 48 48

Ɨ‰÷X±ķĞƽƣÚĞĻåØƐ
÷
ƱϱƽĞŹØƐ
¬‰÷¬ĞÚŇƽƣÚĞĻåØƐ %‰:÷%ŇĮƣƒåƽĞŹØƐ X{šxŹ÷XŇŤĞĻ±ƽĞŹxŹĞƒŇĻ±ƽĞŹØƐ

‰š÷ЃŇĻ±ƽĞŹØƐ‰%8÷‰åĻŇüŇƽĞŹƐ

Įƾ±DžžƐƾåĞďĚƐƒĚåƐÏĚĞĮÚƐ±ĻÚƐ±ÚĥƣžƒƐƒĚåƐ‰Ɛ±ĻÚƐ
šƐÚŇžĞĻďƐ±ÏÏŇŹÚĞĻďĮDž

åüåŹƐƒŇƐĻ±ƒĞŇĻ±ĮƐďƣĞÚåĮĞĻåžƐŇĻƐ
ĻƒĞĝŹåƒŹŇƽĞŹ±ĮƐƒĚåŹ±ŤDžƐüŇŹƐ{±åÚбƒŹĞÏƐ
šƐÚŇžĞĻď

‰ŹĞŤĮåƐĻƣÏĮåŇžĞÚåƐ
‰ƐžĚŇƣĮÚƐck‰ƐÆåƐƣžåÚƐĞĻƐ‰xBFšƐÏŇĝĞĻüåσåÚƐŤ±ƒĞåĻƒžƐƾĚŇƐ
have previously failed ART

4.5.5 Cotrimoxazole Preventive Therapy (CPT)

Cotrimoxazole has been shown to reduce mortality among children infected with HIV.
&PP8'-.:GSMRJIGXIHGLMPHVIRWLSYPHFISǺIVIH(58ERHMXWLSYPHFIWXEVXIHEWWSSR
as possible. The duration of treatment is usually life-long with once-daily dosing.

Integrated Guideline for Tuberculosis, 87

Leprosy and Lung Disease | 2021
 8LI GLMPHVIR WLSYPH FI QSRMXSVIH JSV WMHI IǺIGXW [LMGL MRGPYHI WOMR VEWLIW ERH
gastrointestinal disturbances. Severe adverse reactions are uncommon and usually
include extensive exfoliative rash, Steven-Johnson syndrome, or severe anemia/
pancytopenia. CPT should be discontinued if a child develops severe adverse reactions.
The recommended dosage of Cotrimoxazole for children is shown below.

Table 4.16: Recommended dosages for Cotrimoxazole Preventive Therapy

Weight Child Sus- Child Tablet Single strength Double strength adult tab-
in Kg pension (100mg/20mg) adult tablet let (800mg/160mg)
(200mg/40mg (400mg/80mg)
per 5ml)
<5 2.5ml One tablet ¼ tablet -
5-15 5ml Two tablets ½ tablet -
15-30 10ml Four tablets One tablet ½ tablet
>30 - - Two tablets One tablet

When Dapsone (as a substitute for CPT) is being used as PCP prophylaxis, it is only
recommended for patients in WHO stage 4. It is given at 2mg / kg once daily (maximum
dose 100mg). It is supplied in 25mg and 50mg tablets

.QQYRI7IGSRWXMXYXMSR.RǼEQQEXSV]]RHVSQI .7.
IRIS is a paradoxical deterioration after initial improvement following ART treatment
initiation. It is seen during the initial weeks of TB treatment with initial worsening of
symptoms due to immune reconstitution. IRIS is commonly seen in severely immuno-
compromised TB/HIV co-infected children after initiating ARV treatment.

IRIS is managed by continuing anti-TB therapy and giving non-steroidal anti-

MRǼEQQEXSV]HVYKWYRXMPWIZIVIW]QTXSQWWYFWMHIåüåŹƐƒŇƐƒĚåƐc±ƒĞŇĻ±ĮƐBFšƐ:ƣĞÚåĮĞĻåžƐ
üŇŹƐƒĚåƐķ±Ļ±ďåķåĻƒƐŇüƐFF„.

Prednisone is given at 2mg/kg once daily for 4 weeks, and then taper down over
2 weeks (1mg/kg for 7days, then 0.5mg/kg for 7 days then stop).

4.5.7 Prevention of TB in HIV Infected Children

All HIV-infected children need to be screened for TB. All HIV-infected children exposed
to sputum smear-positive TB case should be evaluated for TB and treated if diagnosed
[MXL 8' HMWIEWI 8LSWI [MXLSYX 8' HMWIEWI WLSYPH FI SǺIVIH 8' TVIZIRXMZI XLIVET]
according to the LTBI guidelines in section 11. In children living with HIV who are less than
12 months of age, only those who have contact with a TB case, and who are evaluated
for TB should receive TB preventive therapy (TPT) if the evaluation shows no TB disease.

88 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
)IPMFIVEXI IǺSVXW WLSYPH FI QEHI XS I\TERH XLI TVIZIRXMSR SJ QSXLIV XS GLMPH
transmission. This is because minimizing HIV infection in children will reduce their risks
of developing TB. Always examine the placenta for tubercles because their presence
may implicate vertical TB transmission.

BCG vaccine is to be given to all newborn babies except those with symptoms of severe
HIV infection. It is also not given to children who started TPT before its administration.
In these children, complete the TPT course and wait 2 weeks after TPT completion to
give BCG.

4.6 Prevention of TB in children

4.6.1 Screening for Child Contacts of Known TB Cases
Young children living in close contact with an index case of smear-positive pulmonary
TB are at a high risk of TB infection and disease.

ƽ 8LIVMWOSJMRJIGXMSRMWKVIEXIWXMJ

ƽ 8LIGSRXEGXMWGPSWIERHTVSPSRKIH

ƽ 8LIGLMPHMWQEPRSYVMWLIHGLMPHVIR

ƽ 8LIGLMPHMWYRHIV]IEVW

ƽ 8LIGLMPHMW-.:MRJIGXIH

Disease usually develops within 2 years of infection. In infants, the time lag can be as
short as a few weeks. TB preventive therapy for children exposed to TB who have not yet
developed disease will greatly reduce the likelihood of developing TB.

Contact screening refers to the evaluation for TB of all children who are close
ÏŇĻƒ±ÏƒžƐŇüƐƱσåŹĞŇĮŇďĞϱĮĮDžƐÏŇĻĀŹķåÚƐ{‰Ɛϱžåž

Reverse contact screening refers to the evaluation of all possible source cases
of a child diagnosed with TB disease.

The main purpose of child contact screening is to:

1. Identify symptomatic children (i.e. children of any age with undiagnosed TB

disease) and treat them for TB.

2. Provide TB Preventive Therapy (TPT) for the high-risk children who have no signs
or symptoms of TB disease.

Integrated Guideline for Tuberculosis, 89

Leprosy and Lung Disease | 2021
 4.6.1.1 Process of Contact Investigation (CI)

When CI is initiated the index case should be interviewed as soon as possible after the
diagnosis (generally within one week) to elicit the names of household members and
other close contacts. The focus should be on household members, where the yield is
potentially highest, but workplace and social contacts should not be ignored.

If the human resources are available, the person conducting the CI should visit the home
of the index patient to ensure that all contacts are interviewed and referred for evaluation
when indicated. This is usually done by the community volunteer or at times the health
care worker. The visit will give a more accurate view of the actual circumstances of the
I\TSWYVIERHTVSZMHIERSTTSVXYRMX]JSVMHIRXMǻGEXMSRSJRIIHIHWSGMEPWYTTSVXERHJSV
education regarding tuberculosis and infection control measures that may be taken.

If a child presents with active tuberculosis, it is important to conduct what is often

referred to as “reverse contact tracing.” Most sick children contracted tuberculosis from
an adult with the disease with whom they have had close contact. With reverse contact
tracing, attempts are made to identify the adult who is the source of the infection.

Data on CI should be collected in the recommended contact tracing tools availed by the
National TB program.

Contact screening is done using a symptom screen using the set of questions as listed
in the ICF tool. These include:
1. Cough
2. Fever and/or night sweats
3. Weight loss or Poor weight gain (Failure to thrive)
4. Lethargy/reduced play/less active
5. Extrapulmonary signs and symptoms e.g. enlarged cervical LN.

A child or contact that has any of the signs and symptoms of TB should be referred to
the nearest health facility to have a full evaluation for TB.

Contacts found to have TB disease are initiated on the full course of treatment while
those without TB are counselled to identify signs and symptoms and advised when to
return. All child contacts are initiated on TPT once TB disease has been ruled out.

4.6.2 TB Preventive Therapy (TPT) in Children

TPT should be given to the following categories of children:
1. (LMPHVIR !  ]IEVW SJ EKI [LS EVI GSRXEGXW SJ FEGXIVMSPSKMGEPP] GSRǻVQIH 8'
patients
2. Children over 5 years’ who are household contacts of a person with bacteriologically
GSRǻVQIH8'TEXMIRXW
3. All HIV positive children above one year.

90 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 4. Children below one year living with HIV and are household contacts of
FEGXIVMSPSKMGEPP]GSRǻVQIH8'TEXMIRX

Refer to LTBI section 11 for diagnosis, testing, and management of latent TB infection

Important to Note:

ƽ Follow up of a child on TPT is done monthly. If TB disease develops in the course

of TPT management, stop TPT, and treat for TB.

ƽ All children on TPT should receive pyridoxine

ÍƉ TPT should NOT be given to children exposed to an adult with proven MDR/
XDR TB. The children should instead be followed up for signs of active TB
disease and managed appropriately

4.6.3 BCG Vaccination

BCG is a live attenuated vaccine derived from aDžÏŇƱσåŹĞƣķƐÆŇƽĞž.XSǺIVWTVSXIGXMSR
against the more severe types of TB such as Milliary TB and TB meningitis, which are
common in young children.

A child who has not had routine neonatal BCG immunization and has symptoms of
advanced HIV disease (WHO stage 3 or 4) should not be given BCG because of the risk
of disseminated BCG disease. In children with suspected TB infection or disease, the
BCG vaccination should be deferred till 2 weeks after completion of TPT/TB treatment
because the anti-TB medicines will denature the vaccine.

4.6.3.1 Disseminated BCG Disease

A small number of children (1–2%) may develop complications following BCG vaccination.
These commonly include:

ƽ 1SGEPEFWGIWWIWEXXLIMRNIGXMSRWMXI

ƽ IGSRHEV]FEGXIVMEPMRJIGXMSRW

ƽ YTTYVEXMZIEHIRMXMWMRXLIVIKMSREPE\MPPEV]P]QTLRSHI

ƽ 1SGEPOIPSMHJSVQEXMSR

ƽ )MWWIQMREXIH'(,HMWIEWI.JE\MPPEV]RSHIIRPEVKIQIRXMWSRXLIWEQIWMHIEW
BCG in an HIV- positive infant, consider BCG disease and refer.

2SWXVIEGXMSRW[MPPVIWSPZIWTSRXERISYWP]SZIVEJI[QSRXLWERHHSRSXVIUYMVIWTIGMǻG
treatment. Children who develop disseminated BCG disease should be investigated for
MQQYRSHIǻGMIRG]ERHXVIEXIHJSV8'YWMRKXLIǻVWXPMRIVIKMQIR7->*XLIR7-8LI
child should always be reviewed by a specialist.

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 4.7 Child Nutrition and TB
2EPRYXVMXMSRMWERMQTSVXERXTYFPMGLIEPXLMWWYITEVXMGYPEVP]JSVGLMPHVIRYRHIVǻZI]IEVW
SJEKI[LSLEZIEWMKRMǻGERXP]LMKLIVVMWOSJQSVXEPMX]ERHQSVFMHMX]XLER[IPPRSYVMWLIH
GLMPHVIR 8LI REXMSREP ǻKYVI JSV EGYXI QEPRYXVMXMSR SJ GLMPHVIR YRHIV ǻZI ]IEVW SPH MW
estimated at 6%.

Children can have a combination of both acute and chronic. Acute malnutrition is
categorized into Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition
(SAM), determined by the patient’s degree of wasting. All cases of bi-lateral oedema are
categorized as SAM.

Chronic malnutrition is determined by a patient’s degree of stunting, i.e. when a child has
not reached his or her expected height for a given age. To treat a patient with chronic
malnutrition requires a long-term focus that considers household food security in the
long run; home care practices (feeding and hygiene practices); and issues related to
public health.

SAM is further classified into two categories: Marasmus and Kwashiorkor. Patients
may present with a combination of the two known as Marasmic-Kwashiorkor. Patients
diagnosed with Marasmic-Kwashiorkor are extremely malnourished and at great risk
of death.

Admission criteria for acute malnutrition are determined by a child’s weight and height,
by calculating weight-for-height as a “z-score” (using WHO Child Growth Standard,
2006), and the presence of oedema. All patients with bilateral oedema are considered
to have severe acute malnutrition. See table 4.17 for anthropometric criteria.

One of the key indicators for clinical monitoring in children being treated for TB is
improvement in nutrition status. There are several ways to monitor the nutrition status
of undergoing TB treatment. All children should have a baseline weight, height, and
MUAC. The MUAC will be an indicator of acute malnutrition and if recent will call for the
appropriate interventions. The weight is then assessed at every visit and appropriate
drug adjustments are made in case of weight gain.

For children 0-59 months of age their age, weight, and height/length is taken and Z–
Scores are recorded as per the reference charts. For children 5-19 years, their age,
weight, and height are used to assess the BMI for age.

4.7.1 Nutritional Assessment, Counselling and Support (NACS)

process
All children diagnosed with TB should receive a nutritional assessment, counselling,
and support, tailored to the individual needs of the patients, including:

Î cƚƋųĜƋĜŅűŸŸåŸŸĵåĹƋ±ĹÚÚĜ±čĹŅŸĜŸ

 &RXLVSTSQIXVMG

 'MSGLIQMGEPMRZIWXMKEXMSRW

 5L]WMGEPERHGPMRMGEPI\EQMREXMSR

92 Integrated Guideline for Tuberculosis,

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  )MIXEV] LVVIGEPPJSVJSSHX]TIJVIUYIRG]ERHLSYWILSPHJSSHWIGYVMX]

 *RZMVSRQIRXEPERHTW]GLSWSGMEP

 +YRGXMSREP EFMPMX]XSGEVIJSVWIPJFIHVMHHIRIXG

Î ŅƚĹŸåĬĬĜĹč¼åÚƚϱƋĜŅĹ

 'IRIǻXWSJQEMRXEMRMRKKSSHRYXVMXMSREPWXEXYWXSE8'TEXMIRX

 4RMRJERXERHGLMPHRYXVMXMSR .(3

 .HIRXMJ]MRK PSGEPP] EZEMPEFPI JSSHW XLI] GER EGGIWW KMZIR XLIMV GSRXI\X JSSH
safety, and food preparation

 -IPTMRKXLIGPMIRXXSTPERQIEPWERHWREGOW[MXLEZEVMIX]SJJSSHWXSQIIX
their energy, high protein, and nutrient needs and treatment plans

 .HIRXMJ]MRKER]GSRWXVEMRXWXLIGPMIRXQE]JEGIERHǻRH[E]WXSQMRMQM^IXLIQ

 -IPTMRKXLIGPMIRXXSYRHIVWXERHXLITSXIRXMEPWMHIIǺIGXWERHJSSHMRXIVEGXMSRW
of the medicines they are taking, and help the client identify ways to manage
XLIWIWMHIIǺIGXW

 *\TPSVMRK [MXL XLI GPMIRX XLI GEYWI W SJ TSSV ETTIXMXI ERH ETTVSTVMEXI
VIWTSRWIW X]TISJJSSHHMWIEWITEMRHITVIWWMSRER\MIX]SVWMHIIǺIGXWSJ
medications)

 (SYRWIPMRKSRLMKLPIZIPWSJWERMXEXMSRERHJSSHL]KMIRI

Î „ƚŞŞŅųƋ

 3YXVMXMSRGEVITPER

 8LIVETIYXMG ERH WYTTPIQIRXEV] JSSHW JSSH F] TVIWGVMTXMSR XLIVETIYXMG

JIIHWJSVXMǻIHFPIRHIHǼSYV

 (SQTPIQIRXEV]JSSHWJSVGLMPHVIRǸQSRXLW

 2MGVSRYXVMIRXWYTTPIQIRXW

 5SMRXSJYWI[EXIVTYVMǻGEXMSRXSTVIZIRX[EXIVFSVRIHMWIEWI

 +SSHWIGYVMX]ERHPMROEKIXSGSQQYRMX]

Upon assessment, anthropometric criteria are used to classify the nutrition status of
the child as shown in the Table 4.17:

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 Table 4.17: Anthropometric criteria to identify severe, moderate, and at-risk
categories of acute malnutrition for children and adolescents

Indicator Severe Acute Moderate Acute At-Risk of Acute

Malnutrition (SAM) Malnutrition (MAM) Malnutrition

Infants less than 6 months

W/L W/L < - 3 Z-Score Static weight or losing

Static weight or losing weight at home
weight at home -2 to <-1 Z -Score

Oedema Oedema Present Oedema Absent Oedema Absent

Other signs Too weak to suckle

or feed Poor feeding Poor feeding

Children 6 months to 10 years

W/H Z-Scores < -3 Z-Score Between -2 to <-1

Between -3 to < -2 Z-Score
ZScore

MUAC (6 - 59 <11.5cm
months only) 11.5 to 12.4cm 12.5-13.4cm

Oedema Oedema Present Oedema Absent Oedema Absent

Adolescent (10 years to 18 years)

MUAC < 16cm N/A N/A

Oedema Oedema Present Oedema Absent Oedema Absent

ĻƒĚŹŇŤŇķåƒŹĞÏƐÏŹĞƒåŹĞ±ƐƱžåÚƐŇĻƐœBkƐĚĞĮÚƐ:ŹŇƾƒĚƐ„ƒ±ĻÚ±ŹÚžƐŦƞǑǑƌŧƐaĞÚĝŽŤŤåŹƐ
ŹķƐĞŹÏƣķüåŹåĻÏåƐ
ŦaŽ
ŧƐ ĞžƐ ŇüƒåĻƐ ƒĚåƐ žÏŹååĻĞĻďƐ ƒŇŇĮƐ ƣžåÚƐ ƒŇƐ ÚåƒåŹķĞĻåƐ ķ±ĮĻƣƒŹĞƒĞŇĻƐ üŇŹƐ ÏĚĞĮÚŹåĻƐ ĞĻƐ ƒĚåƐ ÏŇķķƣĻЃDžƐ
ƣĻÚåŹƐ ĀƽåƐDžå±ŹžƐ ŇĮÚũƐ
ƐƽåŹDžƐ ĮŇƾƐ aŽ
ƐŦĴŐŐũĂÏķƐ üŇŹƐÏĚĞĮÚŹåĻƐ ƣĻÚåŹƐ ĀƽåƐDžå±ŹžŧƐĞžƐ ÏŇĻžĞÚåŹåÚƐ ±Ɛ ĚĞďĚƐ
ķŇŹƒ±ĮЃDžƐŹĞžīƐ±ĻÚƐĞžƐÏŹĞƒåŹĞ±ƐüŇŹƐ±ÚķĞžžĞŇĻƐƾЃĚƐžåƽåŹåƐ±ÏƣƒåƐķ±ĮĻƣƒŹĞƒĞŇĻũƐ‰±ÆĮåƐċũŐíƐŇƣƒĮĞĻåžƐaŽ
Ɛ
ÏŹĞƒåŹĞ±ƐüŇŹƐÏĚĞĮÚŹåĻƐƣĻÚåŹĝĀƽåƐDžå±Źžũ

Table 4.18: MUAC criteria to identify malnutrition of children less than 5 years in the
community

Severely Malnourished Moderately Malnourished At-Risk of malnutrition

Less than 11.5cm 11.5cm to 12.4cm 12.5cm to 13.4cm

Classifying nutrition status using weight for age

In selected situations, one may not be able to get an accurate height. This may happen in:

ƽ (LMPHVIR[LSEVIZIV]WMGOHMWEFPIHLEZIRIYVSPSKMGEFRSVQEPMXMIWSVZIV]MVVMXEFPI

ƽ .RWXERGIW[LIVIXLIMRWXVYQIRXWXSQIEWYVILIMKLXEVIRSXEZEMPEFPI

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In such circumstances, one may use weight for age assessment in children up to 14
years. Use the weight for age WHO charts to assess the nutrition status of the child.

To determine the nutrition intervention to be given to the child, the triage criteria is as
shown in the table below:

Table 4.19: Triage to determine treatment of malnutrition

Has there been any weight loss in the previous month?

Does the patient have an appetite?

ASK: Does the patient have any medical condition that will
impair nutritional status?

Is the breast-feeding child suckling well?

LOOK AND FEEL FOR: Visible signs of wasting
MUAC

CHECK: Weight

Height/length

Bilateral-edema
DETERMINE: Level of malnutrition using W/H reference charts (or W/A)

LOOK AT SHAPE OF GROWTH Has the child lost weight?

CURVE:
.WXLIKVS[XLGYVZIǼEXXIRMRK$

4.7.2 Nutrition Care Process

Once nutrition assessment has been done and a diagnosis made, the child then needs
XS LEZI MRXIVZIRXMSRW XS EHHVIWW XLIMV WTIGMǻG RYXVMXMSR RIIHW 8LIWI MRXIVZIRXMSRW
include nutrition counselling, food supplementation, and food by prescription as
summarized in table 4.19 below:

Table 4.20: Steps in the nutrition care process

Nutrition care (PEWWMǻGEXMSRSJYRHIVRYXVMXMSR

process
Severe Moderate / mild

1. Look for signs of severe wasting 1. Take weight

ƽ loss of muscle mass 2. Measure the MUAC
Nutrition ƽ WIZIVIZMWMFPI[EWXMRK 3. Assess dietary intake
Assessment 2. Check for the presence of bilateral 4. Check for medical complications
pitting edema 5. Assess the social economic status
ƽ any grade 6. Check for bilateral pitting oedema
3. Measure the MUAC 7. Check for clinical signs of
4. Take weight malnutrition
5. Check for medical complications
6. Conduct an appetite test

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 Nutrition care (PEWWMǻGEXMSRSJYRHIVRYXVMXMSR
process
Severe Moderate / mild

Nutrition ƽ Signs of severe visible wasting

Diagnosis ƽ Bilateral pitting Oedema (+, ++, +++)

ƽ 3YXVMXMSRERHMRJERXJIIHMRK ƽ 3YXVMXMSRERHMRJERXJIIHMRK
counselling counselling
ƽ 5VSZMHI0GEP0KHE]798+ ƽ 5VSZMHIKVEQWTIVHE]SJ
279gms per day of RUTF i.e., (21 FBF (for mild malnutrition)
Nutrition sachets per wk)
intervention ƽ 5VSZMHI0GEP0KHE]798+
ƽ KVEQWTIVHE]+'+IZIV] 279gms per day of RUTF i.e., (21
weeks or monthly sachets per wk for moderate
ƽ 4RIFSXXPI QPSJ;TIV malnutrition)
month ƽ 4RIFSXXPI QP;TIV
ƽ .RTEXMIRXWXEFMPM^EXMSRGEVIXSXVIEX month
underlying illnesses ƽ 7SYXMRIFEWMGXVIEXQIRXIK
Vitamin A, deworming, iron-folic
supplementation.
ƽ (LIGO[IMKLX[IIOP] ƽ (LIGO[IMKLXQSRXLP]ERHLIMKLX
Nutrition ƽ (SRHYGXETTIXMXIXIWX[IIOP] every three months
monitoring and ƽ (EVV]SYXSXLIVRYXVMXMSREWWIWWQIRXW ƽ (EVV]SYXRYXVMXMSREWWIWWQIRX
evaluation monthly
ƽ ,MZIIHYGEXMSRERHGSYRWIPPMRKEW
required. ƽ ,MZIIHYGEXMSRERHGSYRWIPPMRKEW
required
ƽ 1MXXPISVRSIHIQEJSVHE]WERH
passed appetite test-continue on
FBF

4.8 TB in Special Circumstances in Childhood

4.8.1 Management of a Baby Born to a Mother with PTB
Congenital TB is TB acquired in-utero through haematogenous spread via the umbilical
vessels, or at the time of delivery through aspiration or ingestion of infected amniotic
ǼYMHSVGIVZMGSZEKMREPWIGVIXMSRW(SRKIRMXEP8'YWYEPP]TVIWIRXWMRXLIǻVWX[IIOW
of life and mortality is high.

Neonatal TB is TB acquired after birth through exposure to an infectious case of

8'  YWYEPP] XLI QSXLIV FYX WSQIXMQIW ERSXLIV GPSWI GSRXEGX .X MW SJXIR HMǽGYPX XS
distinguish between congenital and neonatal TB but management is the same for
both. Transmission of TB within newborn units, paediatric wards, and maternity wards
does occur in overcrowded health facilities, hence the need to implement infection
prevention control measures (including the use of surgical masks) whenever one case
SJ8'LEWFIIRMHIRXMǻIH[MXLMRXLMWWIXYT8LMWMWXSVIHYGIXVERWQMWWMSRXSRI[FSVRW
who are extremely vulnerable to TB.

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The TB-exposed neonate is highly vulnerable and may rapidly progress to symptomatic
ERHWIZIVI8'HMWIEWI]QTXSQWERHGPMRMGEPWMKRWSJRISREXEP8'EVIYWYEPP]RSRWTIGMǻG
and examples are shown in the table below:

Table 4.21: Signs and Symptoms of Neonatal TB

Symptoms Clinical signs

Lethargy Respiratory distress

Fever Non-resolving ‘pneumonia’ or respiratory infection

Poor feeding Hepatosplenomegaly

Low birth weight Lymphadenopathy

Poor weight gain Abdominal distension

Clinical picture of ‘neonatal sepsis’

8LI HMEKRSWMW SJ 8' WLSYPH FI MRGPYHIH MR XLI HMǺIVIRXMEP HMEKRSWMW SJ E GLMPH [MXL
neonatal sepsis, poor response to antimicrobial therapy, congenital infections, and
atypical pneumonia. The most important clue to the diagnosis of neonatal TB is a
maternal history of TB or any contact with a person with a chronic cough.

Clinical evaluation of the infant in the setting of suspected congenital TB should include
TST and interferon-gamma release assay (IGRA), HIV testing, chest radiograph, lumbar
puncture, cultures (blood and respiratory specimens), and evaluation of the placenta
with histologic examination (including acid-fast bacilli [AFB] staining culture). The TST in
newborns is usually negative, but an IGRA test may be positive in some cases.

4.8.2 Management of the Asymptomatic Neonate Exposed to

Maternal TB
If a neonate is born to a mother with TB or is exposed to a close contact with TB, TB
Preventive Therapy (TPT) should be given for 6 months once TB disease has been ruled
out. BCG can be given 2 weeks after completion of TPT. It is not necessary to separate
the neonate from the mother. However, the mother should be educated on infection
prevention control measures.

Breastfeeding is not contraindicated for a child whose mother has TB

Neonates born to mothers with MDR-TB or XDR-TB should however be referred for TB
screening and management. TPT should not be given. Infection control measures such
as the mother wearing a mask are required to reduce the likelihood of mother to child
transmission of DR TB.

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 4.8.3 Management of the Neonate with TB Disease
If a neonate who is exposed to a mother or another contact with TB is found to
have symptoms suggestive of TB, treatment with anti-TBs should be initiated even
[LMPI E[EMXMRK FEGXIVMSPSKMGEP GSRǻVQEXMSR EW 8' TVSKVIWWIW VETMHP] MR RISREXIW
Drug dosages must be tailor-made based on the neonate’s weight. Breastfeeding is
encouraged.

4.8.4 TB Among Children in Congregate Settings

Children may contract TB in congregate settings outside the household. These
congregate settings include childcare (daycare) centers, orphanages, prisons (juvenile
prisons), (day and boarding), and refugee camps. This is due to several factors including
overcrowding, poor hand hygiene, poor cough etiquette, poor ventilation, and general
poor TB infection control measures in place.

4RGI E GLMPH LEW FIIR HMEKRSWIH [MXL 8' [MXLMR XLI GSRKVIKEXI WIXYT EPP IǺSVXW
must be made to screen all contacts of the diagnosed child, while conducting reverse
contact tracing to identify the index case. All presumptive TB cases must be evaluated
according to the algorithm for TB diagnosis and those diagnosed with TB initiated on
XVIEXQIRX ;LIVI JIEWMFPI SPHIV GLMPHVIR [MXL FEGXIVMSPSKMGEPP] GSRǻVQIH 8' [MXLMR
these congregate settings should be separated or isolated from others until they are
considered at low risk for transmission (after sputum conversion).

Congregate settings are an important component of the country’s TB surveillance

activities and should be assessed for TB infection control. Such assessments should
be followed by the screening of all presumptive TB cases and development of infection
prevention and control plans to support administrative, environmental, and respiratory
measures.

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LABORATORY
DIAGNOSIS OF TB 5

5.1 Introduction KEY HIGHLIGHTS:

.HIRXMǻGEXMSR SJ 28'( ERH XLI WYFWIUYIRX MWSPEXMSR SJ
GeneXpert MTB/RIF Assay/
resistant strains is key in Tuberculosis (TB) management.
Xpert MTB/RIF Ultra is the
Tuberculosis (TB) diagnostic laboratories play a critical initial test for TB diagnosis
TEVXF]TVSZMHMRKGPMRMGMERW[MXLMRZEPYEFPIGSRǻVQEXMSR in Kenya while microscopy
of diagnosis, guiding the care of patients and follow should be used for follow up
YT SJ XLSWI [MXL GSRǻVQIH TYPQSREV] HMWIEWI 8LI smears.
RIX[SVOMRK SJ PEFSVEXSVMIW SǺIVMRK 8' HMEKRSWXMGW
requires a tiered network of laboratories diagnostic Stool sample can be used
tools and establishment of sample referral mechanisms for pediatric MTB diagnosis
which is crucial in increasing access. All this should be using GeneXpert MTB/RIF
XMIH YT [MXL UYEPMX] EWWYVERGI JSV IǺIGXMZI PEFSVEXSV] Assay/ Xpert MTB/RIF Ultra.
management. There are a number of currently available
WHO-recommended diagnostic techniques for Interferon Gamma Release
detection of drug susceptible TB and drug resistant TB Assay (IGRA) may be used
XLEX EVI WYMXEFPI JSV GSQTPMQIRXEV] YWI EX XLI HMǺIVIRX for diagnosis of latent TB
levels of the tiered network of TB laboratories. Among infection.
TB patients on treatment with poor response (clinical and
bacteriologic i.e. smear and/or culture conversion), DST TB LAM is a complementary
MWVIUYMVIHJSVMHIRXMǻGEXMSRSJTSWWMFPIVIWMWXERGIQIEV test for TB diagnosis in PLHIV.
QMGVSWGST]MWOI]JSVJSPPS[YTSJTEXMIRXW[MXLGSRǻVQIH
pulmonary DS TB. In patient with DR TB, monthly smear
microscopy and culture are mandatory during follow up.

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  1EFSVEXSV])MEKRSWMWSJ8'c
1EFSVEXSV] QIXLSHW JSV MHIRXMǻGEXMSR SJ 8' ERH ERXMQMGVSFMEP VIWMWXERGI EVI FVSEHP]
GPEWWMǻIHMRXS

a) Microscopy

ƽ 1MKLXIQMXXMRKHMSHI 1*)ǼYSVIWGIRXQMGVSWGST]

ƽ (SRZIRXMSREPPMKLXQMGVSWGST]

b) Molecular and new technologies

ƽ <TIVX28'7.+EWWE]

ƽ <TIVX28'7.+YPXVE

ƽ 1MRI5VSFI&WWE]

 st and 2nd line

 .HIRXMǻGEXMSRSJ2488W382W

ƽ IUYIRGMRK

ƽ ')2E\2)78'

ƽ 8VYIREX

G 5LIRSX]TMGGYPXYVIJSVHIXIGXMSRERHMHIRXMǻGEXMSRSJ8'

 (SQQIVGMEPPMUYMHGYPXYVIW]WXIQW

 (YPXYVISRWSPMHQIHME

d) Drug susceptibility testing

 )8ǻVWXPMRIERXM8'EKIRXW

 )8WIGSRHPMRIERXM8'EKIRXW

I 7ETMHMHIRXMǻGEXMSRXIWXW

ƽ 8'1&29VMRIXIWXJSV51-.:

J .QQYRSHMEKRSWXMGXIWXWYWIHJSV1EXIRXc8'c

ƽ .RXIVJIVSR,EQQE7IPIEWI&WWE] .,7&

Both the DNTLD Program and the National TB Reference Laboratory (NTRL) coordinate
diagnostic services, while the National laboratory technical working group (TWG) guides
in implementation of TB laboratory services.

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In the Public sector NTRL and KEMRI CDC Kisian carry out both culture and DST and
additional facilities i.e. Malindi Sub County Hospital, Kitale County Referral and Machakos
Level V Hospital have been established to carry out molecular testing for TB. All these
facilities are supervised by NTRL for purposes of maintaining quality.

5.3 Specimen Collection

Sample types

Table 5.1: Types of Specimen for every test method and the Handling Procedures

Test Specimen Type Type of container Specimen Transport

volume /storage
conditions
Microscopy TYXYQ(+c&WTMVEXIW A wide-mouthed, 3-5ml 2 – 8 0C
Biopsies, Pus/ swabs unbreakable,
leak-proof
container
28'7MJ&WWE]c Sputum, CSF, Gastric 50 ml falcon 2-3ml 2 – 8 0C
(Gene Xpert) aspirate, Nasopharyngeal tubes
EWTMVEXI5PIYVEPǼYMH
5IVMGEVHMEPǼYMH&WGMXMG
ǼYMH+3&1]QTLRSHI
biopsy, Stool, skin snips,
pus aspirate, bone tissue.
TB culture / TYXYQ(+c&WTMVEXIW 50ml falcon Bronchial 2 – 8 0C
DST 'MSTWMIWTPIYVEPIǺYWMSRWc tubes, 28ml secretion
urine, Laryngeal swab, sterile universal (2–5ml), BAL
gastric aspirates, pus bottles (20–40 ml) Pleural
swabs IǺYWMSRW Ƴ
ml) CSF-(3ml)
Urine(200ml)

Whole blood 4-6mls

IGRA Blood collected in EDTA
(QuantiFERON) tubes
Assay 2 – 8 0C
15&c Sputum, CSF, Aspirates, 50ml falcon Bronchial 2 – 8 0C
'MSTWMIWTPIYVEPIǺYWMSRWc tubes 28ml sterile secretion (2–5ml),
laryngeal swabs, gastric universal bottles BAL (20–40 ml)
aspirate pus swabs 5PIYVEPIǺYWMSRW
(20–50 ml)
CSF-(3ml) Urine
(200ml)

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 NOTE:
Sample Referral to the Decentralized LPA Labs

ƽ 8[SWEQTPIW[MPPFIGSPPIGXIHJVSQXLITEXMIRX

ƽ 4RIWEQTPI[MPPFIXIWXIHMRXLIHIGIRXVEPM^IHPEFJSVWXERHRHPMRI15&)8

ƽ 8LIWIGSRHWEQTPI[MPPFIWIRXJSVTLIRSX]TMG)8XSXLIVIJIVIRGIPEF

NB: The second sample should be sent by the LPA lab for accountability and follow up of
the report.

Types of samples
1. Sputum
+SVKSSHUYEPMX]WTIGMQIRWXSFISFXEMRIHTEXMIRXWQYWXFIMRWXVYGXIHSRLS[cXS
produce sputum ŦåüåŹƐ ƒŇƐ žŤƣƒƣķƐ ÏŇĮĮåσĞŇĻƐ ĥŇÆƐ ±ĞÚŧũ Label each specimen
[MXL XLIc TEXMIRXƶW REQI EW MX ETTIEVW SR XLI PEFSVEXSV] VIUYIWX JSVQ (Refer to
Į±ÆŇŹ±ƒŇŹDžƐŹåŭƣ垃ƐüŇŹķŧũ

Sputum collection procedure

NOTE:
ƽ 8LIFIWXWTIGMQIRGSQIWJVSQXLIPYRKW

ƽ EPMZESVREWEPWIGVIXMSRWEVIYRWEXMWJEGXSV]

ƽ TIGMQIRWWLSYPHRSXGSRXEMRJSSHSVSXLIVTEVXMGPIWFIGEYWIXLIXIWXQE]RSX[SVO
properly.

Instructing patients to collect sputum specimen

{±ƒĞåĻƒžƐžĚŇƣĮÚƐÆåƐĞĻžƒŹƣσåÚƐƒŇƐƒ±īåƐƒĚåƐüŇĮĮŇƾĞĻďƐžƒåŤžƐƒŇƐŤŹŇÚƣÏåƐƒĚåƐÆ垃ƐžŤåÏĞķåĻ×

1. Sputum collection/ expectoration should be done in an open space/ Cough corner/

sputum collection booth

2. Wash your mouth with clean water to remove food and other particles

3. Inhale deeply 2–3 times and breathe out strongly each time

4. Cough deeply from your chest to produce sputum

5. Place the opened container close to your mouth to collect the specimen; do not get
sputum on the outside of the container

6. Close the container tightly

7. Submit to the laboratory as soon as possible.

8. Do not use the request form to wrap the specimen

9. Wash your hands after collecting the sample.

102 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Instructions for HCWs who collect patient samples for evaluation

1. +MPP MR XLI WTYXYQ I\EQMREXMSR JSVQW IRWYVMRK XLEX EPP XLI ǻIPHW EVI GSVVIGXP]
ǻPPIH

2. Instruct the patient to collect sputum samples in a well ventilated area or a

designated cough corner preferably outdoors (not in the facility lavatories).

3. Label the sputum containers on the side (not on the lid) after sputum collection.

4. Give patients clear instructions on when to return for their results.

Results should ideally be available within 24 hours after the sample is submitted.

2. Specimen other than sputum (SOTS)

ƽ 1EV]RKIEP[EF

1EV]RKIEPW[EFWQE]cFIYWIJYPMRGLMPHVIRERHTEXMIRXW[LScGERRSXTVSHYGIWTYXYQ
or may swallow it.

ƽ (SPPIGXPEV]RKIEPW[EFWMRXLIcIEVP]QSVRMRKFIJSVITEXMIRXWIEXSVHVMRO
anything.

ƽ Use a sterile absorbent cotton swab for collection.

ƽ 8VERWTSVX IEGL WTIGMQIR MR Ec GSRXEMRIV[MXL E JI[ HVSTW SJ WXIVMPI  
WEPMRIWSPYXMSRMRSVHIVXSOIITXLIcW[EF[IX

ƽ Other respiratory specimens

8VERWcFVSRGLMEPERHSXLIVFMSTWMIWXEOIRYRHIVWXIVMPIGSRHMXMSRWWLSYPHFIOITX[IX
HYVMRKXVERWTSVXEXMSRF]EHHMRKEJI[HVSTWSJWXIVMPI WEPMRIXSXLIcXMWWYI

NOTE:

TIGMQIRW EVI WSQIXMQIW WIRX MR JSVQEPMR .X QE]c XLIVIJSVI FI EHZMWEFPI XS
VIQMRH XLI TL]WMGMER SJ XLI I\TIGXIH GSPPIGXMSR GSRHMXMSRW XLIc HE] FIJSVI
surgery.

ƽ ,EWXVMG&WTMVEXI

,EWXVMGcEWTMVEXIWSJXIRGSRXEMR2488ERHEVIXLIVIJSVIVEVIP]YWIHJSVEHYPXW XLI]EVI
indicated for children, however, who are not likely to produce sputum.

An early morning specimen is highly recommended especially when the patient has an
empty stomach.

&JXIVWTIGMQIRGSPPIGXMSREHHQKcSJWSHMYQFMGEVFSREXIXSXLIcKEWXVMGEWTMVEXI
XSRIYXVEPM^IMXERHXVERWTSVXMQQIHMEXIP]XSXLIcPEFSVEXSV]SVWXSVIEX}( (Refer to
PMDT Guideline).

c
Integrated Guideline for Tuberculosis, 103
Leprosy and Lung Disease | 2021
 3 Other Extra-pulmonary specimen
The laboratory may receive a variety of specimens for diagnosis of extra-pulmonary TB
ƳFSH]ǼYMHWXMWWYIWYVMRIcIXG&PPXLIWIWEQTPIWWLSYPHFIWIRX JSV,IRI<TIVXERH
culture and DST. These specimens may be broadly divided into two groups which are
TVSGIWWIHMRHMǺIVIRX[E]W

Specimens collected from sterile sites

8LIWIMRGPYHIWTMREPǼYMHTIVMGEVHMEPW]RSZMEPERHEWGMXMGǼYMHFPSSHFSRIQEVVS[cIXG
[LMGLEVIYWYEPP]JVIIJVSQGSRXEQMREXMRKǼSVE

ƽ &PP PMUYMH WTIGMQIRW WLSYPH FI GSPPIGXIH MR WXIVMPI KPEWW GSRXEMRIVW[MXLSYX
using any preservative.

ƽ TIGMQIRWGERFIMRSGYPEXIHHMVIGXP]MRXScPMUYMHZMEPWERHXVERWTSVXIHXScXLI
laboratory for culture.

ƽ TIGMQIRWQYWXFIXVERWTSVXIHXScXLIPEFSVEXSV]MQQIHMEXIP] XLI]WLSYPH
FITVSGIWWIHEWWSSREWTSWWMFPISVOITXEXƳ}(

Specimens collected from non-sterile sites

ƽ & YVMRIc WTIGMQIR WLSYPH GSRWMWX SJ E WMRKPI IEVP]QSVRMRK QMHWXVIEQ

WEQTPIc

ƽ OMRXMWWYIWTYWW[EFWERHTYWEWTMVEXIW

ƽ XSSPc WEQTPIW JVSQ GLMPHVIR JSV ,IRI<TIVX JVSQ MQQYRSGSQTVSQMWIH

TEXMIRXWQE]cFIYWIHQEMRP]XSHIXIGX2488 2MGVSWGST]ERH(YPXYVI

NOTE:

All extrapulmonary samples should be considered for culture and DST.

1EFSVEXSV]7IUYIWXJSVQ
8LI PEFSVEXSV] VIUYIWX JSVQ QYWX FI GPIEVP] ERH GSQTPIXIP] ǻPPIH [MXL EPP XLI
necessary patient details ŦåüåŹåĻÏåƐ„±ķŤĮåƐŹåŭƣ垃ƐüŇŹķŧ.

NOTE: Additions in the request form

ƽ Index case details

ƽ DR TB contacts

ƽ Referral lab

ƽ Person referring the sample

ƽ Stool as a sample for paediatric TB testing

104 Integrated Guideline for Tuberculosis,

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5.5 Transport and Packaging
The basic packaging system for local surface transport of all specimens consists of
triple packaging systems while ensuring that the Biohazard labels are attached on the
outer shipping package as per IATA regulations.

Basic triple packaging system consists of three layers as follows;

1. Primary receptacle. A labelled primary watertight, leak-proof receptacle

containing the specimen. The receptacle is wrapped in enough absorbent
QEXIVMEPXSEFWSVFEPPǼYMHMRGEWISJFVIEOEKI

2. Secondary receptacle. A second durable, watertight, leak-proof receptacle

to enclose and protect the primary receptacle(s). Several wrapped primary
VIGITXEGPIW QE] FI TPEGIH MR SRI WIGSRHEV] VIGITXEGPI YǽGMIRX EHHMXMSREP
absorbent material must be used to cushion multiple primary receptacles.

Outer shipping package. The secondary receptacle is placed in an outer shipping

TEGOEKI[LMGLTVSXIGXWMXERHMXWGSRXIRXWJVSQSYXWMHIMRǼYIRGIWWYGLEWTL]WMGEP
damage and water while in transit.

NOTE:

All samples should be transported in cold chain (cool box, ice packs and if
possible with thermometers to monitor the temperature from packaging to
reception of the sample).

Figure 1: Packing and shipping infectious materials

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 a) Transport conditions
Specimens collected should be transported to the laboratory as soon as possible.
If a delay of a few days cannot be avoided, keep specimens cool (refrigerated
2-8°cYTXSE[IIOMRGSPHGSRHMXMSRW[MPPRSXWMKRMǻGERXP]EǺIGXXLITSWMXMZMX]VEXI
of smear microscopy; however, the additional growth of contaminants will result in
an increased contamination rate on culture media.

b) Sample Acceptance/ Rejection Criteria

Quality specimen is a key to quality results hence, samples should be accepted when;

ƽ Collected in a leak proof container

ƽ The volume is adequate (3-5ml)

ƽ Duly completed request form

ƽ Specimen packed appropriately (triple packaging)

ƽ &GGYVEXIP]PEFIPPIHJSVMHIRXMǻGEXMSR 5EXMIRXƶWREQI.5458'3SJEGMPMX]REQI
date).

Samples are rejected when;

ƽ 8LIVIUYIWXJSVQMWRSXVIGIMZIH[MXLXLIWTIGMQIRSVMXƶWRSXGSVVIGXP]ǻPPIH

ƽ There is a mismatch of information details on the request form with details on the
specimen container.

ƽ Container used is not appropriate

ƽ Specimen unlabelled.

ƽ Specimen container is broken.

ƽ Specimen leaked.

ƽ TIGMQIRZSPYQIMWRSXWYǽGMIRX

ƽ Specimen not appropriately packed (triple packaging).

NOTE:
ƽ (SRXEGXXLIGPMRMGMERSVVIPIZERXTIVWSRFIJSVIVINIGXMRKER]WEQTPI

ƽ 7INIGXIHWEQTPIWERHVIUYIWXJSVQWWLSYPHWXMPPFIEWWMKRIHEPEFSVEXSV]RYQFIVJSV
record purposes.

ƽ 8LIVIEWSRJSVWEQTPIVINIGXMSRWLSYPHFIMRHMGEXIHSRXLIVIUYIWXJSVQERHMRXLI
VIKMWXIVXLIRHMWTEXGLIHERHRSXMǻGEXMSRHSRIXSXLIVIJIVVMRKJEGMPMX]

106 Integrated Guideline for Tuberculosis,

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 1EFSVEXSV]8IWXMRK
5.6.1 GeneXpert (Xpert MTB/RIF Assay/ Xpert MTB/RIF Ultra)
The development of the Xpert MTB/RIF assay (Cepheid USA) was a major step forward
for improving the diagnosis of TB and detection of rifampicin resistance globally
(WHO). GeneXpert is the recommended initial test for TB diagnosis and the detection
of rifampicin resistant TB in Kenya. The Xpert® MTB/RIF assay is a cartridge-based,
automated diagnostic test that can simultaneously identify Mycobacterium tuberculosis
complex bacteria (MTBC) and resistance to rifampicin (RIF) in less than two hours, using
XLI,IRI<TIVXqTPEXJSVQ[MXLLMKLHIKVIISJWTIGMǻGMX]-S[IZIVXLI<TIVX28'7.+
sensitivity is suboptimal, particularly in smear-negative and HIV-associated TB patients.
The Xpert MTB/RIF Ultra was developed by Cepheid as the next-generation assay to
overcome these limitations. It uses the same GeneXpert® as the Xpert MTB/RIF.

Patients diagnosed with TB using the GeneXpert platform should be followed up using
smear microscopy. In situations where GeneXpert is not available, smear microscopy
may be used for initial TB diagnosis and concurrently, a sample specimen sent for
GeneXpert test. (Refer to TB screening and diagnostic Algorithm).

Table 5.2: the strengths and limitations of GeneXpert (Xpert MTB/RIF Assay) and
GeneXpert MTB/RIF ULTRA Assay

Strengths Limitations

ƽ High sensitivity ƽ 7IUYMVIWEWXEFPIIPIGXVMGMX]WYTTP]

ƽ .HIRXMǻIWVMJEQTMGMRVIWMWXERGI ƽ 8LIWLIPJPMJISJXLIGEVXVMHKIWMWSRP]
months
ƽ Reliable
ƽ 8LIMRWXVYQIRXRIIHWXSFIVIGEPMFVEXIH
ƽ TAT shorter compared to culture
annually
ƽ TAT is further improved by use of
ƽ 8LIGSWXSJXLIXIWXGEVXVMHKIW
gene Xpert Detection limit of as few
as 131 colony forming units/mls of ƽ 7IUYMVIWXIQTIVEXYVIQSRMXSVMRKMWGVMXMGEP
MTB compared with approximately
ƽ 7IUYMVMRKGIRXVEPMWIHPEFSVEXSVMIW[MXL
10,000 colony-forming units/mL with
specialised facilities
conventional smear microscopy
ƽ 7IUYMVIWWOMPPIHTIVWSRRIP

5.6.2 Microscopy
Sputum smear microscopy is the oldest method for diagnosis of pulmonary
tuberculosis. Microscopy has low sensitivity and 10,000 bacilli/ml sputum sample. A
spot and a morning sputum sample is collected from presumptive PTB cases for TB
diagnosis in sites that do not have GeneXpert machines. A second sample should be
sent for GeneXpert testing. Patients diagnosed with TB should be followed up with
smear microscopy done at the 2nd, 5th, and 6th months. Specimen other than sputum
(sots), are collected from presumptive EPTB cases for diagnosis according to the
NTLDP guidelines.

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 Table 5.3: The strengths and limitations of microscopy

Conventional light microscopy Light emitting diode (LED) Fluorescent

Microscopy
ƽ Ziehl-Neelsen staining technique. ƽ Auramine staining technique.
ƽ Turnaround time of 24hours. ƽ Turnaround time of 24hours.
ƽ Has a sensitivity of approximately ƽ .XLEWEWIRWMXMZMX]SJETTVS\MQEXIP] 
 ERHEWTIGMǻGMX]SJ ERHEWTIGMǻGMX]SJETTVS\MQEXIP] 
approximately 99%.
Strengths of microscopy Limitations of smear microscopy
technique
ƽ LSVXXYVREVSYRHXMQI !LV ƽ 1S[QSHIVEXIWIRWMXMZMX]GSQTEVIHXS
culture or GeneXpert
ƽ 1S[GSWX
ƽ )SIWRSXHMǺIVIRXMEXIPMZISVHIEH
ƽ .XMW[MHIP]EZEMPEFPI
mycobacteria
ƽ )SIWRSXHMǺIVIRXMEXIQ]GSFEGXIVMYQ
species
ƽ Requires skilled personnel

NOTE:
ƽ 2MGVSWGST]JSVJSPPS[YTSJTEXMIRXWWLSYPHFIHSRIEXXLITIVMTLIVEPPEFSVEXSVMIW

ƽ +SVMRHMZMHYEPW[MXLQMRMQEPTYPQSREV]MRZSPZIQIRXERHSVWGERX]WTYXYQTVSHYGXMSR
induced sputum, gastric lavage or bronchoscopy can increase test sensitivity

ƽ TYXYQTVSGIWWMRKWYGLEWPMUYIJEGXMSRSVGSRGIRXVEXMSRF]GIRXVMJYKEXMSRERHXLIYWI
SJǼYSVIWGIRGIQMGVSWGST]GEREPWSMRGVIEWIXLIWIRWMXMZMX]SJWQIEVQMGVSWGST]

5.6.3 Line Probe Assay

Line Probe Assay (LPA) is a rapid technique based on polymerase chain reaction
(PCR) that is used to detect Mycobacterium tuberculosis complex (MTBC) and drug
WYWGITXMFMPMX]XSǻVWXPMRIERHWIGSRHPMRIHVYKW

ƽ First line LPA (FL LPA) (GenoType a‰%ŤĮƣžƐšƞ) – provides DST on rifampicin,
isoniazid

ƽ First line LPA (FL LPA) (GenoType MTBDRŤĮƣžƐV2)- DST to Fluoroquinolones and
the second line injectable.

.X MW EPWS YWIJYP JSV WTIGMEXMSR SJc Q]GSFEGXIVME SXLIV XLER XYFIVGYPSWMW 2488W EPWS
known as Non-tuberculous mycobacteria (NTMs) (GLI, 2018).

28' HIXIGXMSR IRWMXMZMX]   TIGMǻGMX]   7MJEQTMGMR VIWMWXERGI HIXIGXMSR

IRWMXMZMX]   TIGMǻGMX]   .3- VIWMWXERGI HIXIGXMSR IRWMXMZMX]  
TIGMǻGMX] 

108 Integrated Guideline for Tuberculosis,

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Table 5.4: The strengths and limitations of LPA

LPA strengths Limitations

ƽ LPA produces results in just 24-48 hours, a vast ƽ .XVIUYMVIWEHIUYEXIERH
improvement over the 3 months or longer with appropriate laboratory
conventional methods (culture). infrastructure and equipment
(biosafety level II and III
ƽ .XEPPS[WUYMGOXVMEKISJGSRǻVQIHVMJEQTMGMRVIWMWXERX
laboratory).
or MDR-TB patients into either the shorter MDR-TB
regimen or the conventional longer regimen. ƽ .XVIUYMVIWEHIUYEXIERH
WOMPPIHPEFSVEXSV]WXEǺ
ƽ Hain LPA can be used to diagnose both pulmonary and
Extra-pulmonary tuberculosis. ƽ (ERRSXFIYWIHEWETSMRXSJ
care test.
ƽ 15&LEWELMKLWIRWMXMZMX]SJ ERHEWTIGMǻGMX]SJ
100% for direct samples
ƽ Hain LPA has drug susceptibility testing for both
Rifampicin and Isoniazid
ƽ Short turnaround time of 5 hours for MDR-TB detection
as compared to cultures which takes weeks
ƽ Hain LPA can detect mixed infections especially in
samples having NTM and MTBC
ƽ MTBDRplus can query presence of an Non-tuberculous
mycobacteria and also does not show false negative
ƽ Tests can be run on less than 2ml specimen volume.
ƽ The same extracted DNA may be used for further
testing with Hain LPA
ƽ GenoType MTBDRsl endorsed by WHO as a rule in test
for XDR-TB
ƽ GenoType MTBDRplus can track mono-resistance to
rifampicin and/or Isoniazid
ƽ Genotype MTBDRplus captures infection due to MTB
GSQTPI\ERHGERHMǺIVIRXMEXIXLI28'(GSQTPI\
species i.e. aũƐ±üŹĞϱĻƣķØƐaũÆŇƽĞžƐžƣÆžŤŤƐÆŇƽĞžØƐaũÆŇƽĞžƐƐ
žƣÆžŤŤƐϱŤŹ±åØƐaũƐŇƽĞžƐ:ØƐaũķĞÏŹŇƒĞØƐaũƐϱĻ僃ĞĞØƐaũƐ
ŤĞĻĻĞŤåÚĞĞ
ƽ Hain line probe assay can be used to diagnose
Tuberculosis from both direct specimens and culture
including contaminated cultures
ƽ Hain LPA has full automation allowing high throughput
for high volume laboratories
ƽ Hain LPA is environmentally friendly as there is no
biohazard waste to dispose after running the test
ƽ MTBDRplus ver.2.0 has a higher sensitivity for smear
– ve samples (Sensitivity of 79.8% for smear negative -
š±ĮåŹĞåƐŹƣÚƣƐåƒƐ±ĮƐIaƐƞǑŐƞŧ

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 5.6.4 Culture and Drug Susceptibility Testing for TB
a) Phenotypic Culture
Culture is the gold standard for TB diagnosis and can detect as few as 10-100 viable
FEGXIVMEQPc;ILEZIX[SX]TIWSJGYPXYVIQIXLSHW

ƽ Liquid culture - Mycobacterium Growth Indicator Tubes (MGIT)

ƽ Solid culture - Lowenstein-Jensen (LJ).

8LIWIc EVI YWIH JSV XLI HIXIGXMSR ERH VIGSZIV] SJ Q]GSFEGXIVME &PP X]TIW SJ GPMRMGEP
specimens, pulmonary as well as extra pulmonary can be processed for primary isolation.

Table 5.5: The strengths and limitations of phenotypic culture

Solid Culture Liquid Culture

ƽ 1SRKIV8&8SJYTXSHE]W ƽ LSVXIV8&8SJHE]W
ƽ 1S[VMWOSJ(SRXEQMREXMSR ƽ -MKLIVVMWOSJ(SRXEQMREXMSR
ƽ 2ERYEPXIGLRMUYI ƽ &YXSQEXIHXIGLRMUYI
ƽ  QSVIWIRWMXMZIGSQTEVIH[MXLWSPMHGYPXYVI

Strengths of culture techniques Limitations of culture techniques

ƽ 7IUYMVIWEWJI[EWFEGMPPMQPXS ƽ PS[KVS[XLSJ28'XLYWHIPE]IHXYVREVSYRH

detect TB time
ƽ 5VSZMHIWEHIǻRMXMZIHMEKRSWMWSJ8' ƽ 7IUYMVIWLYKIMRJVEWXVYGXYVEPGETEGMX]XSWIXYT
ƽ &PPS[WHVYKWYWGITXMFMPMX]XIWXMRKERH ƽ 7IUYMVIXVEMRIHPEFSVEXSV]XIGLRMGMERWXS
DR surveillance perform the procedure.

5.6.5 Drug susceptibility testing

It is a laboratory technique that determines whether or not TB bacteria will grow in the
presence of TB drugs. If bacterial growth is observed, it shows resistance, while No growth
shows susceptibility to drugs used. The demand for reliable drug-susceptibility testing
(DST) increases with the expansion of antituberculosis drug-resistance surveillance, and
with the need for an appropriate treatment of drug-resistant tuberculosis.

Indications

 &XXLIZIV]PIEWXXLIJSPPS[MRKTEXMIRXWWLSYPHLEZI)8JSVǻVWXPMRIHVYKW
ƽ 5VIZMSYWP]XVIEXIHTEXMIRXW
ƽ 5IVWSRW[LS HIZIPST EGXMZI8' EJXIV I\TSWYVI XS E TEXMIRX[MXL HSGYQIRXIH
DR-TB;

ƽ 5EXMIRXW[LSVIQEMRWQIEVTSWMXMZIEXQSRXLX[SERHǻZISJXLIVET]

110 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
The following groups are targeted for DST for second-line drugs:

ƽ 5EXMIRXW[MXLE)8WLS[MRKEVIWMWXERGIXSEXPIEWXVMJEQTMGMRMWSRME^MHSVFSXL
rifampicin and isoniazid at baseline

ƽ 5EXMIRXW[LSVIQEMRGYPXYVITSWMXMZISRSVEJXIV2SRXL)78'

ƽ 5IVWSRW[LS HIZIPST EGXMZI8' EJXIV I\TSWYVI XS E TEXMIRX[MXL HSGYQIRXIH

DR-TB. (MSF medical guideline 2017).

5.6.6 Interferon gamma release assay-IGRA

The Interferon Gamma Release Assay (IGRA) is a blood test used to detect Latent TB
infection. It works by measuring the body’s immune response to the TB bacteria. It is
used to test for Latent TB infection. ŦåüåŹƐƒŇƐF:
žƐĥŇÆƐ
ĞÚŧũ

Table 5.6: The strengths and limitations of IGRA

'IRIǻXWSJ.,7& Limitations of IGRA

ƽ Only a single patient visit required. ƽ Costly.

ƽ Ex vivo tests. ƽ More laboratory resources required

ƽ 3SFSSWXIVIǺIGX ƽ Complicated process of lymphocyte

separation.
ƽ Independent of BCG vaccination.

5.6.7 TB LAM
TB-LAM is a rapid point-of-care urine dipstick test based that can be performed at the
bedside for detection of mycobacterial lipoarabinomannan (LAM) antigen in urine (TB)
;-4c1&2ERXMKIRMWEPMTSTSP]WEGGLEVMHITVIWIRXMRQ]GSFEGXIVMEPGIPP[EPPW
released from metabolically active or degenerating bacterial cells and appears to be
present only in people with active TB disease (Refer to TB LAM Job Aid).

Indications of TB LAM
ƽ 51-.:[MXLEHZERGIHHMWIEWI ;-4WXEKISVSV()GSYRXǷGIPPWQQ3
SVǷ JSVGLMPHVIRǷ]IEVWSPH[MXLTVIWYQIH8'
ƽ 51-.:XLEXLEZIER]HERKIVWMKRWSJWIZIVIMPPRIWW VIWTMVEXSV]VEXI#FVIEXLW
per minute, temperature > 390c, heart rate >120 beats per minute, unable to walk
unaided.
ƽ (YVVIRXP]EHQMXXIHXSLSWTMXEP
ƽ &YWIJYPXSSPJSVHIXIGXMRKWTYXYQWQIEVRIKEXMZITEXMIRXW
ƽ )MEKRSWI FSXL TYPQSREV] ERH I\XVE TYPQSREV] 8' JVSQ SRI GSRZIRMIRX YVMRI
sample.

NOTE: TB LAM is a bedside test for TB as an additional test for GeneXpert.

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 5.6.8 Other new molecular methods to be rolled out
a) Truenat MTB
The Truenat MTB, MTB plus and MTB-RIF diagnostic assays (Molbio diagnostic, Goa,
India) were developed in India, and may potentially be used as the same health system
level as Xpert/MTB/RIF. Of the above-mentioned assays, MTB and MTB plus are used
EW MRMXMEP HMEKRSWXMG XIWXW JSV 8' [LMPI 28'7.+ )\ MW YWIH EW E VIǼI\ XIWXW XS HIXIGX
rifampicin resistance for those with positive results of initial Truenat test. The assay use
EYXSQEXIH FEXXIV]STIVEXIH HIZMGIW XS I\XVEGX EQTPMJ] ERH GSRǻVQ XLI TVIWIRGI SJ
genomic DNA loci for TB infection diagnosis by use of real-time micro-PCR. Results for
the test can available under 1 hours’ time. This test is among the new diagnostic tools
the country is planning to adopt under the guidance of National diagnostic committee.

b) BD Max ™

c) Genome Sequencer

5.7 Test turnaround time

Table 5.7: Expected turnaround times (TAT) for the various laboratory techniques/
assays.

8IWXQIRYc Lab TAT Comments

AFB Microscopy 24hrs All specimens (sputum & SOTS)

TB LAM 30 - 40 min Urine sample

GeneXpert 48hrs All specimens except blood

TB culture- 8 weeks Culture Negative

Solid culture 2-8weeks Culture Positives

TB culture- 6weeks Culture Negative

Liquid Culture 5-28days Culture Positives

8'HVYKWYWGITXMFMPMX]XIWXMRKc

cccccccccccc7-* 7-14 days MGIT DST

5>&ccccccccccccccccccccccccccccccc 7- 21 days

Molecular DST –FL-LPA 7 working days Smear Positives

Molecular DST-SL-LPA 7 working days All samples

MTB speciation 7 working days All samples

Gene sequencing 2-14 days All samples

(batched)

112 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Table 5.8: Interpretation of laboratory results

Method Expected results Interpretation Management/ Recom-

mendation
Microscopy Positive (0-9), (1+, MTB bacilli seen. Start Anti TB treatment
2+, 3+) (2HREZ/4HR)

Send another fresh sam-

ple for CDST if GXP is not
available on site.
Negative This shows the TB bacilli A GeneXpert test is
has not been seen howev- indicated. Use XPERT
er it does not rule out the networking hub/courier
absence of Tuberculosis model.
infection / disease.

Note: Correlate with clinical

symptomatology and other
relevant history.

Seek for second senior opin-

ion from SCTLC or CTLC.
Gene Xpert MTB detected, This shows that the patient Collect fresh samples
has TB that is sensitive to for Culture DST. Initi-
-Rifampicin Resis-
Rifampicin ate patient on CAT1
tance not detected
(2HREZ/4HR) treatment.
8c

MTB detected This shows that the patient Collect fresh samples for
has rifampicin resistance TB Culture DST1&2 & 2nd Line
Rifampicin Resis- LPA.
XERGIHIXIGXIHc
Initiate patient on DR TB
(RR / MDR) treatment.
MTB detected Ri- Patient has TB but the bacte- Collect fresh samples for
fampicin Resistance VMEPPSEHMWZIV]PS[cXSHI- the repeat GeneXpert test
indeterminate (TI) termine resistance patterns. and treat according to the
Send another sample second GeneXpert results.
MTB not detected 8LMWWLS[W28'cLEWRSX Correlate with clinical
been detected, however it symptomatology and oth-
does not rule out absence of er relevant history.
8YFIVGYPSWMWc
Seek for second senior
opinion from SCTLC or
CTLC.
348*+SVER]MRZEPMHSVIVVSVKIRI<TIVXXIWXSYXGSQIGSPPIGXERSXLIVcWEQTPIERHVITIEX
XIWXc
XPERT MTB/ MTB detected trace MTB Detected (Trace), RIF
RIF ULTRA (TT) Resistance Indeterminate

NOTE: Trace results interpretation;

1) HIV, Children and EPTB specimen-consider as true positive results for clinical decisions
2) HIV negative with trace call results positive, collect another sample and use the second result for clinical decision
(Clinical/Radiological information can also be used)
3) For any repeat test its advisable to collect two specimen (one for GeneXpert Ultra and the other for LPA

Integrated Guideline for Tuberculosis, 113

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 Method Expected results Interpretation Management/ Recom-
mendation
FL LPA (MTB- 28'(HIXIGXIHc The bacteria is resistant to Rifampicin and Isonia-
)75PYWc both rifampicin (rpoB) & Iso- zid (Including high dose
ƽVTS' 0EX,ERH niazid (KatG and inhA) drugs. isoniazid) should not be
MRL&QYXEXMSRcHI- used
tected

28'(HIXIGXIHc The bacteria is susceptible Rifampicin and Isoniazid

to both rifampicin (rpoB) and (Including high dose iso-
ƽVTS' 0EX,ERH isoniazid (KatG and inhA) niazid) can be used
inhA - Mutation not drugs.
detected
28'(HIXIGXIHc The bacteria is resistant to Rifampicin should not be
rifampicin (rpoB), but sus- used
ƽVTS'2YXEXMSR ceptible to Isoniazid (KatG
detected and inhA)
ƽ0EX,ERHMRL&
-Mutation not de-
tected
28'(HIXIGXIHc The bacteria is susceptible to Isoniazid should not be
rifampicin (rpoB), but resis- used (refer to the table
ƽVTS'2YXEXMSR tant to Isoniazid (KatG and above for Isoniazid resis-
not detected inhA). tance regimen)
ƽKatG and inhA-
Mutation detected
iii. No MTBC detect- MTB complex is absent Evaluate patient for other
ed conditions
SLLPA (MTB- ƽK]V&K]V'2YXE- The bacteria is susceptible to Fluoroquinolones can be
DRsl ) tion not detected FSXLǼYSVSUYMRSPSRIW K]V& used
gyrB) Lfx and Mfx respec-
tively

ƽK]V&K]V'2YXE- The bacteria is resistant to Fluoroquinolones cannot

XMSRcHIXIGXIH FSXLǼYSVSUYMRSPSRIW K]V& be used (refer to the
gyrB) Lfx and Mfx respec- table above for regimen
tively design)
 Aminoglycosides(rrs/eis) Avoid the use of injectable
ƽVVWIMW Capreomycin, Amikacin, Ka- drugs in general (refer to
namycin, Viomycin) the table above on regi-
men design)
The bacteria are resistant to
E2YXEXMSRcHIXIGXIH EPPSVER]SJXLIWTIGMǻGHVYK

c The bacteria is susceptible to

all the drugs
b) Mutation not
HIXIGXIHc
Culture (Sol- Growth/Positive The patient has mycobacte- Continue current
id & Liquid) ria (MTB or MOTT) treatment
No growth/ &FWIRGISVRSRZMEFPIc
Negative mycobacteria(MTB or MOTT)

114 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Method Expected results Interpretation Management/ Recom-
mendation
First Line Susceptible/Sensi- The bacteria is sensitive to all Treat with 1st line anti TB
DST tive, (RHZE) ǻVWXPMRIHVYKW medicines (2HREZ/4HR)
7IWMWXERGIXS7-c The patient is an MDR TB Treat as RR / MDR TB
Resistance to H,Z,E The patient is poly resistant Refer to DR TB Treatment
guide for regimen compo-
sition
Resistance to R The patient is Mono Rifampi- Refer to DR TB treatment
ONLY cin resistant (RR) guide for regimen compo-
sition
Resistance to H The patient is Mono isoniazid Refer DR TB treatment
ONLY resistant guide for regimen compo-
sition
Second line Susceptible/Sen- The bacteria is sensitive to all Refer DR TB treatment
DST sitive second line drugs guide for regimen compo-
sition
Bdq,Dlm,Lzd,-
Clz,Cs,Lfx/Mfx,C-
m,Amk,Kan,
Resistance to Ami- Resistance to any of the Ami- Refer to DR TB treatment
noglycosides (Cm, noglycosides is a Pre XDR guide and regimen com-
Amk, Kan) position
Resistance to Resistance to any of the Flu- Refer to DR TB treatment
Fluoroquinolones oroquinolones is a Pre XDR guide and regimen com-
(Lfx,Mfx) position
Resistance to 7IWMWXERGIXSFSXLǼYSVS- Refer to DR TB treatment
Fluoroquinolones quinolones and Aminoglyco- guide and regimen com-
(Lfx,Mfx) and Amino- WMHIWMWERc<)7 position
glycosides(Cm,Am-
k,Kan)
Resistance to Bdq/ 7IWMWXERGIXSWTIGMǻGHVYKW
Dlm/Lzd,Clz,Cs

NOTE:
ƽ -IXIVSVIWMWXERXSYXGSQIQIERWXLITEXMIRXLEVFSVWFSXLHVYKWYWGITXMFPIERHHVYK
resistant bacteria.

ƽ .RHIXIVQMREXIJSVEWTIGMǻGHVYKSVKVSYTSJHVYKWQIERWXLEXXLIEWWE]WLSYPHFI
VITIEXIHFIJSVIcVITSVXMRKXLIVIWYPXW.JXLIWEQIVIWYPXMWSFXEMRIHYTSRVIXIWXMRK
request for another sample.

ƽ 5EXMIRXWQE]LEZIETSWMXMZIWQIEV[MXLRIKEXMZIGYPXYVIWXLEXQE]FIGEYWIHF]XLI
presence of dead bacilli and hence does not necessarily indicate treatment failure.
DISCUSS such cases with the DR TB clinical management team.

ƽ .RTEXMIRXW[MXLVITIEXIHRIKEXMZIGYPXYVIERHWQIEVVIWYPXWERHRSGSVVIWTSRHMRK
clinical and radiological improvement, then consider other diseases other than MDR-TB.

ƽ (LMPHVIR[MXLLMKLGPMRMGEPWYWTMGMSRSJc8'WLSYPHFIXVIEXIHJSV8'IZIRMJ<TIVXMW
negative.

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 Table 5.9: Managing Discordant Results

Test Discordant Explanation Recommendation

pattern/
reports
Smear Smear Negative
microscopy VS microscopy
GeneXpert
GeneXpert MTBC
detected
RS (Rif. GeneXpert sensitivity Collect fresh samples
Sensitive) ERHWTIGMǻGMX]MW for Culture DST.
superior to smear Initiate patient on
microscopy. CAT1 (2HREZ/4HR)
treatment.
RR (Rif. GeneXpert superior Collect fresh samples
Resistant) sensitivity and for Phenotypic Culture
WTIGMǻGMX]XSWQIEV and DST 1st and 2nd Line
microscopy. and LPA 1st and 2nd line.

GeneXpert looks Initiate patient on

for Mycobacterial DR TB (RR / MDR)
DNA in the rpob loci treatment.
responsible for Rif.
Resistance.

TI (Rif. Poor sample quality. Collect fresh samples

Resistant Emphasize on good for the repeat
Indetermi- quality samples. Low GeneXpert test and
nate) bacillary load. treat according to the
second GeneXpert
results.
I(Invalid) Poor sample quality. Collect fresh sample
Emphasize on good for GeneXpert test and
quality samples. treat according to the
second GeneXpert
results

2.GeneXpert GeneXpert MTBC not Repeat both tests on Rare occurrence. Could
vs Smear detected fresh samples. be a lab error.
microscopy (if
Smear Positive
no GXP on site)
microscopy

116 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Test Discordant Explanation Recommendation
pattern/ reports
3.GeneXpert GeneXpert MTBC GeneXpert may pick Start on RR/MDR TB
VS Culture and Detected, silent mutations in treatment regimen.
DST Rif the rpob genome that Adjust regimen
Resistant. would be missed by according to SLLPA
phenotypic testing. results.
Obtain fresh sample for
Genome sequencing.

Culture and MTBC Continue DR TB

DST Pos Rif treatment.
Sensitive
4. Xpert vs LPA GeneXpert RIF The methods look Start the patient on DR
resistance at the same region TB treatment.
detected but detect resistance
YWMRKWPMKLXP]HMǺIVIRX
probes.
Xpert detects
mutations in codons
531,516 and 526 which
are not detected by
LPA RIF LPA
sensitive

Xpert RIF The methods look Start the patient on DR

resistance at the same region TB treatment.
not but detect resistance
detected YWMRKWPMKLXP]HMǺIVIRX
probes.
LPA RIF
resistance
detected
Xpert No MTBC Repeat test on a The second GXP test
detected fresh sample. Send result to guide the Sub
in a symp- another sample for county clinical team’s
tomatic phenotypic testing decision.
patient. (CDST) Genome
sequencing is
recommended.
LPA Hetero- Treat the patient for DR
resistance TB.
detected
(HR)

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Leprosy and Lung Disease | 2021
 Test Discordant Explanation Recommendation
pattern/ reports
5.GXP,LPA Molecular Molecular Culture is our gold The sub county clinical
and Culture (Xpert and no MTBC standard team to review the
discordance LPA) detected patient and decide on
next action based on
the patient’s condition.
Culture Growth Subject the culture Treat as per LPA result.
reported isolate to LPA

Molecular MTBC Order another sample Treat as per molecular

(Xpert and detected for phenotypic CDST results.
LPA)
Culture culture Non-viable cells Continue treatment as
negative above
6.LPA A clinical team (Sub county) to review the patient and decide on way forward.
Indeterminate
results

NOTE:
ƽ (YPXYVI)8WLSYPHRSXFIYWIHXSGSRǻVQVINIGX,IRI<TIVXVIWYPXW

ƽ *ZIV]HMEKRSWXMGXIWXLEWEVMWOSJTVSZMHMRKEJEPWIVIWYPX
ƽ 7IQIQFIVXLEXRSRXIWXGEYWIWSJJEPWIVIWYPXWEVIZIV]GSQQSR
ƽ &PEFSVEXSV]XIWXVIWYPXMWSRP]TEVXSJXLIGPMRMGEPHIGMWMSRQEOMRKTVSGIWW
ƽ 8VIEXXLITEXMIRXƶW[SVWXGEWIWGIREVMSRSXXLIXIWXVIWYPX

5.8 External Quality Assessment

*\XIVREPUYEPMX]EWWIWWQIRX *6&TVSǻGMIRG]XIWXMRKTVSKVEQ 58VIJIVWXSEW]WXIQ
in which laboratory results are scrutinized objectively by an outside agency in order to
get a general impression of the standard of laboratory practice and to achieve inter-
PEFSVEXSV] GSQTEVEFMPMX]8LIVI EVI HMǺIVIRX[E]W SJ HSMRK *6& MI SRWMXI IZEPYEXMSR
(supervisory visits), panel testing (PT) and blinded checking. A laboratory can adopt one
or more of the stated EQA approaches for every laboratory test performed. This is in line
with the clinical laboratory improvement Act CLIA requirement. This helps the laboratory
identify errors which are not detected by the internal quality program (IQA) as well as
comparing its performance with other laboratories participating in the same. (Refer to
EQA SOP).

 1EFSVEXSV].RJIGXMSR5VIZIRXMSR(SRXVSP
TIGMQIRTVSGIWWMRKMRXLIcPEFSVEXSV]QYWXSFWIVZIEXQMRMQYQXLIOI]WXERHEVHW
of biosafety. (Refer to Chapter 10).

118 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
TUBERCULOSIS IN
SPECIAL CONDITIONS 6

 .RXIRWMǻIH8'(EWI+MRHMRKEQSRK51-.: 7. Bi-directional screening and diagnosis of

ƽ ]QTXSQFEWIH 8' WGVIIRMRK YWMRK Diabetes Mellitus and TB
the ICF tool MUST be performed for all ƽ GVIIRMRKERHHMEKRSWMWSJHMEFIXIWMR
PLHIV at every clinic visit to rule out people with TB
active TB ƽ GVIIRMRK ERH HMEKRSWMW SJ 8' MR
2. TB diagnosis in PLHIV – TB LAM algorithm people with diabetes
for patients with advanced HIV disease 8. TB and Mental Health / Substance
3. HIV Testing in TB patients – updated HIV Dependence
Testing algorithm ƽ &PP8'GSMRJIGXIHWLSYPHVIGIMZIFEWMG
4. Standard package of care for PLHIV screening for depression using the
5. Provision of Antiretroviral Therapy (ART) PHQ-9 tool (Annex 6.3a & 6.3b) before
for TB/HIV Co-Infected Patients initiating TB treatment, and regularly
during follow-up, and whenever there
ƽ 8MQMRKSJ&78TEXMIRXWJSV8'-.:GS is a clinical suspicion of depression.
infected patients
ƽ &PP EHYPX ERH EHSPIWGIRX 8' TEXMIRXW
ƽ 9THEXIH 5VIJIVVIH &78 7IKMQIRW JSV should be screened for alcohol,
TB/HIV Co-infection for Patients Newly tobacco and substance dependence
Initiating 1st Line ART, Patients who before initiating TB treatment and
Develop TB while Virally Suppressed regularly during follow-up using
on 1st Line ART and Patients who CAGE–AID for adults (Annex 6.1a &
Develop TB while Failing 1st Line ART 6.1b) and CRAFFT tools for adolescents
6. Diagnosis of Diabetes and Pre-Diabetes (Annex 6.2a & 6.2b) respectively.
ƽ 8LVIWLSPHW ERH GYXSǺ TSMRXW JSV 9. TB in Pregnancy and Lactation – liver
diabetes and pre-diabetes function tests indicated at baseline and
follow-up.

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 6.1 Introduction
Tuberculosis incidence, risk, progression and treatment may be altered in particular
patient populations such as those with comorbidities (HIV, diabetes, renal disease and
hepatic disease), mental illness, substance dependence and pregnant women. This
chapter provides information on the unique drug-disease interactions and drug-drug
MRXIVEGXMSRW EǺIGX XLI HMEKRSWMW ERH QEREKIQIRX SJ XYFIVGYPSWMW MR XLIWI WTIGMǻG
groups of patients.

6.2 TB and HIV CO-Infection

KEY HIGHLIGHTS:

ƽ -.:XIWXMRKMWVIGSQQIRHIHJSVEPPTVIWYQIHERHGSRǻVQIH8'GEWIW

ƽ &PP8'TEXMIRXW[LSEVI-.:TSWMXMZIWLSYPHVIGIMZIXLIXERHEVHTEGOEKISJ
care for PLHIV

ƽ ]QTXSQFEWIH8'WGVIIRMRKYWMRKXLI.(+XSSP298FITIVJSVQIHJSVEPP
PLHIV at every clinic visit

ƽ &PP51-.:WLSYPHFIEWWIWWIHJSV8'5VIZIRXMZI8LIVET] 858MJWGVIIRIH
negative for TB.

6.2.1 Background
TB is the leading preventable cause of morbidity and mortality among people living with
HIV. The burden of TB is so closely linked to the HIV epidemic that prevention of HIV
must become a priority for TB programs. Patients presenting with signs and symptoms
of any of the two diseases should be actively screened for the other and managed
appropriately.

The co-infected patients face a dual burden of pills, stigma and discrimination as well
as nutritional needs thus providing quality of care is essential. HIV infected individuals
EVIQSVIPMOIP]XSWYǺIVEGYXISTTSVXYRMWXMGMRJIGXMSRWERHHIZIPSTHVYKVIEGXMSRW8LMW
therefore calls for close monitoring during management.

6.2.2 TB and HIV Interaction

Interaction of HIV with TB
ƽ .RGVIEWIHPMJIXMQIVMWOSJ8'JVSQ XS
ƽ .RGVIEWIHVEXISJTVSKVIWWMSRSJRI[8'MRJIGXMSRWXSHMWIEWI
ƽ .RGVIEWIHVMWOSJVIGYVVIRGISJTVIZMSYWP]XVIEXIH8'
ƽ .RGVIEWIHVMWOSJHIEXLJVSQ8'
ƽ .RGVIEWIHVMWOSJEHZIVWIVIEGXMSRWXSERXM8'HVYKW
ƽ .RGVIEWIHWXMKQEXSXLIX[SHMWIEWIW

120 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Interaction of TB with HIV
ƽ 7ETMHTVSKVIWWMSRSJ-.:HMWIEWI
ƽ 8'MWXLIPIEHMRKGEYWISJ-.:VIPEXIHQSVFMHMX]
ƽ 8'MWEPIEHMRKGEYWISJQSVXEPMX]EQSRK51-.: SRIXLMVHSJEPP&.)VIPEXIHHIEXLWEVI
due to TB)
ƽ .RGVIEWMRK8'GEWIWEQSRK51-.:MRGVIEWIWXLIVMWOSJ8'XVERWQMWWMSRMRXLIGSQQYRMX]
regardless of their HIV status.

.RXIRWMǻIH8'(EWI+MRHMRK&QSRK51-.:
8'WGVIIRMRKERHTVIZIRXMSRWIVZMGIWWLSYPHFISǺIVIHXS&1151-.:EXIZIV]GPMRMGEP
visit and to all household contacts of active TB patients. Symptom-based TB screening
using the ICF tool MUST be performed for all PLHIV at every clinic visit to rule out
EGXMZI8'8LSWI[LSWGVIIRTSWMXMZI TVIWYQTXMZI8'GEWIWQYWXGSQTPIXIHIǻRMXMZI
diagnostic pathways (*refer to table) and patients who screen negative should be
evaluated for isoniazid preventive therapy (IPT).

The presentation of TB in HIV infection may be unusual, and may include extra-
pulmonary and disseminated forms. However, patients with advanced disease may be
symptom-free and have no chronic cough.

The following tables summarize the Pediatric and Adult ICF tools used in TB screening:

8EFPI5IHMEXVMG.RXIRWMǻIH(EWI+MRHMRKGVIIRMRK8SSP ]IEVWSJEKI

Screening Questions Y/N

1. Cough of any duration (Y/N)
2. Fever (Y/N)
3. Failure to thrive or poor weight gain (Y/N) (based on z-score/BMI)
4. Lethargy, less playful than usual (Y/N)
5. Contact with a TB case (Y/N)
If “Yes” to any of the above questions, suspect TB, examine the child and use the pediatric TB diagnostic
algorithm to evaluate for active disease. Rule out underlying conditions, refer if necessary

If “No” to all questions, initiate workup for IPT and repeat screening on subsequent visits

8EFPI&HSPIWGIRXERH&HYPX.RXIRWMǻIH(EWI+MRHMRKGVIIRMRK8SSP
Ǹ]IEVWSJEKI

Screening Questions Y/N

1. Cough of any duration (Y/N)
2. Fever (Y/N)

3. Noticeable weight loss (Y/N) (based on BMI)

4. Night sweats (Y/N)

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 If “Yes” to any question, take a detailed history, examine the patient and do sputum examination if coughing
(sputum for GeneXpert and smear, Figure 8.2), and urine TB-LAM if meets criteria (Figure 8.3). Exclude un-
derlying illnesses

If “No” to all questions, initiate workup for IPT and repeat screening on subsequent visits

cŇƒå×%Ź±ĞĻĞĻďƐĮDžķŤĚƐĻŇÚåžƐ±ŹåƐŇüƒåĻƐÚƣåƐƒŇƐ‰ũ

6.2.4 TB Diagnosis in PLHIV

Gene expert RIF/MTB assay is a rapid molecular technique for detection of
2]GSFEGXIVMYQ8YFIVGYPSWMWERH7MJEQTMGMRVIWMWXERGI.XMWXLIVIGSQQIRHIHǻVWX8'
diagnostic test amongst PLHIV. Other tools for diagnosis of TB in PLHIV include imaging
(X-rays and CT scans) and histology.

Since persons with advanced HIV disease may have disseminated disease which may
be missed on GeneXpert testing, it is recommended that PLHIV are tested using lateral
ǼS[PMTSEVEFMRSQERRER 1+1&2TSMRXSJGEVIYVMRIERXMKIRXIWX8LIMRHMGEXMSRWERH
use of TB-LAM are as per the algorithm in Figure 6.1:

Figure 6.1: TB LAM algorithm

122 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
6.2.5 HIV Testing in TB Patients
HIV counseling and testing should be carried out in all presumptive cases as part of the
investigations for TB. A diagnosis of HIV infection at the earliest opportunity possible
LEWWIZIVEPFIRIǻXWMRGPYHMRKTVSZMHMRKWXERHEVHTEGOEKISJGEVIJSV-.:TSWMXMZI-.:
testing for TB patients should preferably be done in the Chest clinic. If HIV testing is
done in other areas apart from the chest clinic, measures such as escorted referrals
should be put in place to ensure that TB patients are not lost during referral and that
they do not queue for long while waiting to be attended.

The HIV testing package includes:

ƽ &pre-test session

ƽ HIV test (see Figure 6.2: HIV testing algorithm) assessment for other health-related
conditions or needs (while HIV tests are running),

ƽ &TSWX-testWIWWMSRMRGPYHMRKEWWMWXIHTEVXRIVRSXMǻGEXMSRWIVZMGIW E53ERHGLMPH
testing

ƽ 7IJIVVEP ERH linkage to other appropriate health services (as part of the post-test
session).

Figure 6.2: HIV testing algorithm

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Leprosy and Lung Disease | 2021
 Those who test HIV negative:

ƽ LSYPHFIMRJSVQIHEFSYXGSYTPIHMWGSVHERGIERHFIIRGSYVEKIHXSVIJIVXLIMV
partners for testing

ƽ LSYPH VIGIMZI FILEZMSV GLERKI GSYRWIPMRK WS EW XS EZSMH EGUYMWMXMSR SJ -.:
infection

ƽ LSYPH FI MRJSVQIH XLEX XLI RIKEXMZI XIWX HSIW RSX VYPI SYX -.: MRJIGXMSR ERH
should be encouraged to receive a retest after 12 weeks

Those who test HIV positive:

ƽ LSYPHFIMRMXMEXIHSRERETTVSTVMEXIVIKMQIRFEWIHSRHVYKWYWGITXMFMPMX]ERH
SXLIVGPEWWMǻGEXMSRåüåŹƐƒŇƐ‰Źå±ƒķåĻƒƐŇüƐ‰ƣÆåŹÏƣĮŇžĞžƐĞĻƐ±ÚƣĮƒžƐ±ĻÚƐÏĚĞĮÚŹåĻ.

6.2.6 Standard Package of Care for PLHIV (9 COMPONENTS)

1. Antiretroviral Therapy

ƽ&PP51-.:EVIIPMKMFPIJSV&78MVVIWTIGXMZISJ()GIPPGSYRXSVTIVGIRXEKI;-4GPMRMGEP
stage, age, pregnancy status, or comorbidities

ƽ&78WLSYPHFIMRMXMEXIHEWWSSREWXLITEXMIRXMWVIEH]XSWXEVXTVIJIVEFP][MXLMRX[S
weeks from time of HIV diagnosis (except for patients with cryptococcal meningitis (5
weeks), or TB meningitis (8 weeks)

2. Positive Health, Dignity, and Prevention, GBV/IPV & Health Education and
Counselling

ƽ &PPTEXMIRXWWLSYPHFIGSYRWIPPIHERHWYTTSVXIHJSVHMWGPSWYVISJ-.:WXEXYW TEVXRIV

family testing and engagement; condom use; family planning; sexually transmitted
infections screening; and treatment adherence services.

ƽ &PPJIQEPIWEKIH]IEVWERHIQERGMTEXIHQMRSVWEGGIWWMRK-.:GEVIWIVZMGIW
should be screened for Intimate Partner Violence (IPV) as part of the standard
package of care.

ƽ &PP51-.:WLSYPHFITVSZMHIH[MXL-.:IHYGEXMSRERHGSYRWIPPMRK

GVIIRMRKJSVERH5VIZIRXMSRSJTIGMǻG4TTSVXYRMWXMG.RJIGXMSRW

ƽ &PP 51-.: WLSYPH VIGIMZI PMJIPSRK (SXVMQS\E^SPI TVIZIRXMZI XLIVET] (58 YRPIWW
they have allergy to sulfur-based drugs or develop toxicity from CPT.

ƽ )YVMRK TVIKRERG] (58 WLSYPH FI MRMXMEXIH MVVIWTIGXMZI SJ XLI KIWXEXMSREP EKI ERH
should continue throughout pregnancy, breastfeeding, and thereafter for life with
doses as indicated in Table 6.3:

124 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Table 6.3: Daily Dose of Cotrimoxazole Preventive Therapy

Weight (kg) If using oral sus- If using single If using double

pension (240mg per strength tablet strength tablet
5ml) 480 960 mg
1–4 2.5 ml ¼ SS tab --
5–8 5 ml ½ SS tab ¼ DS tab
9 – 16 10 ml 1 SS tab ½ DS tab
17 – 30 15 ml 2 SS tabs 1 DS tab
> 30 2 SS tabs 1 DS tab

20 ml
Adult (any weight) 2 SS tabs 1 DS tab

Note: FüƐŹå±ƒĞĻĞĻåƐĮå±Ź±ĻÏåƐŦŹĮŧƐŐĂĝƗǑƐķĮxķĞĻƐƒĚåĻƐƣžåƐĂǑŨƐŇüƐĻŇŹķ±ĮƐŹåÏŇķķåĻÚåÚƐ
ÚŇžåƅƐĞüƐŹĮƐĴƐŐĂƐķĮxķĞĻØƐƒĚåĻƐŇƒŹĞķŇDŽ±ǍŇĮåƐžĚŇƣĮÚƐÆåƐ±ƽŇĞÚåÚũ

When Dapsone (as a substitute for CPT) is being used as PCP prophylaxis, it is only
VIGSQQIRHIH JSV TEXMIRXW MR;-4 XEKI  ERHSV EFWSPYXI () GSYRX Ƿ  GIPPW
QQ SV ()  Ƿ   JSV GLMPHVIR Ƿ  ]IEVW SPH ERH WLSYPH FI HMWGSRXMRYIH SRGI E
patient achieves viral suppression and a sustained CD4 count of > 200 cell/mm3 (or >
 JSVGLMPHVIRǷ]IEVWSPHJSVEXPIEWXQSRXLW

Dapsone Dosage:

ƽ &ZEMPEFPIEWQKERHQKXEFW

ƽ (LMPHVIR QKOK SRGI HEMP] QE\MQYQ HSWI  QK 47  QKOK SRGI [IIOP]
(maximum dose: 200 mg)

ƽ &HYPXWQKSRGIHEMP]

&PP 51-.: WLSYPH FI WGVIIRIH JSV8' EX IZIV]ZMWMX YWMRK XLI .RXIRWMǻIH (EWI +MRHMRK
(ICF) tool and assessed for TB Preventive Therapy (TPT) if screened negative for TB
(Refer to Chapter 11 on LTBI management)

&PPEHSPIWGIRXERHEHYPX51-.:[MXLEFEWIPMRI()GSYRXSJǷGIPPWQQWLSYPH
be screened for cryptococcal meningitis using the serum Cryptococcal Antigen (CrAg)
XIWX ERH QEREKIH EW TIV XLI &78 KYMHIPMRIW 8LMW WLSYPH TVIJIVEFP] FI E VIǼI\ XIWX
performed by the laboratory as soon as the low CD4 count is noted

Integrated Guideline for Tuberculosis, 125

Leprosy and Lung Disease | 2021
 4. Reproductive Health Services

ƽ &PP51-.:WLSYPHFIWGVIIRIHJSV8.EXIZIV]GPMRMGZMWMX

ƽ 5VIKRERG]WXEXYWWLSYPHFIHIXIVQMRIHJSVEPP[SQIRSJVITVSHYGXMZIEKIEXIZIV]
visit and their contraception need determined and met

ƽ &PP-.:TSWMXMZI[SQIRFIX[IIRXLIEKIWSJ]IEVWWLSYPHFIWGVIIRIHJSV
cervical cancer

5. Screening for and Management of Non-Communicable Diseases

ƽD&PP51-.:WLSYPHFIWGVIIRIHJSVL]TIVXIRWMSRHMEFIXIWQIPPMXYWH]WPMTMHIQMEERH
renal disease

ƽ D1MJIWX]PI QSHMǻGEXMSRW EVI EP[E]W XLI ǻVWX PMRI SJ TVIZIRXMSR ERH QEREKIQIRX JSV
hypertension, diabetes mellitus, and dyslipidemia.

6. Mental Health Screening and Management

ƽ &PP51-.:WLSYPHVIGIMZIFEWMGWGVIIRMRKJSVHITVIWWMSRYWMRKXLI5-6XSSPFIJSVI
initiating ART, and annually thereafter, and whenever there is a clinical suspicion

ƽ &PP EHYPXW ERH EHSPIWGIRXW WLSYPH FI WGVIIRIH JSV EPGSLSP ERH HVYK YWI FIJSVI
initiating ART and regularly during follow-up using CAGE-AID and CRAFFT tools

ƽ &PPGEVIKMZIVWWLSYPHEPWSVIGIMZIFEWIPMRIERHJSPPS[YTWGVIIRMRKJSVHITVIWWMSR
and alcohol/drug use using a PHQ-9 questionnaire.

7. Nutrition Services

ƽ&PP51-.:WLSYPHVIGIMZIRYXVMXMSREPEWWIWWQIRXGSYRWIPPMRKERHWYTTSVXXEMPSVIHXS
the individual needs of the patients

ƽ &PP MRJERXW MVVIWTIGXMZI SJ -.: WXEXYW WLSYPH FI I\GPYWMZIP] FVIEWXJIH JSV XLI ǻVWX 
months of life, with timely introduction of appropriate complementary foods after 6
months, and continued breastfeeding up to 24 months or beyond.

For more information on Nutrition in TB refer to Chapter 7.

8. Prevention of Other Infections

ƽ 51-.: MRGPYHMRK GLMPHVIR WLSYPH VIGIMZI ZEGGMREXMSRW EW VIGSQQIRHIH F] XLI
National Vaccines and Immunization Programme

9. TB Contact management among co-infected PLHIV

126 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
+SVEPPFEGXIVMSPSKMGEPP]GSRǻVQIH8'-.:GEWIWIRWYVI

ƽ (SRXEGXQEREKIQIRX .RZMXEXMSR8VEGMRKERHWGVIIRMRKSJEPPGSRXEGXW

ƽ 8'5VIZIRXMZI8LIVET] .58JSVEPPIPMKMFPI51-.:GSRXEGXWMWSǺIVIH8LMWMRGPYHIW
GLMPHVIRPMZMRK[MXL-.:YRHIVXLIEKISJ[MXLGSRXEGXXSFEGXIVMSPSKMGEPP]GSRǻVQIH
TB cases ŦåüåŹƐƒŇƐX‰FƐ̱ŤƒåŹƐŐŐƐ„åσĞŇĻƐüŇŹƐ‰ƐŤŹåƽåĻƒĞƽåƐƒĚåŹ±ŤDžŧ

6.2.7 Provision of Antiretroviral Therapy for TB/HIV Co-

Infected Patients
Timing of ART for TB/HIV co-infected patients:
a) For all newly diagnosed TB patients not yet on ART

ƽ XEVX8'XVIEXQIRXMQQIHMEXIP]

ƽ .RMXMEXI &78 EW WSSR EW ERXM8' QIHMGEXMSRW EVI XSPIVEXIH TVIJIVEFP] [MXLMR 
weeks. For TB meningitis consider delaying ART for up to 8 weeks.

ƽ 2SRMXSVGPSWIP]JSV.7.

b) For all newly diagnosed TB patients who are already on ART

ƽ XEVX8'XVIEXQIRXMQQIHMEXIP]

ƽ (SRXMRYI&78QEOMRKER]VIUYMVIHEHNYWXQIRXWXSXLI&78VIKMQIRFEWIHSR
drug-drug interactions. Always assess for ART failure in patients who develop TB
EJXIVFIMRKSR&78JSVǸQSRXLW

ƽ 2SRMXSVGPSWIP]JSV.7.

Patients being treated concurrently for TB and HIV require close monitoring for toxicity.
MDR TB and HIV co-infection should be managed in settings where close toxicity
monitoring and follow up by experienced clinicians is possible. Patients on TDF and
aminoglycosides are at high risk for renal toxicity and require close monitoring.

The following tables summarize the preferred ART regimens for TB/HIV co-infection in:

a) Patients newly initiating 1st line ART

b) Patients who develop TB while virally suppressed on 1st line ART

c) Patients who develop TB while failing 1st line ART

d) Recommended Ritonavir Dosing for Super-Boosting LPV/r in Children Taking

Rifampicin.

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Leprosy and Lung Disease | 2021
 NOTE:
There are updated guidelines for children and adolescents living with HIV on preferred ART
regimens as shown in the tables below.

Table 6.4: Preferred ART Regimens for TB/HIV Co-infection for Patients Newly
Initiating 1st Line ART

Age Scenario Recommendation

Birth – 4 weeks AZT + 3TC + RAL1 Start anti-TB treatment immediately; start ART after 4
weeks of age, once tolerating anti-TB drugs.

4 weeks - <20kgs ABC/3TC/LPV/r Super Boost LPV/ra

20kgs-35kgs ABC/3TC/DTGb Give ABC/3TC+DTG (morning) + DTG 50mg (evening)

during TB treatment and for additional 2 weeks after
TB treatment is completed, then revert back to AB-
C/3TC+DTGb

>35kg TDF/3TC/DTG DTGb x2 standard dose BD dosing until 2 weeks after

TB treatment is completed, then revert back on OD
dosing
1,a
+SVGLMPHVIR[LSGERRSXXSPIVEXI15:V78: YWYEPP]FIGEYWISJ,.WMHIIǺIGXWXLIEPXIVREXMZIVIKMQIR
MWHSYFPIHSWI7&1SV )8,SRGIETTVSTVMEXIJSVQYPEXMSRWEZEMPEFPIMJǸ]IEVWSPHMJ!]IEVWSPHYWI
triple-NRTI regimen of ABC + 3TC + AZT for the duration of TB treatment, then return to ABC + 3TC + LPV/r
upon completion of TB treatment.
b
For children >30kgs and HIV-TB co-infected, use double DTG standard dose and administer BD. Those who
cannot tolerate DTG, the alternative is RAL at X2 standard weight-based BD dosing

For patients on these regimens who become viremic consult Regional or National HIV Clinical TWG
ŦƣĮĞǍ±Ļ±žÏŇŤÄďķ±ĞĮũÏŇķŧ or call Uliza Toll-free Hotline 0800 72 48 48.

Table 6.5: Preferred ART Regimens for Patients who Develop TB while Virally
Suppressed on 1st Line ART1,2,3

Current Age Recommended substitution

Regimen

PI/r-based < 20kgs Super-boost LPV/r with additional RTV4

(above 4
After completion of TB treatment revert to the recommended
weeks old)
ǻVWXPMRIVIKMQIR &'(8(15:V

ǸOKW Switch from PI/r to DTG and continue this regimen even after
completing TB treatment (give DTG 50 mg BD for duration of
rifampicin-containing TB treatment, then reduce to DTG 50
mg once daily 2 weeks after TB treatment is completed). For
women and adolescent girls of childbearing potential continue
counselling on avoiding pregnancy before use of DTG

EFV-based Any age Continue the same regimen for the duration of TB treatment.
Consider for regimen optimization after completing TB treatment

128 Integrated Guideline for Tuberculosis,

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Current Age Recommended substitution
Regimen
RAL-based All ages Give double the standard dose of RAL until 2 weeks after
completion of rifampicin-based TB treatment, then reduce to
standard weight-based dosing

DTG-based

20kgs – 35kgs

DTG at x2 standard weight-based BD dosing until 2 weeks after completion of Anti TBs. return to
DTG OD 2 weeks after completion of anti TBs

>35kgs Give TDF/3TC/DTG FDC am + DTG 50mg pm for duration of

rifampicin-containing TB treatment and for an additional 2 weeks
after TB treatment is completed, then revert to TDF/3TC/DTG
FDC OD
1.
&PPTEXMIRXW[LSHIZIPST8'EJXIVFIMRKSR&78JSVǸQSRXLWWLSYPHFIEWWIWWIHJSV-.:
treatment failure
2.
For patients on 2nd line ART, subsequent regimens, or nonstandard drugs who require
regimen change because of TB treatment, consult the Regional or National HIV Clinical TWG
(Uliza Toll-free Hotline 0800-724848; [email protected])
3.
NRTIs in the patient’s current regimen do not require any adjustments with anti-TB treatment
4.
For children on rifampicin based anti-TB regimens, LPV/r should be “super-boosted” by
adding additional ritonavir suspension to manage the drug interaction between LPV/r and
rifampicin. Two weeks after TB treatment is completed the dosage of LPV/r should return to
WXERHEVHHSWMRK+SVGLMPHVIRǸ]IEV[LSGERRSXXSPIVEXI15:V78: YWYEPP]FIGEYWISJ,.
WMHIIǺIGXWXLIEPXIVREXMZIVIKMQIRMW7&1 SV)8,SRGIETTVSTVMEXIJSVQYPEXMSRWEZEMPEFPI
at x2 standard weight-based BD dosing until 2 weeks after TB treatment then continue with
RAL (or DTG) standard weight-based BD dosing.
5.
Guidelines recommend LPV/r for children < 3 years, however some children < 3 years maybe
on NVP due to LPV/r toxicity, consult the Regional or National HIV Clinical TWG (Uliza Toll-
free Hotline 0800 72 48 48; [email protected])

NOTE:
a) Studies of RAL in the treatment of pediatric TB are ongoing. Initial data from older
GSLSVXWWYKKIWXXLEXEHSYFPIHSWISJ7&1MWWEJIERHIǺIGXMZIMRXLIXVIEXQIRXSJ-.:
in children receiving TB therapy containing rifampicin. However, there is no data on the
treatment of TB in children under 2 years of age using RAL. Given the highly variable
pharmacokinetics in this age group, caution is advised and routine VL monitoring must
be followed

b) DTG formulations such as 5 mg and 10 mg may become available within the country and
will be the preferred option for TB/HIV patients rather than RAL

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Leprosy and Lung Disease | 2021
 Table 6.6: Recommended ART Regimens for Patients who Develop TB while Failing
1st Line ART

Age/Scenario First-line ART Second-line ART

Start anti-TB immediately. Super-boost the LPV/r 2
while following the viral load monitoring algorithm
(2018 ART guidelines Figure 6.5), including assessing
PI/r-based 1st line for and addressing reasons for treatment failure.

<20kgs 4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTEXMIRXMW
ready to switch to 2nd line, switch to DST-based 2nd
line2
Start anti-TB immediately

ABC (or AZT) + 3TC If <3 years, switch to AZT + ABC + 3TC while follow-
+ EFV ing the viral load monitoring algorithm, including
assessing for and addressing reasons for treatment
failure

If > 3 yrs and on EFV, continue current regimen

while following the viral load monitoring algorithm,
including assessing for and addressing reasons for
treatment failure

4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTEXMIRX
ready to switch to 2nd line, switch to AZT + 3TC +
LPV/r (with super-boosted LPV/r2 until 2 weeks after
completion of TB)
Start anti-TB immediately

Continue current regimen (if on DTG, then use

double dose until 2 weeks after TB treatment com-
pleted) while following the viral load monitoring
ABC (or AZT) + 3TC algorithm, including assessing for and addressing
+ DTG (or EFV) reasons for treatment failure

4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTEXMIRX
20 - 35kgs ready to switch to 2nd line, switch to AZT + 3TC +
LPV/r (with super-boosted LPV/r2 until 2 weeks
after completion of TB treatment). If patient was on
AZT-containing 1st line then switch to ABC in 2nd line
Start anti-TB immediately

Super-boost the LPV/r2 while following the viral load

monitoring algorithm (2018 ART guidelines Figure
PI/r-based 1st line 6.5), including assessing for and addressing reasons
for treatment failure

4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTEXMIRXMW
ready to switch to 2nd line, switch to DRT-based 2nd
line

130 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Age/Scenario First-line ART Second-line ART

Start anti-TB immediately

Add DTG 50 mg pm to their current regimen while

following the viral load monitoring algorithm (2018
TDF (or ABC or ART guidelines Figure 6.5), including assessing for
AZT) + 3TC + DTG and addressing reasons for treatment failure

4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTEXMIRX
ready to switch to 2nd line, switch to AZT + 3TC +
ATV/r (if on TDF or ABC in 1st line) and change to
rifabutin-based anti-TB treatment. If patient was on
AZT-containing 1st line then switch to TDF in 2nd line
Start anti-TB immediately

Continue current regimen (if on NVP, switch to EFV)

Ǹ]IEVW SV while following the viral load monitoring algorithm
TDF (or ABC or
ǸOKFSH] (Figure 6.5), including assessing for and addressing
AZT) + 3TC + EFV
weight) reasons for treatment failure
(or NVP)
4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTEXMIRX
ready to switch to 2nd line, switch to AZT + 3TC +
ATV/r (if on TDF or ABC in 1st line) and change to
rifabutin-based anti-TB treatment1. If patient was on
AZT-containing 1st line then switch to TDF in 2nd line
Start rifabutin-based anti-TB therapy immediately or
consult if rifabutin unavailable1

Continue current regimen while following the viral

PI/r-based 1st line load monitoring algorithm (Figure 6.5), including
assessing for and addressing reasons for treatment
JEMPYVI4RGIXVIEXQIRXJEMPYVIMWGSRǻVQIHERHTE-
tient is ready to switch to 2nd line,

Switch to DRT-based 2nd line

Pregnant or Consult the Regional or National HIV Clinical TWG urgently (Uliza Toll-free
Breastfeeding Hotline 0800 72 48 48; ƣĮĞǍ±Ļ±žÏŇŤÄďķ±ĞĮũÏŇķ)

HIV/HBV Co- &P[E]WQEMRXEMR8)+MRWIGSRHPMRIMRWXIEHSJW[MXGLMRKXSEHMǺIVIRX378.

and instead of adding an additional NRTI
infection

For patients on 2nd line ART, subsequent regimens, or nonstandard drugs who require regimen change
1.

because of TB treatment, consult the Regional or National HIV Clinical TWG (Uliza Toll-free Hotline 0800
72 48 48; ƣĮĞǍ±Ļ±žÏŇŤÄďķ±ĞĮũÏŇķ)
2.
Use “super-boosted” LPV/r by adding additional ritonavir suspension to manage the drug interaction
between LPV/r and rifampicin (see Table 6.7 for dosing recommendations). Two weeks after TB
XVIEXQIRXMWGSQTPIXIHXLIGLMPHWLSYPHKSFEGOXSWXERHEVH15:VHSWMRK+SVGLMPHVIRǸ]IEVW[LS
GERRSXXSPIVEXI15:V78: YWYEPP]FIGEYWISJ,.WMHIIǺIGXWXLIEPXIVREXMZIVIKMQIRMW7&1 SV)8,
once appropriate formulations available) at x2 standard weight-based BD dosing until 2 weeks after TB
treatment then continue with RAL (or DTG) standard weight-based BD dosing.

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 Rifampicin causes drug-drug interactions by cytochrome (CYP) p450 induction and
reduces LPV/r exposure by approximately 90% when used at the normal 4:1 ratio.
Ritonavir is an ideal pharmacologic enhancer because it inhibits cytochrome CYP3A4
in the intestines and in the liver, thus increasing LPV/r maximal plasma concentration
ERHLEPJPMJI8LMWIǺIGXMWQEKRMǻIH[LIR15:VMWWYTIVFSSWXIH[MXL7MXSREZMVJSVE
ratio, thus allowing for use of Rifampicin based TB treatment in children. In adults, the
drug interaction due to Rifampicin is avoided by using Rifabutin instead or using DTG
twice daily dosing instead of Protease Inhibitor (PI) based ART.

The table below shows the dosing of Ritonavir for super-boosting LPV/r in children who
need TB treatment while on PI based ART:

Table 6.7: Ritonavir Dosing for Super-Boosting LPV/r in Children Taking Rifampicin

Weight Standard Dosing of Lopinavir/ritonavir (LPV/r) (Twice Daily) Additional dosing

Range of ritonavir for
(kg) children taking
rifampicin (Twice
Daily)
LPV/r LPV/r LPV/r LPV/r Ritonavir liquid
80/20 mg/ml 40/10mg 100/25mg 200/50mg (80mg/ml, in
solution pellets tablets tablets 90 ml bottle).
(number Ritonavir dose
of pellets) is adjusted to
nearest mark
for the ease of
measurement
3 - 5.9 1 ml BD 2 BD Not Not 1 ml BD
recommended recommended
6 - 9.9 1.5 ml BD 3 BD Not Not 1 ml BD
recommended recommended
10 - 13.9 2 ml BD 4 BD 2 a.m. Not 1.5 ml BD
1 p.m. recommended

14 - 19.9 2.5 ml BD 5 BD 2 BD 1 BD 2 ml BD

20 - 24.9 3 ml BD 6 BD 2 BD 1 BD 2.5 ml BD

25 - 29.9 Not 7 BD 3 BD 2 am 4 ml am
recommended 2 ml pm
1 pm
30-34.9 Not 8 BD 3 BD 2 am 4 ml am
recommended 2 ml pm
1 pm
Ǹ Not 10 BD 4 BD 2 BD 4 ml BD
recommended

132 Integrated Guideline for Tuberculosis,

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6.2.8 Appointment Management
Schedule follow up for stable versus unstable TB patients:

1. For Stable patients:

ƽ .RXLIMRXIRWMZITLEWI(PMRMGETTSMRXQIRXWIZIV][IIOW 8[MGIEQSRXL

ƽ .RXLIGSRXMRYEXMSRTLEWI(PMRMGETTSMRXQIRXWIZIV][IIOW QSRXLP]

2. For unstable patients, more frequent appointments should be booked for closer
monitoring.

6.2.9 Adherence Preparation, Monitoring & Support

Following a TB diagnosis, patients should be supported using an individualized
patient management plan that includes establishing appropriate adherence support
interventions. This is essential for the patient’s well-being and good health outcomes.
To prevent non adherence and default from treatment the following measures are
essential:

1. Structural interventions including:

ƽ &WWIWWQIRXSJGPMIRXVIEHMRIWWXSMRMXMEXIERHGSRXMRYI[MXLXVIEXQIRX

ƽ &WWIWWQIRXJSVVMWOJEGXSVWJSVRSREHLIVIRGIIKEPGSLSPEFYWI

ƽ &TTVSTVMEXIXVIEXQIRXHIPMZIV]WIXXMRKWIK)MǺIVIRXMEXIW(EVI

ƽ 1MROEKIXSGSQQYRMX]FEWIHWIVZMGIWERHWSGMEPWYTTSVXTVSKVEQQIW

ƽ 4YXPMRIEVIXYVRXSGEVITEGOEKI

ƽ &HLIVIRGIQSRMXSVMRKXLVSYKLTEXMIRXWIPJVITSVXMRKERHTMPPGSYRXW

2. TB health education and literacy package:

ƽ -IEPXLXEPOWERHXVIEXQIRXPMXIVEG]

ƽ 4RISRSRITEXMIRXIHYGEXMSRWIWWMSRW

 .HIRXMǻGEXMSRSJXVIEXQIRXWYTTSVXIV)48WWYTTSVXIV

4. Address stigma and discrimination issues

ƽ (SRHYGX WXMKQE EWWIWWQIRX ERH WYTTSVX YWMRK ER MRHMZMHYEPM^IH 8'

treatment plan. Stigma may arise from the patient themselves, family
members, the community, and other patients

5. Defaulter prevention and tracking

ƽ 9WISJETTSMRXQIRXQEREKIQIRXW]WXIQ

ƽ 2VIQMRHIVW

ƽ -ERHPMRKXVIEXQIRXMRXIVVYTXMSRW

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Leprosy and Lung Disease | 2021
 6.2.10 Establishing TB/HIV Collaborative Activities
+SVIǺIGXMZIMQTPIQIRXEXMSRSJ8'-.:GSPPEFSVEXMZIEGXMZMXMIWXLIVIWLSYPHFIEHIUYEXI
coordination at county, sub county and facility level. The county and sub county TB/HIV
coordinating committees need to constantly conduct supportive supervision to identify
WXVIRKXLWERH[IEORIWWIWERHQSXMZEXIWXEǺ

Referrals within the health facility, to and from the community should also be
strengthened and made easy for the patients.

Collaborative TB/HIV activities which need to be implemented in facility settings are

summarized in the table below:

Table 6.8: Collaborative TB/HIV Activities

Objective/ Activity

A. To enhance TB/HIV collaboration (5 I’s)

ƽ .RXIRWMǻIH8'GEWIǻRHMRK
ƽ 8'5VIZIRXMZI8LIVET]
ƽ 8'MRJIGXMSRGSRXVSPMRLIEPXLGEVIWIXXMRKW
ƽ 8'-.:WIVZMGI.RXIKVEXMSR
ƽ .QQIHMEXI&78MRMXMEXMSR

B. To decrease the burden of TB in PLHIV

ƽ *RLERGIIEVP]HMEKRSWMWXLVSYKL.(+
ƽ +EGMPMXEXIMQQIHMEXI8'XVIEXQIRX
ƽ ]RGLVSRM^EXMSRSJETTSMRXQIRXW
ƽ XVIRKXLIRMRXIVMRXVEJEGMPMX]VIJIVVEPW

C. To decrease the burden of HIV in TB patients

1. -.:XIWXMRKERHGSYRWIPPMRKJSVGSRǻVQIHERHTVIWYQIHGEWIW
2. HIV combination prevention
3. Cotrimoxazole preventive therapy
4. HIV/AIDS care and support
5. Antiretroviral therapy to TB/HIV co-infected patients

134 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 8'ERH)MEFIXIW2IPPMXYW

KEY HIGHLIGHTS:

ƽ &PPEHYPX8'TEXMIRXWWLSYPHFIWGVIIRIHJSVHMEFIXIWEX8'XVIEXQIRXMRMXMEXMSR

ƽ 5EXMIRXW[MXLHMEFIXIWWLSYPHFIWGVIIRIHJSV8'EXIZIV]GPMRMGZMWMXYWMRK858.(+
symptom questionnaire

ƽ ,IRI<TIVX28'7.+MWXLITVIJIVVIHHMEKRSWXMGXIWXJSV8'MRHMEFIXIW

ƽ 8VIEXQIRXSJ8'MRTEXMIRXW[MXLHMEFIXIWMWWMQMPEVXSXLEXMRTEXMIRXW[MXLSYX
diabetes

ƽ 8'XVIEXQIRXMWEXGLIWX8'GPMRMG[LMPIGSQTVILIRWMZIHMEFIXIWQEREKIQIRX
should be in diabetes clinic.

ƽ -S[IZIVTEXMIRXIHYGEXMSRSRPMJIWX]PIQSHMǻGEXMSRERHFEWMGQSRMXSVMRKSJ
treatment for diabetes be also carried out in chest/TB clinic

ƽ .RWYPMRMWXLIHVYKSJGLSMGI[LIVIFPSSHWYKEVGSRXVSPMWRSXEXXEMRIHWIZIVI8'
renal disease or liver disease

ƽ (PSWIP]QSRMXSVXVIEXQIRXVIWTSRWIEHLIVIRGIERHEHZIVWIVIEGXMSRWXS8'ERH
diabetes

6.3.1 Introduction
Diabetes mellitus is a serious and usually life-long condition characterized by
hyperglycemia, as a result of defects in insulin secretion, insulin action or both. Insulin is
secreted as a hormone from the endocrine pancreas to regulate the level of glucose in
the body. The prevalence of diabetes is markedly increasing in every country, including
sub-Saharan Africa.

)MEFIXIWMWGPEWWMǻIHMRXSXLIJSPPS[MRKKIRIVEPGEXIKSVMIW

1. Type 1 diabetes Ƴ HYI XS EYXSMQQYRI TERGVIEXMG GIPP HIWXVYGXMSR YWYEPP]

PIEHMRKXSEFWSPYXIMRWYPMRHIǻGMIRG]ERHEGGSYRXWJSVƳ SJHMEFIXIW

2. Type 2 diabetesƳHYIXSETVSKVIWWMZIPSWWSJEHIUYEXITERGVIEXMGGIPPMRWYPMR
secretion in the background of insulin resistance; accounts for over 90% of
diabetes

 TIGMǻGGEYWIWSJHMEFIXIWWYGLEW
ƽ QSRSKIRMGHMEFIXIWW]RHVSQIWƳQEXYVMX]SRWIXHMEFIXIWSJXLI]SYRK
ƽ HMWIEWIWSJXLII\SGVMRITERGVIEWƳG]WXMGǻFVSWMWGLVSRMGTERGVIEXMXMW
ƽ IRHSGVMRIHMWIEWIWƳ(YWLMRKƶWW]RHVSQIEGVSQIKEP]
ƽ HVYKMRHYGIHHMEFIXIWƳW]WXIQMGKPYGSGSVXMGSMHWERXMTW]GLSXMGW
4. Gestational diabetes – diagnosed in the second or third trimester

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 Diabetes can result into many serious complications including microvascular and
macrovascular complications. Globally, 15% of tuberculosis cases are estimated to be
attributable to diabetes. Among diabetic patients, the risk of TB increases. Diabetes
increases the risk of developing active tuberculosis 2 to 3-fold and is associated with
worse tuberculosis treatment outcomes. Diabetes may also potentiate the adverse
IǺIGXWSJWSQIERXM8'HVYKWIWTIGMEPP]VIREPH]WJYRGXMSRERHTIVMTLIVEPRIYVSTEXL]

On the other hand, tuberculosis disease, can lead to stress-induced hyperglycemia and
unmask diabetes in susceptible individuals. Some anti-TB drugs like Isoniazid also have
L]TIVKP]GIQMGIǺIGXW&HHMXMSREP[E]WXLEXXLIX[SHMWIEWIWMRXIVEGXEVIEWWLS[RMR
the table below.

Table 6.9: Interactions between Diabetes Mellitus and Tuberculosis

*ǺIGXSJ)MEFIXIW2IPPMXYWSR8' *ǺIGXSJ8'SR)MEFIXIW2IPPMXYW

On incidence and prevalence - TB may unmask diabetes

- increases risk of TB 2-3 times - TB increases glucose intol-

erance and hyperglycemia
- increases risk of MDR-TB
- TB impairs glycemic control
On clinical presentation

- TB may present atypically

- TB may progress faster

- TB may present with more chest and systemic symp-

toms

- TB may present with more frequents and higher grade

smear/culture positivity

On response to TB treatment

- prolonged smear/ culture positivity

- higher risk of adverse drug reactions eg hepatitis, renal

XS\MGMX],.8IǺIGXW

On TB treatment outcome

- increased risk of death

- increased risk of treatment failure

- increased risk of loss to follow-up

- increased risk of relapse

On post-TB complications

- extensive TB disease, late presentation & delayed diagnosis/treatment initiation may increase
risk of post-TB complications like chronic obstructive and chronic restrictive lung disease

136 Integrated Guideline for Tuberculosis,

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6.3.2 Risk factors for diabetes mellitus

Table 6.10: Risk Factors for Diabetes Mellitus

3SRQSHMǻEFPIVMWOJEGXSVWJSV)2 2SHMǻEFPIVMWOJEGXSVWJSV)2

Age (increasing age >40 years) Overweight/obesity

Gender (higher in males) Physical inactivity

Family history of diabetes Dietary factors (red meat, sugary beverages)

Genetic markers Alcohol consumption and tobacco use

Ethnicity (higher in Africans and Asians) Hypertension

Previous gestational diabetes 5VIREXEPIEVP]PMJIMRǼYIRGIW TVIQEXYVMX]

6.3.3 Symptoms of diabetes

Figure 6.3: Symptoms of Diabetes

The Classic Symptoms of DM are:

Polyuria– need to urinate frequently Polydipsia – increased thirst

ERHǼYMHMRXEOI Tiredness and fatigue

Unexpected weight loss

Other key symptoms of DM include:

Blurred vision Increased appetite/ Extreme Slow healing of wounds

hunger

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 6.3.4 Diagnosis of Diabetes Mellitus and pre-Diabetes
Diabetes is a chronic progressive disease and its diagnosis is not always straightforward.
8LI XLVIWLSPH SV GYXSǺZEPYIW JSV HMEKRSWMW EVI PEVKIP] FEWIH SR XLI PIZIPW EX[LMGL
XLIVMWOSJGSQTPMGEXMSRWMRGVIEWI)MEFIXIWQE]XLYWFIMHIRXMǻIHER][LIVIEPSRKXLI
spectrum of clinical scenarios.

The WHO recommends the following four tests for the diagnosis of diabetes and pre-
diabetes:

1. Oral glucose tolerance test (OGTT)

2. Fasting blood glucose (FBG)

3. Glycosylated haemoglobin (HbA1c)

4. Random blood glucose in the presence of signs and symptoms of DM

8LIXEFPIFIPS[KMZIWXLIGYXSǺTSMRXWJSVHMEKRSWMWSJHMEFIXIWERHTVIHMEFIXIW

8EFPI8LVIWLSPHWERHGYXSǺTSMRXWJSVHMEFIXIWERHTVIHMEFIXIW

Diagnostic Test Normal Pre-diabetes Diabetes

Values

Fasting blood glucose >3.5 to <5.5 5.6 to 6.9 mmol/L >7.0 mmol/L
(FPG) mmol/L

Two-hour blood glucose <7.8 mmol/L 7.8 to 11.1 mmol/L >11.1 mmol/L
(2-h PG) during oral
glucose tolerance test
(OGTT) using 75gm
glucose in water

Glycated haemoglobin <42 mmol/L 42-47 mmol/L >47 mmol/L

A1c (HbA1c)
(<6.0%) (6.0-6.4%) (>6.4%)

Random blood glucose >3.5 to 7.8 7.8 to 11.0 mmol/L >11.1 mmol/l if classic
mmol/L symptoms of diabetes or
hyperglycaemic crisis are
present.

š±ĮƣåžƐ±ŹåƐƱžåÚƐŇĻƐŤĮ±žķ±ƐďĮƣÏŇžåƐŦƽåĻŇƣžŧƐž±ķŤĮåžũ

8LIHMEKRSWMWSJ)2MWQEHIYWMRKXLIWIXLVIWLSPHWERHGYXSǺTSMRXWFEWIHSR[LIXLIV
the person investigated is žDžķŤƒŇķ±ƒĞÏ (for example, polyuria, polydipsia, unexplained
weight loss) or ±žDžķŤƒŇķ±ƒĞÏ.

138 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 NOTE:
 Ƹ+EWXMRKƹMWHIǻRIHEWRSGEPSVMGMRXEOIJSVEXPIEWXIMKLXLSYVW

2. “OGTT” The test should be performed as described by World Health Organization (WHO),
using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in
QP[EXIVMRKIWXIHSZIVǻZIQMRYXIW

 Ƹ7ERHSQƹ GEWYEPMWHIǻRIHEWER]XMQISJHE][MXLSYXVIKEVHXSXMQISJPEWXQIEP

The classic symptoms of hyperglycaemia include polyuria, polydipsia and weight loss.
“Hyperglycaemic crisis” refers to diabetic ketoacidosis or hyperosmolar nonketotic
hyperglycaemia.

 1MJIWX]PIQSHMǻGEXMSRWMRGPYHI[IMKLXQEREKIQIRXEHIUYEXITL]WMGEPI\IVGMWIERH
PS[GEVFSL]HVEXIPS[JEXLMKLǻFVIHMIX

6.3.5 Bi-directional screening and diagnosis of Diabetes

Mellitus and TB
&PP GSRǻVQIH HMEKRSWIH8' TEXMIRXW WLSYPH FI WGVIIRIH JSV HMEFIXIW EX XLI XMQI SJ
diagnosis or registration for TB.

Additionally, all people diagnosed with Diabetes Mellitus should be screened for
Tuberculosis at each clinic appointment.

The following two algorithms are used in bi-directional screening.

Figure 6.4: Screening and diagnosis of diabetes in people with TB

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 Figure 6.5: Screening and diagnosis of TB in people with diabetes

ÃÉƐŤŹåƽåĻƒĞƽåƐƒĚåŹ±ŤDžƐĞžƐĻŇƒƐŹåÏŇķķåĻÚåÚƐüŇŹƐŤ±ƒĞåĻƒžƐƾЃĚƐÚбÆåƒåžũ

6.3.6 Management of Diabetes Mellitus and TB

The management of diabetes is aimed at reducing short- and long-term complications
VIPEXIHXSXLIHMWIEWI8LIQEREKIQIRXSJHMEFIXIWGSRWMWXWSJPMJIWX]PIQSHMǻGEXMSRMI
diet, weight loss, physical activity, smoking cessation, avoiding alcohol, administration
of glucose lowering agents, instituting measures to reduce risk of cardiovascular and
related complications, and management of existing complications like diabetic foot,
neurological and eye problems.

In patients with both diabetes and TB, the priority is to treat TB disease while at the same
time controlling the blood glucose levels. In such patients, TB should be treated at the
chest/TB clinic while diabetes should be treated in conjunction with diabetes specialists.
However, the chest clinicians should be able to give patient education geared towards
PMJIWX]PI QSHMǻGEXMSR IRWYVI XLEX XLI TEXMIRX MW EHLIVIRX XS XLI KPYGSWI PS[IVMRK
medications, and be aware of the patient’s blood glucose levels. The comprehensive
management of diabetes should be left with the diabetes specialists. To minimize
transmission of TB it is important to minimize visits to the diabetes clinics especially in
XLIǻVWX[IIOWXSQSRXLWSJ8'XVIEXQIRXJSVFEGXIVMSPSKMGEPP]GSRǻVQIHTEXMIRXW

Treatment of drug sensitive and drug resistant TB is similar in persons with or without
diabetes. Rifampicin may cause new-onset hyperglycemia or worsen glycemic control
in existing diabetes. Insulin is the preferred treatment in early stages of TB treatment,
in severe TB and in renal or liver impairment. Note that insulin requirements might
increase while on Rifampicin. Later the patients can be switched to Oral Glycemic

140 Integrated Guideline for Tuberculosis,

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Agents (OGLAs) with caution once the disease has settled. Metformin is preferred as
the OGLA for patients with TB since it is not metabolized by cytochrome P450 enzymes
compared to other OGLAs which have drug-drug interactions with rifampicin (due to
induction of cytochrome P450 enzymes) that limit their use e.g. sulfonylureas.

Optimal glycemic control might improve outcomes of tuberculosis treatment and prevent
many of the complications associated with diabetes. However, tuberculosis often leads
XS HIGVIEWIW MR ETTIXMXI FSH][IMKLX ERH TL]WMGEP EGXMZMX] EPP SJ [LMGL QMKLX EǺIGX
KPYGSWI LSQSISWXEWMW 8' XVIEXQIRX GER LEZI STTSWMXI FYX YRTVIHMGXEFPI IǺIGXW F]
HIGVIEWMRKMRǼEQQEXMSRERHMRGVIEWMRKETTIXMXIFSH][IMKLXERHTL]WMGEPEGXMZMX]EW
WLS[RMRXLIǻKYVIFIPS[

+MKYVI+EGXSVWEǺIGXMRKKP]GIQMGGSRXVSPJSVTEXMIRXW[MXLHMEFIXIWHYVMRK8'
treatment

6.3.7 Comprehensive Diabetes management

The goals of management of DM include controlling blood glucose as well as reducing
short-term and long-term complications such as cardiovascular disease, eye problems
and foot amputations. Personalized pragmatic glycemic targets might be needed that
account for various factors, such as severity and prognosis of a patient’s TB disease,
risk of adverse events such as hypoglycemia, duration of diabetes, comorbidities, age,
patient capabilities and treatment preferences, and available resources. Increased
vigilance is needed in monitoring treatment response to both the anti-TB and diabetes
treatment by doing the routine sputum follow-ups, blood glucose levels, renal function,
monitoring adherence, adverse events and other complications.

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 Poorly controlled Type 1 diabetes increases the risk of stunted growth and diabetes
complications, including diabetic ketoacidosis. Comprehensive management of Type 1
diabetes includes the following:

1. Insulin treatment – required for all type 1 diabetes patients

2. Blood glucose monitoring

3. HBA1c monitoring

4. Nutritional management and physical activity

5. Diabetes education

6. Psychosocial support

Insulin comes in two broad categories as shown below:

1. Human insulin – short acting (regular or soluble), intermediate (Neutral protamine

Hagedorn insulin, Humulin N, Insulatard), and pre-mix short-acting (regular) and
intermediate-acting (NPH) insulins usually in the combination 70/30 (Mixtard,
Humulin) or 50/50 (Humulin 50/50)

2. Analogue insulin – rapid acting (Humalog, Novo rapid, Apidra), long acting
(Levemir, Lantus) and pre-mix (Humalog 75/25, NoVo mix 70/30)

8LIJSPPS[MRKǻKYVIWYQQEVM^IWXLIQSHISJEGXMSRERHEHQMRMWXVEXMSRSJXLIZEVMSYW
types of insulin currently available.

Figure 6.7: Types of Insulin, mode of action and administration of Insulin

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Comprehensive management of Type 2 diabetes includes the following:

1. Treatment of hyperglycemia and hypoglycemia

2. Treatment of hypertension and dyslipidemia

3. Prevention and treatment of micro-vascular complications (retinopathy,

neuropathy, nephropathy, sexual dysfunction and diabetic foot)

4. Prevention and treatment of macro-vascular complications (coronary artery

disease, cerebrovascular disease and peripheral vascular disease)

Lifestyle changes and nutritional management complement pharmacological treatment

of hyperglycemia in diabetic patients. Oral pharmacotherapy is indicated for patients with
Type 2 diabetes when an individual’s glycemic targets are not met by the combination
SJ HMIXEV] QSHMǻGEXMSRW ERH TL]WMGEP EGXMZMX]I\IVGMWI 8LI GLSMGI SJ 4VEP ,PYGSWI
Lowering Agents (OGLAs) should depend on the patient’s characteristics, lifestyle,
degree of glycemic control, cardiovascular and renal risks, access to drugs, economic
status and agreement between the doctor and the person living with diabetes.

Table 6.12 below summarizes the characteristics of the OGLAs which are frequently
used in controlling glycaemia in diabetes care. The list is not exhaustive but includes
agents that are most commonly used in Kenya.

8EFPI4VEPKPYGSWIPS[IVMRKEKIRXWMHI*ǺIGXWERH(SRXVEMRHMGEXMSRW

Drug 2ENSVMHI*ǺIGX Contraindication / Precautions

A. Sulphonylureas – stimulate the pancreas to release insulin (regardless of time and glucose
levels

Glibenclamide Hypoglycemia, weight gain, skin Caution in liver and renal disease
rashes
Gliclazide MR Hypoglycemia, weight gain, skin Pregnancy, caution in liver disease
rashes
Glimepiride Hypoglycemia, weight gain, skin Pregnancy, caution in liver and renal
rashes disease
Glipizide Hypoglycemia, weight gain, skin Pregnancy, caution in liver and renal
rashes disease
B. Biguanides – cause reduction glucose production in liver and peripheral insulin resistance

Metformin Nausea, diarrhea, abdominal Renal failure (GFR <30 ml/min), heart
bloating failure stage 3 or 4 and liver failure
C. Thiazolidinediones – improve insulin sensitivity in muscle, adipose tissue and liver, reduce
glucose output from liver and change fat distribution by decreasing visceral fat and increasing
peripheral fat
Pioglitazone 1MZIVMQTEMVQIRXǼYMHVIXIRXMSR Heart failure, liver failure; pregnancy
weight gain, dilutional anemia, and bone fractures
osteoporosis

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 Drug 2ENSVMHI*ǺIGX Contraindication / Precautions

D. Meglitinides – stimulate the pancreas to release more insulin

Caution in liver disease (metabolized

Repaglinide Hypoglycemia
primarily in the liver)

E. Alpha glucosidase inhibitors – slow digestion of complex sugars (sucrose and starch) by and
therefore delay glucose absorption, leading to slow post-meal rise in blood glucose

Acarbose Flatulence, diarrhea, abdominal Renal failure (GFR <25 ml/min)

pain

F. Dipeptidyl-peptidase-4 inhibitors – increase incretin hormones causing increased insulin

release and decreased glucagon secretion from the pancreas (leading to reduced hepatic
glucose production)

Sitagliptin Headaches, skin reactions, Allergic reaction, pancreatitis

pancreatitis
Vildagliptin Headaches, skin reactions, Allergic reaction, pancreatitis
pancreatitis
Saxagliptin Headaches, skin reactions, Allergic reaction, pancreatitis,
pancreatitis caution in heart failure
Linagliptin Headaches, skin reactions, Allergic reaction, pancreatitis
pancreatitis

G. Sodium-glucose co-transporter-2 inhibitors – suppress renal glucose reabsorption resulting

in increased urinary glucose excretion

)ETEKPMǼS^MR Genital and urinary tract Dose adjustment in renal disease

infections
*QTEKPMǼS^MR Genital and urinary tract Dose adjustment in renal disease
infections

H. Glucagon-like peptide-1 receptor agonists - increase insulin secretion while inhibiting

glucagon release and delays gastric emptying with subsequent decreased food intake

Liraglutide Nausea, vomiting Medullary thyroid carcinoma

Exenatide Nausea, vomiting Medullary thyroid carcinoma

In initiating treatment for people living with type 2 diabetes, the use of HbA1c test is
important. Table 6.7 provides a guide for initiating therapy using the HbA1c levels.

As patients with diabetes are at increased risk of TB disease, the general principles
of Infection Prevention and Control of TB transmission should be applied in diabetes
clinics. These include administrative, environmental and personal protection measures.

6.3.7 Recording and reporting for diabetes mellitus and tb

Screening for and diagnosis of diabetes in patients with TB should be recorded in the
primary tools for managing patients with TB including TB patient record card (TB5),
treatment register (TB4), patient appointment cards and TIBU. Screening for and

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HMEKRSWMWSJ8'MRTEXMIRXW[MXLHMEFIXIWWLSYPHFIVIGSVHIHMRTEXMIRXǻPIWGLEVXWERH
registers used in diabetic outpatient clinics.

Figure 6.7: Medical management of Type 2 Diabetes Based on HbA1c levels

6.4 TBMRQIRXEPLIEPXLERHWYFWXERGIHITIRHIRGI
The risk of active TB is substantially elevated in persons who consume more than 40 g
alcohol per day; most likely due to depressed immune system. Alcohol is also injurious
to the liver in various ways including:

1. Alcohol-associated fatty liver (steatosis) – via reduced oxidation of hepatic fatty

acids and increased lipogenesis

2. Alcohol-associated steatohepatitis – via impaired cell mediated immunity with;

TIVWMWXIRX LITEXMG MRǼEQQEXMSR GEYWMRK PSWW SJ LITEXMG VIKIRIVEXMSR GETEGMX]
ERHTVSKVIWWMZIǻFVSWMW

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 Anti-TB drugs may also lead to drug induced liver injury. Alcohol use and abuse increase
oxidative stress, while the combination of alcohol and anti-TB drugs may lead to a
higher risk of hepatic reactions. It is advisable therefore, to encourage patients on anti-
TB treatment to avoid alcohol use entirely or at least during treatment.

Cigarette smoking is the leading preventable cause of mortality. Tobacco smoking

should be strongly discouraged in TB patients since it is injurious to body organs in
various ways:

ƽ QSOMRKXSFEGGSLEWFIIREWWSGMEXIH[MXLWIZIVEPGERGIVWMRZEVMSYWWMXIWWYGL
as lung, bladder, colorectal, liver, kidney, head and neck

ƽ 8SFEGGSWQSOMRKGERGEYWIGEVHMSZEWGYPEVHMWIEWIERHHIEXLHYIXSGSVSREV]
vasoconstriction, increased hypercoagulability, dyslipidemia, and endothelial
dysfunction

ƽ (MKEVIXXIWQSOMRKMWXLIQSWXMQTSVXERXVMWOJEGXSVJSV(45)ERHMWMQTPMGEXIHEW
[IPPMRMRXIVWXMXMEPPYRKHMWIEWIWERHTYPQSREV]ǻFVSWMW

ƽ (MKEVIXXIWQSOMRKGSRJIVWEVIPEXMZIVMWOSJEFSYXXSJSVXLIHIZIPSTQIRXSJ
TB while also is a risk factor for TB relapse and mortality.

ƽ QSOMRKMRGVIEWIWVMWOSJHIZIPSTMRKX]TI)2SWXISTSVSWMWMR[SQIRHIPE]IH
wound healing and peptic ulcer disease

5EXMIRXW[MXL8'QE]WYǺIVJVSQQIRXEPHMWSVHIVWWYGLEWHITVIWWMSRER\MIX]HMWSVHIVW
and post-traumatic stress disorder. This may be compounded by the fact that TB and
mental illnesses have similar underlying factors such as poverty, malnutrition and
stress. Persons with mental illnesses and substance use disorders are more likely to
be exposed to TB, develop active TB, delay seeking care, miss doses and default from
treatment. There is also a greater risk for advanced disease, drug resistance, treatment
failure, death, and community transmission (prolonged infectiousness). Incidence of
mental and substance abuse disorders in TB patients may occur due to various reasons:

ƽ &WEVIWYPXSJXLIHMEKRSWMWƳPMROIHXSWXMKQE

ƽ &WEVIWYPXSJ8'QIHMGEXMSRW

ƽ *\EGIVFEXMSRSJGYVVIRXHMEKRSWIHQIRXEPLIEPXLGSRGIVRW

ƽ &WERI[TVIWIRXEXMSRSJYRHMEKRSWIHQIRXEPLIEPXLGSRGIVRW

Patients receiving TB treatment should be encouraged to abstain from alcohol and/

or other substances. Strict DOT should be implemented for patients with substance
dependence at high risk of abandoning treatment. Adherence support should be
established to avoid treatment interruption as much as possible to avoid development
of drug resistant TB.

Further recommendations for mental health and substance dependence screening in

TB patients include:

ƽ &PP8' GSMRJIGXIH WLSYPH VIGIMZI FEWMG WGVIIRMRK JSV HITVIWWMSR YWMRK XLI
PHQ-9 tool (Annex 6.3a and b) before initiating TB treatment, and regularly
during follow-up, and whenever there is a clinical suspicion of depression.

146 Integrated Guideline for Tuberculosis,

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 ƽ &PPEHYPXERHEHSPIWGIRX8'TEXMIRXWWLSYPHFIWGVIIRIHJSVEPGSLSPXSFEGGS
and substance dependence before initiating TB treatment and regularly
during follow-up using CAGE–AID for adults (Annex 6.1a and b) and CRAFFT
tools for adolescents (Annex 6.2a and b) respectively.

ƽ &PPGEVIKMZIVWJSVGLMPHVIRERHEHSPIWGIRXWWLSYPHEPWSVIGIMZIFEWIPMRIERH
follow-up screening for depression and alcohol/drug use using the above
mentioned tools.

6.5 TB and liver disease

Patients with history of liver disease can receive anti-TB drug regimens provided there
is no clinical evidence of severe chronic liver disease, hepatitis virus carriage (especially
Hepatitis C), recent history of acute hepatitis or excessive alcohol consumption.
Hepatotoxicity following use of anti-TBs however, may be more common in these
patients and close monitoring of liver enzymes is advised.

Pyrazinamide is the most hepatotoxic anti-TB agent, while rifampicin is least likely to
cause hepatocellular damage, although it is associated with cholestatic jaundice with
elevations in serum bilirubin and alkaline phosphatase concentrations. There is also
overlap in the pattern of liver injury caused by rifampin, isoniazid, and pyrazinamide; all
three may be associated with elevations in serum transaminase concentrations. Patients
should be counseled to avoid use of alcohol and drugs associated with hepatotoxicity
(such as Paracetamol).

Patients should be educated about the signs and symptoms of hepatic toxicity; these
include anorexia, nausea, vomiting, dark urine, icterus, rash, pruritus, fatigue, fever,
abdominal discomfort (particularly right upper quadrant discomfort), easy bruising or
bleeding, and arthralgias. All symptomatic patients should be evaluated clinically and
have liver function tests performed.

In patients with unstable or advanced liver disease, liver function tests should be
conducted at treatment initiation to determine a baseline and determine severity. Clinical
judgement is necessary where a patient with TB has a concurrent acute hepatitis that is
unrelated to TB or anti-TB treatment. In some cases, anti-TB treatment may be deferred
until the acute hepatitis has resolved. In other cases where TB treatment is needed
during acute hepatitis, use a combination of four non-hepatotoxic drugs. Patients must
continue follow-up by a specialist during TB treatment.

An asymptomatic increase in aspartate transaminase concentration occurs in

approximately 20% of patients treated with the standard four-drug regimen; in most
patients, asymptomatic aminotransferase elevations resolve spontaneously over days
to weeks. Generally, majority of patients on TB treatment do not develop hepatotoxicity
and it is not necessary to monitor liver function unless there is a clinical reason (such as
history of prior liver disease or injury).

Risk factors for drug-induced liver injury include underlying liver disease (particularly
hepatitis C) and co-administration of antiretroviral therapy for patients with HIV infection,
especially with use of NNRTIs such as NVP.

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 The approach to management of hepatotoxicity associated with antituberculous
drugs should be guided by liver function test results and the agent(s) most suspected
of causing such results. In general, all hepatotoxic drugs should be discontinued if
XLI WIVYQ FMPMVYFMR MW Ǹ xQSP1 SV WIVYQ XVERWEQMREWIW EVI QSVI XLER ǻZI XMQIW
the upper limit of normal. Once liver function tests return to baseline (or fall to less
than twice normal), potentially hepatotoxic drugs can be restarted one at a time with
careful monitoring between resumption of each agent. Close expert consultation with a
physician or hepatic specialist or the National Program is advised if possible.

For further information on detection and management of hepatitis induced by anti-TB

drugs, review Chapter 15 on Pharmacovigilance (section on adverse events associated
with Anti-TB drugs).

6.6 TB and kidney disease

8LI XIVQ OMHRI] HMWIEWI VIǼIGXW XLI IRXMVIX] SJ EGYXI OMHRI] HMWIEWIW ERH HMWSVHIVW
ERH GLVSRMG OMHRI] HMWIEWI ERH GER FI HIǻRIH JYVXLIV FEWIH SR HYVEXMSR MI &GYXI
OMHRI] HMWIEWI HYVEXMSR Ƿ QSRXLW SV (LVSRMG OMHRI] HMWIEWI HYVEXMSR # QSRXLW
The risk of TB among patients with chronic renal disease risk is 6.9 to 52.5 times that
of individuals without renal disease. Uremia causes reduced cellular immunity. Other
factors that may diminish immunity in the setting of renal failure include malnutrition,
ZMXEQMR)HIǻGMIRG]ERHL]TIVTEVEXL]VSMHMWQ

Urogenital tuberculosis (TB) is the third most common form of extrapulmonary TB (after
P]QTLRSHIMRZSPZIQIRXERHXYFIVGYPSYWTPIYVEPIǺYWMSR(SQTPMGEXMSRWSJVIREPERH
urologic TB can lead to chronic kidney disease, especially in the setting of bilateral renal
involvement and/or in the setting of interstitial nephritis or glomerulonephritis. Acute
OMHRI]HMWIEWIGERFIJYVXLIVHIǻRIHEWJSPPS[W

ƽ &GYXIOMHRI]HMWIEWI &0)Ƴ&GYXI0MHRI].RNYV] &0.SV,+7!Q1QMRTIV

1.73 m2SVQEVOIVWSJOMHRI]HEQEKIJSVǷQSRXLWSVHIGVIEWIMR,+7F]Ǹ 
SVMRGVIEWIMRWIVYQGVIEXMRMRIF]# JSVǷQSRXLW

ƽ &GYXI OMHRI] MRNYV] &0. Ƴ WYFGEXIKSV] SJ &0) SPMKYVME JSV # LSYVW VMWI MR
serum creatinine >0.3 mg/dL in 2 days or by >50% in 1 week

(LVSRMGOMHRI]HMWIEWI (0)MWHIǻRIHEW,+7!Q1QMRTIVQ2 or markers of

OMHRI] HEQEKI JSV # QSRXLW (0) GER FI JYVXLIV GPEWWMǻIH SR FEWMW SJ ,PSQIVYPEV
Filtration Rate as shown in the Figure 6.8 with the treatment options outlined.

148 Integrated Guideline for Tuberculosis,

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Figure 6.8: Stages of Chronic Kidney Disease and Recommended Action Plan

Patients with CKD Stage 5 undergoing chronic dialysis are 6–52.5 times more likely
to develop TB than the general population, mainly because of the impaired cellular
MQQYRMX]5VSXIMRQEPRYXVMXMSR^MRGERHT]VMHS\MRIHIǻGMIRG]ERHHIJIGXWMRPIYOSG]XI
function following exposure to dialysis membranes increase the susceptibility of dialysis
patients to TB.

Extra-pulmonary TB in patients on dialysis is more frequent (reported to be between

50% and 100%) with the most common forms of presentation being lymphadenitis,
KEWXVSMRXIWXMREP FSRI KIRMXSYVMREV] TIVMXSRMXMW TPIYVEP IǺYWMSR TIVMGEVHMEP IǺYWMSR
miliary TB, and pyrexia of unknown origin (PUO). TB in dialysis has a poor prognosis and
LMKL QSVXEPMX] QEMRP] HYI XS HIPE] MR HMEKRSWMW ERH EHZIVWI IǺIGXW SJ ERXM8' HVYKW
Therefore, a high index of suspicion for early TB diagnosis and treatment is required in
patients on dialysis.

5EXMIRXW[MXLVIREPJEMPYVISVWIZIVIVIREPMRWYǽGMIRG]GERVIGIMZIXLIWXERHEVHERXM8'
regimens. Isoniazid and Rifampicin are eliminated by biliary excretion, so no change in
HSWMRKMWRIGIWWEV]8LIVIMWWMKRMǻGERXVIREPI\GVIXMSRSJIXLEQFYXSPERHQIXEFSPMXIW
of pyrazinamide, and doses should therefore be adjusted. Three times per week
administration of these two drugs at the following doses is recommended: pyrazinamide
(25 mg/kg), and ethambutol (15 mg/kg). While receiving isoniazid, patients with severe
VIREPMRWYǽGMIRG]SVJEMPYVIWLSYPHEPWSFIKMZIRT]VMHS\MRIMRSVHIVXSTVIZIRXTIVMTLIVEP
neuropathy.

8VIEXQIRXSJ8'MRHMEP]WMWMWHMǽGYPXERHGLEPPIRKMRK8LIVIMWELMKLMRGMHIRGISJWMHI
IǺIGXW JVSQ ERXM8' HVYKW IWTIGMEPP] RIYVSTW]GLMEXVMG LITEXMG ERH KEWXVSMRXIWXMREP
For patients on hemodialysis, administration of Ethambutol and Pyrazinamide should
be done immediately after hemodialysis to facilitate directly observed therapy and
minimize premature removal of the drugs.

Generally, it is not necessary to monitor renal or liver function, or blood counts unless
there are clinical reasons to do so (e.g. a history of prior renal disease or injury or co-
QSVFMHHMWIEWIWXLEXQE]EǺIGXXLIOMHRI]WYGLEW-.:SVL]TIVXIRWMSR8LITEXMIRX

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 should be reviewed by the renal specialist regularly in the renal unit while undergoing
TB follow-up at the TB clinic. The patient undergoing dialysis should use appropriate
IPC methods while in the dialysis unit.

5EXMIRXW[MXLVIREPMRWYǽGMIRG]QE]LEZIEHHMXMSREPGPMRMGEPGSRHMXMSRW WYGLEWHMEFIXIW
[MXLEWWSGMEXIHKEWXVSTEVIWMWXLEXQE]EǺIGXXLIEFWSVTXMSRSJERXMXYFIVGYPSYWHVYKW
or may be taking other medications that interact with antituberculous drugs. Therefore,
careful clinical and pharmacological assessment is required.

6.7 TB in pregnancy and lactation

6.7.1 TB and pregnancy

5VIKRERG]LEWRSXFIIRWLS[RHIǻRMXMZIP]XSMRǼYIRGIXLITEXLSKIRIWMWSJ8'SVXLI
likelihood of progression from latent infection to active disease, nor has it been shown
XSEǺIGXXLIVIWTSRWIXSXVIEXQIRX8'MRTVIKRERG]LS[IZIVGERTVIWIRXMRWMHMSYWP]
since symptoms of malaise and fatigue may be attributed to pregnancy rather than
HMWIEWI.REHHMXMSRHYVMRKTVIKRERG]MXGERFIHMǽGYPXXSVIGSKRM^I[IMKLXPSWW

Pregnant women with active TB disease should be treated as soon as the diagnosis of
TB has been made with the standard 6-month regimen of 2RHZE/4RH. These anti-TBs
are not dangerous in pregnancy and are compatible with breastfeeding. Active TB in
pregnancy is associated with adverse maternal and fetal outcomes; untreated active TB
represents a greater hazard to the mother and fetus than anti-TB therapy.

Pregnancy and the early postpartum period may confer increased risk for isoniazid-
induced hepatotoxicity. Therefore, pregnant women and postpartum women within
three months of delivery should have baseline liver function testing prior to initiation of
treatment for active TB and monthly testing in follow-up. Additional evaluation includes
testing for HIV and hepatitis B and C.

Adherence to anti-TBs will cure tuberculosis, and prevent spreading tuberculosis to

XLI YRFSVR GLMPH EW [IPP EW XLI LSYWILSPH .HIRXMǻGEXMSR ERH XVIEXQIRX SJ QEXIVREP
8'MWXLIFIWX[E]SJTVIZIRXMRK8'MRXLIRI[FSVR8LIVIMWRSWMKRMǻGERXMRGVIEWIMR
malformations for infants born to infected mothers and there is also no indication for
therapeutic abortion.

6.7.2 TB and lactation

Breast feeding should be continued during anti-TB therapy as the excretion of these
HVYKWXLVSYKLFVIEWXQMPOMWQMRMQEPERHHSIWRSXEǺIGXRISREXIWERHMRJERXW8LIWI
trace amounts of anti-TB in breast milk are however not enough to treat or prevent TB in
the neonate, and children born to mothers with TB must therefore be evaluated for TB
as well.

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NUTRITION ASSESSMENT,
COUNSELING AND
SUPPORT IN TB
7

7.1: Introduction
Evidence has shown important links between improved treatment outcomes and good
nutrition. Adequate nutrition is necessary to maintain the immune system and optimize
response to medical treatment and sustain healthy levels of physical activity. Good
nutrition also supports optimal quality of life for people with TB. Nutrition interventions
EPWSLIPTXSSTXMQM^IXLIFIRIǻXWSJERXM8'EW[IPPEWMRGVIEWIGSQTPMERGI[MXLXVIEXQIRX
regimens, both of which are essential for curing and preventing transmission of TB

)IǻRMXMSRSJXIVQW

Term )IǻRMXMSR

Nutrition Nutrition refers to the sum of all processes involved in taking in of

nutrients, their assimilation and use for proper body functioning and
maintenance of health. The successive stages include; ingestion,
digestion, absorption, assimilation and excretion.

Malnutrition 2EPRYXVMXMSRVIJIVWXSHIǻGMIRGMIWI\GIWWIWSVMQFEPERGIWMRE
person’s intake of energy and/or nutrients. The term malnutrition
covers 2 broad groups of conditions. One is ‘undernutrition’—
which includes stunting (low height for age), wasting (low weight
for height), underweight (low weight for age) and micronutrient
HIǻGMIRGMIWSVMRWYǽGMIRGMIW EPEGOSJMQTSVXERXZMXEQMRWERH
minerals). The other is overweight, obesity and diet-related non
communicable diseases (such as heart disease, stroke, diabetes,
and cancer).

Nutrients These are molecules in food that all organisms need to make
energy, grow, develop and reproduce.

Categories of nutrients Carbohydrates

1. Macronutrients Protein
Lipids

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 2. Micronutrients Vitamins A, B, C, D, E, K
Minerals- Iron, zinc, selenium, calcium

3. Others Fiber /Roughage

Water: At least 8 glasses or 2 litres per day

8EFPI(SQTSWMXMSRSJ+SSH )MǺIVIRXJSSHWTVSZMHIZEVMSYWRYXVMIRXWXLEXLEZI
HMǺIVIRXJYRGXMSRWMRXLIFSH]

Nutrient Function Food sources

Protein - Body-building &RMQEPJSSHW2IEXǻWLQMPO HEMV]
products, eggs

- Aiding in immune function

Plant foods: Legumes (beans, lentils),nuts
(groundnuts, peanuts) , soybean products
Controlling foods (meat, bean, milk)
biochemical reactions

Carbohydrates - Source of energy Cereal grains and their products: maize,

millet, wheat, sorghum, rice, Roots and
Tubers: Potatoes, cassava, yam, sweet
potatoes, plantain (cooking bananas)

Lipids (Fats/oils) - Energy reserve Visible fats (solid at room temperature)

Visible oils (liquids at room temperatures)

- Protection of vital organs

Invisible fats/oils: nuts, animal foods,
avocado
- Thermal insulation
Vitamins - Reducing infection by Fruits: mango, oranges, pawpaw,
supporting in the immune pineapple, passion, melon
system Vegetables: sukuma wiki, cabbages,
- Aiding in metabolism spinach, lettuce, carrots, broccoli

Minerals - Responsible for building Vegetables, meats and meat products,

structures like bones and milk and milk products
teeth
-Support various chemical
reactions

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TEN FOOD GROUPS

1. Grains, white roots and tubers, and plantains

2. Pulses (beans, peas and lentils)

3. Nuts and seeds

4. Dairy

 2IEXTSYPXV]ERHǻWL

6. Eggs

7. Dark green leafy vegetables

8. Other vitamin A-rich fruits and vegetables

9. Other vegetables

10. Other fruits

7.2 Components of a Healthy Diet

When planning a meal, it is important to consider the following basic principles. The
food groups below will help you achieve good feeding practices

Figure 7.1: Food Pyramid Guide Ŧ„ŇƣŹÏå×Ɛ%бÆåƒåžƐ)ÚƣϱƒŇŹØƐƞǑŐǑŧ

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  7IPEXMSRWLMTFIX[IIR3YXVMXMSR8'1ITVSW]ERH
Lung Disease
Pulmonary diseases with nutrition implications include TB, COPD, Asthma, Pneumonia,
bronchitis, among others. Poor nutrition status in lung disease has been related to
EHZIVWIIǺIGXWXLEXQE]GSRXVMFYXIXSGSQTPMGEXMSRWERHMRGVIEWIHQSVXEPMX]5EXMIRXW
[MXL PS[ FSH] [IMKLX LEZI KVIEXIV KEW XVETTMRK PS[IV HMǺYWMRK GETEGMX] ERH PIWW
exercise capacity. The presence of malnutrition and weight loss is associated with poor
prognosis. In lung disease, resting energy expenditure (REE) is 15-20% above the normal
values for adults and 25-50% for infants. The increased energy required for breathing
EGGSYRXWJSVXLIHMǺIVIRGI

 .RXIVEGXMSRFIX[IIR8'ERH2EPRYXVMXMSR
8'EǺIGXWXLIQIXEFSPMWQSJMQTSVXERXRYXVMIRXWWYGLEWTVSXIMRERHWSQIQMGVSRYXVMIRXW
Malnutrition on the other hand limits cell mediated immunity and increases susceptibility
XS MRJIGXMSR  3YXVMXMSREP HIǻGMIRGMIW EVI EWWSGMEXIH [MXL MQTEMVIH MQQYRI JYRGXMSRW 
8LMWEǺIGXWGIPPQIHMEXIHMQQYRMX]F]VIHYGMRKXLII\TVIWWMSRSJKEQQEMRXIVJIVSR
tumor necrosis alpha and other myco-bactericidal substances that are important for
containing and restricting TB. This leads to nutritional stress and weight loss, thus
[IEOIRMRKMQQYRIW]WXIQGEYWMRKFSH]ƶWMREFMPMX]XSǻKLXMRJIGXMSRW3YXVMXMSREPWXEXYW
is one of the most important determinants of resistance to infection. It is well known that
there is a close association between TB and malnutrition as malnutrition increases the
risk of developing TB and the vice versa

Figure 7.2: Interaction between TB and Malnutrition

„ŇƣŹÏå×Ɛ‰ƐcƣƒŹĞƒĞŇĻƐďƣĞÚåĮĞĻåžØƐƞǑŐƞ

154 Integrated Guideline for Tuberculosis,

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Malnutrition markedly increases mortality among both TB and HIV/AIDS patients and
should be treated concurrently with treatment of the infections.

&GXMZI8'SJXIRPIEHWXSQEPRYXVMXMSR8'TEXMIRXWJVIUYIRXP]WYǺIVJVSQEPSWWSJ[IMKLX
and appetite and consequently present a low body mass index and skin fold thickness.
Nutritional derangements include;

i) There’s a 13% increase in basal metabolic rate (BMR) change with every 1-degree
Celsius rise in body temperature

ii) The adipose and glycogen stores normally decrease due to increase in energy
expenditure

MMM 1SWW   SJ FSH] ǼYMHW  W[IEXMRK ERH YVMREXMSR HYVMRK XLI   EGYXI TLEWI LIRGI
electrolyte loss

iv) Loss of body weight due to increased catabolism

v) Reduced appetite and ability to take food (anorexia, Cachexia and generalized
weakness

vi) Reduced ability of body to absorb nutrients

vii) Increased nutritional needs through metabolic changes

ZMMM2MGVSRYXVMIRXHIǻGMIRGMIWPMOI^MRGZMXEQMRW&(ERH)ERHMVSR

 7SPISJRYXVMXMSRMR8F1ITVSW]ERH1YRK)MWIEWI
Optimal Nutrition enhances:

ƽ ,VS[XLHIZIPSTQIRXVITPEGIQIRXERHVITEMVSJGIPPWERHXMWWYIW

ƽ -IPTW GLIQMGEP TVSGIWWIW WYGL EW HMKIWXMSR QIXEFSPMWQ EWWMQMPEXMSR ERH

excretion

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ƽ 5VIZIRX[EWXMRKERHSXLIVJSVQWSJQEPRYXVMXMSRQMGVSRYXVMIRXMRGPYHIH

ƽ )IPE]-.:TVSKVIWWMSR

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ƽ 4TXMQM^I GIPPYPEV EGXMZMX] ERH XMWWYISVKER JYRGXMSR F] TVSZMHMRK WYǽGMIRX

amounts that meets daily body requirements

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 7.6 Nutrition care process
There are four steps of nutrition care process

ƽ 3YXVMXMSREWWIWWQIRX

ƽ 3YXVMXMSRHMEKRSWMW

ƽ .RXIVZIRXMSRW

ƽ 2SRMXSVMRKERHIZEPYEXMSR

Nutrition assessment counseling and support (NACS)

Figure 3:

„ŇƣŹÏå×ƐU±Æ±Ź±īƐŽĻĞƽåŹžĞƒDžĝƐUåĻDž±ƐƞǑŐŁ

KEY HIGHLIGHT
ƽ&PP8'TEXMIRXWWLSYPHVIGIMZIRYXVMXMSREPEWWIWWQIRXGSYRWIPPMRKERHWYTTSVXEX
baseline and monthly tailored to individual needs

7.7 Components of nutrition assessment, counseling

and support

7.7.1: Nutrition assessment and diagnosis

5VSTIV RYXVMXMSR EWWIWWQIRX QIEWYVIQIRX ERH GPEWWMǻGEXMSR MW E TVIVIUYMWMXI JSV
provision of good nutritional care. NACS aims to establish routine nutrition assessment as
an integral component of facility and community-based screening, care, and support. This
can be interpreted by obtaining information from dietary, biochemical, anthropometric
and clinical studies which are made up of surveys, surveillance or screening.

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7.7.2 Aims of Nutrition assessment
M .HIRXMJ]QIHMGEPGSQTPMGEXMSRWXLEXEǺIGXRYXVMXMSREPWXEXYW

ii. Track growth and weight trends

MMM)IXIGXHMIXLEFMXWXLEXQEOIMXHMǽGYPXXSMQTVSZILIEPXLSVXLEXMRGVIEWIXLIVMWOSJ
disease

iv. Inform nutrition messages and counseling

Z *WXEFPMWLEJVEQI[SVOJSVERMRHMZMHYEPRYXVMXMSRGEVITPER[LMGLWTIGMǻIWRYXVMXMSR
goals and interventions, feasible changes in behavior, and practices to meet those
goals

7.8: Types of Nutrition Assessment

1. Anthropometric assessment

2. Biochemical assessment

3. Clinical assessment

4. Dietary assessment

5. Environmental assessment

6. Psychosocial assessment

7. Functional assessment

7.8.1 Anthropometric assessment

Anthropometric screening is carried out through serial measurements of weight, height,
mid upper arm circumference (MUAC) and skin fold thickness (SFT). The values obtained
are used to show changes in body mass and dimensions (refer to the SOPs)

7.8.2 Biochemical
These are chemical assays/ Lab assessments/analysis in most cases done on body
ǼYMHWERHLEZIRYXVMXMSRMQTPMGEXMSRWIK-IQSKPSFMRWYKEVPIZIPW1MZIVJYRGXMSR()
Thyroid function, calcium levels, creatinine, kidney functions.

7.8.3 Clinical assessment

8LMWMRZSPZIWTL]WMGEPSFWIVZEXMSRNYHKIQIRXMKRWSJRYXVMIRXHIǻGMIRGMIWPMOIZMWMFPI
Wasting, hair changes, oedema, skin changes

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 8EFPI(PMRMGEP&WWIWWQIRXJSV3YXVMXMSR)IǻGMIRGMIW

Body part or Signs/Symptoms 5SWWMFPIHIǻGMIRG]

system

Hair Lackluster, Thinness, sparseness, dryness, dys- Proteins, protein-energy,

pigentation, easy pluckability, texture change Zinc, copper biotin.

Face Paleness, Moon face (swollen), Greasy scaling 7MFSǼEZMR3MEGMR

around nostrils (nasolabial) Pyridoxine, Iron

Eyes Pale white eyes and eyelid lining (pale conjunc- Iron, folate, vitamin A, C, B2
XMZEI7IHRIWWERHǻWWYVMRKSJI]IPMHGSVRIVW B6 and B12
dullness and dryness (corneal or conjunctival
xerosis), redness, lesions of conjunctivae (Bi-
tot’s spots)

Mouth Angular redness, lesions or scars at the corners 7MFSǼEZMR3MEGMR

of the mouth (stomatitis), swelling and redness pyridoxine iron
of lips and mouth (cheilosis)

Tongue QSSXLRIWWWPMGORIWW ǻPMJSVQTETMPPEV]EXVS- 3MEGMRT]VMHS\MRIVMFSǼE-

TL]FIIǻRIWWVIHRIWWTEMR KPSWWMXMWW[SP- vin, vitamin B12 folate, iron
len, magenta color

Gums Swelling, sponginess, bleeding, receding Vitamin C

Skin Dryness, scaling, lightening of skin color often Vitamin A, C and K, Zinc,
GIRXVEPP]SRXLIJEGI HMǺYWITMKQIRXEXMSR essential fatty acids, protein,
VSYKLKSSWIǼIWLWOMR JSPPMGYPEVL]TIVOIV- Niacin.
atosis), small skin hemorrhages (petechiae),
excessive bruising, hyper pigented patches that
QE]TIIPSǺPIEZMRKWYTIVǻGMEPYPGIVWSVL]TS
TMKIRXIHWOMR ǼEO]TEMRXHIVQEXSWMWSIHIQE
delayed wound healing.

Nails Spoon-shape (kiolonychia), pale, brittle, ridged. Iron

Glands Enlarged thyroid or parotid Protein, iodine

Musculoskele- Bowlegs knock knees, enlarged joints, hemor- Protein-energy, Vitamin D

tal system rhages, muscle and fat wasting. and C, Calcium

Neurological Mental confusion, irritability, psychomotor 8LMEQMR7MFSǼEZMRERH

system changes, motor weakness, sensory loss Vitamin B12

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7.8.4 Dietary assessment
24-hour recall, food diary, food frequency and diet history

7.8.5 Environmental and psychosocial assessment

The environmental and psychosocial assessment will identify factors that might be
supporting or weakening TB management. Assessment of a client’s living environment
should accompany the nutritional management. This includes assessment of:

ƽ 5IVWSREPL]KMIRIERHWERMXEXMSR

ƽ -SYWMRKIRZMVSRQIRX

ƽ +SSHLERHPMRKTVEGXMGIWXLEXEǺIGXWYWGITXMFMPMX]XSMRJIGXMSR

ƽ8LIGPMIRXƶWTIVGITXMSRSJWIPJERHXLIMVEFMPMX]XSJYRGXMSRMRXLIGSQQYRMX]XLEX
contributes to nutrition outcome.

1. Strategies to improve sanitation and hygiene

ƽ&P[E]W[EWLERHVMRWIJVIWLJVYMXWERHZIKIXEFPIWSVGPIER[MXLQMPHHMWMRJIGXERXW
and thoroughly rinse in clean running water

ƽ5VEGXMGIKSSHL]KMIRIIWTIGMEPP]LERH[EWLMRK[MXLWSETERH[EXIVEXEPPGVMXMGEP
times (for example, before preparing food, before eating, before feeding a baby,
after visiting the toilet, after changing the baby’s diapers).

ƽXSVIJSSHETTVSTVMEXIP]XSTVIZIRXGSRXEQMREXMSRF]FEGXIVMEERHQSYPHW

ƽ &ZSMH IEXMRK ER] JSSH XLEX QE] WIIQ WTSMPX JSV MRWXERGI QSYPH] JSSH SV WXEPI
leftovers, even if they are reheated.

7.8.6 Functional
Functionality of body parts assess the energy levels- (ability to prepare or consume
meals and mobility) lethargy and disability.

7.9 Making a Nutrition Diagnosis

8LMWMWXLIMHIRXMǻGEXMSRSJERI\MWXMRKRYXVMXMSRTVSFPIQ[LMGLQE]FIEGYXISVGLVSRMG
in nature and varies as the patient/client/group’s response changes.

&XXLIRYXVMXMSRHMEKRSWMWWXITHSGYQIRXEXMSRVIUYMVIHMRGPYHIW &RXLVSTSQIXVMGGYXSǺ
TSMRXW ^WGSVI'2.JSV&KI(PEWWMǻGEXMSRSJ2EPRYXVMXMSR

Changes can be expressed as a percentage of weight loss or gain;

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 Rapid weight loss is associated with 5% of usual body weight over a 2 to 3 months
hospitalization risks period warrants a carefully executed diagnostic
evaluation to determine any correctable or
treatable confounding conditions.

Associated with Mortality More than a 10% decrease in body weight over 2
to 3 months requires follow up

7.9.1 Nutrition Diagnosis

Nutrition Diagnosis is the second step of the Nutrition Care Process, and is the
MHIRXMǻGEXMSRERHPEFIPMRKXLEXHIWGVMFIWEREGXYEPSGGYVVIRGIVMWOSJSVTSXIRXMEPJSV
developing a nutritional problem that dietetics professionals are responsible for treating
independently. At the end of the assessment step, data are clustered, analyzed, and
synthesized. This will Reveal a nutrition diagnostic category from which to formulate a
WTIGMǻG RYXVMXMSR HMEKRSWXMG XEXIQIRX & RYXVMXMSR HMEKRSWMW GLERKIW EW XLI TEXMIRX
client/group’s response changes.

7.9.2 Nutrition Diagnosis Component

Nutrition Diagnosis has 3 distinct components:

i. Problem (P) (Diagnostic Label

ii. Etiology (E) – this is the cause and/or Contributing Risk Factor(s)

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7.9.3 Nutrition Diagnostic Statement

A nutrition diagnostic statement is written in a PES format that states the Problem (P),
the Etiology (E), and the Signs & Symptoms (S). However, if the problem is either a risk
(potential) or wellness problem, the nutrition diagnostic statement may have only two
elements, Problem (P), and the Etiology (E), since Signs & Symptoms (S) will not yet be
exhibited in the patient.

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8EFPI&WWIWWQIRX)MEKRSWMWERH(PEWWMǻGEXMSRSJ2EPRYXVMXMSR

CLASSIFICATION OF NUTRITIONAL STATUS AND MANAGEMENT

CHILDREN 6-59 MONTHS

Weight/ Height (PEWWMǻGEXMSR Management

Level
80% or >-1z score or Normal i) Nutrition counseling on weight main-
MUAC >=12.5 tenance

ii) Vitamin A supplementation as per

WHO recommendation

iii) Monthly nutrition assessments

<80% or <-2z score or Moderate acute malnu- i) Nutrition counselling on weight in-
MUAC <12.5CM trition crease

ii) Monthly nutrition assessments

iii) Nutrition supplementation( Vitamin

&+SVXMǻIHFPIRHIHJSSHWPMOIJEWX
food, Ready To Use Supplementary
Food

<70% 0R -3 Z score or Sever acute malnutrition i. Nutrition counseling on weight in-

MUAC <11.5 without medical compli- crease
cation ( passes appetite
ii. Weekly nutrition assessment
test, alertness, care giver
willing to manage SAM iii. Therapeutic feeds (Ready To Use
at home Therapeutic Foods either bar or
Paste) per kg Bwt

<70% or -3 z score with Severe acute malnutri- Manage in inpatient set up as per IMAM
oedema +++ or MUAC tion with medical com- guidelines
<11.5 plication( fail appetite
test, intractable vomit-
ing, anorexia, high fever,
convulsions, no alert-
ness, lethargy, lower RTI,
severe anemia or dehy-
dration, hypoglycaemia
and hypothermia)

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 Table 7.4: BMI FOR AGE 5- 17 YEARS

BMI FOR AGE CLASSIFICATION MANAGEMENT

80% or >-1z score Normal Nutrition counseling on weight

or MUAC 5-9years maintenance
>=14.5cm
Vitamin A supplementation as per
10-14years >=18.5 WHO recommendation
15-17years >=19.5 Monthly nutrition assessments

<80% or <-2z score or Moderate acute malnutrition Nutrition counseling on weight gain
MUAC
Monthly nutrition assessments
5-9years>=13.5 to
Nutrition supplementation (Vitamin A,
<14.5cm
JSVXMǻIHFPIRHIHǼSYVW7IEH]8S9WI
10-14years>=16 to< Supplementary Food
18.5cm
15-17years>=17.5 to
<19.5

<70% 0R -3 Z score or Severe acute malnutrition Nutrition counseling on weight gain

MUAC without medical
Weekly nutrition assessment
complication
5-9years>=13.5cm
Therapeutic feeds (Ready To Use
(passes appetite test,
10-14years<16cm Therapeutic Foods either bar or
alertness, caregiver willing
Paste)
15-17years17.5cm to manage SAM at home
Hydrolysed feed for DRTB

<70% or -3 z score Severe acute malnutrition Manage in inpatient set up as per

with oedema with medical complication IMAM guidelines
+++ or MUAC
Fail appetite test( fail
5-9years<13.5cm
appetite test, intractable
10-14years<16cm vomiting, anorexia,high
fever, convulsions, no
15-17years17.5cm
alertness, lethargy, lower
RTI, severe anemia or
dehydration, hypoglycaemia
and hypothermia)

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Table 7.5 : BMI for Adults 18 Years and Above

BMI FOR AGE CLASSIFICATION MANAGEMENT

BMI >30 Obese ƽ 3YXVMXMSRGSYRWIPPMRKSR[IMKLX

reduction and physical exercise
ƽ :MXEQMR&WYTTPIQIRXEXMSR
ƽ 2SRXLP]RYXVMXMSREWWIWWQIRX

BMI>25cm-29.9 Overweight ƽ 3YXVMXMSRGSYRWIPPMRKSR[IMKLX

reduction and physical exercise
ƽ :MXEQMR&WYTTPIQIRXEXMSR
ƽ 2SRXLP]RYXVMXMSREWWIWWQIRX

BMI >=18.5-24.9 Normal ƽ 3YXVMXMSRGSYRWIPPMRKSR[IMKLX

or maintenance
Pregnant and ƽ :MXEQMR&WYTTPIQIRXEXMSREWTIV
postpartum WHO recommendation
up to 6months
ƽ 2SRXLP]RYXVMXMSREWWIWWQIRXW
MUAC= >23CM

BMI<18.5 or Moderate acute malnutrition ƽ 3YXVMXMSRGSYRWIPPMRKSR[IMKLX

MUAC <23cm increase
ƽ 2SRXLP]RYXVMXMSREWWIWWQIRXW
ƽ 3YXVMXMSRWYTTPIQIRXEXMSR :MXEQMR&
+SVXMǻIHFPIRHIHJSSHWPMOIJSYRHEXMSR
plus, Read To Use Supplementary
Food

BMI<16.5 CM or Severe acute malnutrition ƽ 3YXVMXMSRGSYRWIPPMRKSR[IMKLX

MUAC <19CM without medical complication
ƽ ;IIOP]RYXVMXMSREWWIWWQIRX
ƽ 8LIVETIYXMGJIIHW 7IEH]XS9WI
Therapeutic Foods either bar or Paste)
ƽ -]HVSP]WIHJIIHJSV)78'

BMI < 16.5CM Severe acute malnutrition ƽ 2EREKIMRMRTEXMIRXWIXYTEWTIV

with bilateral with medical complication( IMAM guidelines
pitting oedema fail appetite test, intractable
+++ or MUAC vomiting, anorexia,high fever,
<16CM convulsions, no alertness,
lethargy, lower RTI, severe
anemia or dehydration,
hypoglycaemia and
hypothermia)

For pregnant MUAC >23 <23 <19 CLASS Normal MAM SAM
and postpartum
mother CLASS Normal MAM SAM MANAGEMENT ƽ3( ƽ798+ERH
and advantage plus
ƽ.+& ƽ.+&
c

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 Figure 7.3: Cycle of Nutrition Interventions

{±ƒĚƾ±DžžƐƒĚŹŇƣďĚƐƾĚĞÏĚƐüŇŇÚƐ±žžĞžƒ±ĻÏåƐϱĻƐÏŇĻƒŹĞÆƣƒåƐƒŇƐƒŹå±ƒķåĻƒƐžƣÏÏåžžũƐ
Ú±ŤƒåÚƐüŹŇķƐ
ÚåƐ{ååƐ„ØƐ:ŹåÚåƐcũƐ8ŇŇÚƐ±ĻÚƐĻƣƒŹĞƒĞŇĻƐ±žžĞžƒ±ĻÏåƐĞĻƐ‰ƐŤŹŇķķĞĻď×ƐŹ±ƒĞŇĻ±ĮåƐ±ĻÚƐŤŹ±ÏƒĞÏåũƐ
„DžķŤŇžĞƣķƐŵ
σĞŇĻƐŇĻƐƒĚåƐžŇÏбĮƐÚåƒåŹķĞĻ±ĻƒžƐŇüƐƒƣÆåŹÏƣĮŇžĞž×Ɛ±ŹåƐžŇÏбĮƐŤŹŇƒåσĞŇĻƐĞĻƒåŹƽåĻƒĞŇĻžƐ
ƞǑŐƞũƭĚƒƒŤ×xxƒÆžDžķŤŇžĞƣķũĮžĚƒķũ±ÏũƣīxĀĮåžxƞǑŐƞxǑƞxcĞĮžĝ:ŹåÚåũŤÚüc&GGIWWIH2E]

8LMW HIWGVMFIW EGXMZMXMIW XS FI GEVVMIH SYX SRGI QEPRYXVMXMSR MW MHIRXMǻIH [LIVI XLI
nutritionist or nutrition service provider;

ƽ IPIGXWXLIWYMXEFPIMRXIVZIRXMSRJSVXLITEXMIRX

ƽ 5PERW[MXLXLITEXMIRXSRLS[XSMQTPIQIRXMX

ƽ .QTPIQIRXMRKETTVSTVMEXIEGXMSRWXSQIIXGPMIRXKVSYTWƶRYXVMXMSRRIIHW

NOTE
The selection of nutrition interventions is driven by the nutrition diagnosis and provides the
basis upon which outcomes are measured and evaluated.

7.10 Nutrition Counseling

Upon assessing the clients and making a nutrition diagnosis. This should be an interactive
process where a nutrition service provider uses information from nutrition assessments
to prioritize actions to improve nutritional status. Nutrition education and counseling

164 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
enlightens the patients on their status and requirements. Counseling helps identify
client preferences, barriers to behavior change, and possible solutions to overcome
those barriers. With this information, the client and care provider jointly plan a feasible
course of action to support healthy practices. The care provider may use job Aids to
select appropriate messages and guide counseling sessions. Group education on key
nutrition topics can be provided in health facility waiting rooms or for community groups
using various print and audiovisual media.

7.10.1 Nutrition Support

Nutrition support includes:

ƽ8LIVETIYXMGERHWYTTPIQIRXEV]JSSHWXSXVIEXGPMRMGEPQEPRYXVMXMSR

ƽ2MGVSRYXVMIRXWYTTPIQIRXWXSTVIZIRXZMXEQMRERHQMRIVEPHIǻGMIRGMIW

ƽ5SMRXSJYWI[EXIVTYVMǻGEXMSRTVSHYGXWXSTVIZIRX[EXIVFSVRIHMWIEWI

Vitamins and Minerals

The body should be provided with liberal amounts of vitamins and minerals. In TB,
GSRZIVWMSRSJFIXEGEVSXIRIXSVIXMRSPMWEǺIGXIHMRXLIMRXIWXMREPQYGSWE )IGVIEWI8LI
client should be supplemented with Vitamin A (every six months or as per the National
Vitamin A supplementation schedule) and encouraged to eat vitamin A rich foods.

Patients on Isoniazid should ideally be supplemented with 10mg of pyridoxine B6 daily

or 25mg once neuropathy is experienced since the drug inhibits its absorption. Additional
amounts of vitamin C is recommended in the diet to facilitate healing of lesions. Other
antioxidants Vitamin E, zinc and selenium neutralize free radicals and prevent the
production of peroxides from lipids. Consider iron folic acid supplementation depending
on the hemoglobin level.

Water

Drink at least 8 glasses or more of safe water per day. This helps in preventing dehydration
ERHǼYWLMRKSYXXS\MRW PMXVIW

Fiber

1S[ǻFIVHMIXMWVIGSQQIRHIHEWXLITEXMIRXRYXVMIRXMRXEOIMWMQTEMVIH-MKLǻFIVMW
likely to Keep the patient feeling full but of few calories.

i) Diet should be based on locally available foods

ii) Maintain a balanced diet with diversity

MMM8LIGSWXSJXLIEHZMWIHJSSHWLSYPHFIEǺSVHEFPIRSXGEXEWXVSTLMGXSXLILSYWILSPH

iv) Foods should be rich in all the essential Nutrients, carbohydrates proteins vitamins
and minerals

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 v) The food should be appetizing and easy to ingest and digest

vi) Warm food often provides more appetite than cold food.

vii) Patients should eat enough food to maintain adequate nutrition.

viii) Avoid intoxicants and other harmful substances e.g. alcohol, cigarettes

7.11 Nutrition in special conditions

7.11.1 Nutrition Management of TB in Pregnant and Lactating

Women
Healthy well-nourished woman should gain between 10 kg and 14 kg during pregnancy,
to increase the likelihood of delivering a full-term infant weighing at least 3.3 kg. To
support increased nutrient needs during pregnancy and lactation, women are advised
to consume an additional amount of foods (WHO, TB, 2013). TB and HIV/AIDS could
EǺIGXTVIKRERG]SYXGSQIMJXLIMRGVIEWIHHMIXEV]RIIHWEVIRSXQIX

Weight gain Recommendations for Pregnancy

Pre pregnancy BMI Weight in Kgs.

BMI < 19.8 12.5 – 18.0

BMI 19.8 – 26.0 11.5 – 16.0

BMI > 26.0 – 29.0 7.0 – 11-5

„ŇƣŹÏå×Ɛ8ŇŇÚƐ±ĻÚƐcƣƒŹĞƒĞŇĻƐұŹÚƐĝŐŁŁŁƐ

Table 7.6: Recommended Energy and Protein Requirements for Women during
Pregnancy and Lactation in TB

PREGNANCY Extra energy

for women
Energy requirements Protein with TB and
requirements or HIV

Total nutrient 36-40 kcal/ 0.8-1.0g/kg/day 20-30%

requirements kg/day

First trimester 0-12 wks +150 kcal/day +0.7g/kg 20-30%

Second trimester 13-27 +300 Kcal/day +3.3g/kg/day 20-30%

wks
3rd trimester 28-40 wks +300 kcal/day 5.8g/kg/day 20-30%

166 Integrated Guideline for Tuberculosis,

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 LACTATION
Total nutrient +500 kcal/day +20g/day 20-30%
requirements

„ŇƣŹÏå×ƐœBkØƐƞǑǑŁ

All pregnant women need routine supplementation of iron and folic acid, minerals
involved in building the skeleton- calcium, magnesium and phosphorus are
in great demand, consumption of proteins of high biological value (animal
products) whenever possible helps to achieve this.

7.11.2 Nutritional Management of Children

a) Infant and young child feeding in the context of TB
In the past, infants were sometimes separated from their mothers, at least until their
mothers became noninfectious. Separation made breastfeeding and care by the natural
QSXLIVMQTSWWMFPIERHTYXMRJERXWEXVMWOSJMRJIGXMSRERHQEPRYXVMXMSRGEYWIHF]EVXMǻGMEP
feeding. These measures are no longer recommended.

Current recommendations for TB infected mothers are on the following principles:

ƽ 8LI FIWX[E] XS TVIZIRX MRJIGXMSR MR MRJERXW SJ MRJIGXIH QSXLIVW MW XMQIP] ERH
properly administered chemotherapy for the mother

ƽ *\GPYWMZIFVIEWXJIIHMRKJSVGSQTPIXIHQSRXLW

ƽ .RXVSHYGXMSRSJEHIUYEXIGSQTPIQIRXEV]JSSHERHGSRXMRYEXMSRSJFVIEWXJIIHMRK
up to 2 years or beyond

ƽ 5VSZMHI8'5VIZIRXMZI8LIVET] 858JSVLMKLVMWOGLMPHVIR[LSLEZIRSWMKRSV

symptoms of TB disease (Refer to LTBI).

b) Infant and Young Child Nutrition (IYCN) in the context of TB/HIV

Breastfeeding is an unequalled way of providing ideal food for the healthy growth
and development of infants. WHO recommends breastfeeding with appropriate use of
anti- retroviral drugs for the mother and baby is the best option for overall well-being
and survival of HIV exposed children. All HIV positive pregnant women shall be put on
HAART and the child will be put on prophylaxis for 12 weeks.

c) Breastfeeding in Drug Resistance -TB

A breastfeeding mother with DR-TB should receive a full course of anti-TB treatment,
EWXMQIP]ERHIǺIGXMZIXVIEXQIRXMWXLIFIWX[E]XSTVIZIRXXVERWQMWWMSRXSLIVFEF]
The mother and her baby should not be completely separated. However, if the mother
is sputum smear- positive, the cooperation of a family member should be sought to
primarily care for the infant until the mother becomes sputum smear-negative.

In cases where the mother has converted to smear negative the mother and infant
may spend time together, in a well-ventilated area or outdoors. The mother should

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 wear a surgical cloth mask during breastfeeding. Replacement feeding should only be
considered in special conditions. (DR-TB guidelines Kenya 2014, Egypt, TB 2007)

NOTE
Breastfeeding should be given on demand and mothers supported to exclusively
breastfeed for 6months with a continuation to 24months. Babies staying away from their
mothers should be fed on Expressed breast milk.

d) Dietary needs of children

The rapid growth periods of infancy and childhood can only be maintained if a child’s
nutrient intake is optimal. Children with acute and chronic pulmonary disease need
high energy and proteins because of the increased basal metabolic rate, catabolism
and growth. The fact that children have limited stomach capacity and appetite makes
it particularly challenging to meet the nutrient requirements. It is therefore necessary
to modify and plan the diet carefully to ensure adequate intake of food. Pulmonary
HMWIEWISJXIREHZIVWIP]EǺIGXWRYXVMXMSREPMRXEOIHYIXSTSSVETTIXMXIQEPEFWSVTXMSR
exposing patients to malnutrition

Recommendations

ƽ M\WQEPPIVQIEPWTIVHE]EVIMRHMGEXIHMRWXIEHSJXLVII

ƽ 8LI QIEPW WLSYPH FI ETTIXM^MRK MR ETTIEVERGI XEWXI ERH TVSZMHI IRSYKL
energy and protein

ƽ -SYWILSPHMRKVIHMIRXWWYGLEWWYKEVZIKIXEFPISMPTIERYXFYXXIVIKKWERH
non-fat dry milk powder can be used in porridge, soups, or milk based-drinks
to increase the protein and energy content without adding to the bulk of the
meal.

ƽ &XPIEWXQPXSQPSJQMPOSV]SKLYVXWLSYPHFIGSRWYQIHHEMP]XSIRWYVI
adequate intakes of vitamin D and calcium

ƽ &XPIEWXǻZIXSWM\WIVZMRKWSJJVYMXERHZIKIXEFPIWWLSYPHFIIEXIRTIVHE]5YVI
fruit juice can be used to decrease the bulk of the diet. Approximately half a
glass of fruit juice is equal to one serving of fruit.

ƽ8LIFIWXHMIXEV]WSYVGIWSJZMXEQMR' T]VMHS\MRIEVI]IEWX[LIEXKIVQTSVO
liver, whole grain cereals, legumes, potatoes, bananas and oatmeal

7.11.3 Substance use and abuse and Tuberculosis

Smoking has been shown to lower the level of vitamin C and B-carotene in plasma
and decrease the bioavailability of selenium (6). Smoking, alcohol use and abuse
increases oxidative stress. Oxidative stress is an imbalance between the production of
JVIIVEHMGEPWERHXLIEFMPMX]SJXLIFSH]XSGSYRXIVEGXSVHIXS\MJ]XLIMVLEVQJYPIǺIGXW
through neutralization by antioxidants. Oxidative stress leads to many pathophysiological

168 Integrated Guideline for Tuberculosis,

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conditions in the body. Therefore, foods rich in antioxidants (Vitamin A, C, E and selenium)
are recommended. Refer to table on local sources of vitamins

Macronutrient requirements
&RXM8' XVIEXQIRX QE] RSX FI JYPP] IǺIGXMZI MJ SXLIV JVIUYIRX GSRHMXMSRW WYGL EW
malnutrition are not properly addressed. The extraordinarily high pill burden that MDR-
TBHIV patients may face also merits attention. These treatments could amount to more
than 30 pills a day. There is currently no evidence to suggest that the proportion of
HMIXEV] IRIVK] JVSQ QEGVSRYXVMIRXW IK TVSXIMR GEVFSL]HVEXI ERH JEX MW HMǺIVIRX JSV
people with active TB than for those without TB. It is generally recommended that all
people consume approximately,15–30% of energy as protein, 25–35% as fat and 45–65%
as carbohydrate (9). However, special advice regarding fat intake might be required for
individuals undergoing antiretroviral therapy or experiencing persistent diarrhea (10).

Therefore, in TB HIV Co-infection;

ƽ .RGVIEWIHIRIVK]MRXEOISJEFSYX XS MWVIGSQQIRHIHJSVEHYPXWHYVMRK

periods of symptomatic disease or opportunistic infection (e.g. in TB HIV
Co- infection), to maintain body weight. In children energy intakes need to be
increased by 50% to 100% over normal requirements experiencing weight loss.

Additionally, referral to a nutritionist/dietician should be done in cases that require

specialized nutrition management or in patient care

Micronutrients requirements in TB HIV Co-infection

ƽ 8SIRWYVIQMGVSRYXVMIRXMRXEOIEX7)&PIZIPW-.:MRJIGXIHEHYPXWERHGLMPHVIR
are encouraged to consume healthy diets.

ƽ 3IZIVXLIPIWWHMIXEV]MRXEOISJQMGVSRYXVMIRXWEX7)&PIZIPWQE]RSXFIWYǽGMIRX
XSGSVVIGXRYXVMXMSREPHIǻGMIRGMIWMR-.:MRJIGXIHMRHMZMHYEPW

8LI0IR]E3EXMSREP8IGLRMGEP,YMHIPMRIWJSV2MGVSRYXVMIRX)IǻGMIRG](SRXVSPVIGSQQIRHW
Vitamin A supplementation for tuberculosis among other conditions of public health
concern (MOH, 2008). There is evidence that some micronutrient supplements, e.g.
vitamin A, zinc and iron, can produce adverse outcomes in HIV-infected populations. It
is reasonable to support the current WHO recommendations to promote and support
adequate dietary intake of micronutrients at RDA levels whenever possible.

Úåŭƣ±ƒåƐķĞÏŹŇĻƣƒŹĞåĻƒƐĞĻƒ±īåƐĞžƐÆ垃Ɛ±ÏĚĞåƽåÚƐƒĚŹŇƣďĚƐ±ĻƐ±Úåŭƣ±ƒåƐÚĞåƒũƐBŇƾåƽåŹØƐ
in settings where these intakes and status cannot be achieved, multiple micronutrient
supplements may be needed within the recommended RDA

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 In established under nutrition, enteral nutritional and parenteral nutrition supplements
are recommended. Intradialytic parenteral nutrition (IDPN) or intraperitoneal amino
acids may be considered for selected cases if tube feeding is declined or clinically
inappropriate (8ŇƣĻÚ±ƒĞŇĻØƐƞǑǑċ) (žƒŹ±ƒŇĻØƐƞǑǑĂ)) (Refer to in-patient management).

For adults with CKD (Stages Three to Five), the dose and timing of phosphate binders
should be individually adjusted to the phosphate content of meals and snacks to achieve
desired serum levels (FīĞǍĮåŹƐ‰
ØƐŐŁŁƌ)

Other considerations:

ƽ Nutrition assessments-biochemical assessment should be reviewed on every

visit to check urea, creatinine, sodium and potassium

ƽ Referrals-any known cases of patients with kidney disease should be referred to

a facility with a nephrology team and equipment.

7.11.4 Nutrition Management in TB and Diabetes

Goals of nutrition therapy
ƽ &XXEMRERHQEMRXEMRFPSSHKPYGSWIPIZIPWEWGPSWIXSRSVQEPEWTSWWMFPI

ƽ 5VIZIRXL]TSERHL]TIVKP]GIQME 4VEPL]TSKP]GIQMGQE]VIUYMVIXLITEXMIRXXS

increase the dosage.)

ƽ &XXEMR STXMQYQ FPSSH PMTMHW ERH FPSSH TVIWWYVI GSRXVSP ERH VIHYGI XLI VMWO SJ
macro vascular disease

ƽ &WWIWW IRIVK] MRXEOI XS EGLMIZI STXMQYQ FSH] [IMKLX XLMW GER QIER XEOMRK
action to either increase or decrease body weight)

ƽ 5VSQSXITL]WMGEPWSGMEPERHTW]GLSPSKMGEP[IPPFIMRK

ƽ 5VIZIRXHIPE]SVQMRMQM^IXLISRWIXSJGLVSRMGHIKIRIVEXMZIGSQTPMGEXMSRWIK
hypertension and renal diseases

ƽ &GLMIZIERHQEMRXEMRSTXMQEPQIXEFSPMGERHTL]WMSPSKMGSYXGSQIW

ƽ 5VSZMHIVIPMIJJVSQW]QTXSQW

ƽ .RHMZMHYEPM^I QIEP TPER EGGSVHMRK XS E TIVWSRƶW PMJIWX]PI ERH FEWIH SR YWYEP
dietary intake.

XVEXIKMIWJSV*ǺIGXMZI2EREKIQIRX
TB patients initiated on TB treatment with diabetes comorbidity experience delayed
recovery of body mass and hemoglobin, which are important for the functional recovery
from disease. TB treatment leads to decreasing blood glucose levels 6 suggesting that
integrated management of tuberculosis in people with high blood glucose could lead
to better diabetes control.

170 Integrated Guideline for Tuberculosis,

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Management
ƽ 5]VMHS\MRI :MXEQMR'MWVIGSQQIRHIHHYVMRKXVIEXQIRXSJ8'MRTEXMIRXW[MXL
DM

ƽ 7IZMI[ SJ )2 XVIEXQIRX EW E VIWYPX SJ8' HMWIEWI Ƴ8' PMOI ER] SXLIV MRJIGXMSR
leads to impaired glucose control - Adjust dose of Oral Glucose Lowering Agents
(OGLA). Some patients might have to switch to insulin during the duration of TB
disease.

ƽ (PSWIQSRMXSVMRKSJFPSSHKPYGSWIPIZIPWERHETTVSTVMEXIEHNYWXQIRXWHSRISR
the doses of OGLAS needed for adequate DM management

ƽ .RHMZMHYEPM^IH HMIXEV] QSHMǻGEXMSR MW SRI SJ   XLI GSVRIVWXSRIW SJ   HMEFIXIW
management, and it is based on the principle of healthy eating in the context of
WSGMEPGYPXYVEPERHTW]GLSPSKMGEPMRǼYIRGIWSJJSSHGLSMGIW)MIXEV]QSHMǻGEXMSR
and physical activity are core in the management of newly diagnosed people
with diabetes and have to be maintained.

Nutrition status monitoring and management needs to be done to ensure optimum

management of the co-morbidities. This monitoring is especially important for
patients whose nutritional indicators are approaching severe under-nutrition

7.11.5: Nutritional management of patients with other

comorbidities
8LIWI TL]WMSPSKMGEP HMWSVHIVW IMXLIV VIWYPX JVSQ EPXIVIH QIXEFSPMWQ SV EǺIGXIH
metabolism. They include but are not limited to: - diabetes mellitus, hyper/
hypothyroidism, hypertension, cardiovascular disorders. Comorbidity with TB/HIV
further complicates their nutritional management. The table below highlights some of
the conditions and gives nutritional recommendations that need to be considered in the
overall management.

Food drug interaction

8EFPIMHI*ǺIGXW7IPEXIHXS8')VYKWERH+SSH.RXEOIERH7IGSQQIRHEXMSRWXS
Minimize (Refer to PV)

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172 Integrated Guideline for Tuberculosis,
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DRUG RESISTANT
TUBERCULOSIS (DRTB) 8

8.1. Introduction to DRTB

Drug resistant tuberculosis (DR TB) remains a major
public health concern globally. The Global Surveillance
data 2018 estimated 558,000 cases with MDR/RR TB Injectable free regimen
(IFR): This is a fully oral
and death rate of 240 000 cases and a treatment success regimen recommended
rate (TSR) of 56%. for MDR/RR and Pre-
XDR (resistant to SLIs) TB
Kenya is among the highly burdened countries with TB, patients including adults,
MDR TB and TB-HIV with an estimate of 1.3% among new children and pregnant
TB cases and 4.4% of previously treated TB cases. In women.
)78'GEWIW[IVIRSXMǻIHERMRGVIEWIJVSQ  3I[;-4(PEWWMǻGEXMSRJSV
RSXMǻIHMREXXVMFYXIHXSMQTVSZIH)78'WYVZIMPPERGI second line drugs used in
that continues to expand through increased molecular the treatment for DRTB
access to molecular diagnostic testing. In 2019, 60% of Treatment of DRTB
the new cases and 79% of the previously treated cases in special conditions
(children, HIV, pregnancy
received a Drug Susceptibility Test (DST) with Gene
and lactation, DM,
Expert, Culture and Line probe Assay. Psychiatric and mental
disorders, drug and
substance abuse, DRTB
contacts and renal disease)
Use of PHQ-9 and CAGE 9
8.2. Basic Concept(s) on Drug forms for the assessment
of psychiatric and mental
7IWMWXERGI)IZIPSTQIRXc disorders in TB
Post treatment follow up
The cause of Drug-resistance TB is due to Mycobacteria’s
for DRTB patients
genetic machinery to mutate at a certain rate and still keep
SRKVS[MRKIREFPMRKXLIQXSWYVZMZISXLIV[MWIIǺIGXMZI
anti TB drugs. There are three principal pathways of drug
resistance development as outlined in the Table 8.1:

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 Table 8.1: Pathways of Drug-Resistant TB development

1.Natural Resistance 2.Primary Resistance 3.Acquired Drug Resistance

- Occurs when all live species -A patient is infected -Due to inadequate therapies
reach a certain number of with a resistant strain leading to selection of mutant
divisions of the bacilli. resistant strains-it’s an expression
of poor treatment
-They undergo random genomic
mutations giving rise to
organisms with certain altered
functions

8.2.1: Factors associated with Drug-Resistant TB

Development
8LIVIEVIWIZIVEPJEGXSVWEWWSGMEXIH[MXL)78'HIZIPSTQIRX8LIWIGERFIGPEWWMǻIH
in to three, namely:

1. Health care-related factors

2. Drugs –related factors

3. Patient related factors

The table below describes each in details.

Table 8.2. Factors associated with Drug-Resistant TB Development

Healthcare factors Drugs related factors Patient-related factors

ƽ 3SRGSQTPMERGIXS ƽ .REHIUYEXIWYTTPMIW ƽ 5SSVEHLIVIRGISV
guidelines ƽ 5SSVUYEPMX] poor DOT
ƽ .REHIUYEXIXVEMRMRK ƽ 5SSVWXSVEKIGSRHMXMSRW ƽ 1EGOSJMRJSVQEXMSR
ƽ 5SSVXVIEXQIRXQSRMXSVMRK ƽ ;VSRKHSWISVGSQFMREXMSRW ƽ 1EGOSJ
ƽ 5SSVP]SVKERM^IHSV transportation
ƽ 5SSVVIKYPEXMSRSJQIHMGMRIW
funded TB control ƽ &HZIVWIIǺIGXW
programs ƽ 9REZEMPEFMPMX]SJGIVXEMR
medicines ƽ SGMEPFEVVMIVW
ƽ 2EPEFWSVTXMSR

174 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
(PEWWMǻGEXMSRSJ)VYK7IWMWXERX8'
(PEWWMǻGEXMSRSJ)78'MWEWHIWGVMFIHMRXLIXEFPIWFIPS[

(PEWWMǻGEXMSRFEWIHSRXLI7IWMWXERGITEXXIVRWEJXIVHVYKWYWGITXMFMPMX]
testing.
8EFPI(PEWWMǻGEXMSRFEWIHSRXLI7IWMWXERGITEXXIVR

Resistance pattern )IǻRMXMSR

Presumptive drug- These are Individuals with a higher risk of getting drug resistant TB than
resistant TB case the general population. They include: smear-positive previously treated
patients such as relapse, return after default (RAD) and failure; new
smear-positive pulmonary TB patients whose sputum remains smear-
positive at month 2; symptomatic close contacts of the known MDR-TB
patient, refugees, prisoners, health care workers with symptoms of TB, DR
8'GSRXEGXWc

Monoresistance 7IWMWXERGIXScSRIǻVWXPMRIERXM8'QIHMGMRISRP]

Poly-drug 7IWMWXERGIXSQSVIXLERSRIǻVWXPMRIERXM8'QIHMGMRI SXLIVXLERFSXL

resistance (PDR) Isoniazid and Rifampicin)

Multi-drug Resistance to at least both Isoniazid and Rifampicin

resistance (MDR)

Rifampicin Resistance to Rifampicin detected using phenotypic or genotypic

resistance(RR) methods, with or without other anti-TB drugs. It includes any resistance
to Rifampicin, whether mono resistance, multidrug resistance, Poly-drug
VIWMWXERGISVI\XIRWMZIHVYKVIWMWXERGIc

Isoniazid resistance Refers to Mycobacterium tuberculosis strains with resistance to isoniazid

ERHWYWGITXMFMPMX]XSVMJEQTMGMRGSRǻVQIHMRZMXVS

Pre-XDR 7IWMWXERGIXS.WSRME^MHERH7MJEQTMGMRERHIMXLIVEǼYSVSUYMRSPSRISVE
second-line injectable agent but not both.

Extensive drug Resistance to any Fluoroquinolone and at least one of three second-line
resistance (XDR) injectable drugs (Capreomycin, Kanamycin and Amikacin), in addition to
multidrug resistance.

(PEWWMǻGEXMSRFEWIHSRXLIVIKMWXVEXMSRKVSYT
8EFPI(PEWWMǻGEXMSRFEWIHSRXLIVIKMWXVEXMSRSJ)78'TEXMIRXW

Registration group )IǻRMXMSR

New (N) Patients who have never received anti-tuberculosis treatment, or

who have received anti-tuberculosis treatment for less than one
month. (Note: patients who had DST at the start or within one month
of a WHO regimen and are then switched to a second-line regimen
because of resistance are placed in this group, even if they received
more than one month of Category I treatment).

Integrated Guideline for Tuberculosis, 175

Leprosy and Lung Disease | 2021
 Registration group )IǻRMXMSR

Relapse (R) Patients previously treated for tuberculosis that has been declared
cured or treatment completed and then diagnosed with MDR-TB.

Return after loss to follow- 5EXMIRXW [LS VIXYVR XS XVIEXQIRX [MXL GSRǻVQIH 2)78' EJXIV
up interruption of treatment for two months or more.

After the failure of First- 5EXMIRXW[LSVIXYVREJXIVLEZMRKJEMPIHXLIǻVWXXVIEXQIRXMIWQIEV

Line Treatment (FFT) positive at earliest, month 5

After the failure of 5EXMIRXW[LSVIXYVREJXIVLEZMRKJEMPIHXLIVIXVIEXQIRXc

7IXVIEXQIRXc +78

(PEWWMǻGEXMSRFEWIHSRXLIEREXSQMGEPTEXLSPSKMGEPWMXISJXLIPIWMSRIMXLIV
within or outside the lung parenchyma as described in the table below.
8EFPI(PEWWMǻGEXMSRFEWIHSRXLI&REXSQMGEPWMXI

(PEWWMǻGEXMSR )IǻRMXMSR
Pulmonary Drug &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'
resistant TB involving the lung parenchyma or the tracheobronchial tree. This exclude
TPIYVEPIǺYWMSR

2MPPMEV]8'MWGPEWWMǻIHEW58'FIGEYWIXLIPIWMSRWEVIMRXLIPYRKW

-Tuberculous intrathoracic lymphadenopathy (mediastinal and/or hilar)

SVXYFIVGYPSYWTPIYVEPIǺYWMSR[MXLSYXVEHMSKVETLMGEFRSVQEPMXMIWMRXLI
lungs, constitutes a case of extra pulmonary TB.

-A patient with both pulmonary and extra pulmonary TB should be

GPEWWMǻIHEWEGEWISJ58'
Extra pulmonary &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'
Drug Resistant TB involving organs other than the lung parenchyma, e.g. pleura, lymph
nodes, abdomen, genitourinary tract, skin, joints and bones, meninges.

(PEWWMǻGEXMSRFEWIHSRXLIWXEXYWSJ-.:MRJIGXMSREPP8'HMEKRSWIHTEXMIRXW
should have an HIV test done and documented.
8EFPI(PEWWMǻGEXMSRFEWIHSR-.:WXEXYW

HIV Positive &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'[LSLEWE

TB patient positive result from HIV testing conducted at the time of TB diagnosis or other
documented evidence of enrolment in HIV care, such as enrolment in the pre-
ART register or in the ART register once ART has been started
HIV negative &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'[LSLEWE
patient negative result from HIV testing conducted at the time of TB diagnosis. Any
HIV-negative TB patient subsequently found to be HIV-positive should be re-
GPEWWMǻIHEGGSVHMRKP]

176 Integrated Guideline for Tuberculosis,

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 HIV status &R]FEGXIVMSPSKMGEPP]GSRǻVQIHSVGPMRMGEPP]HMEKRSWIHGEWISJ8'[LSLEWRS
unknown TB result of HIV testing and no other documented evidence of enrolment in HIV
patient care. If the patient’s HIV status is subsequently determined, he or she should be
VIGPEWWMǻIHEGGSVHMRKP]

8.4: Diagnosis of Drug Resistant TB

The approach to diagnosis begins by identifying the high DR TB suspects or the individuals
at high risk of developing DRTB and obtaining relevant samples for Mycobacteriological
testing.

5ISTPIEXcLMKLVMWOJSVc)78'MRGPYHI

1. DR TB contacts with symptoms of TB. Includes children with TB symptoms who

are contacts of DR TB source persons.

2. Failures on Drug susceptible TB treatment (smear positive at month 2 and 5)

3. Patients who develop TB while on IPT

4. Health care workers with TB symptoms.

5. Refugees with TB symptoms

6. Prisoners with TB symptoms

7. All previously treated patients. They include, failures, relapses, return after loss to
follow ups.

8LIHIǻRMXMZIHMEKRSWMWSJHVYKVIWMWXERX8'VIUYMVIWXLIHIXIGXMSRSJ2]GSFEGXIVMYQ
tuberculosis bacteria and determination of resistance to anti-TB drugs using the methods
outlined below:

a) Genotypic:

These include:

ƽ ,IRI<TIVX

It’s an instrument used to rapidly diagnose Mycobacterium Tuberculosis and

determination of Rifampicin resistance.

.XMWTVIJIVVIHEWXLIǻVWXXIWXJSV8'HMEKRSWMWERHMHIRXMǻGEXMSRSJ7MJEQTMGMR7IWMWXERGI
JSVEPPTVIWYQTXMZI8'GEWIW.XLEWEWIRWMXMZMX]SJ ERHWTIGMǻGMX]SJ 

Its limitations and strengths are outlined in the Table 8.7.

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 Table 8.7: Strengths and limitations for Gene Xpert testing

Strengths Limitations
ƽ.RGVIEWIHWIRWMXMZMX] ƽ.XMWNOT recommended for patient monitoring treatment (it
detects both live and dead bacilli)
ƽ)IXIGXMSRSJ7MJEQTMGMRVI-
sistance pattern ƽ.XQE]VIWYPXMRHMWGSVHERGI[MXLTLIRSX]TMG)8VIWYPXW
,IRI<TIVXGSZIVW SJcXLIKIRIVIKMSR
ƽ7IHYGIHXYVREVSYRHXMQI
ƽ1MQMXIHEFMPMX]XSHIXIGX2M\XYVIWSJWYWGITXMFPIERHVIWMWXERX
ƽ7IUYMVIWQMRMQEPWOMPPWERH
TB
infrastructure

ƽ 1MRI5VSFI&WWE] 15&

The techniques share the same fundamental principles as GeneXpert. They are both
PCR based.

This technique is used to detect Mycobacterium Tuberculosis Complex (MTC) as

well as drug sensitivity to 1st line drugs (Rifampicin and Isoniazid) and 2nd line drugs
(Fluoroquinolones and 2nd line injectable drugs).

The strengths and limitations for Line Probe assay is outlined in the table below.

Table 8.8: Strengths and limitations for Line Probe Assay

Strengths Limitations

ƽ15&TVSHYGIWVIWYPXWMRNYWXLSYVW ƽ.XVIUYMVIWEHIUYEXIERH
appropriate laboratory
ƽ.XEPPS[WUYMGOXVMEKISJGSRǻVQIHVMJEQTMGMRVIWMWXERX
MRJVEWXVYGXYVIERHIUYMTQIRXc
or MDR-TB patients into either the shorter MDR-TB
VIKMQIRSVXLIGSRZIRXMSREPPSRKIVVIKMQIRcccc ƽ.XVIUYMVIWEHIUYEXIERHWOMPPIH
PEFSVEXSV]WXEǺc

cF5LIRSX]TMG

1. Culture

It is the gold standard for TB diagnosis and can detect as few as 10-100 live bacteria/ml.

)DŽ±ķŤĮåž×

1. Liquid Culture-Mycobacterium Growth Indicator Tube (MGIT)

2. Solid Culture-Lowenstein-Jensen (LJ)

Culture and drug susceptibility testing is indicated for all bacteriological diagnosed TB
cases.

178 Integrated Guideline for Tuberculosis,

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 Strengths Limitations

ƽ7IUYMVIWEWJI[EWFEGMPPMQPXSHIXIGX8' ƽ8LIWPS[KVS[XLSJ28'XLYWHIPE]IHXYVR
around-time
ƽ&PPS[WHVYKWYWGITXMFMPMX]XIWXMRKERH)7
surveillance ƽ7IUYMVIWLYKIMRJVEWXVYGXYVEPGETEGMX]XS
set up

2. Drug Susceptibility Testing (DST)

A laboratory method that determines whether bacteria will grow in the presence of TB
drugs. If bacterial growth is observed, that indicates resistance, while no growth indicates
susceptibility to TB drugs used.

Indications for DST

First Line DST Second Line DST

ƽ 5VIZMSYWP]XVIEXIHTEXMIRXW ƽ5EXMIRXW[MXLE)8WLS[MRKVIWMWXERGIXSEX
PIEWXVMJEQTMGMRMWSRME^MHSVFSXLcVMJEQTMGMRERH
ƽ 5IVWSRW[LSHIZIPSTEGXMZI8'EJXIV isoniazid at baseline
exposure to a patient with documented
ƽ5EXMIRXW[LSVIQEMRGYPXYVITSWMXMZISRSVEJXIV
DR-TB
Month 3 DR TB.
ƽ 5EXMIRXW[LSVIQEMRWQIEVTSWMXMZIEX ƽ5IVWSRW[LSHIZIPSTEGXMZI8'EJXIVI\TSWYVIXS
QSRXLX[SERHǻZISJXLIVET] a patient with documented DR-TB

c8VIEXQIRX
Treatment and care for DRTB has been decentralized in Kenya’s 47 counties and 300
sub-counties. The implementation of the programmatic management of drug resistant
TB (PMDT) began in 2006 with injectable agents as core medicines in the treatment
regimens and has rapidly evolved ever since based on WHO guidelines.

In 2018, the World Health Organization (WHO) recommended the use of injectable free
regimens (IFR) for the treatment of drug-resistant TB following new evidence that the
new molecules (Bedaquiline and Delamanid) and repurposed drugs (Linezolid and
Clofazimine) were safer and QSVIIǽGEGMSYW compared to the injectable medicines, and
Kenya transitioned on 1st January 2020 following a rapid communication on the same.

8.5.1 Principles and rationale for DR TB treatment

The treatment of DRTB is based on the following principles and rationale:

ÍƉ Drug combinations should be used for TB/DR TB treatment. This prevents the
appearance of resistance as it avoids the selection of naturally occurring resistant
mutants.

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 ÍƉ Intentional or inadvertent monotherapies should NEVER be used for it may result in
the high possibility to select naturally occurring mutants to the single drugs used.
It is important to note that anti TB medicines do not select the resistant mutants, as
they do not cause mutations.

ÍƉ The regimen composition should have drugs with Sterilizing and Bactericidal
IǺIGXW

ÍƉ Treatment should be long enough to permit action against all bacillary populations.

8.5.2 Treatment objectives:

They include:

1. To rapidly reduce the patient’s risk of death, symptomatology and their

infectiousness

2. To cure without relapses

3. To avoid selection of resistance by using an adequate number of drugs for each

treatment phase.

 (PEWWMǻGEXMSRSJERXM8'HVYKWYWIHMRXLIQEREKIQIRX
of DR-TB
8LI;-4GPEWWMǻGEXMSRSJERXM8'HVYKWYWIHMRXLIQEREKIQIRXSJ)78'MW
FEWIHSRXLIMVIǽGEG]ERHI\TIVMIRGIJSVYWIEWHIWGVMFIHMRXLIXEFPIFIPS[

Table 8.9: Grouping Medicines for use in the treatment of drug-resistant TB

Group Medicine Abbreviation

Group A 1IZSǼS\EGMRSV Lfx

Include all three medicines 2S\MǼS\EGMR Mfx
(Unless the cannot be used)
Bedaquiline Bdq

Linezolid Lzd

Group B Clofazimine Cfz

Add both medicines
Cycloserine or Cs
(Unless they cannot be used)
Terizidone Trd

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 Group C Ethambutol E
Add to complete the regimen and when medicines
Delamanid Dlm
from Group A and B cannot be used
Pyrazinamide Z

Imipenem/Cilastatin or Imp/Cln
Meropenem Mpn

Amikacin or Am (s)
(Streptomycin)

Ethionamide or Eto
Prothionamide Pto

p-amino salicylic acid PAS

NOTE
ƽ 8LMWRI[GPEWWMǻGEXMSRMWMRXIRHIHXSKYMHIXLIHIWMKRSJPSRKIVMRHMZMHYEPM^IHVIKMQIRW 
however, majority of DRTB patients will be on standardized regimens.

ƽ 2IHMGMRIWMR,VSYT&ERH(EVIWLS[RMRHIGVIEWMRKSVHIVSJYWYEPTVIJIVIRGIJSVYWI
QSWXTVIJIVVIHGSQIWǻVWX

ƽ &P[E]WYWI(EVFETIRIQWIK.QMTIRIQ(MPEWXEXMRXSKIXLIV[MXL(PEZYPEREXI

ƽ ,VSYT(HVYKWWLSYPHSRP]FIEHHIHXSGSQTPIXIXLIVIKMQIRERH[LIRQIHMGMRIWJVSQ
Group A and B cannot be used.

8.5.4 Treatment regimens by resistant patterns

The Injectable free treatment regimen:

It is the recommended regimen for MDR/RR and Pre-XDR (resistant to SLIs) TB patients
including adults, children and pregnant women. The Drugs used in these regimens are
administered orally.

This regimen has two phases:

1. Intensive phase: 6 months

8LIIRHSJMRXIRWMZITLEWIMWHIǻRIHF]ERIKEXMZIGYPXYVIEXXLIIRHSJXLIrd month
and three consecutive negative smears taken 30 days apart after month 3. This phase
may be extended in consultation with the National PMDT to 7 and/or 8 months in any
of the following situations
a) Slow clinical response to treatment after clinical evaluation, characterized by:
i. Ongoing /worsening TB (pulmonary) symptoms (cough, fever, drenching night
sweats and weight loss/poor weight gain)
 MM ;SVWIRMRKVEHMSPSKMGEPJIEXYVIWMIGEZMXMIWMRǻPXVEXIWSTEGMXMIW

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 b) Delayed smear or culture conversion

c) Cases where baseline SL LPA results are indeterminate/FLQ susceptibility is not

GSRǻVQIH

A negative culture at month 4 and negative smears at the end of month 7and/or 8 month
marks the END of the extended intensive phase and should not be extended further.

2. Continuation phase: 12 months

The continuation phase starts from month 7 as determined by culture/smear results or

at the end of the extended intensive phase where applicable. The continuation phase
is 12 – 14 months depending on the DST pattern. Reversion of sputum cultures (from
negative to positive) indicates treatment failure. In case of reversion, a multi-disciplinary
team should urgently review the patient and the national clinical team informed as soon
as possible.

The following should be reported to the National Clinical Team;

ƽ Any person with DRTB who is not eligible for the standardized regimens due to previous
history of DRTB treatment

ƽ &R]TIVWSR[MXL)78'VIUYMVMRKQSHMǻGEXMSRSJVIKMQIRMRXLIGSRXMRYEXMSRTLEWIIKYWI
of both Bedaquiline, Delamanid and linezolid in the continuation phase

ƽ &R]TIVWSR[MXL)78'[LSLEWER]GSRXVEMRHMGEXMSRSVXS\MGMX]XSSRISJXLIǻZIGSVIHVYKW
in the intensive phase thus requiring an individualized regimen

ƽ Any person with DRTB who has Hb<8g/dl, neutrophils <0.75x109/L or platelets <50 x109/L
during treatment while on linezolid

The table below describes the treatment of DRTB according to the resistant patterns

Table 8.10: Kenya DR-TB treatment regimens according to resistant patterns

Pattern of Drug Resistance Regimen Duration

2)777c8' .RXIRWMZITLEWIc'HU(J^1J\(W1^H 18 months

(SRXMRYEXMSRTLEWIc(J^1J\(W

Pediatric MDR / RR TB (<6yrs and Intensive phase: c2J\(J^(W1^H 18 months

!OKc
(SRXMRYEXMSRTLEWIc2J\(J^(W

5VI<)7c.RNIGXEFPIVIWMWXERX .RXIRWMZITLEWIc'HU(J^1J\(W1^H 18 months

(SRXMRYEXMSRTLEWIc(J^1J\(W

Pre-XDR - Fluoroquinolones .RXIRWMZITLEWIc'HU)PQ1^H(J^(W 20 months

7IWMWXERXcc
(SRXMRYEXMSRTLEWIc)PQ(J^(W

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 Pattern of Drug Resistance Regimen Duration

5VI<)75IHMEXVMGWƶc+PYSVS- Intensive Phase: 20 months

quinolone Resistance
6 Bdq**/*Dlm/Lzd/Cfz/Cs
Continuation phase: 14 Dlm/Cfz/Cs/Z

ISONIAZID mono resistance 7>*1J\c 6 months

(with pyridoxine)

Bedaquiline Intolerance .RXIRWMZI5LEWIc)PQ1^H1J\(J^(W 18 months

(In cases of Severe Adverse (SRXMRYEXMSRTLEWIc1J\(J^(Wcc
Events or hypersensitivity)

Poly-drug resistance (PDR TB) 9 RZE/Lfx 9 Months

(HE/HEZ +-S) (with pyridoxine)

Pyrazinamide mono-resistance(Z) 2 RHZE 6 months

Or 4 RH
Pyrazinamide and Ethambutol (EZ) (with pyridoxine)
without INH resistance
Or
Ethambutol Mono-resistance(E)

Extensively Drug-resistance (XDR) Individualized regimen 18-24

months

Any case excluded from any of Individualized regimen 18-24

the regimens above months

Ã%åĮ±ķ±ĻĞÚƐ žĚŇƣĮÚƐ ŇĻĮDžƐ ÆåƐ ŤŹåžÏŹĞÆåÚƐ ĞĻƐ ÏĚĞĮÚŹåĻƐ ƣĻÚåŹƐ ƗƐDžå±ŹžƐ ±üƒåŹƐ ÏŇĻžƣĮƒ±ƒĞŇĻƐƾЃĚƐ ƒĚåƐ c±ƒĞŇĻ±ĮƐ ĮĞĻĞϱĮƐ
ƒå±ķ

ÃÃåÚ±ŭƣĞĮĞĻåƐƣžåƐĞĻƐ{±åÚбƒŹĞÏžƐŹåŭƣĞŹåžƐÚĞžžŇĮƣƒĞŇĻƐĞĻƐƾ±ƒåŹ

‰ĚåƐÏŇĻžƒŹƣσĞŇĻƐŇüƐĞĻÚĞƽĞÚƣ±ĮĞǍåÚƐŹåďĞķåĻžƐžĚŇƣĮÚƐÆåƐĞĻƐÏŇĻžƣĮƒ±ƒĞŇĻƐƾЃĚƐƒĚåƐc±ƒĞŇĻ±ĮƐÏĮĞĻĞϱĮƐŹåƽĞåƾƐƒå±ķ

8.5.6: Dosing schedules for DRTB treatment

Table 8.11 describes the dosing schedules for DRTB treatment in adults and adolescent
patients.

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 Table 8.11: Adult & Adolescent dosing schedules

Drugs Weight Class

Average daily dosing 33-50kg 51-70kg >70kg
Isoniazid (H) (100,300 MG) 10-20 mg/kg daily 200 - 300 mg 300mg 300mg
daily daily or

Rifampicin ® ( 150, 300m 10-20 mg/kg daily 450-600 mg 600 mg 600 mg

mg)
Ethambutol (E) (100, 400 25 mg/kg daily 800-1200 mg 1200-1600 1600-2000
mg) mg mg
Pyrazinamide (Z) (500 mg) 30-40 mg/kg daily 1000-1750 mg 1750-2000 2000-2500
mg mg
*Kanamycin Km (1G vial) 15-20mg/kg daily 500-750 mg 1000 mg 1000 mg

Amikacin (AM) (1G vial) 15-20mg/kg daily 500-750 mg 1000 mg 1000 mg

Capreomycin (CM) (1G vial) 15-20mg/kg daily 500-750 mg 1000 mg 1000 mg

4ǼS\EGMR 4J\ The usual adult dose for 800 mg 800 mg 800-1000 mg
(200,300,400mg) MDR-TB is 800 mg
1IZSǼS\EGMR 1+<  The usual adult dose for 750 mg 750 mg 750-1000 mg
mg) MDR-TB is 750 mg
2S\MǼS\EGMR 2J\ The usual adult dose for 400 mg 400 mg 400 mg
MDR-TB is 400 mg
,EXMǼS\EGMR ,J\ QK The usual adult dose for 400 mg 400 mg 400 mg
MDR-TB is 400 mg
Ethionamide (Eto) (250 MG) .15-20 mg/kg daily 500 mg 750 mg 750-1000 mg

Prothionamide (Pto) (250 15-20 mg/kg daily 500 mg 750 mg 750-1000 mg

MG)
Cycloserine (Cs) (250 MG) 15-20 mg/kg daily 500 mg 750 mg 750-1000 mg

Terizidone (Trd) (300 MG) 15-20 mg/kg daily 500 mg 750 mg 750-1000 mg
PAS 4gm sachets 150mg/kg daily 8gm 8gm 8-12gm

Clofazimine 100mg 100 mg

Bedaquiline 400mg daily for 2 weeks followed by 200mg three times/week (Monday,
Wednesday and Friday) for 22 weeks

Delamanid 100mg twice daily for 24 100mg twice daily

weeks

Linezolid Reduce to 300mg if 300mg daily 600mg daily

severe ADR

Pyridoxine (50mg) For every 250 mg of Cycloserine, give 50 mg of Pyridoxine. Maximum

dose of 200 mg

ÃU±Ļ±ķDžÏĞĻƐķ±DžƐÆåƐÚŇžåÚƐƒĚŹååƐƒĞķåžƐŤåŹƐƾååīƐŦ‰FœŧƐüŇŹƐķŇĻƒĚžƐĂĝƌƐƾååīƐŇüƐƒĚåƐžĚŇŹƒåĻåÚƐ%‰ƐŹåďĞķåĻƐ
±ĻÚƐüŇŹƐƒĚåƐüƣĮĮƐÚƣŹ±ƒĞŇĻƐŇüƐĞĻƒåĻžĞƽåƐŤĚ±žåƐĞĻƐĮŇĻďåŹƐĞĻÚĞƽĞÚƣ±ĮĞǍåÚƐ%Ɛ‰ƐŹåďĞķåĻžƐĞĻÏĮƣÚĞĻďƐ{Źåĝ£%Ɛ±ĻÚƐ
£%Ɛ‰ũ

ÃÃFüƐ±ƐĚĞďĚåŹƐÚŇžåƐŇüƐaŇDŽĞāŇDŽ±ÏĞĻƐíǑǑķďƐĞžƐĻŇƒƐƒŇĮåŹ±ƒåÚƐŹåÚƣÏåƐƒŇƐċǑǑķď

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Table 8.12: Paediatric Dosing schedule

Drug name Daily paediatric dose in mg/kg (maximum dose in mg)

Amoxicillin-Clavulanate 80 mg/kg (4000 mg amoxicillin and 500 mg Clavulanate):

only to be given with Meropenem

Clofazimine 2 – 3 mg/kg

Delamanid 50 mg twice daily for 20 to 34 kg, for 6 months 100 mg twice

daily for > 35 kg, for 6 months

Ethambutol 15 – 20 mg/kg (1000 mg) twice a day

Isoniazid 15 – 20 mg/kg

1IZSǼS\EGMR 15 – 20 mg/kg (1000 mg)

Linezolid 10 mg/kg/dose twice daily

Meropenem 20 – 40 mg/kg (6000 mg)

2S\MǼS\EGMR 7.5 – 10 mg/kg (800 mg)

PAS 200 – 300 mg/kg

Pyrazinamide 30 – 40 mg/kg

Terizidone 10 -20 mg/kg (1000 mg) twice a day

8.5.7 Treatment Delivery models in Kenya:

There models of DRTB care and treatment and the criteria for selecting each care
models is dependent on the following factors:

1. Clinical status and the general condition of the patient

2. The geographical location / terrain and ease for accessibility

3. The distance between the patient’s home and the nearest health facility

4. Mental status of the patient

5. Patient’s preference

6. Social dynamics surrounding the patient.

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 Below is a detailed description on the criteria for selecting a DRTB treatment / care
model

Isolation +EGMPMX]FEWIH EQFYPEXSV] (SQQYRMX]FEWIH

5VIJIVVIHJSVc Preferred when Preferred for
- Severely ill patients - Patient chooses to receive care - Patient choice to receive
in the health facility care while in the community
- Patients with poor
adherence - Access to a health facility with (SRǻVQIHXVIEXQIRX
access to transport supporter
- Refugees, street families
and the homeless - Stable General condition of the - Transport challenges to
patient. access a health facility
- Mobile populations
- Stable general condition.
- Patients with Total Drug
resistance
- Patients with mental illness
without family support

)78'(PMRMGEPXIEQWƶGSQTSWMXMSRcERHXLIMVVSPIW
Clinical teams will be established at the County and Sub-County levels and they will be
responsible for managing DR TB patients in those regions.

The team is composed of the following:

 (SYRX]8'GSSVHMREXSVc
 8LIGPMRMGMER 5L]WMGMER24c
 YFGSYRX]8'GSSVHMREXSVc
 5LEVQEGMWX)483YVWIc
 SGMEP[SVOIVc
 5YFPMGLIEPXLSǽGIVc
 1EFXIGLRSPSKMWXc
 3YXVMXMSRMWXc
9. Community Health Extension Worker.

Roles:

4ZIVEPPVIWTSRWMFMPMX]SJQEREKMRK)78'MRXLIMVVIKMSRWc

ƽ 7IGSQQIRHMRMXMEXMSRSJ)78'XVIEXQIRXc

ƽ (EVV]SYXJSPPS[YTSJ)78'TEXMIRXWSRXVIEXQIRXc

ƽ 7IZMI[MRKEPPPEFSVEXSV]VIWYPXWMRGPYHMRK)8ERHGYPXYVISJ)78'WYWTIGXWERH
patients on treatment

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 ƽ 7IZMI[MRKGSQTPI\GEWIWEWRIIHEVMWIWIKEHZIVWIHVYKIǺIGXWGSQSVFMHMXMIW
ERHVIGSQQIRHMRKETTVSTVMEXIMRXIVZIRXMSRWc

ƽ *RWYVMRKEHIUYEXIERHGSRWMWXIRXGSQQSHMX]WYTTP]MRXLIMVVIKMSRWERH(SSVHMREXI
VIJIVVEPWSJ)78'TEXMIRXWXSERHJVSQXLIMVGSYRXMIWc

8.5.9 Patient workup

After the diagnosis of DRTB, pre-treatment preparation, evaluation, investigations
and procedures should be done before initiating treatment. This is aimed at boosting
compliance and adherence to the already complex DRTB treatment and prevent
negative outcomes.

1. Pretreatment evaluation

ƽ (SRǻVQHMEKRSWMWSJ)78'

Note: DR-TB is a laboratory diagnosis (except in child contacts of DR TB who are

YREFPIXSI\TIGXSVEXILIRGIIZIV]IǺSVXWLSYPHFIQEHIXSSFXEMREWTIGMQIR
and conduct (drug susceptibility testing) DST.

ƽ .RJSVQXLITEXMIRXSJXLIHMEKRSWMW

ƽ *HYGEXIERHGSYRWIPXLITEXMIRXSR)78'MXWXVIEXQIRXRIIHJSVEHLIVIRGIERH
DR TB models of care.

ƽ 4FXEMREXLSVSYKLLMWXSV]ERHTIVJSVQETL]WMGEPI\EQMREXMSR

ƽ 4FXEMRERMRJSVQIHXVIEXQIRXGSRWIRXJSVXVIEXQIRX

ƽ (SRHYGXELSQIZMWMXERHGSRXEGXWGVIIRMRK

ƽ 'EWIPMRI*(,:MWYEPEGYMX]XIWXMRK3IYVSTEXL]WGVIIRMRK

ƽ 'EWIPMRIPEFXIWXW

ƽ *WXEFPMWLE52)8XIEQXSKYMHIGPMRMGEPQEREKIQIRXJSPPS[YT

NOTE:
*ǺSVXWWLSYPHFIKIEVIHXS[EVHWQIIXMRKEPPXLIEFSZIGSRHMXMSRWFIJSVIXVIEXQIRX
initiation. However, failure to meet the above conditions should not be a reason to delay
treatment initiation.

2. History taking

What history should be taken from DR TB patients?

ƽ )IQSKVETLMG)EXE5EXMIRXFMSHEXE

ƽ 8' -MWXSV] SR )EXI SJ TVIZMSYW HMEKRSWMW X]TI SJ 8' WXEVX ERH IRH HEXIW SJ
treatment, history of HIV co-infection, Microscopy, culture and DST results,
&HZIVWIIǺIGXW GSQTPMGEXMSRW

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 ƽ 5EWX2IHMGEPERHWSGMEP-MWXSV][MXLJSGYWSR125 QIXLSHSJGSRXVEGITXMSR
Prior comorbidities, history of medication, Alcohol, drug & tobacco use, drug
allergies

ƽ )78'(SRXEGXW.HIRXMJ]GSRXEGXWPMRIPMWXMRXLIGSRXEGXQEREKIQIRXVIKMWXIV
screen using Chest X-ray and symptoms screening and test all presumptive DR
TB using GeneXpert. Conduct home visits to screen contacts and assess TB IPC
measures

3. Physical Examination

On examination, the clinicians should elicit the following

1. Vital signs: Blood pressure, Temperature, Pulse, respiration and Oxygen Saturation
(SpO2)

2. Anthropometric measurements: BMI and Z-scores

3. General and Systemic examination

ƽ &PPFSH]W]WXIQWWLSYPHFII\EQMRIHRSXNYWXXLIVIWTMVEXSV]W]WXIQ

ƽ :MWYEPEGYMX]XIWXW .WLMLEVEGLEVXWERHRIPPIRƶWGLEVXWERHRIYVSTEXL]WGVIIRMRK
should be done for all patients.

4. Review of systems for the suggestion of advanced disease

ƽ +IZIV

ƽ *\XVETYPQSREV]WMKRWIK(3WMKRWIǺYWMSRW

ƽ 7IWTMVEXSV]HMWXVIWW

ƽ (EGLI\ME I\XVIQI[IMKLXPSWW

4. Laboratory, radiological and clinical investigations

i. Radiological

ƽ (LIWX<7E] (LIWX(8JSVTEXMIRXW[MXLEGGIWW

ƽ &R]SXLIVVEHMSPSKMGEPXIWXEWRIGIWWEV]JSVI\XVETYPQSREV])78'IK-IEH(8
scan for patients with CNS signs

MM'EGXIVMSPSKMGEP.RZIWXMKEXMSRWc

ƽ TYXYQJSVQIEVQMGVSWGST]

ƽ (YPXYVI)8ERH15&JSVǻVWXERHWIGSRH1MRIHVYKW

iii. Laboratory investigations Lancet request forms.pdf

ƽ -.:XIWXJSVEPPTEXMIRXW

ƽ 'MSGLIQMWXV]9VIE(VIEXMRMRI*PIGXVSP]XIW&18&8'MPMVYFMRIVYQ&PFYQMR
RBS (FBS/HbA1c may be done if accessible)

188 Integrated Guideline for Tuberculosis,

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 ƽ 8-

ƽ -EIQSKVEQ

ƽ +SV[SQIRSJGLMPHFIEVMRKEKIHSETVIKRERG]XIWX

MZ*(,c

v. Audiometry (hearing test) if injectable drugs are to be used.

4. Patient Education and Counselling

Counselling for DRTB patients is important. It is aimed at identifying underlying

TW]GLSWSGMEPMWWYIWXLEX[SYPHEǺIGXXVIEXQIRXHIPMZIV]8LIXEFPIFIPS[MWEHIXEMPIH
description of counselling sessions and the content covered in the course of treatment.

Table 8.13: DRTB counseling sessions

Phase Session Content

At Baseline First contact with the ƽ*WXEFPMWLVETTSVXERHEWWYVMRKGSRǻHIRXMEPMX]
patient
ƽ.RXVSHYGXMSRXS)78'ERHGPMRMGEPXIEQ
(Provide a session
at the time of giving ƽ*HYGEXITEXMIRXWSR8'XVIEXQIRXERHTVIZIRXMSR 
results) XVERWQMWWMSRGSQQSRHVYKWWMHIIǺIGXW

ƽ5EXMIRXWEWWIWWQIRXWSGMEPERHQIRXEP VIJIVHI-
tails in the tools)

ƽ+EQMP]TPERRMRKERHGSRXVEGITXMSRMRGPYHMRKXIWX-
ing-HIV and Pregnancy.

ƽ7SPIWERHVIWTSRWMFMPMXMIWJSVXLITEXMIRXWJEQMP]
patient supporter and health care worker

ƽ8LIWMKRMRKSJXLIGSRWIRXJSVQ
Intensive At week 2 ƽ&HLIVIRGIWYTTSVXMZIIHYGEXMSR
phase
ƽ2IRXEPLIEPXLEWWIWWQIRX5EXMIRX-IEPXL6YIWXMSR-
c REMVI 5-6cc

ƽ5W]GLSWSGMEPVIZMI[ERHWYTTSVX

ƽMHIIǺIGXQSRMXSVMRK

If major issues are iden- ƽ&HLIVIRGIWYTTSVXMZIIHYGEXMSR

XMǻIHMRXIRWMJ]EHLIV-
ence session (every 2 ƽ2IRXEPLIEPXLEWWIWWQIRX
weekly) ƽ5W]GLSWSGMEPVIZMI[ERHWYTTSVX

ƽMHIIǺIGXQSRMXSVMRK

ƽ+PEKǻPIJSVGPMRMGEPXIEQE[EVIRIWW

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 Phase Session Content

If NO major issue iden- ƽ&HLIVIRGIWYTTSVXMZIIHYGEXMSR

XMǻIHWIIXLITEXMIRX
on monthly basis ƽ2IRXEPLIEPXLEWWIWWQIRX

ƽ5W]GLSWSGMEPVIZMI[ERHWYTTSVX

ƽMHIIǺIGXQSRMXSVMRK
Continua- Once a month, until ƽ&HLIVIRGIWYTTSVXERHIHYGEXMSR
tion phase: completion of treat-
ƽ2IRXEPLIEPXLEWWIWWQIRX
follow-up ment
ƽMHIIǺIGXWQSRMXSVMRK

ƽ5VITEVEXMSRJSVVIMRXIKVEXMSRXSGSQQYRMX]

ƽ    *QSXMSREP ZEPMHEXMSR VIEWWYVERGI EFSYX VIKEMRMRK

functionality (at work, sexual life etc.)

ƽ+EQMP]TPERRMRKERHGSRXVEGITXMSR

NOTE:
1. Patients may have a positive smear with a negative culture. That may be caused
by the presence of dead bacilli and hence does not necessarily indicate treatment
failure.
Action: DISCUSS such cases with the Sub-county and County DR TB Clinical teams.

2. In patients with repeated negative culture and smear results with no corresponding
clinical and radiological improvement.

ccccccccAction: County or Sub County clinical team to evaluate for other conditions.

3. Children with high clinical suspicion of TB should be treated for TB (empirically with
the same regimen as the source contact) even if the result is negative.

The Patient Health Questionnaire -9 (PHQ-9)

The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and
measuring the severity of depression.

This easy to use patient questionnaire is a self-administered version of the PRIME-MD

diagnostic instrument for common mental disorders.

It is not a screening tool for depression but it is used to monitor the severity of depression
and response to treatment. However, it can be used to make a tentative diagnosis of
depression in at-risk populations.

The PHQ-9 score is obtained by adding scores for each question (total points).

190 Integrated Guideline for Tuberculosis,

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An image of the PHQ-9 form and interpretation is shown below.

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 Interpretation

Provisional Diagnosis and Proposed Treatment Actions

PHQ-9 Score Depression Severity Proposed Treatment Actions

0–4 None-minimal None

5–9 Mild Watchful waiting; repeat PHQ-9 at follow-up

Treatment plan, considering counseling, follow-up

10 – 14 Moderate
and/or pharmacotherapy

Active treatment with pharmacotherapy and/or

15 – 19 Moderately Severe
psychotherapy

Immediate initiation of pharmacotherapy and, if

severe impairment or poor response to therapy,
20 – 27 Severe
expedited referral to a mental health specialist for
psychotherapy and/or collaborative management

ƽ 8SXEPWGSVIWSJERHVITVIWIRXGYXTSMRXWJSVQMPHQSHIVEXIQSHIVEXIP]
severe and severe depression, respectively.

ƽ 3SXI6YIWXMSRMWEWMRKPIWGVIIRMRKUYIWXMSRSRWYMGMHIVMWO&TEXMIRX[LSERW[IVW
yes to question 9 needs further assessment for suicide risk by an individual who is
competent to assess this risk.

8.6: DR TB in Special Situations

Drug-resistant TB may coexist with a number of medical problems and thereby present
clinical challenges in the management of both diseases.

Sub-County TB Coordinators must be informed about these cases and further guidance
sought from the National PMDT COE. Reference should be made to 2020 National PMDT
Guidelines for detailed management of each case.

The table below is a summarized guide on the management of DRTB in special conditions.

Table 8.13: Treatment for DR TB in Special Conditions

Special population Comments / recommendations

HIV - Bdq cannot be used with EFV containing regimen (EFV reduces Bdq
levels in the blood). Optimize ART regimen with Dolutegravir (DTG).
- Monitor for other potential additives/overlapping toxicities for ART
and Anti TB’s.
- Avoid Lzd if Hb<8 with pancytopenia
- Give preference to TB treatment in TB and HIV Co-infection. Initiate
ART treatment within 2-8 weeks.
2SRMXSVJSV.7. .QQYRI7IGSRWXMXYXMSR.RǼEQQEXSV]]RHVSQIERH
manage according to ART guidelines.

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Special population Comments / recommendations

Children 2S\MǼS\EGMRMWTVIJIVVIHJSVYWIMRTIHMEXVMG)78'VIKMQIRWSZIV
PIZSǼS\EGMRFIGEYWISJMXWWYTIVMSVFEGXIVMGMHEPERHWXIVMPM^MRKEGXMZMX]
and is well tolerated in most instances.
- Children who are contacts of DR TB should be treated as the Index
case (the person who is likely to have infected the child)
8VIEXQIRXWLSYPHFIMRMXMEXIHIZIR[MXLSYX1EFGSRǻVQEXMSR
(Empirically using the DST of the index case)
- 9WISJ6YMRSPSRIWMWTIVQMXXIHEWFIRIǻXWSYX[IMKLXLIVMWOWc
- The duration of treatment is the same as for adults.
- Dosing should be weight based

Pregnancy and - Pregnancy is not a contraindication for treatment of active drug-

Lactation resistant TB
(SRWMHIVHVYKWEJIX]TVSǻPIW&ZSMHGPEWW)HVYKW EQMRSKP]GSWMHIW
- Lactation is permitted. However, limit time of contact with the child to
prevent the spread of infection.
- Nausea and vomiting may be additive, observe and monitor for
severity and manage accordingly.
- Linezolid, Bedaquiline, Clofazimine and Delamanid can be used
safely.

Diabetes Mellitus - Monitor blood sugars closely (glycemic controls).

*HYGEXITEXMIRXWcSRHMIXXVIEXQIRXGSQTPMERGIERHPMJIWX]PI
QSHMǻGEXMSR
2SRMXSVJSVVIREPMRWYǽGMIRG]RIYVSTEXL]ERHWGVIIRJSVZMWYEP
impairment
- Refer to DM care clinics.

Renal disease - Monitor and correct electrolyte impairment ŦŹåüũƐƒŇƐƒ±ÆĮåƐŇĻƐåĮåσŹŇĮDžƒåƐ

ŹåŤĮ±ÏåķåĻƒĝžĞÚåƐåýåσžŧ
- Refer for specialized care

Liver disorders - Monitor closely for liver function tests

- Closely monitor for potential hepatotoxic drugs (pyrazinamide,
MWSRME^MHǼYSVSUYMRSPSRIW'IHEUYMPMRI
-Refer for specialized care.

Psychiatric / - Screen for depression and mental illness using the PHQ9 form.
mental disorders
- Cycloserine deserves close monitoring as it may worsen the
W]QTXSQW YWIEHIUYEXIIǺIGXMZIHSWEKIW
- Refer for specialized care.

Drug and - Screen using CAGE 9

substance
- May require admission and specialized inpatient care (isolation
dependence
house/ward).

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 Special population Comments / recommendations

DR TB contacts -Trace, screen and investigate using CXR and GXP testing for those who
are symptomatic.
-Those diagnosed with active disease should be treated as the index
case (inform County and Sub-County clinical teams).
4ǺIV.5(QIWWEKIW
-Invitation and symptom screening in the course of treatment for index
cases every 3 months.

8.7 DR TB Treatment Monitoring and Follow up

Treatment monitoring and ensuring the delivery of quality healthcare is critical in DR TB
QEREKIQIRXKMZIRXLIQ]VMEHSJGLEPPIRKIWEWWSGMEXIH[MXLMXc

Rationale

c5EXMIRXWSR)78'XVIEXQIRXRIIHXSFIQSRMXSVIHJSVXVIEXQIRXVIWTSRWISVJEMPYVI
and safety, using reasonable schedules of relevant clinical, radiological and laboratory
testing. Response to treatment and toxicity is monitored through regular history taking,
physical examination, chest radiography, special tests such as audiometry, visual acuity
tests, electrocardiography and laboratory monitoring.

Table 8.14: The role of health care givers in the delivery of quality of care

Cadre Role in monitoring and recommended frequency

Clinician - Review patients every day if hospitalized and at least every week
MJQEREKIHEWERSYXTEXMIRXc
- Conducts patient counseling, screening for substance abuse,
ADR screening, monitor patient weight, height and BMI/ Z score
at baseline and monthly thereafter until completion of treatment

- Supervises daily intake of medication and signals any concerns

to the clinician.

Multidisciplinary clinical 5L]WMGEPP]VIZMI[WcEPP)78'TEXMIRXW[MXLMRXLIWYFGSYRX]EX

VIZMI[cXIEQ (78cccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccc
least once a month, and updates the clinical review checklist in
the patient logbook
- Document guidance to the clinician and DOTs provider on patient
management for the next month in the patient logbook

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8.7.1: Treatment monitoring and quality of care
Treatment monitoring refers to a systematic process of tracking patients through the
whole continuum of care.

This process is aimed at ensuring adherence to treatment and management of adverse

events with an aim of improving treatment outcomes.

Below is a description of monitoring schedule with parameters monitored and the

frequency.

Table 8.15: Laboratory and other parameters monitored during DR TB treatment

Parameters +VIUYIRG]c
Monitored

TYXYQWQIEVERHc - Done at baseline and repeated every month until the end of treatment.
cultures
- Microscopy is used for monitoring response to treatment while Culture is
YWIHXSHIXIVQMRIVIWTSRWIERHHIǻRIGYVI

Audiometry - Done monthly if on an injectable drug. If any abnormality is detected,

stop the injectable and refer for audio care. Repeat audiometry 3 and 6
months thereafter.

1st Line DST - At baseline. This should also be done anytime there is a positive culture
in a previously culture negative case.

2nd Line DST - Done for all patients at baseline, month 3 and if a previously culture
negative patient turns positive.

CXR - At baseline and at the end of treatment

+YPP-EIQSKVEQc - At baseline, month 1 to 6 and monthly for every month the patient is on
Linezolid

Serum Creatinine - Done at baseline and monthly if on an injectable drug. Otherwise repeat
only if the baseline creatinine was abnormal or if clinically indicated

Serum potassium, - Done at baseline and monthly if on an injectable drug. Otherwise repeat
Magnesium if vomiting, diarrhea, if QTcF is prolonged or if clinically indicated

TSH - For patients on Prothionamide / PAS. Done at baseline and at month 2 if

any abnormality was detected at baseline.

- If hypothyroidism is present monitor monthly until treatment completion.

Serum Albumin - Done at baseline for patients on Bedaquiline & Delamanid. Repeat as
necessary

LFTs (AST, ALT, - Done at baseline. Repeat if patient is vomiting, abdominal pain, jaundice
Bilirubin) or any evidence of liver injury

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 Parameters +VIUYIRG]c
Monitored

HIV screening - At baseline. Repeat at month 3, 6, 12 and 18 if negative

CD4 &XFEWIPMRI7ITIEXEXcQSRXLERHMJFEWIPMRI()[EW!

Viral Load - Done at 6 months then yearly.

Review of - All women of childbearing age should be encouraged to use long-term

Contraception contraception. This should be reviewed monthly.

Pregnancy test - At baseline for women of child bearing age; repeat if indicated.

RBS - At baseline, repeat if clinically indicated

NOTE:
5EXMIRXW[MXLQSRScERHTSP]HVYKVIWMWXERGIXSSXLIVHVYKW*<(*587MJEQTMGMRWLSYPH
have gene Xpert done at month 2 and 3.
8LI9WISJ,IRI<TIVXEXQSRXLERHMWXSHIXIGX7MJEQTMGMRc7IWMWXERGIERHRSXJSV
monitoring response to treatment or follow up.

8.8. DR TB Treatment Outcomes

)IǻRMXMSRWSJ8VIEXQIRX4YXGSQIWJSV)VYK7IWMWXERX
Patients

Cured DRTB patient who completes treatment with three or more consecutive negative
cultures taken at least 30 days apart after the intensive phase

Treatment DRTB patient who has completed Treatment as recommended without evidence
completed of failure BUT no record that three or more Consecutive cultures taken at least
30 days apart are negative after the intensive phase

Death A patient who dies from any cause while on DR-TB treatment.

Loss to A patient who interrupts DR-TB treatment for two or more consecutive Months
Follow-Ups

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 Treatment Treatment terminated or need for permanent regimen change of at Least two
failure anti-TB drugs because of:
ƽ1EGOSJGSRZIVWMSRF]IRHSJXLIMRXIRWMZITLEWI SV
ƽ'EGXIVMSPSKMGEPVIZIVWMSRMRXLIGSRXMRYEXMSRTLEWIEJXIVGSRZIVWMSRXSRIKEXMZI
ƽ*ZMHIRGISJEHHMXMSREPEGUYMVIHVIWMWXERGIXSǼYSVSUYMRSPSRIWSVIGSRHPMRI
injectable drugs; or
ƽ&HZIVWIHVYKVIEGXMSRW

Transfer out A patient who has been transferred to a reporting unit in another County and for
whom the treatment outcome is unknown

Not A patient for whom no treatment outcome is assigned. (This includes cases
evaluated “transferred out” to another treatment unit and whose treatment outcome is
unknown).

Treatment The sum of Cured and Treatment completed

success

Treatment failed or lack of conversion by the end of the intensive phase implies that the
patient did not convert within the maximum duration of the intensive phase. If no maximum
HYVEXMSRMWHIǻRIHERQSRXLGYXSǺMWTVSTSWIH+SVVIKMQIRW[MXLSYXEGPIEVHMWXMRGXMSR
FIX[IIRMRXIRWMZIERHGSRXMRYEXMSRTLEWIWEGYXSǺIMKLXQSRXLWEJXIVXLIWXEVXSJXVIEXQIRX
is suggested to determine when the criteria for Cured, Treatment completed and Treatment
JEMPIHWXEVXXSETTP]XLIXIVQWƵGSRZIVWMSRƶERHƵVIZIVWMSRƶSJGYPXYVIEWYWIHLIVIEVIHIǻRIHEW
follows:
Conversion (to negative): Culture is considered to have converted to negative when two
consecutive cultures, taken at least 30 days apart, are found to be negative. In such a case, the
WTIGMQIRGSPPIGXMSRHEXISJXLIǻVWXRIKEXMZI(YPXYVIMWYWIHEWXLIHEXISJGSRZIVWMSRc
Reversion (to positive): Culture is considered to have reverted to positive when, after an initial
conversion, two consecutive cultures, taken at least 30 days apart, are found to be positive.
+SVTYVTSWIWSJHIǻRMRK8VIEXQIRXJEMPYVIVIZIVWMSRMWGSRWMHIVIHSRP][LIRMXSGGYVWMRXLI
continuation phase.

 )78'8VIEXQIRXJEMPYVIWcccc
While treating MDR TB, some unfavorable outcomes are anticipated, including treatment
JEMPYVIWERHXLITVIWIRGISJI\XIRWMZIP]HVYKVIWMWXERX8' <)78'cYWTIGXXVIEXQIRX
failure (except when there are Adverse drug reactions) when any of the following is
present:
ƽ 5EXMIRXƶWGPMRMGEPGSRHMXMSRHIXIVMSVEXIW[IMKLXPSWWERHVIWTMVEXSV]MRWYǽGMIRG]
despite being on treatment.
ƽ 5IVWMWXIRXP]TSWMXMZIGYPXYVIWSVWQIEVWTEWXQSRXLWSJXVIEXQIRX
ƽ 5VSKVIWWMZI I\XIRWMZI ERH FMPEXIVEP PYRK HEQEKI GSRǻVQIH SR <7E] [MXL RS
option for surgery.
ƽ 7IZIVWMSRXSGYPXYVISVWQIEVTSWMXMZIEJXIVXLI]LEZIFIIRRIKEXMZI

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 When this happens, the following steps are recommended:

ƽ 7IZMI[XLIXVIEXQIRXGEVHERHEWWIWWEHLIVIRGIXSHIXIVQMRIMJXLITEXMIRXMW
receiving all the right drugs and doses.

ƽ 7IZMI[EPP)8VITSVXWXSHIXIVQMRIXLIEHIUYEG]SJXLIVIKMQIRERHGSRWMHIV
an alternative regimen where possible.

ƽ 7ITIEXst and 2ndPMRI)8XSPSSOJSVVIWMWXERGIEQTPMǻGEXMSR

ƽ c & GPMRMGEP QEREKIQIRX QIIXMRK WLSYPH FI GSRZIRIH YVKIRXP] XS HMWGYWW XLI
patient.

ƽcc1SSOJSVSXLIVMPPRIWWIWXLEXQE]HIGVIEWIEFWSVTXMSRSJQIHMGEXMSR PMOIGLVSRMG
diarrhoea)

8.10: Adverse reactions and their management

Introduction
TB program systematically monitor patient safety to prevent and manage adverse
drug reactions (ADRs), as well as improve health-related quality of life and treatment
outcomes for patients who have TB. National tuberculosis programmes is actively
pursuing drug safety monitoring and management to better preparedness to introduce
new tuberculosis (TB) drugs and novel regimens.

{̱Źķ±ÏŇƽĞďĞĮ±ĻÏåƐÚåĀĻЃĞŇĻƐ
The science and activities related to detection, assessment, understanding and
TVIZIRXMSR SJ EHZIVWI IǺIGXW SV ER] SXLIV TSWWMFPI QIHMGMRI VIPEXIH TVSFPIQW 8LI
Pharmacovigilance of importance in PMDT is active Drug safety monitoring for serious
adverse drugs reactions.

Active TB Drug Safety Monitoring and Management (aDSM)

&GXMZI 8' HVYK WEJIX] QSRMXSVMRK ERH QEREKIQIRX E)2 MW HIǻRIH EW ER EGXMZI
and systematic clinical and laboratory assessment of patients while on treatment (ref).
aDSM applies to patients on treatment with: (i) new anti-TB drugs; (ii) novel MDR-TB
regimens; or (iii) extensively drug-resistant TB (XDR-TB) regimens, in order to detect,
QEREKIERHVITSVXWYWTIGXIHSVGSRǻVQIHHVYKXS\MGMXMIW8LIVIGSVHMRKERHVITSVXMRK
SJ E)2 TVMQEVMP] XEVKIXW GSQQSR WMHI IǺIGXW ERH EHZIVWI HVYK VIEGXMSRW &)7W
as a core requirement. Core components of aDSM include clinical monitoring, clinical
management, recording and reporting.

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Detection of ADRs and Adverse events
&)7W ERH EHZIVWI IZIRXW GER EǺIGX FSXL TL]WMSPSKMGEP ERH TEXLSPSKMGEP TEXL[E]W
QEOMRKXLIQHMǽGYPXXSHMWXMRKYMWL8LIWXIT[MWIETTVSEGLFIPS[MWVIGSQQIRHIHJSV
assessing ADRs;

a) Ensure the correct medication and dosing is prescribed to the patient

b) Verify that the onset of the suspected ADR was after the drug was taken, not
before and discuss carefully the observation made by the patient;

c) Determine the time interval between the beginning of drug treatment and the
onset of the event;

d) Evaluate the suspected ADR after discontinuing the drugs or reducing the dose
and monitor the patient’s status. If appropriate, restart the drug treatment and
monitor recurrence of any adverse events.

e) Analyse the alternative causes (other than the drug) that could on their own have
caused the reaction;

f) Report any suspected ADR to the person nominated for ADR reporting in the
hospital or directly to the National PV Centre (PPB).

1EFSVEXSV]2SRMXSVMRKXSWYTTSVX.HIRXMǻGEXMSRSJ&)7W*EVP]
Regular laboratory tests for patient taking DR TB treatment is recommend in detecting
and averting ADRS before clinical presentation. Detecting abnormalities in select clinical
surrogate markers in a timely manner is an important step in identifying potential drug
safety issues with the patient.

Risk Factors for ADRs

When evaluating and determining the ADR it is important to consider some Risk factors
that could be associated with the patient.

ƽ &HZERGIHEKI

ƽ 2EPRYXVMXMSR

ƽ 5VIKRERG]ERHPEGXEXMSR

ƽ &PGSLSPMWQ

ƽ 1MZIVJEMPYVI

ƽ (LVSRMGVIREPJEMPYVI

ƽ -.:MRJIGXMSR

ƽ )MWWIQMREXIHERHEHZERGIH8'

ƽ &PPIVK]&XST]

ƽ &REIQME

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 ƽ )MEFIXIWQIPPMXYW

ƽ +EQMP]LMWXSV]EHZIVWIHVYKVIEGXMSRW

ƽ 5EXMIRXVIGIMZMRKMRXIVQMXXIRXXVIEXQIRX

Patients receiving medication for other disorders, in addition to anti-tuberculosis drugs

Management of Adverse Drug reactions

Management of ADRs include reassuring the patient, drug removal or replacement, dose
adjustment, symptomatic management and in some cases discontinuation of treatment
depending on clinical presentation and the severity of the ADR. Proper management
SJ&)7WMWMQTSVXERXEWMXQE]EǺIGX)7TEXMIRXƶWEHLIVIRGIXSXLIMVQIHMGMRIW[LMGL
MR XYVR EǺIGXW VIWMWXERGI Hence, designing DRTB regimens should consider adverse
reactions and the possibility of defaulting.

Principles in the Management of Adverse Drug Reactions

ƽ *EVP]MHIRXMǻGEXMSRERHXVIEXMQQIHMEXIP] EHIUYEXIP]

ƽ 7YPISYXSXLIVGEYWIW

ƽ (SRWMHIVEHHMXMZISVTSXIRXMEXMRK*[MXLGSRGSQMXERXXLIVET]

ƽ (SRWMHIVHVYKHVYKMRXIVEGXMSR

ƽ +SV QMRSV ERH QSHIVEXI VIEGXMSRW ]QTXSQEXMG QEREKIQIRX VIGSQQIRHIH

algorithms, OTCs and ancillary medications)

ƽ +SVQSHIVEXIP]WIZIVIVIEGXMSRW7IHYGIHSWEKIJVIUYIRG]SJXLIWYWTIGXIH
drug.

ƽ IZIVI VIEGXMSRW 5EXMIRX LSWTMXEPM^IH ERH QEREKIH .J E VIHYGIH HSWI HSIW
not help to resolve stop and replace or immediate stoppage of all treatment or
removal of a drug from the regime

Recording and Reporting of ADRs and Adverse events

&PP&)7WEHZIVWIIZIRXERHWMHIIǺIGXRIIHXSFIVITSVXIH)78'WMHIIǺIGXWEHZIVWI
events and ADRs should be recorded in the primary source of data, which is the DRTB
patient logbook. The main source of ADR data at the facility is patient logbook.

%ƐŹåŤŇŹƒĞĻďƐƒŇŇĮžƐĞĻÏĮƣÚåƐ±%„ax
%ƐŹåŤŇŹƒĞĻďƐƒŇŇĮƐ±ĻÚƐ{{Ɛ
%ƐŹåŤŇŹƒĞĻďƐüŇŹķƐŦDžåĮĮŇƾƐ
üŇŹķŧƐŦ±ĻĻåDŽåÚƐ‰±ÆĮåƐíũƞŧũƐ

200 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Grading for ADRs
When reporting ADRS should be graded as below

(PEWWMǻGEXMSR )IǻRMXMSR

Mild 8LIEHZIVWIHVYKVIEGXMSRHSIWRSXMRXIVJIVIMREWMKRMǻGERXQERRIV[MXL
the patient’s normal functioning.

Moderate The adverse drug reaction produces some impairment in the patient’s
functioning but is not hazardous to the health of the patient.

Severe: 8LIEHZIVWIHVYKVIEGXMSRTVSHYGIWWMKRMǻGERXMQTEMVQIRXSV
incapacitation of functioning.

Life-threatening: The adverse drug reaction causes extreme impairment of functioning,

requiring hospitalization and if left untreated could result in the death of the
patient.

Adverse drug reaction related to DR TB drugs

a) Peripheral Neuropathy
Causes of neuropathy: Cs, Lzd, H,

:Ź±ÚĞĻďƐŤåŹĞŤĚåŹ±ĮƐĻåƣŹŇŤ±ƒĚDž

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life-

Moderate threatening

Neurosensory
žDžķŤƒŇķ±ƒĞÏƐƾЃĚƐ „åĻžŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ „åĻžŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ %Ğž±ÆĮĞĻďƐžåĻĝ

alteration (in- žåĻžŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ ŇŹƐŤ±Ź±åžƒĚåžĞ±Ɛ ŇŹƐŤ±Ź±åžƒĚåžĞ±Ɛ žŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ
cluding paraes- ŇĻƐåDŽ±ķƐŇŹƐķĞĻĞĝ ϱƣžĞĻďƐďŹå±ƒåŹƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐ ŇŹƐŤ±Ź±åžƒĚåžĞ±Ɛ
thesia and painful ķ±ĮƐŤ±Ź±åžƒĚåžĞ±Ɛ ƒĚ±ĻƐķĞĻĞķ±ĮƐĞĻƒåŹĝ ƒŇƐŤåŹüŇŹķƐƣžƣ±ĮƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐ
neuropathy) ϱƣžĞĻďƐĻŇƐŇŹƐķĞĻĝ üåŹåĻÏåƐƾЃĚƐƣžƣ±ĮƐ žŇÏбĮƐ±ĻÚƐüƣĻÏĝ ƒŇƐŤåŹüŇŹķƐƱžĞÏƐ
Ğķ±ĮƐĞĻƒåŹüåŹåĻÏåƐ žŇÏбĮƐ±ĻÚƐüƣĻÏĝ ƒĞŇĻ±ĮƐ±ÏƒĞƽЃĞåž žåĮüĝϱŹåƐüƣĻÏĝ
ƾЃĚƐƣžƣ±ĮƐžŇÏбĮƐ ƒĞŇĻ±ĮƐ±ÏƒĞƽЃĞåž ƒĞŇĻž
±ĻÚƐüƣĻσĞŇĻ±ĮƐ
±ÏƒĞƽЃĞåž
Monitor. If symp- Stop Cs and Lzd Stop Cs and Lzd. Stop Cs and
toms improve (high dose H). If If symptoms Lzd. If symp-
after 2 weeks, symptoms resolve improve after 2 toms improve
consider restarting after 2 weeks, weeks consider after 2 weeks
these drugs. consider restart- restarting cy- consider re-
Action
ing cycloserine. closerine. starting cy-
Consider restart- closerine.
ing Lzd at a lower Do not reintro- Do not reintro-
dose. duce Lzd. duce Lzd. Do not reintro-
duce Lzd.

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 Symptomatic relief for peripheral neuropathy:

ƽ cŅĹěŸƋåųŅĜÚ±Ĭ±ĹƋĜěĜĹā±ĵĵ±ƋŅųƼÚųƚčŸ or acetaminophen helps alleviate

symptoms.

ƽ Tricyclic antidepressants have also been used successfully. Start amitriptyline 25

mg at bedtime. The dose should be increased to a maximum of 150 mg daily for
refractory symptoms.

ƽ Carbamazepine MW IǺIGXMZI MR VIPMIZMRK TEMR ERH SXLIV W]QTXSQW SJ TIVMTLIVEP
neuropathy.

b) Myelosuppression
Possible anti-TB drug causes: Lzd, Cfz,

Ɛ:Ź±ÚĞĻďƐaDžåĮŇžƣŤŤŹåžžĞŇĻ

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life

Moderate threatening
Absolute ŐǑǑǑƐôƐŐƗǑǑx ƆĂǑƐôƐŁŁŁxƐķķƗ ĂǑǑƐôƐƆċŁxķķƗ ĴƐĂǑǑxƐķķƗ
neutrophil count ķķƗ
Haemoglobin*1 ŐǑũĂƐĝƐŁũĂƐďxÚX ŁũċƐĝƐíũǑƐďxÚX ƆũŁƐĝƐƌũĂƐďxÚX ĴƐƌũĂƐďxÚĮ
Platelets ŐǑǑũǑǑǑĝ ĂǑũǑǑǑĝŁŁũŁŁŁx ƞĂũǑǑǑĝċŁũǑǑǑx ĴƞĂũǑǑǑxķķƗ
decreased ŐƞċũŁŁŁxķķƗ ķķƗ ķķƗ
WBC decreased ƞũǑǑǑĝƞũĂǑǑx ŐũĂǑǑĝŐũŁŁŁxķķƗ ŐũǑǑǑĝŐũċŁŁxķķƗ ĴŐũǑǑǑxķķƗ
ķķƗ
Monitor Monitor carefully, Stop Lzd Stop Lzd
carefully, and consider immediately. immediately.
and consider reduction of dose Restart at Consider
reduction of of Lzd to 300mg reduced dose haemotransfusion
dose of Lzd daily; once toxicity or erythropoietin.
(300mg daily has decreased Restart at reduced
or 600 mg In case of Grade 2 to Grade 1. dose once toxicity
Action thrice weekly) neutropenia, stop has decreased to
Lzd immediately. Grade 1.
Restart at
reduced dose
once toxicity has
decreased to
Grade 1.

1
Hemoglobin should be interoperated with baseline hemoglobin value

202 Integrated Guideline for Tuberculosis,

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c) Prolonged QTcF Interval
Possible anti-TB drug causes: Bdq, Mfx, Lfx, Cfz

Possible other causes:

ƽ 2ER] SXLIV HVYKW GER GEYWI 68 TVSPSRKEXMSR  IV]XLVSQ]GMR GPEVMXLVSQ]GMR

UYMRMHMRIOIXSGSRE^SPIǼYGSRE^SPIERXMTW]GLSXMGWLEPSTIVMHSPGLPSVTVSQE^MRI
risperidone, methadone and anti-nausea drugs that include ondansetron/
granisetron, domperidone,

ƽ ,IRIXMGGEYWIWWYGLEWPSRK68W]RHVSQI L]TSXL]VSMHMWQ

Figure 8.16: Normal vs Prolonged Q-T intervals2

Note: ‰ĚåƐ}‰ƐĞĻƒåŹƽ±ĮƐĞžƐķ属ƣŹåÚƐüŹŇķƐƒĚåƐÆåďĞĻĻĞĻďƐŇüƐ}ĝƾ±ƽåƐƒŇƐƒĚåƐåĻÚƐŇüƐƒĚåƐ‰Ɛƾ±ƽåũƐFƒžƐ
ÚƣŹ±ƒĞŇĻƐƽ±ŹĞåžƐÚåŤåĻÚĞĻďƐŇĻƐƒĚåƐĚå±ŹƒƐŹ±ƒåũƐFƒžƐķ属ƣŹåķåĻƒƐķƣžƒƐÆåƐÏŇŹŹåσåÚƐ±ÏÏŇŹÚĞĻďƐ
ƒŇƐ ƒĚåƐ Ěå±ŹƒƐ Ź±ƒåũƐ FƒƐ ĞžƐ ŹåÏŇķķåĻÚåÚƐ ƒŇƐ ƣžåƐ ƒĚåƐ 8ŹåÚåŹĞÏбƐ ķåƒĚŇÚƐ ƒŇƐ ϱĮÏƣĮ±ƒåƐ ƒĚåƐ }‰Ï8Ɛ
Ŧ{̱Źķ±ÏDžũƣķ±ŹDžĮ±ĻÚũåÚƣŧ

}‰Ï8Ɛ{ŹŇĮŇĻď±ƒĞŇĻƐŦķžŧƐ:åĻÚåŹƐÏƣƒĝŇýž3

QTc Prolongation (ms) Normal Borderline Abnormal

Men Ƿ 431- 450 >450

Women Ƿ 451-470 >470

ƐƐĚƒƒŤž×xxķDžũÏĮåƽåĮ±ĻÚÏĮĞĻĞÏũŇŹďxĚå±ĮƒĚxÚĞžå±žåžxŐƆŐíƗĝĮŇĻďĝŭĝƒĝžDžĻÚŹŇķåĝĮŭƒž
ƞ

3
Cite this: QTc Prolongation and Risk of Sudden Cardiac Death: Is the Debate Over? - Medscape - Feb 03, 2006.

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 :Ź±ÚĞĻďƐŇüƐŤŹŇĮŇĻďåÚƐ}‰ƐĞĻƒåŹƽ±Į

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4:

Moderate Life-threatening
Prolongation of
žDžķŤƒŇķ±ƒĞÏØƐ
žDžķŤƒŇķ±ƒĞÏØƐ
žDžķŤƒŇķ±ƒĞÏØƐ }‰Ï8Ɛĕ÷ƐĂǑŐķžƐŇŹƐƐĕƐ
QTcF }‰Ï8ƐċĂǑƐôƐċíǑƐ }‰Ï8ƐċíŐƐôƐĂǑǑƐ }‰Ï8Ɛĕ÷ƐĂǑŐƐķžƐ ƌǑƐķžƐÏ̱ĻďåƐüŹŇķƐ
ķžƐ ķž ƾЃĚŇƣƒƐžĞďĻžx ƱžåĮĞĻåƐ±ĻÚƐŇĻåƐŇüƐ
žDžķŤƒŇķžƐŇüƐžåŹĞĝ ƒĚåƐüŇĮĮŇƾĞĻď×Ɛ‰ŇŹĝ
kƐFĻÏŹå±žåƐĞĻĝ kƐFĻÏŹå±žåƐĞĻƐ ŇƣžƐ±ŹŹĚDžƒĚķб ž±ÚåƐÚåƐŤŇĞĻƒåžƐŇŹƐ
ƒåŹƽ±ĮƐ< 0.03 žåÏƐ ĞĻƒåŹƽ±ĮƐǑũǑƗôƐ ŤŇĮDžķŇŹŤĚĞÏƐƽåĻƒŹĞÏĝ
±ÆŇƽåƐƱžåĮĞĻå ǑũǑĂƐžåÏƐ±ÆŇƽåƐ kƐFĻÏŹå±žåƐĞĻƐ ƣĮ±ŹƐƒ±ÏĚDžϱŹÚбƐŇŹƐ
ƱžåĮĞĻå ĞĻƒåŹƽ±ĮƐdzƐǑũǑƌƐžåÏƐ žĞďĻžxžDžķŤƒŇķžƐŇüƐ
±ÆŇƽåƐƱžåĮĞĻå žåŹĞŇƣžƐ±ŹŹĚDžƒĚķб
Monitor more Monitor more Stop the sus- Stop the suspect-
closely; at least closely; at least pected causative ed causative drug.
weekly ECG weekly ECG drug. Hospitalize Hospitalize and
until QTcF has until QTcF has and replete elec- replete electrolytes
Action
returned to returned to trolytes as neces- as necessary.
grade 1 or less. grade 1 or less. sary.

Suggested Management strategy

ĚåÏīĞĻďƐ±ĻÚƐŹåŤĮåĻĞžĚĞĻďƐžåŹƣķƐåĮåσŹŇĮDžƒåžƐ

ƽ IVYQ TSXEWWMYQ 0 MSRM^IH GEPGMYQ MSRM^IH (E ERH QEKRIWMYQ 2K
should be obtained in the event a prolonged QT interval is detected.

ƽ 8LIGEYWISJEFRSVQEPIPIGXVSP]XIWWLSYPHFIGSVVIGXIH

ƽ ;LIRIZIVEPS[TSXEWWMYQMWHIXIGXIHMXWLSYPHXVMKKIVYVKIRXQEREKIQIRX[MXL
replacement and frequent repeat potassium testing (often daily or multiple times
a day) to correct the levels of potassium.

ƽ .J TSXEWWMYQ MW JSYRH PS[ EP[E]W GLIGO QEKRIWMYQ ERH MSRM^IH GEPGMYQ ERH
compensate as needed. (If unable to check, consider oral empiric replacement
doses of magnesium and calcium).

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d) Optic Neuritis
Possible anti-TB drug causes: Lzd, E

Ɛ:Ź±ÚĞĻďƐŇüƐŇŤƒĞÏƐĻåƣŹĞƒĞž

Grade 1 Mild Grade 2: Grade 3: Severe Grade 4

Moderate life-threatening
Visual changes šĞžƣ±ĮƐÏ̱ĻďåžƐ šĞžƣ±ĮƐÏ̱ĻďåžƐ šĞžƣ±ĮƐÏ̱ĻďåžƐ %Ğž±ÆĮĞĻďƐƽĞžƣ±ĮƐ
(from baseline) ϱƣžĞĻďƐķĞĻĞķ±ĮƐ ϱƣžĞĻďƐďŹå±ƒåŹƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐƒŇƐ ĮŇžž
ŇŹƐĻŇƐĞĻƒåŹüåŹåĻÏåƐ ƒĚ±ĻƐķĞĻĞķ±ĮƐĞĻƒåŹĝ ŤåŹüŇŹķƐƣžƣ±ĮƐžŇĝ
ƾЃĚƐƣžƣ±ĮƐžŇÏбĮƐ üåŹåĻÏåƐƾЃĚƐƣžƣ±ĮƐ ÏбĮƐ±ĻÚƐüƣĻσĞŇĻ±ĮƐ
±ĻÚƐüƣĻσĞŇĻ±ĮƐ žŇÏбĮƐ±ĻÚƐüƣĻÏĝ ±ÏƒĞƽЃĞåž
±ÏƒĞƽЃĞåž ƒĞŇĻ±ĮƐ±ÏƒĞƽЃĞåž
Action Stop LZD imme- Stop LZD imme- Stop LZD imme- Stop LZD imme-
diately if there are diately if there are diately if there are diately if there are
any suspicion of any suspicion of any suspicion of any suspicion of
optic neuritis. Do optic neuritis. Do optic neuritis. Do optic neuritis. Do
not restart. not restart. not restart. not restart.

Suggested management strategy

ƽ )SRSXVIWXEVXXLIWYWTIGXIHGEYWEXMZIHVYK 1MRI^SPMHSV*XLEQFYXSP

ƽ 7IJIVTEXMIRXWXSERSTLXLEPQSPSKMWXJSVJYVXLIVIZEPYEXMSRERHQEREKIQIRX

ƽ 4TXMGRIYVMXMWKIRIVEPP]MQTVSZIWJSPPS[MRKGIWWEXMSRSJSǺIRHMRKHVYKMJMXGER
be stopped early enough.

e) Hepatitis
Possible anti-TB drug causes: H, R, Z, Bdq,

:Ź±ÚĞĻďƐŇüƐBåŤ±ƒĞƒĞž

Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life

threatening

ALT (SGPT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

AST (SGOT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

Continue treatment Continue treat- Stop all drugs, Stop all drugs,
regimen. Patients ment regimen. including anti-TB including anti-TB
should be followed Patients should drugs; measure drugs; measure
until resolution (re- be followed until LFTs weekly. LFTs weekly.
turn to baseline) or resolution (return Treatment may Treatment may
ACTION stabilization of AST/ to baseline) or sta- be reintroduced be reintroduced
ALT elevation. bilization of AST/ after toxicity is after toxicity is
ALT elevation. resolved. resolved.

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 Suggested management strategy

Reintroduce anti-TB drugs once liver enzymes return to normal level. Anti-TB drugs
should be reintroduced in a serial fashion by adding a new medicine every three to four
days. The least hepatotoxic drugs while monitoring liver function tests after each new
exposure.

(SRWMHIVWYWTIRHMRKXLIQSWXPMOIP]SǺIRHMRKHVYKTIVQERIRXP]MJMXMWRSXIWWIRXMEPXS
XLIVIKMQIR8LMWMWSJXIRXLIGEWIJSVT]VE^MREQMHIMJMXMWPIWWPMOIP]XSFIIǺIGXMZIF]
clinical history.

f) Hearing Impairment
Possible anti TB drugs causing hearing impairment: Km, Am, Cm.

:Ź±ÚĞĻďƐBå±ŹĞĻďƐĞķŤ±ĞŹķåĻƒċ

Grade 0: None Grade1: Slight Grade 2: Mod- Grade 3: Grade 4: Pro-

erate Severe found
Decibel ƞĂƐÚƐŇŹƐĮåžž ƞƌĝċǑƐÚ ĚĞĮÚĝƐƐƗŐĝƌǑƐÃÚ ƌŐĝíǑƐÚ ĕíǑƐÚ
(dB) range

ÚƣĮƒĝƐċŐĝƌǑÃƐÚ
Severity No/ Slight Hears/ repeats Hears/ repeats Hears words cannot hear/
problems words in nor- words in raised shouted into understand
mal voice at 1 voice at 1 meter better ear shouted voice
Hears Whis- meter
pers

ÉĚåƐÚåžxžåƽåŹĞƒDžƐŇüƐĚå±ŹĞĻďƐĮŇžžƐĞžƐ±ĮžŇƐϱƒåďŇŹĞžåÚƐÚĞýåŹåĻƒĮDžƐüŇŹƐÚĞýåŹåĻƒƐ±ďåƐďŹŇƣŤžƐŦžååƐ±ĻĻåDŽŧũ

Suggested management strategy:

Perform a monthly assessment of hearing loss and balance. Audiometry is helpful in

detecting early high-frequency hearing loss that the patient may not even be aware of.
If the patient is experiencing hearing loss, stop the injectable and replace it with a non-
ototoxic drug. Even when non-ototoxic drugs are not available, stopping the injectable
can be considered based on the patient’s desire to maintain hearing. If moderate or
severe vertigo, tinnitus (ringing in the ears) or vestibular disturbances arise, with or without
WMKRMǻGERXLIEVMRKPSWWGSRWMHIVHIGVIEWMRKJVIUYIRG]SVWXSTTMRKXLIMRNIGXEFPIEKIRX

ƐƐƐĚƒƒŤž×xxƾƾƾũķƒ±±ũŇŹďũ±ƣxĚå±ŹĞĻďĝƱÏīďŹŇƣĻÚ
ċ

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g) Acute Kidney Injury/Failure
Possible anti-TB drug causes

Aminoglycosides (Km, Am, Cm)

:Ź±ÚĞĻďƐ
ÏƣƒåƐīĞÚĻåDžƐĞĻĥƣŹDžx8±ĞĮƣŹå

Grade 1: Mild Grade 2: Mod- Grade 3: Severe Grade 4: Life

erate threatening
Acute Kidney GFR= 60-89 mL/ GFR= 45-49 mL/ GFR= 30-44 mL/ GFR= 15-29 mL/
Injury/ Chronic min min min min and <15 mL/
Kidney Disease min
Consider stopping Stop injectable Stop injectable Stop injectable
injectable until until creatinine until creatinine until creatinine
creatinine has re- has returned to has returned to has returned to
turned to baseline. baseline. baseline. baseline.
Action
Consider restart- Consider re- Consider restart- Consider restart-
ing the injectable starting the in- ing the inject- ing the injectable
at lower frequen- jectable at low- able at lower at lower frequency
cy (e.g. MWF). er frequency OR frequency OR OR substitute with
substitute with substitute with a a non-nephrotoxic
a non-nephro- non-nephrotoxic drug
toxic drug drug

ÃƐ‰ĚåƐÆ垃Ɛķ属ƣŹåƐŇüƐīĞÚĻåDžƐüƣĻσĞŇĻƐĞžƐ:ĮŇķåŹƣĮ±ŹƐ8ĞĮƒŹ±ƒĞŇĻƐ±ƒåƐŦ:8ŧũƐ

Suggested management strategy:

Monitor serum creatinine and electrolytes frequently in patients receiving injectable.

Patients with pre-existing kidney disease, diabetes, or HIV are at high risk of injectable
nephrotoxicity and may be monitored more frequently.

Repeat electrolytes if necessary:

Injectable nephrotoxicity may be associated with injectable-induced electrolyte

wasting. For example, it is possible to see elevated creatinine and severe hypokalaemia/
hypomagnesemia at the same time. The aetiology of this phenomenon is unclear, but
it may occur more often in HIV co-infected patients. Discontinue the suspected drug
(usually the injectable). If the acute renal failure is severe, then stop all drugs. Follow
serum creatinine and electrolytes closely until the creatinine has returned to baseline
or has stabilized. Consider strict weight-based dosing of the injectable if the patient’s
weight is less than 50 kg. Suspend the injectable permanently if the nephrotoxicity recurs
despite intermittent dosing, and add additional anti-TB drugs to reinforce the regimen.

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 h) Hypokalaemia
Possible anti-TB drug causes: Cm, Km, Am

cŇŹķ±ĮƐƽ±ĮƣåžƐŇüƐŤŇƒ±žžĞƣķƐĮåƽåĮƐ±ĻÚƐŭƣ±ĻƒĞƒDžƐŇüƐƐUXƐŹåŭƣĞŹåÚƐ

Potassium level Normal value (3.5-5.0 Meq/L) Quantity of KCl

3.7 or more None

3.4-3.6 40 meq

3.0-3.3 60 meq

2.7-2.9 80 meq

2.4-2.6 80 -120 meq

2.0-2.3 60 meq IV and 80 meq PO

<2.0 60 meq IV and 100 meq PO

:Ź±ÚĞĻďƐBDžŤŇī±Į±åķб

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life

Moderate threatening
Hypokalaemia 3.4 - 3.0mmol/L 2.9 – 2.5 mmol/L 2.4 - 2.0 mmol/L or < 2.0 mmol/L or
intensive replace- abnormal potas-
ment therapy or sium with paresis,
hospitalization ileus or life-threat-
required ening arrhythmia
Continue in- Continue inject- Consider stopping Stop injectable
jectable. able. the injectable temporarily.
temporarily.
Action
Start oral Start aggressive Start IV potassi-
potassium oral potassium Start IV potassium um replacement
replacement replacement replacement ther- therapy in addition
therapy. therapy. apy in addition to to oral.
oral.

Check serum Replace magne- Replace magne-

magnesium sium as neces- Replace magne- sium and other
and replace if sary. sium and other electrolytes as
necessary electrolytes as necessary.
necessary.

208 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
8.11. WHO Grouping of DRTB medicines with common
adverse drug reactions
,VSYT&c;-4KVSYTMRKSJQIHMGMRIWJSVPSRKIV2)78'7IKMQIRW

Drug Activity against Common Adverse Contraindications and special

TB, Mechanism Drug Reactions consideration
of action, and
metabolism
,VSYT&c;-4KVSYTMRKSJQIHMGMRIWJSVPSRKIV2)78'7IKMQIRW

1IZSǼS\EGMR Bactericidal: Nausea and bloating. Fluoroquinolones intolerance,

(Lfx) has strong anti- Headache, dizziness, prolonged QTcF, pregnancy (relative
TB activity. insomnia or contraindication).
Cross-resistance tremulousness.
with other
ǼYSVSUYMRSPSRIW Rare tendon rupture,
but may not be arthralgia (can
complete. Data usually be treated
suggests greater symptomatically).
activity than Moderate QTcF
GMTVSǼS\EGMRSV prolongation,
4ǼS\EGMR.RLMFMXW hypoglycaemia
DNA gyrase
2S\MǼS\EGMR Bactericidal: Nausea and Fluoroquinolones intolerance,
(Mfx) inhibits DNA gyrase; diarrhoea. prolonged QTc
cross-resistance Headache and
with other dizziness.
ǼYSVSUYMRSPSRIW
but may be more Rare tendon rupture;
active based on in arthralgia. Rare
vitro data hepatotoxicity. QTc
Prolongation, hypo/
hyperglycaemia
Bedaquiline Bactericidal: Nausea, vomiting, Do not use or discontinue
(Bdq) Inhibits ATP abdominal pain, loss Bedaquiline:
synthesis. of appetite, joint pain, (PMRMGEPP]WMKRMǻGERXZIRXVMGYPEV
Mainly eliminated in LIEHEGLIc arrhythmia.
faeces. &68G+MRXIVZEPSJ#QWc
QT prolongation, Severe liver disease.
hyperuricemia,
phospholipidosis, Abnormal electrolytes.
elevated Use with caution in the following
EQMRSXVERWJIVEWIWc situations:
Use with other QT prolonging drugs
(see drug interactions)
A history of torsade de pointes
A history of congenital long QT
syndrome
A history of hypothyroidism and
Brady arrhythmias
A history of uncompensated heart
failure
Serum calcium, magnesium or
potassium levels below the lower
limits of normal

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 Linezolid (Lzd) Has in vitro 2]IPSWYTTVIWWMSRc Hypersensitivity to Oxazolidinones
bactericidal Diarrhoea and nausea.
activity –
increasing clinical Optic and peripheral Symptoms of neuropathy (pain,
experience7; RIYVSTEXL]c numbness, tingling or weakness in
inhibits protein Lactic acidosis – the extremities
synthesis patients who develop
recurrent nausea or
vomiting.

,VSYT'c;-4KVSYTMRKSJQIHMGMRIWJSVPSRKIV2)78'7IKMQIRW

Clofazimine In vitro activity Discoloration of skin, Allergy to Clofazimine

(Cfz) against M. conjunctiva, cornea Electrolytes should be monitored and
ƒƣÆåŹÏƣĮŇžĞžƐwithout ERHFSH]ǼYMHW replaced if vomiting is severe
much in vivo data. Dry skin, pruritus,
Generally reserved In the case of Gastritis, dosing on
rash, ichthyosis, antacids should be carefully times (>
for cases with and xerosis.
few other options. 2 hours apart) so as not to interfere
Gastrointestinal with the absorption of anti-TB drugs
Tissue half-life intolerance.
estimated to be
around 70 days Photosensitivity.

Cycloserine Bacteriostatic: CNS toxicity: Relative contraindications include

(Cs) inhibits cell wall including seizure, seizure disorder, psychotic disease or
synthesis depression, psychosis alcohol abuse
and suicidal ideation Initiate anticonvulsant therapy
c4XLIVWMHIIJJIGXW (e.g. valproic acid, phenytoin,
include peripheral phenobarbitone) to address the side
neuropathy and skin IǺIGXWEWWSGMEXIH[MXL(3XS\MGMX]
changes. Increase pyridoxine to 300mg daily
Lower the dose of the suspected
agent or discontinue or replace the
suspected agent if this can be done
without compromising the regimen
For psychotic symptoms, initiate
antipsychotic drugs and halt
administration of Cs for 1-4 weeks
while symptoms of psychosis are
brought under control. Lower the
dose if this can be done without
compromising the regimen
,VSYT(c;-4KVSYTMRKSJQIHMGMRIWJSVPSRKIV2)78'7IKMQIRW
Imipenem- Given that imi- Common: Diarrhoea, Carbapenems intolerance; meningitis
GMPEWXEXMRc penem is rapidly nausea, or vomiting. (use meropenem rather than
degraded by renal Less common: imipenem).
proximal tubule Seizure (noted with
dipeptidases, it CNS infection),
is used in com- palpitations,
bination with the pseudomembranous
dipeptidases colitis.
inhibitor, cilastatin.
(Conversely, mero-
penem a similar
drug as imipenem
is stable to renal
dipeptidases and
requires no cilas-
tatin). Cilastatin is
partially metabo-
lized renally.

210 Integrated Guideline for Tuberculosis,

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Meropenem In vitro activity Diarrhoea, nausea Carbapenems intolerance
– very limited or vomiting. Seizure
clinical experience (noted with CNS
(meropenem is infection), but
stable to renal rare compared to
dipeptidases imipenem. Rarely
and requires no elevated LFTs,
cilastatin). hematologic toxicity,
hypersensitivity
*Delamanid Inhibition of the Nausea, vomiting, and Do not use or discontinue
(Dlm) synthesis of the dizziness. Delamanid
mycobacterial cell ƽ (PMRMGEPP]WMKRMǻGERXZIRXVMGYPEV
wall components, arrhythmia.
methoxy-mycolic QT prolongation
and keto-mycolic ƽ &68G+MRXIVZEPSJ#QW
EGMHc GSRǻVQIHF]VITIEX*(,
ƽ IZIVIPMZIVHMWIEWI
Delamanid ƽ IVYQ&PFYQMRPIWWXLER
disappears from ƽ &FRSVQEPIPIGXVSP]XIW
plasma with a t1/2
Use with caution in the following
of 30-38 hours.
situations (with more frequent ECG
Delamanid is not
monitoring and evaluation of risk
excreted in urine.
ZIVWYWFIRIǻX
ƽ 9WI[MXLSXLIV68TVSPSRKMRK
drugs (see drug interactions).
ƽ &LMWXSV]SJXSVWEHIHITSMRXIW
ƽ &LMWXSV]SJGSRKIRMXEPPSRK68
syndrome.
ƽ &LMWXSV]SJL]TSXL]VSMHMWQERH
Brady arrhythmias.
ƽ &LMWXSV]SJYRGSQTIRWEXIH
heart failure.
ƽ IVYQGEPGMYQQEKRIWMYQ
or potassium levels below the
lower limits of normal.
Use with caution in patients
sensitive to lactose

Ethambutol Bacteriostatic: Retro bulbar neuritis 5VII\MWXMRKSTXMGRIYVMXMW c

(Emb) inhibitor of cell (dose-related –
wall synthesis; exacerbated during
bactericidal only renal failure). Visual changes on Ethambutol
at the high end of
the dosing range.
At doses used over
long periods of
time, Ethambutol
protects
against further
development of
resistance

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 Pyrazinamide Bactericidal for Gout (hyperuricemia) Allergy to pyrazinamide; severe gout
(Pza) semi-dormant and arthralgia.
M. tuberculosis. Hepatotoxicity.
Mechanism unclear Rash.
Photosensitivity.
Gastrointestinal upset
Amikacin (Am) Bactericidal: 3ITLVSXS\MGMX]c Relative contraindication in
Inhibits protein Ototoxicity pregnancy and
synthesis. Hypersensitivity to aminoglycosides
Excreted primarily
unchanged through
the kidney. Caution with renal, hepatic, vestibular
or auditory impairment.

Prothionamide Weakly Gastrointestinal upset MHIIǺIGXWQE]FII\EKKIVEXIHMR

(Pto) bactericidal: and anorexia: Metallic patients also taking Cycloserine
blocks mycolic acid taste. Hepatotoxicity. For hypothyroidism, initiate
synthesis *RHSGVMRIIǺIGXW L-thyroxine therapy (50-100 mcg/
Gynaecomastia, hair day). If there is no possibility of
loss, acne, impotence, switching, monitor TSH for thyroxine.
menstrual irregularity,
and reversible
L]TSXL]VSMHMWQc

Kanamycin Bactericidal: has 3ITLVSXS\MGMX]c Pregnancy (congenital deafness seen

(Km) strong anti-TB Ototoxicity (hearing with streptomycin and
activity. Cross- loss) and vestibular Kanamycin use in pregnancy);
resistance with toxicity: Increases with hypersensitivity to aminoglycosides;
Amikacin and some advanced age and caution with renal, vestibular or
data suggesting prolonged use auditory impairment; patients with
cross-resistance MRXIWXMREPSFWXVYGXMSRWc
with Capreomycin;
inhibits protein
synthesis
Para-amino Bacteriostatic. Gastrointestinal Pregnancy (relative).
salicylic acid distress
(PAS) Rare hepatotoxicity
and coagulopathy
Reversible
hypothyroidism

Others
Isoniazid (Inh) Bactericidal: Hepatitis (age- Patients with high-level isoniazid
Especially for related). Peripheral resistance who have failed an
rapidly dividing neuropathy. isoniazid-containing regimen should
GIPPW&ǺIGXW Hypersensitivity not receive isoniazid. History of
mycolic acid (cell reactions. allergic reaction to isoniazid
wall) synthesis. Other reactions,
Inclusion of including optic
isoniazid in the neuritis, arthralgia,
regimen of patients CNS changes, drug-
with strain W induced lupus,
MDR-TB was also diarrhoea, and
associated with cramping with liquid
improved outcomes product

212 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Rifampicin Bactericidal: Orange staining of Rifamycins allergy; due to drug
(Rif) inhibits protein FSH]ǼYMHW7EWL interactions, may be contraindicated
synthesis; and pruritus with concurrent use of certain drugs
cross- Gastrointestinal
resistance YTWIXWǼYPMOI
with other W]RHVSQIc
Rifamycins
Hepatotoxicity.
Haematological
abnormalities
(thrombocytopenia,
haemolytic
anaemia).
Rifapentine Bactericidal: Red–orange History of hypersensitivity to any
(Rpt) same staining of body of the Rifamycins (i.e. Rifampin or
mechanism ǼYMHW7EWLERH Rifabutin)
of action as pruritus
Rifampin, Hypersensitivity
inhibits RNA reaction
polymerase. Hepatotoxicity
100% cross-
resistant with Haematological
Rifampin. abnormalities

8.12. Post treatment Follow up

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214 Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
NON-TUBERCULOUS
MYCOBACTERIUM
(NTM)
9

9.1. Epidemiology
These are free-living organisms found in air, water and soil from where they cause
infection. Zoonotic spread can occur from domestic and wild animals. There is no
person-to-person spread documented with paucity of data in most of the world since it
MWRSXERSXMǻEFPIHMWIEWI8LITVIZEPIRGISJ382MWVMWMRKEWXLEXSJaũƐƒƣÆåŹÏƣĮŇžĞž is
going down; possible causes include:

ƽ Improvements in diagnostics: better clinical recognition of the disease.

ƽ Development and wider use of diagnostic support tools (such as CT scan, new
laboratory methods)

ƽ Better characterization of mycobacteria, along with greater disease awareness

ƽ The worldwide HIV epidemic and the increase in number of immunocompromised

hosts

ƽ The increase in chronic lung diseases

NTM can cause pulmonary disease (NTM-PD) in vulnerable persons and can
contaminate clinical samples due to harmless colonization. Over 150 NTM species have
been described while over 60 species cause human disease, the majority of which are
VIWMWXERX XS QSWX ERXMXYFIVGYPSYW HVYKW 3825) GER FI GPEWWMǻIH FEWIH SR GYPXYVI
speed:

1. Rapidly growing NTM - aũƐ±ÆžÏåžžƣž

2. Slowly growing NTM - aũƐ±ƽĞƣķƐÏŇķŤĮåDŽ, aũƐī±Ļž±žĞĞ, aũƐDŽåĻŇŤĞ, aũƐķ±ĮķŇåĻžå

Integrated Guideline for Tuberculosis, 215

Leprosy and Lung Disease | 2021
 9.2. Associated risk factors
Risk factors for developing NTM-PD include the following:

ƽ .QQYRIHIǻGMIRG]

ƽ Smoking

ƽ 5EXMIRXWTSSVP]VIWTSRHMRKXSǻVWXERHWIGSRHPMRI&RXM8YFIVGYPSYW8LIVET]

ƽ Previously treated TB patients

ƽ Presence of underlying lung disease

9.3. Clinical presentation

Symptoms of NTM-PD (Pulmonary Disease) are very similar to PTB and are impossible
to distinguish clinically, thus the basis for performing culture:

ƽ Chronic cough - dry, productive or hemoptysis

ƽ Fever

ƽ Night sweats

ƽ Weight loss and wasting

9.4. Investigations (Important considerations)

ƽ Sputum smear exam and Mantoux test may be positive in both MTB and NTM
infection.

ƽ GeneXpert will detect MTB BUT WILL NOT detect NTM. (FĻƐŤ±ƒĞåĻƒžƐƾЃĚƐŤŇžĞƒĞƽåƐ

8Ɛ žŤƣƒƣķƐ žķå±ŹƐ ±ĻÚƐ ±Ɛ Ļåď±ƒĞƽåƐ :åĻå£ŤåŹƒƐ ŹåžƣĮƒƐ üŇŹƐ a‰ØƐ ÏŇĻžĞÚåŹƐ c‰aƐ ±ĻÚƐ
ÏƣĮƒƣŹå).

ƽ Chest X-ray and other imaging may also not distinguish between MTB and NTM
infection.

ƽ (YPXYVIMWXLIKSPHWXERHEVHJSVHIXIGXMSRERHHMǺIVIRXMEXMSRSJ28'JVSQ382
Every attempt should be made to obtain a sample for culture when NTM is
suspected.

216 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
9.5. Management of NTM
8LIHIGMWMSRXSWXEVXXVIEXQIRXWLSYPHFIMRǼYIRGIHF]XLIWIZIVMX]SJ382TYPQSREV]
disease, the risk of progressive NTM-pulmonary disease, the presence of comorbidity
and the goals of treatment. Decision to treat remains individualized with DNTLD/P
consultation and individuals may require a period of longitudinal assessment (symptoms,
radiological change and mycobacterial culture results) to inform NTM treatment
decisions.

To determine the clinical relevance of NTM positive cultures, it is essential to distinguish

transient or persistent colonization (which is usually not treated) from true infection
SV HMWIEWI 9WI SJ XLI &8  .)&  HIǻRMXMSR SJ 382TYPQSREV] HMWIEWI MW
VIGSQQIRHIHXSHIǻRIHMWIEWIEWWLS[RMRXLIXEFPIFIPS[

8EFPI)IǻRMXMSRSJ3825YPQSREV]HMWIEWI

Clinical and microbiological criteria for diagnosing non-tuberculous mycobacterial lung

disease
Clinical (both 1. Pulmonary symptoms, nodular or cavitary opacities on chest radiograph,
required) or an HRCT scan that shows multifocal bronchiectasis with multiple small
nodules.
and

2. Appropriate exclusion of other diagnoses

Microbiolog- 1. Positive culture results from at least two separate expectorated sputum
ical samples. (If the results from the initial sputum samples are nondiagnostic,
consider repeat sputum AFB smears and cultures.)
or

2. Positive culture results from at least one bronchial wash or lavage.

or

3. Transbronchial or other lung biopsy with mycobacterial histopathologic

JIEXYVIW KVERYPSQEXSYWMRǼEQQEXMSRSV&+'ERHTSWMXMZIGYPXYVIJSV
NTM or biopsy showing mycobacterial histopathologic features (granulo-
QEXSYWMRǼEQQEXMSRSV&+'ERHSRISVQSVIWTYXYQSVFVSRGLMEP[EWL-
ings that are culture positive for NTM.

4. Expert consultation should be obtained when NTM are recovered that are
either infrequently encountered or that usually represent environmental
contamination.

5. Patients suspected of having NTM lung disease but who do not meet the
HMEKRSWXMGGVMXIVMEWLSYPHFIJSPPS[IHYRXMPXLIHMEKRSWMWMWǻVQP]IWXEF-
lished or excluded.

6. Making the diagnosis of NTM lung disease does not, ŤåŹƐžå, necessitate
the institution of therapy, which is a decision based on potential risks and
FIRIǻXWSJXLIVET]JSVMRHMZMHYEPTEXMIRXW

Management of NTM-PD depends on the type of NTM cultured as shown in

Table 9.2.

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Leprosy and Lung Disease | 2021
 Table 9.2: Management of NTM-PD

Mycobacteria Drugs used for treatment Treatment duration

species

Mycobacterium ƽ Nodular/bronchiectatic disease: Clarithromycin Treat until culture

avium complex 1gm/Azithromycin 500mg, Rifampin 600 mg negative on therapy
and Ethambutol 15-25mg/kg, thrice weekly or for 1 year.
HEMP] WIZIVIHMWIEWI&QMOEGMRMRXLIǻVWX
months
Treat until CD4 above
ƽ In HIV co-infection: Substitute rifampicin with
100 in HIV co-infection
Rifabutin, daily clarithromycin or azithromycin
with ethambutol. Add streptomycin/amikacin if
no response

ƽ Prophylaxis for all with low CD4 count less than

50: Clarithromycin 1g daily or azithromycin 1g
[IIOP]47EǼYSVSUYMRSPSRIMJQEGVSPMHIVIWMW-
tant MAC

ƽ For Clarithromycin resistant disease: Rifamp-

in 600mg, Ethambutol 15-25mg/kg,Isoniazid
QK2S\MǼS\EGMRQKHEMP]&QMOEGMR
MRXLIǻVWXQSRXLW
M. fortuitum ƽ &R]SJXLIJSPPS[MRKHVYKW&QMOEGMRǼYSVS- 6-12 months, until cul-
quinolones, sulfonamides, imipenem, linezolid, tures are negative
cefoxitin or clarithromycin

ƽ Debridement of cutaneous, lung or other foci of

infection and removal of implants
M. abscessus ƽ *\XVIQIP]HMǽGYPXXSIVEHMGEXI2YPXMHVYKVIK- 4-8 weeks of IV drugs
imens (that include clarithromycin 1g/ day and then 6-12 months of
intermittent courses of 2 or more drugs of the per oral (P.O) regimen
following drugs: amikacin, imipenem, cefoxitin,
XMKIG]GPMRIǼYSVSUYMRSPSRIWHS\]G]GPMRISV
linezolid) is recommended may cause symptom- Treat until sputum is
atic improvement and disease regression. culture negative
ƽ Surgical resection of localized disease combined
with multidrug clarithromycin-based therapy
SǺIVWXLIFIWXGLERGIJSVGYVISJXLMWHMWIEWI
M. kansasii ƽ Drug susceptible strains- RHZE (use conven- Treat until sputum
tional anti-TB doses) cultures negative for
more than 6 months
ƽ Rifampicin resistant isolates-use any 2 of clar-
ithromycin(1stSTXMSRSVEǼYSVSUYMRSPSRI MJ
macrolide resistance noted), sulfamethoxazole
or streptomycin and ethambutol
M. szulgai ƽ Responds to treatment Treaty until cultures
are negative
ƽ Combinations of rifampicin, ethambutol and clari-
thromycin
M. malmoense ƽ Not very responsive to treatment At least 2 years

ƽ Clarithromycin, rifampicin and ethambutol had

better response and less mortality

218 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
TUBERCULOSIS
INFECTION PREVENTION
AND CONTROL (IPC)
10

10.1 Introduction KEY HIGHLIGHTS:

Infection prevention and control is a critical Levels of TB infection control

component of End TB strategy and primarily focuses measures include:
on decreasing the risk of TB transmission. TB Infection I. Administrative (managerial)
prevention and control (TB IPC) in the health care control measures
settings is therefore an important step forward in the II. Environmental control measures
IǺSVXW XS TVIZIRX XVERWQMWWMSR SJ 8' ,SSH 8' .5(
III. Personal protective equipment
practices which include administrative, environmental
(respiratory protection).
and respiratory controls can make health care safer,
by protecting patients, clients, HCWs and community
from Tuberculosis. Administrative control measures

Additionally, IPC becomes more important in control ƽ 5EXMIRXƶWXVMEKI

against transmission of TB, drug resistant TB (DR-TB) ƽ (SRXVSPPIHǼS[SJQSZIQIRX
and other infectious respiratory conditions like Covid-19 within the facility
ƽ 8VMEKMRKSJLSWTMXEPM^IH
patients
Environmental Control Measures

10.2 TB Infection prevention  3EXYVEPZIRXMPEXMSR

control measures  2IGLERMGEPZIRXMPEXMSR

Personal protective Equipment
10.2.1 Levels of TB infection control (respiratory protection)
measures ƽ 7IJIVWXSMXIQWWTIGMǻGEPP]
used to protect the health
8LIc8'MRJIGXMSRGSRXVSPcWLSYPHFIFEWIHSREXLVII care provider, the patient and
PIZIPcLMIVEVGL]SJGSRXVSPcQIEWYVIWcERHMRGPYHI the community from exposure
I. Administrative (managerial) control measures ƽ 8LI]KSLERHMRLERH
with administrative and
II. Environmental control measures environmental measures
III. Personal protective equipment (respiratory
protection).
Integrated Guideline for Tuberculosis, 219
Leprosy and Lung Disease | 2021
 Administrative control measures are the most important among the three levels.
Environmental control measures and personal protective equipment (respiratory
protection) will not work in the absence of solid administrative control measures. Each
PIZIPSTIVEXIWEXEHMǺIVIRXTSMRXMRXLI8'MRJIGXMSRGSRXVSPTVSGIWW

The levels of operation include;

First priority; Administrative control measures reduce health care workers and patient
exposure to infectious droplet nuclei

Second priority; Environmental control measures reduce the concentration of infectious

droplet nuclei

Third priority; Personal protective equipment (respiratory protection) protects HCWs,

patients and family members in areas where the concentration of droplet nuclei cannot
be adequately reduced by administrative and environmental control measures.

10.2.2 Administrative (Managerial and Policy) Control

Measures
&HQMRMWXVEXMZI QIEWYVIW EVI HIǻRIH EW XLI QEREKIVMEP SV [SVO TVEGXMGIW IK IEVP]
diagnosis, prompt isolation or separation of potential TB patients, prompt initiation of
ERXMXYFIVGYPSWMWXVIEXQIRXERHQMRMQM^IEIVSWSPKIRIVEXMRKTVSGIHYVIWXSWMKRMǻGERXP]
reduce the risk of TB transmission by preventing the generation of droplet nuclei or
reducing exposure to droplet nuclei. They include:

A.Patients triage

9TSRIRXV]MRXSXLILIEPXLJEGMPMX]EQIQFIVSJXLIQIHMGEPWXEǺWLSYPHMHIRXMJ]TEXMIRXW
with a cough as soon as possible. All patients with cough should receive tissues or face
masks, and they should be advised on cough etiquette.

'(SRXVSPPIHǼS[SJQSZIQIRX[MXLMRXLIJEGMPMX]

Inside the TB department, circulation of patients and attendants should be controlled

Figure 10.1: Direction of natural ventilation/ correct working setup

220 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Encourage patients/attendants to spend as much time as possible outdoors if weather
permits or in areas that are open.

In addition,

ƽ -EZI ZMWMFPI WMKREKI SR IRXV] HSSVW XS 8' [EVHW XLEX GEYXMSR ZMWMXSVW EW XLI]
enter.

ƽ 1MQMXZMWMXEXMSRHYVEXMSRTEVXMGYPEVP]JSVGSRXEKMSYWTEXMIRXW

ƽ *RGSYVEKIZMWMXWSYXWMHIXLIFYMPHMRKIWTIGMEPP]JSVGSRXEKMSYWTEXMIRXW

ƽ -EZIZMWMXMRKEVIEW[IPPMHIRXMǻIH[MXLWMKREKI

ƽ 'IJSVI ER] ZMWMX XLI RYVWI WLSYPH TVSZMHI MRJSVQEXMSR SR XVERWQMWWMSR VMWO
including the usage of respirators if caregivers need to go in high risk areas,
such as smear-positive, drug- resistant TB (DR-TB), re-treatment smear-positive
inpatient units and areas or clinics where diagnosis of TB is being undertaken.

ƽ 7IWXVMGXIRXV]JSVTIVWSRWQSWXEXVMWOSJMRJIGXMSRMRGPYHMRK]SYRKGLMPHVIRXLI
elderly and the immunocompromised.

ƽ &ZSMH GSRXEGX [MXL ORS[R MRHI\ GEWIW SV VIWXVMGX QSZIQIRX SJ TSXIRXMEPP]
infectious TB patients to areas where they may infect other patients, and vice
versa. Equally patients without TB should not be permitted in areas where they
are unnecessarily exposed to TB.

C.Triaging of hospitalized patients

TB care is primarily an ambulatory care and patients should preferably be treated as

outpatients. Hospitalization should be limited to critically unwell patients. Wards
attending to TB patients must be separated from the other wards in the health facility.
Ideally, within the TB department, patients should be placed in single rooms. If this is not
TSWWMFPIGSLSVXMWSPEXMSRQYWXFIMQTPIQIRXIHERHHMǺIVIRXWIGXMSRWWLSYPHFIPEFIPPIH
according to the degree of contagiousness (smear/culture status) and risk of resistance.

NOTE:
All TB inpatient facilities should have an isolation room. If none exists, a very high
priority is to establish one. (Refer to the TB isolation policy).

'EGXIVMSPSKMGEPP] GSRǻVQIH 8' TEXMIRXW ERH WYWTIGXIH )78' TEXMIRXW MRGPYHMRK

chronic cases and re- treatment cases that are likely to have DR-TB should have single
isolation rooms. It is particularly important not to mix DR TB patients with other patients.
Where possible, presumptive TB cases should not be hospitalized for diagnosis. If
hospitalization is necessary, these patients need isolation rooms.

Integrated Guideline for Tuberculosis, 221

Leprosy and Lung Disease | 2021
 Components to good work practice (and administrative) controls
There are four key components to good work practice (and administrative) controls.

These include:
a. TB Infection, prevention and control assessment
b. Development of an infection control plan
c. Patient management
d. Infrastructure management i.e. clinics, laboratory and pharmacy.

a) TB Infection, prevention and control assessment

At facility and community levels, the tuberculosis infection prevention and control
assessment entails an initial and ongoing evaluation of the risk of TB transmission.
This is done using TB Infection control assessment tool Annex 6.1: TB Infection control
assessment tool

The infection control assessment should cover the following topics:

ƽ Review of the statistical reports on TB in the community and facility
ƽ .HIRXMǻGEXMSRSJXLIQSWXEXVMWOWIXXMRKW[MXLMRXLIJEGMPMX]ERHTVMSVMXM^IXLIQJSV
MRMXMEPIǺSVXWXSMQTVSZI8'MRJIGXMSRGSRXVSP
ƽ .HIRXMǻGEXMSRSJGEXIKSVMIWSJ-(;WXLEXRIIHXSFIMRGPYHIHMRE8'WGVIIRMRK
program
ƽ .HIRXMǻGEXMSRSJQIGLERMWQWXSTVSQTXVIGSKRMXMSRERHVITSVXMRKSJTVIWYQTXMZI
TB episodes of transmission in the facility and community

b) TB Infection, prevention and control plan

All relevant stakeholders should be involved in the development and review of the TB
IPC plan.

This plan should be implemented and monitored according to its recommendations.

The plan should include:

ƽ )IWGVMTXMSRSJXLIMRGMHIRGISV8'ERH8'-.:MRXLIJEGMPMX]
ƽ &WWIWWQIRXSJ-(;XVEMRMRKRIIHWERHXVEMRMRKTPER
ƽ &HQMRMWXVEXMZI TSPMGMIW [MXL VIKEVH XS XVMEKI ERH WGVIIRMRK VIJIVVEP ERH
diagnosis, separation and isolation
ƽ 9WMRKERHQEMRXEMRMRKIRZMVSRQIRXEPGSRXVSPW
ƽ 5SPMG]SRXLIXVEMRMRKERHYWISJVIWTMVEXSV]TVSXIGXMSR
ƽ &VIEWTIGMǻGMRJIGXMSRGSRXVSPVIGSQQIRHEXMSRW
ƽ )IWGVMTXMSRSJVSPIWERHVIWTSRWMFMPMXMIWJSVMQTPIQIRXEXMSRERHQSRMXSVMRK
the infection control plan

ƽ 8MQIPMRIERHFYHKIX

222 Integrated Guideline for Tuberculosis,

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Composition of IPC Committee (County, Sub county and Facility Level)
IPC team should include expertise in:

ƽ Administration

ƽ Infection Prevention Control

ƽ Clinical

ƽ Epidemiology

ƽ Laboratory

ƽ Medical engineering

ƽ Occupational health

IPC team should be responsible for all aspects of the facility TB IPC plan development,
implementation and review

c) Steps for patient management to prevent transmission of TB in

community, workplace and health care settings

Table 10.1: Steps for patient management

Step Action Description

1. Screen *EVP]MHIRXMǻGEXMSRSJTVIWYQTXMZI8'TEXMIRXWSVGSRǻVQIH
TB patients.

This can be achieved by assigning a health worker to screen

patients for TB immediately when they arrive at the facility.

2. Educate Instruct all patients with chronic cough on cough hygiene i.e.
covering the mouth and nose when coughing or sneezing,
where possible use face masks or tissues to assist them in
covering their mouths.

Educate on safe sputum disposal methods

3. Separate Presumptive TB clients and TB patients must be separated

from other patients in a well-ventilated waiting area

4. Investigate for TB or TB diagnostic tests should be done onsite or, if not available
refer onsite, the facility should have an established link with a TB
diagnostic and treatment site to which presumptive patients
or samples can be referred.

5. Treatment (SRǻVQXLIHMEKRSWMWSJ8'HMWIEWI[MXLMRLSYVWJSV
sputum smear microscopy and Gene Xpert results and 2-6
weeks for culture.

Patients diagnosed with TB should be started on anti-TB

treatment as soon as possible

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 6. Discharge Plan For inpatient and outpatient settings, coordinate a discharge
plan with the patient for continuity of care

10.2.3. Environmental Control Measures

These are measures that are used to reduce the concentration of droplet nuclei in the
air. Such measures include maximizing natural ventilation and controlling the direction
SJ EMVǼS[ 4TIRMRK [MRHS[W ERH HSSVW MW XLI QSWX TVEGXMGIH JSVQ SJ IRZMVSRQIRXEP
control.

There are two types of environmental controls: -

A. Natural ventilation

Simple natural ventilation may be optimized by maximizing the size of the opening of
windows and doors and locating them on opposing walls.

ÜĚåŹåƐŤŇžžĞÆĮåØƐƒĚåƐƣžåƐŇüƐĻ±ƒƣŹ±ĮƐƽåĻƒĞĮ±ƒĞŇĻƐžĚŇƣĮÚƐÆåƐķ±DŽĞķĞǍåÚƐÆåüŇŹåƐÏŇĻžĞÚåŹĞĻďƐ
ŇƒĚåŹƐƽåĻƒĞĮ±ƒĞŇĻƐžDžžƒåķžũ

B. Mechanical Ventilation

Well-designed, maintained and operated fans (mixed-mode ventilation) can help

XS SFXEMR EHIUYEXI HMPYXMSR [LIR REXYVEP ZIRXMPEXMSR EPSRI GERRSX TVSZMHI WYǽGMIRX
ventilation rates.

In some settings, mechanical ventilation (with or without climate control) will be needed.

This may be the case, for example, where natural or mixed-mode ventilation systems
GERRSXFIMQTPIQIRXIHIǺIGXMZIP]SV[LIVIWYGLW]WXIQWEVIMREHIUYEXIKMZIRPSGEP
conditions (e.g. building structure, climate, regulations, culture, cost and outdoor air
quality).

8LIJSPPS[MRKEVIXLIǻZIQEMRTVMRGMTPIWSJIRZMVSRQIRXEPGSRXVSPQIEWYVIW

ƽ +EGMPMX]HIWMKR

ƽ )MPYXMSR IK:IRXMPEXMSRW]WXIQW

ƽ +MPXVEXMSR IK-*5&ǻPXIVW

ƽ 5YVMǻGEXMSR IK9:,.]WXIQW

ƽ )MWMRJIGXMSR IKGLIQMGEPXLIVQEP

224 Integrated Guideline for Tuberculosis,

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Facility Design
The design should take into consideration

 5EXMIRXǼS[TEXXIVR

ƽ 2MRMQM^IWGSRKVIKEXIWMXYEXMSRW

ƽ 5VSZMHIEVIEWJSVXVMEKMRKSJTSXIRXMEPP]MRJIGXMSYWTEXMIRXW

ƽ 5VSZMHIMWSPEXMSRVSSQWJSVMRJIGXMSYWTEXMIRXW

ƽ 2MRMQM^IGVSWWMRJIGXMSR

2. Maximize natural ventilation

ƽ )MVIGXMSRSJ[MRHǼS[

ƽ Placement and sizes of doors, windows and corridors

ƽ -IEPXLGEVIWXEǺWLSYPHFIQMRHJYPSJXLIHMVIGXMSRSJEMVǼS[XSIRWYVIXLITEXMIRX
MWGPSWIWXXSXLII\LEYWXJERWERHXLIWXEǺEVIGPSWIWXXSXLIGPIEREMVWSYVGI8LMW
arrangement should be done every morning.

ƽ 5VSQSXIW EMVǼS[ TEXXIVRW JVSQ XLI PIEWX MRJIGXIH LIEPXL GEVI [SVOIV XS XLI
most infected (patients)

ƽ 2E\MQM^I REXYVEP HVEYKLX XLVSYKL GLMQRI] EǺIGXW ZIRXMPEXMSR KVMPPW STIR

verandas

3. Maximize availability of sunlight as a natural deterrent to growth of MTB colonies

C. Dilution

8LMW MW XLI WMQTPIWX I\XVIQIP] IǺIGXMZI ERH PIEWX I\TIRWMZI XIGLRMUYI .X MRZSPZIW
removal and dilution of infectious air by maximizing natural ventilation

D. Filtration

.XƶWEQIXLSHXLEXMRZSPZIWVIQSZMRKMRJIGXMSYWTEVXMGPIWERHFVMRKWFEGOǻPXIVIHEMV8LMW
MRZSPZIWXLIYWISJ-*5&GPIERIV -MKL*ǽGMIRG]5EVXMGYPEXI&MVGPIERIV

ƽ In-duct application

ƽ .RGSRNYRGXMSR[MXL7SSQEMVGPIERIV QSFMPISVǻ\IH

* 5YVMǻGEXMSR

It involves the use of Ultraviolet Germicidal Irradiation (UVGI) to inactivate M. tuberculosis

organisms

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 F. Disinfection

This involves the process of eliminating many or all pathogenic microorganisms, except
bacterial spores, on inanimate objects.

It includes,

ƽ Chemical disinfection for general equipment and surfaces

ƽ Thermal disinfection e.g. steam sterilization or autoclaving

.J XLIVI EVI MREHIUYEXI SV MRWYǽGMIRX EHQMRMWXVEXMZI GSRXVSP QIEWYVIW IRZMVSRQIRXEP
control measures will not eliminate the risk.

10.2.4. Personal protective Equipment (respiratory

protection)
8LMWVIJIVWXSMXIQWWTIGMǻGEPP]YWIHXSTVSXIGXXLILIEPXLGEVITVSZMHIVXLITEXMIRXERH
the community from exposure to body substances or from droplet or airborne organisms
in the line of duty providing or seeking services.

They include; gloves, aprons, gowns, caps, surgical masks, respirators and protective
eyewear.

Respiratory protection is an important aspect for protecting HCWs against TB nosocomial

infection. It goes hand in hand with administrative and environmental measures.

This measure is important in high risk areas such as DR-TB treatment facilities, centers
handling presumptive TB and DR specimens, surgical centers handling bronchoscopy
and autopsy, sputum induction and other aerosol –generating procedures plus people
handling disposal waste from the laboratory and wards.

Table 10.2: Type of recommended protective equipment and recommended use

Type of PPE Recommended use Primary protects

Gloves When there is a reasonable chance of hands Service providers

coming in contact with blood or other body
ǼYMHWQYGSYWQIQFVERIWSVRSRMRXEGXWOMR
Before performing invasive medical
procedures, for example, when performing
sputum induction
Before handling contaminated waste items or
touching contaminated surfaces

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Caps, gowns or ƽ;LIRTIVJSVQMRKMRZEWMZITVSGIHYVIW Service providers,
aprons during which tissue beneath the skin is patients
exposed
ƽ;LIREXXIRHMRKXSTEXMIRXW[MXLMRJIGXMSYW
disease
ƽ;LIRLERHPMRKGSRXEQMREXIH[EWXI

N-95 masks ƽ ;LIRLERHPMRKTEXMIRXW[MXLEMVFSVRISV Service providers,

droplet infections visitors and caregivers

Surgical/ Procedural ƽ When performing invasive procedures Patients, service

masks providers
ƽ When handling medical waste

Goggles or glasses Situations in which splashing of blood, body Service providers,

ǼYMHWWIGVIXMSRWSVI\GVIXMSRWEVIPMOIP]
ERHPEFSVEXSV]WXEǺ

Closed boots or Situations in which sharp instruments or in Service providers and

shoes which spillage or infectious agents are likely patients

Use of surgical or procedure masks for patients

ƽ Surgical masks are used by the patients to prevent transmission of droplets
during exhalation - coughing, sneezing, talking or singing.

ƽ However, it is still paramount to educate the patient on cough etiquette practices

WYGLEWGSZIVMRKXLIQSYXLYWMRKXMWWYIWSVGPSXLIWRSXWTMXXMRKSRXLIǼSSVERH
proper disposal of soiled tissues.

ƽ Patient and HCW education regarding the importance and appropriate use of
wearing surgical masks should accompany their distribution.

N 95 for health care workers

3  EVI E WTIGMEP X]TI SJ VIWTMVEXSVW XLEX TVSZMHI   ǻPXVEXMSR IǽGMIRG] EKEMRWX
0.3-0.4 micrometer particles.

8LI]WLSYPHFIGPSWIP]ǻXXIHXSXLIJEGIXSTVIZIRXPIEOEKIEVSYRHXLIIHKIW.JXLI
respirator is not worn correctly, infectious droplet nuclei can easily enter a person’s
airways, potentially resulting in infection.

ƽ The N95 masks can be re-used repeatedly if they are properly stored.

ƽ Respirators should be stored in a clean dry location devoid of humidity, dirt and
ǻPXIVHEQEKI

ƽ Plastic bags should never be used since they retain humidity.

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 Protection in high risk areas

ƽ Respirators should be worn by all personnel entering high risk areas such as
bronchoscopy rooms, sputum induction rooms, MDR-TB isolation wards, people
handling specimens in the laboratory, MDR-TB Clinic.

ƽ The use of powered air- purifying respirator (PAPR) is also recommended where
LMKLVMWOTVSGIHYVIWEVITIVJSVQIHJSVXLI]EVIGSWXIǺIGXMZIERHEVIVIYWEFPI
ERHHSIWRSXVIUYMVIǻXXIWXMRK

 8YFIVGYPSWMW1EFSVEXSV]EJIX]

KEY HIGHLIGHTS:

ƽ TYXYQQMGVSWGST]MWEPS[VMWOEGXMZMX] 'MSWEJIX](EFMRIXWEVIRSXQERHEXSV]
for performing direct sputum-smear microscopy.

ƽ 8LIQSWXMQTSVXERXJEGXSVMRXLITVIZIRXMSRSJPEFSVEXSV]8'EGUYMVIHMRJIGXMSR
is good technique on the part of the individual health care provider. Specialized
equipment may aid good laboratory practice but does NOT replace it.

ƽ 7IWTMVEXSVWERHWYVKMGEPQEWOWEVIRSXXLIWEQIYVKMGEPQEWOWTVSZMHIRS
IǺIGXMZIVIWTMVEXSV]TVSXIGXMSRJVSQEIVSWSPWERHQYWXRSXFIYWIH

Laboratory facilities are designated as:

ƽ Basic – Biosafety Level 1(Smear microscopy for AFB, Gene Xpert)

ƽ Basic –Biosafety Level 2 (Smear microscopy for AFB, Gene Xpert, LPA)

ƽ Containment – Biosafety Level 3 (Smear microscopy for AFB, Gene Xpert, LPA,
culture and phenotypic DST)

ƽ Maximum containment – Biosafety Level 4(Marburg virus, Corona Virus, Ebola

virus etc).

Biosafety level designations are based on a composite of the design features,

construction, containment facilities, equipment, practices and operational procedures
required for working with agents from the various risk groups.

10.3.1 Risk level and laboratory areas

The entry area should be reserved for ‘clean’ activities. ‘Dirty’ activities should be furthest
away from the entry.

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Low-risk activities include:

ƽ &HQMRMWXVEXMSR LERH[EWLMRK WXEXMSR QMGVSWGST] ,IRI <TIVX GSRWYQEFPIW

and reagent storage, staining.

Moderate-risk activities include:

ƽ (YPXYVITVSGIWWMRKERHQIHMEMRSGYPEXMSR

High-risk activities include:

ƽ -ERHPMRK TSWMXMZI GYPXYVIW MHIRXMǻGEXMSR SJ 28' )8 TVITEVMRK )3& *\XVEGXW
from positive cultures.

Table 10.3: Risk levels and assessments of risk in TB laboratories

RISK LEVEL LABORATORY ACTIVITIES ASSESSMENT OF RISK SAFETY

EQUIPMENT

Low risk Direct sputum Low risk of generating Handwashing/Eye

microscopy; preparation infectious aerosols wash station
of specimens for the from specimens;
Xpert MTB/RIF assay low concentration of
infectious particles

Moderate risk Processing and Moderate risk of Handwashing/Eye

concentration of generating infectious wash station
specimens for inoculation aerosols from specimens;
Biosafety
on primary culture media; low concentration of
cabinet(BSC)
direct molecular testing infectious particles
on processed sputum by Autoclave
a line probe assay

High risk Culture manipulation for High risk of generating Handwashing/Eye

MHIRXMǻGEXMSRTLIRSX]TMG infectious aerosols wash station
DST, or a line probe assay from cultures; high
Biosafety
on cultures concentration of
cabinet(BSC)
infectious particles
Autoclave

Biosafety level 3 lab

Risk assessment for TB laboratories

)IGMWMSRW EFSYX [LMGL EVI XLI QSWX ETTVSTVMEXI FMSWEJIX] QIEWYVIW JSV E WTIGMǻG
laboratory should be undertaken using an approach based on risk assessment that
GSRWMHIVWXLIHMǺIVIRXX]TIWSJTVSGIHYVIWTIVJSVQIHF]XLIPEFSVEXSV]

The risk-assessment approach for a TB laboratory considers:

ƽ 8LI[SVOPSEH 3SWPMHIWI\EQMRIHQMGVSWGSTMGEPP]TIVHE]

ƽ 8LIFEGXIVMEPPSEHSJQEXIVMEPW WYGLEWWTYXYQWTIGMQIRWERHGYPXYVIWERHXLI
viability of TB bacilli

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 ƽ 5SWWMFPIVSYXISJXVERWQMWWMSRJSV8'

ƽ ;LIXLIVXLIQEXIVMEPLERHPIHERHXLIQERMTYPEXMSRWVIUYMVIHJSVIEGLTVSGIHYVI
are likely to generate infectious aerosols

ƽ 8LI RYQFIV SJ QERIYZIVW JSV IEGL XIGLRMUYI XLEX QE] TSXIRXMEPP] KIRIVEXI
aerosols

ƽ 8LI[SVOPSEHSJXLIPEFSVEXSV]ERHMRHMZMHYEPWXEǺQIQFIVW

ƽ 8LIPSGEXMSRSJXLIPEFSVEXSV]

ƽ 8LI ITMHIQMSPSK] SJ XLI HMWIEWI ERH XLI TEXMIRX TSTYPEXMSR WIVZIH F] XLI
laboratory

ƽ 8LIPIZIPSJI\TIVMIRGIERHXLIGSQTIXIRGISJXLIPEFSVEXSV]ƶWXIGLRMGMERW

ƽ 8LILIEPXLSJXLIPEFSVEXSV]ƶW[SVOIVW IWTIGMEPP]-.:TSWMXMZIXIGLRMGMERW

10.3.2 Personal protective equipment in the laboratory

Masks: One of the greatest false beliefs is that a standard surgical mask will protect the
wearer from becoming infected with TB. These masks are made from porous material
XLEX[MPPRSXXVET8'FEGMPPMERHLEZIERI\XVIQIP]TSSVǻXGVIEXMRKPEVKIKETWFIX[IIR
the face and mask.

Surgical masks provide no respiratory protection from aerosols and must not be used in
a laboratory setting.

Respirators: 7IWTMVEXSVW QYWX ǻPXIV #  SJ MRJIGXMSYW TEVXMGPIW KVIEXIV XLER ƌQ MR
size. N95 and FFP2 respirators meet the requirements and are lightweight, disposable
devices that cover the nose and mouth.

Both FFP2 and N95 respirators may be ‘valved’ or ‘unvalved’

ƽƵ:EPZIHƶVIWTMVEXSVWEPPS[I\TMVIHEMVXSQSZIIEWMP]JVSQXLIPYRKWXSXLIIRZMVSRQIRX
but closes when breathing in occurs

ƽƵ9RZEPZIHƶVIWTMVEXSVWHSRSXLEZIEZEPZI

Respirators are not usually required for work in a TB culture laboratory. However, they
must be worn when setting up DST.

They can be reused provided that they are properly worn, stored and cared for.

RESPIRATORS ARE NOT A SUBSTITUTE FOR A PROPERLY MAINTAINED AND FUNCTIONING

BIOLOGICAL SAFETY CABINET

230 Integrated Guideline for Tuberculosis,

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.JVIWTMVEXSVWEVIYWIHWXEǺQYWXFI

ƽ .RWXVYGXIHMRGSVVIGXYWI

ƽ 8EYKLXLS[XSGEVIJSVEVIWTMVEXSV

Gloves: Disposable gloves only are to be worn in a TB laboratory.

DO NOT RE-WEAR USED GLOVES

IZIVEPTEMVWSJKPSZIW[MPPFIYWIHIEGLHE] EWYǽGMIRXWYTTP]QYWXFIVIEHMP]EZEMPEFPI

Gloves must be worn for all procedures that involve contact with specimens or laboratory
items used in handling specimens or cultures.

Allergic reactions such as skin rash (dermatitis) and hypersensitivity reactions may occur
MRWXEǺ[IEVMRKPEXI\KPSZIW TS[HIVIHERHRSRTS[HIVIH&PXIVREXMZIKPSZIQEXIVMEPW
include vinyl and nitrile which rarely cause allergic reactions.

DO NOT TAKE GLOVES OUTSIDE OF THE LABORATORY

Wearing and removing gloves:

)MǺIVIRXWM^IWSJKPSZIWQYWXFIEZEMPEFPI WQEPPQIHMYQPEVKI5SSVP]ǻXXMRKKPSZIW
VIHYGI XLI HI\XIVMX] SJ XLI ǻRKIVW ERH MRGVIEWI XLI VMWO SJ KPSZI GSRXEQMREXMSR ERH
accidents.

ƽ 8SSWQEPPERHXLI]EVIIEW]XSXIEV

ƽ 8SSPEVKIERHǻRIQSXSVWOMPPWEVIPSWX

Used gloves must be discarded into a laboratory infectious waste bin.

Once gloves are removed, wash your hands immediately.

Laboratory Coats and Gowns: Laboratory Coats must be worn at all times when working
in the laboratory and various sizes should be provided.

They should be tied at the back, not the front, and be made from water-resistant materials
to avoid liquids soaking into the gown.

LABORATORY COATS MUST NOT BE WORN OR CLEANED OUTSIDE THE LABORATORY

ƽ 7IYWEFPI KS[RW QYWX FI EYXSGPEZIH s( JSV  QMRYXIW FIJSVI FIMRK XEOIR
away for cleaning
ƽ +SV VIYWEFPI KS[RW XLIVI WLSYPH FI EX PIEWX XLVII KS[RW EZEMPEFPI TIV WXEǺ
member
– In-use
– Being cleaned
– Ready for use

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 ƽ ,S[RWWLSYPHFIGLERKIH[IIOP]SVEJXIVERSFZMSYWWTMPPSGGYVW

ƽ ,S[RWQYWXFIEZEMPEFPIMRWQEPPQIHMYQERHPEVKIWM^IW

Coats

Laboratory coats are open at the front and may have short or long sleeves.

NEVER CARRY LABORATORY COATS HOME.

10.3.3 Safety precaution in sputum smears preparation

ƽ 8LI QENSV VMWO SJ8' MRJIGXMSR MR XLI PEFSVEXSV] MW EWWSGMEXIH[MXL MRLEPEXMSR SJ
aerosols generated by laboratory processes. Minimizing their production is the
QSWXIǺIGXMZIQIERWSJWXE]MRKWEJI

ƽ TYXYQQMGVSWGST]MWEPS[VMWOEGXMZMX] 'MSWEJIX](EFMRIXWEVIRSXQERHEXSV]
for performing direct sputum-smear microscopy.

ƽ ;MXLKSSHQMGVSFMSPSKMGEPXIGLRMUYIHMVIGXWTYXYQWQIEVQMGVSWGST]IRXEMPWE
low risk of generating infectious aerosols, and such procedures may therefore be
performed on an open bench, provided that adequate ventilation can be assured

ƽ ;LIVI KSSH PEFSVEXSV] TVEGXMGIW EVI YWIH VMWO SJ MRJIGXMSR XS PEFSVEXSV]
technicians is very low during smear preparation.

ƽ &LMKLIVVMWOSJMRJIGXMSRI\MWX[LIRGSPPIGXMRKWTYXYQWTIGMQIRWJVSQTEXMIRXW

ƽ &IVSWSPWQE]FITVSHYGIHMRXLI8'PEFSVEXSV][LIRLERHPMRKPIEOMRKWTIGMQIRW
opening sample containers, and preparing smears. When care and appropriate
techniques are used, handling sputum presents a minimal risk of acquiring
infection to a technician.

ƽ +SV PEFSVEXSV] WXEǺ XLI KVIEXIWX VMWO SJ MRJIGXMSR MRZSPZIW WTYXYQ GSPPIGXMSR
People with presumptive TB may cough and in doing so, spread TB bacilli in tiny
droplets in the air which may infect others when they are inhaled. Precautions
must be taken to minimize this exposure.

ƽ 8LIPEFSVEXSV]XIGLRMGMERMWEXGSRWMHIVEFP]QSVIVMWO[LIRWTYXYQMWTVSGIWWIH
for culture and drug susceptibility testing. These procedures require shaking and
centrifugation

ƽ (SRWIUYIRXP] WTIGMEP IUYMTQIRX WYGL EW FMSPSKMGEP WEJIX] GEFMRIXW[LMGL EVI

costly to purchase and maintain, are required. However, this equipment is not
NYWXMǻIHMRXLI&+'WQIEVQMGVSWGST]PEFSVEXSV]

Proper collection of sputum: If a coughing patient comes into the laboratory, ask them
to cover their mouth.

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 !
CAUTION!

NEVER COLLECT SPUTUM SPECIMENS IN LABORATORIES, TOILETS, WAITING ROOMS,

RECEPTION ROOMS, OR ANY OTHER ENCLOSED SPACE.

Wherever possible, collect specimens outside where air movement will rapidly dilute
infectious droplets and UV rays from the sun will rapidly inactivate TB bacilli.

Sputum collection areas

Designated sputum collection areas should be clearly marked and wherever possible,
outside in open air where bacilli will naturally be dispersed by wind rather than in a
closed room where the concentration of bacilli will be high.

Designated sputum collection booths can be established with instructions on steps in

collecting a good sputum sample posted on the wall.

Laboratory arrangement: The TB laboratory should be a well-ventilated area which is

dedicated to microbiology with restricted access. The air movement should consider
the following;

ƽ )MVIGXMSREPEMVǼS[XLEXLIPTWVIHYGIVMWO.XMWGVIEXIHYWMRKERIKEXMZITVIWWYVI
gradient.

ƽ Air should move from the entry, where low risk activities take place, to the end of
the laboratory where the highest risk activities occur.

*WXEFPMWL EMVǼS[ MR [SVOMRK EVIEW XLEX [MPP HMVIGX TSXIRXMEPP] MRJIGXMSYW TEVXMGPIW E[E]
from personnel. Air must be exhausted into a remote area. An extraction fan can be
YWIJYPXSZIRXEMVJVSQEWQIEVTVITEVEXMSREVIE[MXLTSSVZIRXMPEXMSRXLEXMWGPSWIHSǺ
due to extreme climatic conditions.

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 Appropriate Disinfectants: Phenolic agents (5% phenol in water or a phenolic disinfectant
product diluted as per label) are excellent disinfectants for cleaning up sputum spills
and for decontaminating equipment and single use items prior to disposal. Fresh
household bleach (5% sodium hypochlorite) diluted 1:10 with water can also be used as
a general disinfectant. Bleach solution works well for cleaning up blood spills; however,
MXMWWSQI[LEXPIWWIǺIGXMZIXLERTLIRSPMGEKIRXWEKEMRWX8'.XMWMQTSVXERXXLEXFPIEGL
dilutions be made fresh since it loses potency with time. 70% alcohol is a good agent for
cleaning bench tops.

Safe disposal of infectious waste

After smears have been processed, place all infected materials including closed sputum
containers in a biohazard bag (polyethylene, if available). Discard applicator sticks
used for smearing immediately after use. Since all sputum specimens are considered
potentially infectious, treat all materials in the procedure as contaminated.

Discard specimens by one of the following methods:

ƽ .RGMRIVEXMSR

ƽ 'YV]MRK

ƽ &YXSGPEZMRK

To protect the surrounding population, the laboratory must dispose of waste safely.
Incineration is usually the most practical way for safe destruction of laboratory waste.
If incineration cannot be arranged, discard the waste in a deep pit of at least 1.5-meter
depth. If an autoclave is available, place infected materials inside and follow procedures
for safe and adequate sterilization.

Ventilated Cabinets
Ventilated Cabinets include Laboratory Fume Hoods and Biological Safety Cabinets.

The details of these devices follow.

1. Laboratory Fume Hoods

The least expensive ventilated cabinet for laboratories is the Laboratory Fume Hood.
This type of environmental control is designed for the purpose of worker protection (no
protection of the environment or the product [specimen/ culture]). These devices, like
Biological Safety Cabinets, are designed to minimize worker exposures by controlling
emissions of airborne contaminants (including aerosols) through the following:

ƽ 8LIJYPPSVTEVXMEPIRGPSWYVISJETSXIRXMEPGSRXEQMRERXWSYVGI

ƽ 8LIYWISJEMVǼS[ZIPSGMXMIWXSGETXYVIERHVIQSZIEMVFSVRIGSRXEQMRERXWRIEV
their point of generation.

ƽ 8LIYWISJEMVTVIWWYVIVIPEXMSRWLMTWXLEXHIǻRIXLIHMVIGXMSRSJEMVǼS[MRXSXLI
cabinet

234 Integrated Guideline for Tuberculosis,

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2. Biological Safety Cabinets (BSC)

BSCs are categorized as Class I, Class II, or Class III.

Class I

(PEWW.'(WHVE[YRǻPXIVIHVSSQEMVXLVSYKLXLIJVSRXSTIRMRKTEWWMRKMXSZIVXLI[SVO
WYVJEGIERHI\TIPPMRKMXXLVSYKLERI\LEYWXHYGXERHXLVSYKLE-*5&ǻPXIV

Class I BSCs protect the worker but do not protect the work area against contamination
FIGEYWIYRǻPXIVIHVSSQEMVMWHVE[RMRXSXLIGEFMRIXERHSZIVXLI[SVOWYVJEGI

Class II

(PEWW'(WHVE[EVSYRH SJTYVMǻIHEMVJVSQXLI-*5&ǻPXIVEFSZIXLI[SVOEVIE
and around 30% air through the front grille.

Class II provides protection for the user, environment and the work area. There are four
types of BSC Class II: A1, A2, B1 and B2. The most suitable for all TB work is the type A2.

Class III

Also known as glove boxes, generally they are installed only in maximum containment
laboratories.

Do not use class III BSCs in TB laboratories..

4RISJXLIQSWXTIVWMWXIRXQ]XLWLIPHF]PEFSVEXSV]WXEǺXLI[SVPHSZIVMWXLEXE
BSC provides complete protection from the infectious material it contains. THIS IS
NOT TRUE!!!

GOOD SAFE WORKING PRACTICE IS YOUR BEST PROTECTION

!
Poor technique when using a BSC will expose you to potential infection.

ƽ&'(GERQEMRXEMRXLIPIZIPSJWXIVMPMX]]SYGVIEXIMXGERRSXTVSHYGIMXF]MXWIPJ

ƽ=SYVEGXMSRWQYWXEP[E]WGSQTPIQIRXXLISTIVEXMSRSJXLI'(

ƽ=SYTVIZIRXGVSWWGSRXEQMREXMSRF]YWMRKWEJI[SVOMRKTVEGXMGI

(IVXMǻGEXMSRSJ'(W

8SGLIGOMXWTIVJSVQERGIE'(QYWXFIGIVXMǻIHEXPIEWXERRYEPP]

&UYEPMǻIHIRKMRIIVQYWXEWWIWWXLI'(YWMRKEREGGITXIHREXMSREPSVMRXIVREXMSREP
standard. The engineer will decontaminate the BSC before inspection.

.XMWXLIVIWTSRWMFMPMX]SJXLIPEFSVEXSV]QEREKIVXSSVKERM^IGIVXMǻGEXMSRERHXSEHZMWI
WXEǺXLEXXLI'(QE]FIWEJIP]YWIH

Integrated Guideline for Tuberculosis, 235

Leprosy and Lung Disease | 2021
 .X MW XLI VIWTSRWMFMPMX] SJ XLI GSYRX] QEREKIQIRX XS WYTTSVX ERRYEP GIVXMǻGEXMSR SJ
biosafety cabinets

ƒƉÎåųƋĜĀΰƋĜŅĹƉĜŸƉųåŧƚĜųåÚ

ƽ 'IJSVIǻVWXYWISJERI[P]MRWXEPPIH'(

ƽ &RRYEPP]

ƽ ;LIRE'(MWQSZIH[MXLMRXLIPEFSVEXSV]

ƽ ;LIRIZIVE-*5&ǻPXIVMWVITPEGIH

ƽ ;LIRIZIVGSQTSRIRXW[MXLMRXLITPIRYQEVIVITPEGIH

kĻÏåƐÏåŹƒĞĀϱƒĞŇĻƐĞžƐÚŇĻåØƐЃƐķƣžƒƐÆåƐÚĞžŤĮ±DžåÚƐŇĻƐƒĚåƐ„ũ

10.4. Infection prevention at radiology departments

Appropriate placement of patients with TB in an isolation room reduces the risk of
infection and disease to HCWs.

The patient should be explained and instructed to wear a surgical mask at all times
while being wheeled to the radiology department.

10.5. Prevention and control of TB transmission within

the community
Increase awareness on reducing transmission of TB in the community by creating
GSQQYRMX]E[EVIRIWWIEVP]MHIRXMǻGEXMSRSJ5VIWYQTXMZI8'ERHVIJIVVEPJSVJSPPS[YT
in the health care setting.

.HIRXMǻIH 8' GEWIW WLSYPH FI XEYKLX SR GSYKL IXMUYIXXI ERH GSYKL L]KMIRI (VIEXI
Community awareness on the importance of adherence to TB treatment.

10.6. IPC in congregate settings

There are special settings in the community that are of high risk and call for special
attention as far as TB infection, prevention and control is concerned. TB is spread more
readily in congregate settings and this is because of longer duration of potential exposure,
crowded environment, poor ventilation, and limited access to health care services.

236 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
These include:

ƽ 5VMWSRWERHVIQERHGIPPW

ƽ .RJSVQEPWIXXPIQIRXW WPYQW

ƽ 7IJYKIIERHMRXIVREPP]HMWTPEGIHTIVWSRW .)5GEQTW

ƽ PIEVRMRKMRWXMXYXMSRW WGLSSPWGSPPIKIW

ƽ IGYVMX] JSVGIW XVEMRMRK GEQTW QMPMXEV] ,IRIVEP IVZMGI 9RMX ,9 5SPMGI
National Youth Service (NYS) etc

Correctional facilities (Prisons and Remands)

All inmates on admission should be screened for TB.

The prison and remand cell should follow and implement TB infection control guidelines.
There is need for active advocacy and sensitization of relevant ministries and departments
for the implementation of TB infection control guidelines in the prisons.

Informal settlements (slums)

To reduce TB transmission in the informal settlement, there is need to have adequate
sensitization and advocacy on proper ventilation on the existing structures/ housing
and practice of cough etiquette. The implementation of community TB infection control
guidelines should be emphasized. Screening, contact tracing and treatment interrupter
tracking should be highly emphasized in such settings

Learning institutions and security forces training camps

Learning institutions should embrace TB infection control guidelines. TB infection control
should be incorporated in the school health program. Learning institutions should
adopt and own TB environmental measures and Ultraviolet Germicidal Irradiation (UVGI)
among others.

Public services transport

ƽ 2EXEXYWFYWIWERHXVEMRW

ƽ &MVXVERWTSVX

TB infection control guidelines should be implemented in public transport sectors.

There should be adequate ventilation by opening windows on both sides of the vehicles
or applying mechanized ventilation. Airline services should implement TB Infection
control guidelines.

Integrated Guideline for Tuberculosis, 237

Leprosy and Lung Disease | 2021
 10.7. Infection control and isolation of TB patients
5ISTPI EǺIGXIH F] 8' GER FI WYFNIGXIH XS EVFMXVEV] ERH LEVQJYP QIEWYVIW WYGL EW
involuntary treatment, detention, isolation and incarceration.

&GGSVHMRK XS ;-4 Ƹ.RZSPYRXEV] MWSPEXMSR I\GITX MR REVVS[P] HIǻRIH GMVGYQWXERGIW
WII FIPS[ JSV I\GITXMSREP GMVGYQWXERGIW ERH WTIGMǻG GSRHMXMSRW XLEX QYWX FI QIX
is unethical and infringes an individual’s rights to liberty of movement, freedom of
association, and to be free from arbitrary detention. It is unethical to isolate persons with
8'MJXLITIVWSRMWRSXGSRXEKMSYWSVMJMWSPEXMSRLSPHWRSGPIEVTYFPMGLIEPXLFIRIǻXXS
the community.’’

;-4 JYVXLIV WTIGMǻIW I\GITXMSREP GMVGYQWXERGIW [LIR MRZSPYRXEV] MWSPEXMSR GER FI
considered as the last resort for an individual who is:

M 0RS[RXSFIGSRXEKMSYWVIJYWIWIǺIGXMZIXVIEXQIRXERHEPPVIEWSREFPIQIEWYVIW
to ensure adherence have been attempted and proven unsuccessful

ii) Known to be contagious, has agreed to ambulatory treatment, but lacks the
capacity to institute infection control in the home, and refuses care at medical
facilities

iii) Highly likely to be contagious (based on laboratory evidence) but refuses to

YRHIVKS EWWIWWQIRX SJ LMWLIV MRJIGXMSYW WXEXYW[LMPI IZIV] IǺSVX MW QEHI XS
work with the person with TB to establish a treatment plan that meets his needs.

And ALL of the following nine conditions must be met in order to justify any involuntary
isolation:

1. Isolation is necessary to prevent the spread of TB

2. *ZMHIRGIXLEXMWSPEXMSRMWPMOIP]XSFIIǺIGXMZIMRXLMWGEWI

3. Person with TB refuses to remain in isolation despite being adequately informed

of the risks, the meaning of being isolated and the reasons for isolation

4. A person with TB’s refusal puts others at risk

5. All less restrictive measures have been attempted prior to forcing isolation

6. All other rights and freedoms (such as basic civil liberties) besides that of
movement are protected

7. Due process and all relevant appeal mechanisms are in place

8. Person with TB has, at least, basic needs met

9. The isolation time given is the minimum necessary to achieve its goals

238 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
10.8. Evaluation of TB infection control measures
Evaluation of TB infection control measures is done by reviewing the medical records
of a sample of TB patients seen in the facility. The evaluation of outcome measures can
then be used to identify the areas where improvement may be needed. The process of
developing and implementing the TB infection control plan is not static, but is a process
that should be continually monitored and adapted, with ongoing education integrated
at all steps.

Monitoring and Evaluation key areas

Periodic supervision of the measures outlined in the IPC plan.

1. Surveillance of active TB rates among HCWs in the health facility

2. Review medical records of a sample of TB patients seen in the facility to evaluate

the following outcome measures;

ƽ Time interval from admission to suspicion of TB

ƽ Time interval from suspicion of TB to ordering sputum for AFB smears

ƽ Time interval from ordering to the collection of sputum

ƽ Time interval from the examination of the smear to the reporting of results

ƽ Time interval from the return of laboratory results to the initiation of treatment.

Integrated Guideline for Tuberculosis, 239

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240 Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
MANAGEMENT OF
LATENT TB INFECTIONS 11

)IǻRMXMSRSJXIVQW
Adolescent: A person aged 10–19 years

Adult: A person over 19 years of age

'EGXIVMSPSKMGEPP] GSRǻVQIH 8' TB diagnosed in a biological specimen by smear

microscopy, culture or a WHO-approved molecular test such as Xpert MTB/RIF®

Child: A person under 15 years of age

Contact: Any person who was exposed to a person with tuberculosis

Contact investigation: A systematic process for identifying previously undiagnosed

people with TB disease and TB infection among the contacts of an index TB patient
and/or other comparable settings where transmission occurs. Contact investigation
GSRWMWXWSJMHIRXMǻGEXMSRGPMRMGEPIZEPYEXMSRERHSVXIWXMRKERHTVSZMWMSRSJETTVSTVMEXI
ERXM8'XLIVET] JSVGSRǻVQIH8'GEWIWSV8'TVIZIRXMZIXVIEXQIRX JSVXLSWI[MXLSYX
TB disease).

Close contact: a person who is not in the household but shared an enclosed space,
such as a social gathering place, workplace or facility, for extended periods during the
day with the index case during the 3 months before commencement of the current TB
treatment episode.

High TB transmission setting: setting with a high frequency of individuals with

undetected or undiagnosed TB disease, or where infectious TB patients are present and
there is a high risk of TB transmission. TB patients are most infectious when they are
untreated or inadequately treated. Transmission will be increased by aerosol-generating
procedures and by the presence of susceptible individuals.

Household contact: A person who shared the same enclosed living space as the index
case for one or more nights or for frequent or extended daytime periods during the 3
months before the start of current treatment

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Leprosy and Lung Disease | 2021
 Index case (index patient) of TB: 8LIMRMXMEPP]MHIRXMǻIHTIVWSRSJER]EKI[MXLRI[SV
VIGYVVIRX8'MREWTIGMǻGLSYWILSPHSVSXLIVGSQTEVEFPIWIXXMRKMR[LMGLSXLIVWQE]
have been exposed. An index case is the person on whom a contact investigation is
centered but is not necessarily the source case.

Infant: A child under 1 year (12 months) of age

Latent tuberculosis infection (LTBI): A state of persistent immune response to stimulation

by M. tuberculosis antigens with no evidence of clinically manifest TB disease. There is
RS KSPH WXERHEVH XIWX JSV HMVIGX MHIRXMǻGEXMSR SJ 2 XYFIVGYPSWMW MRJIGXMSR MR LYQERW
Most infected people have no signs or symptoms of TB but are at risk for TB disease.
This is also at times referred to as TB infection (TBI).

People who use drugs: refers to people who engage in the harmful or hazardous use of
psychoactive substances, which could impact negatively on the user’s health, social life,
resources and legal situation.

Programmatic management of tuberculosis preventive treatment (PMTPT): All

coordinated activities by public and private health caregivers and the community aimed
at scaling up TB preventive treatment to people who need it.

At risk group: any group of people in which the prevalence or incidence of TB is

WMKRMǻGERXP]LMKLIVXLERMRXLIKIRIVEPTSTYPEXMSR

Systematic screening for active TB:W]WXIQEXMGMHIRXMǻGEXMSRSJTISTPI[MXLTVIWYQIH8'

disease, in a predetermined target group, using tests, examinations or other procedures
that can be applied rapidly. Among those screened positive, the diagnosis needs to
be established by one or several diagnostic tests and additional clinical assessments,
which together have high accuracy.

TB preventive treatment (TPT):8VIEXQIRXSǺIVIHXSMRHMZMHYEPW[LSEVIGSRWMHIVIHEX

risk of developing TB disease, in order to reduce that risk. Also referred to as treatment
of TB infection or LTBI treatment.

Tuberculosis (TB): The disease that occurs in someone infected with M. tuberculosis.
It is characterized by signs or symptoms of TB disease, or both, and is distinct from
tuberculosis infection, which occurs without signs or symptoms of TB. In this document,
it is commonly referred to as “active” TB or TB “disease” in order to distinguish it from
LTBI or TBI.

Underweight: Among adults this usually refers to a body mass index <18.5 and among
children < 10 years to a weight-for-age < –2 z-scores.

Introduction
Latent TB infection (LTBI) is a state of persistent immune response to stimulation by
aũƐ ƒƣÆåŹÏƣĮŇžĞžƐ antigens with no evidence of clinically manifestation of active TB. It is
estimated that approximately one-quarter of the world’s population (about 1.3 billion
people) have LTBI and 5-10% of these are at risk of progression to active TB disease over
XLIGSYVWISJXLIMVPMZIWQSWXSJXLIQ[MXLMRXLIǻVWX]IEVWEJXIVMRMXMEPMRJIGXMSR

When a person inhales the air that contains droplets with M. tuberculosis bacilli, most of

242 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
the larger droplets become lodged in the upper respiratory tract (the nose and throat).
However, smaller droplet nuclei may reach the small air sacs of the lung (the alveoli),
where infection may begin. In the alveoli, some of the tubercle bacilli are killed, but a
few multiply in the alveoli and enter the bloodstream and spread throughout the body.
Bacilli may reach any part of the body. Within 2 to 8 weeks, however, the body’s immune
system usually intervenes, halting multiplication and preventing further spread. The
immune system is the system of cells and tissues in the body that protects the body
from foreign substances. At this point, the person has latent TB infection (LTBI).

The risk of progression to active TB disease after infection depends on several factors,
the most important being immunological status such as HIV, severe malnutrition,
patients on immunosuppressive therapy etc. Provision of TB Preventive Therapy (TPT)
LEWTVSZIRMXWIPJERIǺIGXMZIMRXIVZIRXMSRXSEZIVXXLIHIZIPSTQIRXSJEGXMZI8'HMWIEWI
[MXLIǽGEG]VERKMRKJVSQ XS 

The World Health Organization’s (WHO) 2015 End TB Strategy recognized that people
with LTBI are important as they are the “seedbeds” (reservoirs) of active TB disease thus
SǺIVMRK858[MPPIRHYTPS[IVMRKXLIFYVHIRSJ8'

8EFPI)MǺIVIRGIFIX[IIR1EXIRX8'.RJIGXMSRERH&GXMZI8')MWIEWI

Targeted populations for TPT

The following are the targeted populations to be initiated on Tb preventive therapy in
Kenya. These populations are vulnerable due to prolonged exposure, compromised
MQQYRMX]GPSWIHGSRǻRIQIRXERHTVSKVIWWMSRXSEGXMZI8'HMWIEWI
a. People Living with HIV

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Leprosy and Lung Disease | 2021
 b. &PPLSYWILSPHGSRXEGXWSJETIVWSR[MXL'EGXIVMSPSKMGEPP]GSRǻVQIHTYPQSREV]
TB patients (children, adolescents and adults)
c. 5VMWSRIVWERH5VMWSRWXEǺ
d. -IEPXLGEVI[SVOIVWERHWYTTSVXWXEǺ[SVOMRKMRLIEPXLGEVIWIXXMRKW
e. Others population at risk.
i. Patients on immunosuppressant’s.
ii. Patients on dialysis
iii. Patients preparing for an organ or haematological transplant
iv. Patients with silicosis

NB- The country is not yet recommending TPT for contacts of multidrug-resistant (MDR)
or extensively drug-resistant TB.

Risk factors for Latent TB infections

ƽ High prevalence of TB disease in population
ƽ Smear positivity of cases in population (infectivity of cases)
ƽ Type of TB disease
ƽ Proximity and duration with the infectious cases
ƽ Environmental factors e.g poor ventilation, overcrowding
ƽ Immunocompromised patients (HIV, patient on dialysis, diabetic, organ transplant
patients, Patient using immunosuppressive drugs)

How to rule out active TB

Rule out active TB using the following screening questions before initiating TB preventive
therapy:
ƽ Cough of any duration
ƽ ;IMKLXPSWWPSWWSJETTIXMXI
ƽ 3MKLXW[IEXW
ƽ +IZIV
For children also assess for;
ƽ +EMPYVIXSXLVMZI
ƽ 7IHYGIHTPE]JYPRIWWPIXLEVK]
ƽ -MWtory of contact with a TB patient

NB; Any one presenting with any of the above symptoms should be investigated further
to rule out TB disease before initiating TPT.

Algorithm for use before initiating TB Preventive Therapy in the at risk population

244 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Figure 11.1: Algorithm for Tuberculosis Preventive Therapy (TPT) in individuals at risk

Algorithm for Tuberculosis Preventive Therapy (TPT) in individuals at riska

Any of the following present?

Adults Childrenb
x Cough of any duration x Cough
x Fever x Fever
x Night sweat x Reduce playfulness
x Weight loss x Failure to thrive/ poor weight gain

Any symptom present Symptoms absent

x x
Evaluate for TB
(5HIHUWR7%GLDJQRVWLFDOJRULWKP)

Active TB present Active TB absent Evaluate for Contraindication for TPTc

Treat for TB
(5HIHUWR7%WUHDWPHQWSURWRFROV) No contraindication Contraindication

Provide TPT Defer TPT

5HHYDOXDWHDWIROORZXSYLVLWV 

At follow-up
x Assess for Adherence
x Assess for active TB disease
x Assess for Adverse Drug Reactions

TPT Treatment Options

Age category HIV status Treatment Options Frequencyd
HIV negative 3RH (Rifampicin/Isoniazid) Daily for 3 months
<15 years HIV positive 6H (Isoniazid) Daily for 6 months
•\HDUV Regardless of HIV status 3HP (Isoniazid/Rifapentine) Once weekly for 3 months
If 3HP or 3RH is contraindicated or In Pregnancy 6H Daily for 6 months
Pyridoxine is given with all of the above options

Note:
a. Individuals at risk are: PLHIV, household contacts of bacteriologically confirmed pulmonary TB, healthcare workers, prisoners, patients on
dialysis, on cancer treatment, undergoing organ or haematological transplant and those with silicosis
b. Child – a person under the age of 10 years
c. Contra-indications for TPT include active hepatitis (DFXWHRUFKURQLF), symptoms of peripheral neuropathy and chronic alcohol abuse
d. Refer to dosing charts for appropriate dose

LTBI testing by TST or IGRA is not a requirement for initiating TPT in PLHIV and child household contacts aged <5 years. However, it
PD\ be provided prior to TPT to the rest of the at-risk population if available and does not delay or hinder access to TPT.

Integrated Guideline for Tuberculosis, 245

Leprosy and Lung Disease | 2021
 Diagnosis and testing of latent TB infections
A diagnosis of latent TB infection is made if a person’s medical evaluation does not
MRHMGEXI 8' HMWIEWI 8' HMWIEWI MW ǻVWX VYPIH SYX XLVSYKL QIHMGEP LMWXSV] TL]WMGEP
examination, chest x-ray, and other laboratory tests.

Testing and diagnosis of Latent TB infections is essential to ensure that we detect the
VMKLXTIVWSRWXSFIRIǻXJVSQ858XLYWVIHYGMRK[EWXEKISJVIWSYVGIW

The diagnostic options for Latent TB infections are as follows;

ƽ Tuberculin skin test (TST)

ƽ Interferon-gamma release assays (IGRA)

51-.:W ERH GLMPHVIR PIWW XLER ǻZI ]IEVW I\TSWIH XS FEGXIVMSPSKMGEPP] GSRǻVQIH 8'
patients do not need TST/IGRA before initiating treatment for LTBI

NOTE:
LTBI testing using TST or IGRA, or even assessment with chest radiography is not
mandatory and should not be a hindrance for initiating TPT.

TB Preventive Therapy Options

5VSZMWMSRSJ8'TVIZIRXMZIXVIEXQIRXLEWTVSZIRXSFIERIǺIGXMZIMRXIVZIRXMSRXSEZIVX
the development of active TB disease.

Initiation of TPT
Patient Preparation

Before initiation of TPT, all eligible persons should be subjected to symptom-based

screening to rule out active TB and to prevent emergence of antimicrobial resistance
(AMR). Persons screening negative for TB and are eligible, should be initiated on
appropriate TPT regimen to reduce the risk of progression from LTBI to active TB disease.
Other key considerations will include assessment of:

ƽ   MKRW ERH W]QTXSQW SJ PMZIV HMWIEWI WYGL EW]IPPS[RIWW SJ I]IWNEYRHMGI
tenderness of the abdomen

ƽ     4XLIV GSQSVFMHMXMIW PMOI HMEFIXIW QIPPMXYW ERH EWWSGMEXIH RIYVSTEXL]

(persistent numbness and burning sensation in the feet and hands).

ƽ&GXMZIWYFWXERGISVEPGSLSPYWIEFYWI

ƽ3YXVMXMSREPEWWIWWQIRX '2.^WGSVI

Where available; baseline LFT s are recommended for all eligible for TPT. Note that lack
of LFT results should not delay the initiation of TPT in asymptomatic patients

If the patient does not have any abnormality based on the assessment above, conduct
patient education and assess for adherence using the criteria on the backside of the
ICF/ TPT card.

246 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Recommended Treatment Options
There are 3 regimens that can be used as TPT listed below

ƽ 7MJETIRXMRI.WSRME^MH

ƽ 7MJEQTMGMR.WSRME^MH

ƽ .WSRME^MH

Table 11..2: Recommended regimens for TPT and their indications.

TPT Regimen Indications Further considerations

Rifapentine and isoniazid ƽ Adult PLHIVs excluding ƽ 8LIVIMWGYVVIRXP]MRWYǽGMIRX

(3HP) patients on PI-based ARV data to support the use of
regimens RPT and INH in pregnancy
Once Weekly for three
months ƽ All household contacts of ƽ Rifapentine can decrease
'EGXIVMSPSKMGEPP]GSRǻVQIH levels of hormonal
(ŐƞƐÚŇžåž)
pulmonary TB patients, who contraception
EVIEKIHǸ]IEVW
ƽ INH should not be given to
ƽ Health care workers persons with known pre-
existing liver damage to
 5VMWSRIVWERHWXEǺMRTVMWSR
EZSMHEREHHMXMZIIǺIGXSR
settings
liver dysfunction
ƽ Other adult population at risk
ƽ INH can cause peripheral
(e.g., patients undergoing
neuropathy. Vitamin B6
chemotherapy, patients on
helps prevent peripheral
dialysis, patients undergoing
neuropathy
transplant, patients with
silicosis)
Rifampicin plus Isoniazid ƽ HIV negative children aged
(3RH) <15 years who are contacts of
'EGXIVMSPSKMGEPP]GSRǻVQIH
Daily for 3 Months
pulmonary TB patients
(íċƐÚŇžåž)

Isoniazid (6H) ƽ Adult PLHIV on PI-based ARV

regimens
Daily for 6 months
ƽ All CLHIV aged below 15 years
(ŐƌíƐÚŇžåž)
 Any patient with intolerance
or contraindication to 3HP or
3RH
ƽ Pregnant women

Note:Ɛ
ĮĮƐ‰{‰ƐŹåďĞķåĻžƐžĚŇƣĮÚƐÆåƐŇýåŹåÚƐƾЃĚƐŤDžŹĞÚŇDŽĞĻåũƐ8ƣĮĮƐŤ±ƒĞåĻƒƐÚŇžåƐžĚŇƣĮÚƐÆåƐ±ƽ±ĞĮ±ÆĮåƐüŇŹƐ
ƒĚåƐåĻƒĞŹåƐƒŹå±ƒķåĻƒƐŤåŹĞŇÚƐÆåüŇŹåƐĞĻЃбƒĞĻďƐƒŹå±ƒķåĻƒƐĞĻƐ±ĮĮƐŹåďĞķåĻũ

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 DOSING SCHEDULE FOR TPT REGIMENS
A. Daily INH for 6 months (6H)
Weight (kg) Dose (mg) Number of 100mg INH Number
tablets of 300mg
(Adult)
tablet
<5 50 ½ tablet -
5.1-9.9 100 1 tablet -
10-13.9 150 1 ½ tablet or ½ tablet
14-19.9 200 2 tablets -
20-24.9 250 2 ½ tablet -
Ǹ 300 3 tablets or 1 tablet
Adult 300 3 tablets or 1 tablet
Note: Syrup INH (50mg/5ml) is available for younger children

B1. Daily RH for 3 months (3RH) for children <25kgs

Weight (kg) Number of How to reconstitute the medicine
tablets (RH
75/50mg)
Less than 2 ¼ Dissolve one (1) tablet of RH in 20 ml of safe drinking water. Once fully
dissolved, give 5ml (1/4) of this solution measured with a syringe.
2 – 2.9 ½ Dissolve one (1) tablet of RH in 20 ml of safe drinking water. Once fully
dissolved, give 10ml (1/2) of this solution measured with a syringe.
3 – 3.9 ¾ Dissolve one (1) tablet of RH in 20 ml of safe drinking water. Once fully
dissolved, give 15ml (3/4) of this solution measured with a syringe.
After giving the child their dose for that day, discard the rest of the solution. Prepare a fresh solution every
day.
4-7.9 1 Dissolve the tablet(s) of RH in 20mls of safe drinking water.
8-11.9 2
12-15.9 3 Once fully dissolved, give ALL this solution to the child
16-24.9 4

B2. Daily RH for 3 months (3RH) for children ǸOKW 8SYWI&HYPXJSVQYPEXMSR

Weight (kg) Number of tablets (RH 150/75 mg)
25-39.9 2
40-54.9 3
55kg and above 4

(;IIOP]-5 -5 +SVEHYPXWERHEHSPIWGIRXWǸ]IEVW

3HP products No of Tablets
Rifapentine 150mg tabs 6
Isoniazid 300 mg tabs 3
Rifapentine 300mg+Isoniazid 300mg (FDC) 3

248 Integrated Guideline for Tuberculosis,

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D. Dosage of Pyridoxine (Vitamin B6)
Weight (kgs) Dosage in mg Number of 25mg Number
tablets of 50mg
tablets
<5 6.25 mg ½ Tablet 3 times a week, -
alternate days
5.0-7.9 12.5 mg Half a tablet -
8.0-14.9 25 mg One tablet Half of
50mg
tablet
15kg and above 50 mg Two tablets One
50mg
tablet
Adults 50 mg Two tablets One
50mg
tablet

Follow Up of Patients on TB Preventive Therapy (TPT)

Patients on TPT should be followed up on a monthly basis and clinic harmonized with
any other routine clinic schedule. During each clinic visit, conduct the following;

ƽ (SRHYGX W]QTXSQ FEWIH8' WGVIIRMRK EX IZIV] GPMRMGZMWMX JSV TEXMIRXW SR858
and update TB status

ƽ &WWIWW ERH VIMRJSVGI EHLIVIRGI SJ XLI TEXMIRXW EX IZIV] ZMWMX XS EWGIVXEMR
compliance and completion of doses

ƽ .JETEXMIRXXIWXWTSWMXMZIJSV8'[LMPISR858WXST858ERHMRMXMEXI8'XVIEXQIRX

Assess for any adverse drug reactions at each visit and intervene appropriately

Management of Drug toxicities

(i) Peripheral neuropathy

May be potentiated by other neurotoxic drugs, alcoholism, metabolic disease (diabetes),

malnutrition and infections

Rarely severe enough to require drug withdrawal

Preventable with low dose supplemental pyridoxine (Table 4)

Treated with high dose pyridoxine (25-50mg/day)

Relief of symptoms- Give any of these Analgesics, Tricyclic antidepressants (amitriptyline,

nortriptyline) Anticonvulsants (carbamazepine, phenytoin)

Integrated Guideline for Tuberculosis, 249

Leprosy and Lung Disease | 2021
 (ii) Drug induced hepatitis

*PIZEXMSRSJPMZIVIR^]QIWQE]SGGYVMRXLIǻVWX[IIOWSJXVIEXQIRX

Serum liver enzyme levels do not need to be monitored routinely, as asymptomatic

QMPHIPIZEXMSRSJWIVYQPMZIVIR^]QIW PIWWXLERǻZIXMQIWXLIRSVQEPZEPYIWMWRSXER
indication to stop treatment

All clients with gastrointestinal symptoms (nausea and vomiting, liver tenderness,
hepatomegaly or jaundice) should have their liver function assessed

Grading and management of Hepatitis

Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life

threatening

ALT (SGPT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

AST (SGOT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

Continue treatment Continue Stop all drugs, Stop all drugs,

regimen; treatment regimen; including TPT including TPT drugs;
drugs;
Patients should Patients should Measure LFTs
be followed until be followed until Measure LFTs weekly. Treatment
resolution (return resolution (return weekly; may be reintroduced
ACTION to baseline) or to baseline) or after toxicity is
stabilization of AST/ stabilization of Treatment may resolved
ALT elevation. AST/ALT elevation. be reintroduced
after toxicity is
resolved.

Advise patient to return immediately if they develop complaints relating to ADRs as

captured above

Assess for patient adherence to medication and emphasize on the importance of

adherence during clinic visits.

Screen for active TB during each clinic visit using symptom based on TPT card/ tool.

Update the TPT record cards and the TPT register at every visit and document the
outcome on completion of therapy

Contraindications for TPT

(i) Active TB disease

(ii) Signs and symptoms of hepatitis (Jaundice, elevated liver enzymes)

(iii) Symptoms of peripheral neuropathy. In adults and older children; persistent

numbness, tingling or burning sensation, in limbs. In younger children; regression in
motor milestones, refusal to crawl, walk or run.

250 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Note: If the client has any of the above contraindications, defer TPT and manage
underlying cause.

Defer TPT in cases of the following scenarios;

Contraindications, abnormal Chest X Ray, Active substance abuse, History of poor

adherence.

Defer and manage the underlying condition and re-evaluate for TPT in the next visit.

Note: History of TB and current pregnancy is not a contraindication for starting TB

preventive treatment.

Managing interruptions for TPT

Scenario Action

1. For a client initiated on TPT and ƽ (SRHYGXEHLIVIRGIGSYRWIPPMRK

discontinues for any reason within
XLIǻVWX[IIOW ƽ &HHVIWWVIEWSRWJSVMRXIVVYTXMSRW

2. For a client on TPT for more than ƽ GVIIR JSV EGXMZI 8' ERH MJ EW]QTXSQEXMG
28 days and subsequently misses restart TPT
TPT doses for more than 2 weeks ƽ *RWYVI XLI] LEZI GSQTPIXIH E JYPP GSYVWI SJ
treatment

ƽ +SVXLI[IIOP]HSWIWXEOIXLIQMWWIHHSWIEW
soon as they remember

3. For a client on TPT for more than ƽ (SRHYGXEHLIVIRGIGSYRWIPPMRK

28 days and subsequently misses
TPT doses for less than 2 weeks ƽ &HHVIWWVIEWSRWJSV858MRXIVVYTXMSR
(<28 days) ƽ GVIIR JSV EGXMZI 8' ERH MJ EW]QTXSQEXMG
continue with TPT and compensate for the
duration doses were missed
ƽ *RWYVI XLI] LEZI GSQTPIXIH E JYPP GSYVWI EW
per the national guidelines

4. For a client with maximum two ƽ )SRSXVIMRMXMEXISR858

TPT interruptions

TPT Outcomes
Treatment Completed: An individual who has taken a full course of LTBI treatment in
line with the guidelines

Treatment not completed: An individual who did not take a full course of LTBI treatment.

Failure to complete treatment could be due to:

a) Lost to follow up – An individual whose LTBI treatment was interrupted for more
than one month

Integrated Guideline for Tuberculosis, 251

Leprosy and Lung Disease | 2021
 b) Discontinued –An individual whose LTBI treatment was discontinued due to;

ADR - Adverse drug reactions

TB - Develop active TB disease in the course of treatment

c) Died - An individual who died in the course of LTBI treatment

Follow up after completion of TPT

ƽ (SRHYGXW]QTXSQFEWIH8'WGVIIRMRKEXIZIV]GPMRMGZMWMXJSVTEXMIRXW[LS
have completed TPT at 6 and 12month (from TPT completion) and TB status
for every patient in the TPT register

ƽ .J E TEXMIRX WGVIIRW TSWMXMZI EJXIV GSQTPIXMRK 858 QEREKI EGGSVHMRK XS
national TB guidelines.

TPT Adherence
Adherence

Adherence refers to the degree to which a client follows an agreed course of treatment
as recommended by a healthcare provider.

Optimizing adherence

Once clients have been initiated on TPT, health care workers need to monitor patient
progress and provide information on

ƽ the usefulness of TPT

ƽ importance of completing treatment

ƽ ER]ERXMGMTEXIHWMHIIǺIGXWERHXS\MGMXMIW

Barriers to treatment adherence can arise from the following factors.

ƽ(PMIRX
ƽSGMEPMRǼYIRGI
ƽ-IEPXLW]WXIQ
ƽ2IHMGEXMSR
ƽ(PMRMGEP

What are some of the key interventions in reducing the non-adherence to treatment?
ƽ Ensure the patient has adequate information regarding TPT
ƽ Ensure a good treatment plan between the client and the facility
ƽ *RWYVIER]WMHIIǺIGXWEVIHIXIGXIHIEVP]ERHQEREKIH
ƽ Adapt available social support mechanisms
ƽ 9XMPM^EXMSRSJ.RRSZEXMZILIEPXLGSQQYRMGEXMSRYWISJHMKMXEPLIEPXLTPEXJSVQ

252 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
What should the national and county level do to Improve TPT adherence

Policy makers Health care workers Clients

Health systems: Empowerment: Develop health Education

strengthen health systems package for clients on LTBI:
a). Build the capacity of
to ensure availability and
the health care workers to Importance of taking the
accessibility of diagnostic
understand LTBI, diagnosis, treatment and completing
services for LTBI
VIKMQIRWIǽGEG]TSWWMFPIWMHI
treatment and care Anti-Stigma campaigns
IǺIGXWERHXLIVMWOW
Train on myths and
b). Train healthcare workers on
misconceptions of LTBI
Human Rights and stigma and
discrimination reduction

Develop, print and Develop health Education Educate the clients on the use
disseminate policies / package on LTBI: treatment for of technology to facilitate /
guidelines clients on diagnosis, regimens, promote adherence
IǽGEG]FIRIǻXWTSWWMFPIWMHI
Avail both hard and soft Initiate mini groups on
IǺIGXWERHXLIVMWOWERHSR
copies (websites) treatment adherence
Importance of taking the
Develop Reminders messages
treatment and completing
for patients
Anti-Stigma campaigns
Make a calendar or pill box for
Train on myths and the client
misconceptions of LTBI

Advocate for Increase Ensure availability of guidelines, Involve patient in treatment

budgetary / resources algorithm from the national plan: Patients centered
allocation to facilitate levels at the county, Sub- County interventions: One to one
engage of more health levels and facility level *HYGEXMSR(SYRWIPMRKSǺIVMRK
workers in service delivery the available options

Provide mentorship, Use of alarm, SMS Agree on verbal consents for

counselling and on the treatment
Family members support
job training on the health
as reminders for treatment
care workers
adherence

Develop, print and Promote Community support

distribute IEC / groups at the health facilities to
promotional materials SǺIVTW]GLSWSGMEPWYTTSVX

Develop social media

materials for mass
campaign

Implement rights based

approach LTBI treatment
and care

Improve health cares

system to ensure access
ERHEǺSVHEFMPMX]

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Leprosy and Lung Disease | 2021
 Roles of health care workers and clients to improve TPT adherence

Health care Providers Client

Educate patients/clients on LTBI: treatment patient/client should ask and agree with
IHYGEXMSRJSVGPMIRXW HMEKRSWMWVIKMQIRWIǽGEG] the health provider on treatment plan
FIRIǻXWTSWWMFPIWMHIIǺIGXWERHXLIVMWOW
on the importance of taking the treatment and
completing

Anti-Stigma campaigns

Train on myths and misconceptions of LTBI

Sensitize the public on demand for LTBI treatment 7ITSVXER]WMHIIǺIGXSVVIEGXMSRXSXLI

and care health care provider

Use of alarm, SMS, Family members support as Follow the treatment plan and take
reminders for treatment adherence medication as instructed by health care
provider

Promote Community support groups at the Participate in patient support mini group
LIEPXLJEGMPMXMIWXSSǺIVTW]GLSWSGMEPWYTTSVX

Counselling Demand for one to one counselling session

with the health care provider

Have high index of suspicion to rule out Active TB Request for TB screening

Order for a repeat X ray if the patient develop

signs /symptoms suggestive of TB disease

Carry out periodic assessment of treatment Participate in periodic adherence

adherence assessment

Provide Post treatment follow up Report any abnormal condition, signs and
symptoms to the health care provider

Carry out continuous education to clients on TPT

Document and keep the records of TST and IGRA Keep records of all documents on testing
results and other medical records for the clients and treatment provided by the health care
on treatment and after treatment provider

Monitoring and Evaluation

Monitoring is the routine tracking of service and program performance. It is a continuous
process intended to provide information on the extent to which a program is achieving its
MRXIRHIHXEVKIXW[MXLMRWTIGMǻIHXMQIJVEQIW.XMRZSPZIWEGXYEPVIGSVHMRKERHVITSVXMRK
processes using standard tools (±žƐÚåžÏŹĞÆåÚƐÆåĮŇƾƐ±ĻÚƐ±ĻĻåDŽåÚƐĞĻƐƒĚåžåƐďƣĞÚåĮĞĻåžŧ.

254 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Recording and Reporting Tools
Recording tools

All facilities should have the following tools either in paper or electronic form:
1. TPT/ Contact management register
2. TPT Appointment card
3. TPT/ICF Patient record card
4. Daily activity drugs register (DADR)
5. Facility consumption data report and request form (FCDRR).

Reporting tools

1. KHIS- MOH 731, FMAPS (729B)

2. 8.'9 (EWIǻRHMRKJSVQERH(SLSVXEREP]WMWJSVQ

‰Ęå‰{‰xŅĹƋ±ÏƋĵ±Ĺ±čåĵåĹƋųåčĜŸƋåų

This register is used to capture all clients put on TPT regardless of their HIV status. It also
serves as the contact management register thus capturing the details of the index case
whenever appropriate. Depending on the setting at the facility, it is advisable to place
this register in all relevant service delivery points. Health care workers handling this
VIKMWXIVEVIEHZMWIHXSKSXLVSYKLXLIMRWXVYGXMSRWSRLS[XSǻPPXLMWVIKMWXIV

TPT appointment card

This card is issued to the client upon initiation of TPT. It contains the client’s demographic
details, a brief on the clinical information and the clinic schedule. The client should be
advised to present this card every time they are visiting a health facility for review and/
or drugs collection.

‰{‰xF8{±ƋĜåĹƋųåÏŅųÚϱųÚ

8LMWGEVHWIVZIWEWXLIGPMIRXƶWǻPIEWMXGSRXEMRWEPPHIXEMPWSJXLITEXMIRXJVSQXLIXMQI
TPT is initiated to its completion. All clinical details related to the client while on TPT
should be well captured.

%±ĜĬƼ±ÏƋĜƴĜƋƼÚųƚčųåčĜŸƋåų

This register captures drugs transactions and regimens dispensed to clients on a

WTIGMǻIHGPMRMGHEXI

8±ÏĜĬĜƋƼÏŅĹŸƚĵŞƋĜŅĹÚ±Ƌ±ųåŞŅųƋ±ĹÚųåŧƚåŸƋüŅųĵ

This is a monthly data capturing tool that summarizes consumption, reporting and
ordering of commodities for the health facility.

Integrated Guideline for Tuberculosis, 255

Leprosy and Lung Disease | 2021
 Reporting tools

Data from the CCC shall be reported on the MOH 731 tool and entered on KHIS on
monthly basis while that from all other clinics shall be entered in TIBU by the sub-county
TB and Leprosy coordinator on a monthly basis. FMAPs(729B) summarizes patients on
TPT regimen among PLHIV.

NOTE:
Every health care provider involved in TB treatment or prevention has a professional
responsibility to record and report people treated for TB (latent or active TB)
8'MWERSXMǻEFPIHMWIEWIYRHIVXLI5YFPMG-IEPXL&GX(ETERHXLIVIJSVIEPPXLSWI
XVIEXIH F]XLITYFPMGSVTVMZEXIWIGXSVQYWXFIRSXMǻIHXSXLI24-

256 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
DIFFERENTIATED
APPROACH TO TB
CONTROL
12

12.1 Introduction KEY HIGHLIGHTS:

TB patient needs are not homogeneous, it is therefore  )MǺIVIRXMEXIHGEVIEMQWXS

important to design interventions for TB control that provide patient-centred
EVI TEXMIRXWTIGMǻG ERH WTIEO XS XLI MRHMZMHYEP TEXMIRX TB care and prevention
needs. The End-TB strategy recommends integrated, services while improving
IǽGMIRGMIWMRXLILIEPXL
patient centered care with bold policies and supportive
system
LIEPXLW]WXIQW)MǺIVIRXMEXIHGEVIJSV8'MWERMRRSZEXMZI
way of organizing patient care that includes all services All persons receiving TB
aimed at identifying, diagnosing, treating and supporting WIVZMGIWWLSYPHFITVSǻPIH
people in need of TB services. This is also sometimes at baseline and at each visit
called tiered care, patient-centered care or patient- to determine eligibility for
HMǺIVIRXMEXIHGEVI
tailored care. This approach provides individualized
care based on the patient needs that enhances client Patients receiving care
experience, by co-creating solutions with the patient. YRHIVXLIHMǺIVIRXMEXIH
approach must adhere
to the TB monitoring and
follow up schedules to
 5VSFPIQWXEXIQIRX ensure quality of care.

Tuberculosis (TB) is a chronic infectious disease caused Options for TB services for
by various species of the aDžÏŇƱσåŹĞƣķ genus. If Key populations have been
untreated, an infected patient can infect an average organized around their
of 10-15 persons in a year. Globally, an estimated 10.0 needs, and the capacity
million (range, 9.0–11.1 million) people fell ill with TB in of the health system to
provide client centered
2019. There were an estimated 251 000 deaths among
services.
-.:TSWMXMZITISTPI8'EǺIGXWTISTPISJFSXLWI\IWMR
all age groups but the highest burden is in men (aged 15
years and over), who accounted for 65% of all TB cases
in 2018. By comparison, women accounted for 25% and
children (under 15 years of age) for 9.7%.

Integrated Guideline for Tuberculosis, 257

Leprosy and Lung Disease | 2021
 In 2019, there were an estimated 147,000 new TB cases in Kenya. A total number of
 8' GEWIW[IVI RSXMǻIH MR XLI]IEV   GEWI HIXIGXMSR VEXI[MXL E8VIEXQIRX
success rate (TSR) for drug susceptible TB patients of 84% among the 2017 cohort. This
was mostly attributed to death rate of 6.3% and loss to follow-up rate of 5.4%.

Interruption of treatment has been a major obstacle to treatment adherence, and is an

important challenge in TB control. Inability to complete the prescribed 6-month regimen
is an important cause of treatment failure, relapse, acquired drug resistance and on-
going transmission of infection. Treatment interruption is a precursor to loss to follow up
which therefore provides an opportunity for early intervention in the course of treatment
to prevent treatment interruption.

Risk factors for treatment interruption include:

ƽ Long transportation time to health facilities

ƽ Male gender

ƽ Patients with low level of information about TB, inadequate education and
counselling on TB

ƽ Poor quality of communication between patients and health workers,

ƽ Long distances to treatment centres,

ƽ .REHIUYEXIORS[PIHKISJ8'XVIEXQIRXHYVEXMSRERHTSWWMFPIEHZIVWIIǺIGXWSJ
anti-TB medication.

 /YWXMǻGEXMSR
The rate of treatment interruption was highest during the initial two months (the intensive
phase of treatment). Enhanced patient pre-treatment counseling and education about
TB is key in the reduction of loss to follow up and deaths due to inadequate quality of
TB care. (Adherence study, Kimuu)

)MǺIVIRXMEXIH WIVZMGI HIPMZIV] EPWS ORS[R EW HMǺIVIRXMEXIH GEVI MW E GPMIRXGIRXIVIH
ETTVSEGL XLEX WMQTPMǻIW ERH EHETXW 8' WIVZMGIW XS VIǼIGX XLI TVIJIVIRGIW ERH
expectations of various groups of people diagnosed with TB while reducing unnecessary
FYVHIRW SR XLI LIEPXL W]WXIQ '] TVSZMHMRK HMǺIVIRXMEXIH WIVZMGI HIPMZIV] XLI LIEPXL
W]WXIQ GER VIEPPSGEXI VIWSYVGIW XS XLSWI QSWX MR RIIH )MǺIVIRXMEXIH (EVI 8SSPOMX
Global Fund)

)MǺIVIRXMEXIH WIVZMGI HIPMZIV] EMQW XS IRLERGI XLI UYEPMX] SJ XLI GPMIRX I\TIVMIRGI
It puts the client at the centre of service delivery. It also ensures the health system
JYRGXMSRWMRFSXLEQIHMGEPP]EGGSYRXEFPIERHIǽGMIRXQERRIV

258 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 4FNIGXMZIWSJHMǺIVIRXMEXIHGEVIMR8YFIVGYPSWMW
management
)MǺIVIRXMEXIHGEVIEMQWXS

ƽ *RLERGIXLIUYEPMX]SJXLITEXMIRXI\TIVMIRGI

ƽ 5YXXLITEXMIRXEXXLI(IRXVISJWIVZMGIHIPMZIV]

ƽ *RWYVIXLEXXLILIEPXLW]WXIQJYRGXMSRWIǽGMIRXP]

9RHIVEHMǺIVIRXMEXIHETTVSEGLTEXMIRXWEVITVSǻPIHFEWIHSR 

ƽ (PMRMGEP WXEXYW MI WXEFPI YRWXEFPI FEWIH SR HMWIEWI WIZIVMX] GSQSVFMH
conditions e.g. HIV, Diabetes, malnutrition, sputum conversion, nutritional status
and adherence to treatment.

ƽ 5W]GLSWSGMEPERHWSGMSIGSRSQMGWXEXYWIQTPS]QIRXWXEXYWTVIWIRGISJWSGMEP
support, homeless and street families

ƽ 5EXMIRXHIQSKVETLMGW2IRXLIIPHIVP]EHSPIWGIRXW]SYRKGLMPHVIRVIJYKIIW
mobile populations, vulnerable groups such as PWIDs, alcoholics, health
care workers, people in congregate settings and contacts of bacteriologically
GSRǻVQIHTYPQSREV]8'

 2SHYPIWMR)MǺIVIRXMEXIH(EVI
8LIVIEVIXLVIIQSHYPIWMRTVSZMWMSRSJHMǺIVIRXMEXIHGEVI

ƽ )MǺIVIRXMEXIHWGVIIRMRKERHXIWXMRKJSV8'

ƽ )MǺIVIRXMEXIH8'XVIEXQIRXERHGEVI

ƽ )MǺIVIRXMEXIHHVYKHIPMZIV]JSV8'

 )MǺIVIRXMEXIHWGVIIRMRK XIWXMRKJSV8'

)MǺIVIRXMEXIH WGVIIRMRK ERH XIWXMRK ETTVSEGLIW EVI FEWIH SR XLI TVIJIVIRGIW SJ
XEVKIXIH KVSYTW XLI GSWX SJ WIVZMGI HIPMZIV] ERH XLI I\TIGXIH XIWXMRK IǽGMIRG]
&ZEMPEFPISTXMSRWMRGPYHI&GXMZI8'GEWIǻRHMRKMRLIEPXLJEGMPMXMIWXEVKIXIHWGVIIRMRK
for TB in at risk groups in hotspots and integrated community screening and testing

8]TMGEP TSTYPEXMSR KVSYTW XLEX QE] FIRIǻX JVSQ MRXIKVEXIH8' WGVIIRMRK ERH XIWXMRK
include:

ƽ -.:GPMIRXW[LSEVITSXIRXMEPP]GSMRJIGXIH[MXL8'MRXIKVEXMSRSJ8'WGVIIRMRK
and testing with HIV testing

ƽ .RJERXWERHGLMPHVIR8EVKIXIH8'WGVIIRMRKERHXIWXMRKHYVMRKMQQYRM^EXMSR

Integrated Guideline for Tuberculosis, 259

Leprosy and Lung Disease | 2021
 ƽ 5VIKRERX[SQIRRI[QSXLIVWERHMRJERXWGVIIRMRKERHXIWXMRKJSV8'HYVMRK
ANC visits, Child welfare clinics and mother and child health outreaches

ƽ 7YVEPGSQQYRMXMIWPMZMRKMRVIQSXIEVIEWGVIIRMRKERHXIWXMRKJSV8'EPSRKWMHI
other primary care services

ƽ .RNIGXMRK HVYK YWIVW MRXIKVEXMRK 8' WGVIIRMRK ERH XIWXMRK [MXL QIXLEHSRI
assisted therapy (MAT) clinics, drop-in centers(DiCES), and harm reduction
outreach services

ƽ 2IRSǺIVMRK8'WGVIIRMRKERHXIWXMRKMR[SVOTPEGIWHYVMRKGSQQYRMX]LIEPXL
campaigns, in locations such as social places or bars where men are more likely
to attend.

ƽ -IEPXL GEVI[SVOIVW 'MERRYEP WGVIIRMRK ERH XIWXMRK JSV8' JSV EPP LIEPXL GEVI
workers integrated in world TB day and World AIDS day celebration activities.

ƽ &HSPIWGIRX8EVKIXIH8'WGVIIRMRKERHXIWXMRKMRPIEVRMRKMRWXMXYXMSRW.RXIKVEXMRK
TB screening and testing in youth friendly clinics and programs

ƽ (SRXEGXWSJFEGXIVMSPSKMGEPP]GSRǻVQIHTYPQSREV]8'(SQQYRMX]FEWIHGSRXEGX
screening and testing

ƽ 8LIIPHIVP].RXIKVEXMSRSJ8'WGVIIRMRKERHXIWXMRK[MXLI\MWXMRKWSGMEPWYTTSVX
mechanisms e.g. The older person’s cash transfer

 )MǺIVIRXMEXIHXVIEXQIRX GEVI

12.5.1 Introduction
)MǺIVIRXMEXIHXVIEXQIRXERHGEVIETTVSEGLIWEVIQSWXETTPMGEFPIXSJEGMPMXMIWXLEXLEZI
a high volume of patients and provide all health services. The approaches increase
GSWXIǽGMIRG] F] STXMQM^MRK WXEǺ [SVOPSEH 8LI] JYVXLIV MQTVSZI LIEPXL SYXGSQIW
for patients through higher adherence to treatment and retention in care through the
GSQFMRIH IǺIGXW SJ XEVKIXIH GSYRWIPMRK TIIV WYTTSVX VIHYGIH [EMXMRK XMQIW ERH
reduced congestion at the facility.

Design of approaches should start from what is known about patient perspectives on
existing arrangements for services and the proposed new models of service delivery.
Community and patient engagement is vital to bring meaningful improvements in
services.

8SMHIRXMJ]STXMSRWJSVHMǺIVIRXMEXIHXVIEXQIRXERHGEVIXLIJSPPS[MRKUYIWXMSRW[MPPFI
considered;

a) What needs do TB patients require regarding treatment and care?

This will involve evaluation of the patients’:

ƽ )IQSKVETLMGW2IRXLIIPHIVP]EHSPIWGIRXW]SYRKGLMPHVIR

ƽ :YPRIVEFMPMX]5;.)-IEPXLGEVI[SVOIVWEPGSLSPMWQVIJYKIIW

ƽ -IEPXLGSRHMXMSRWGSQSVFMHGSRHMXMSRWIK-.:)MEFIXIW5VIKRERG]IXG

260 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
b) What barriers do patients and health care workers face?

Patient-related barriers

ƽ &GGIWW XS LIEPXL WIVZMGIW  5L]WMGEP GSRWXVEMRXW WYGL EW HMWEFMPMX] MRǼI\MFPI
hospital working hours, long hospital waiting time.

ƽ 5SSV SVKERM^EXMSR SJ LIEPXL WIVZMGIW IK SZIVGVS[HMRK MR [EMXMRK FE]W PEGO SJ
GSRǻHIRXMEPMX]PSRK[EMXMRKXMQIWJVIUYIRXLSWTMXEPETTSMRXQIRXWERHWXMKQEF]
community members

ƽ 5EXMIRX WTIGMǻG RIIHW IK FSEVHMRK WGLSSP EXXIRHMRK EHSPIWGIRXW YRMZIVWMX]

students, employee working hours

Bå±ĮƒĚƐϱŹåƐƾŇŹīåŹƐĝƐŹåĮ±ƒåÚƐƱŹŹĞåŹž

ƽ .REHIUYEXIGETEGMX]XSSǺIVUYEPMX]8'WIVZMGIWIKMREHIUYEXIXVEMRMRKPEGOSJ
relevant equipment, lack of job aids and tools.

ƽ .REHIUYEXIGPMRMGWTEGIJSV8'WIVZMGITVSZMWMSR

ƽ 1EGOSJGSRWYQTXMSRSJHEXEJSVHIGMWMSRQEOMRK

c) What are the available opportunities in TB treatment and care?

Opportunities for task shifting- TB services can be administered by various

GEHVIWMRLIEPXLGEVIWIVZMGITVSZMWMSRWYGLEWHSGXSVWGPMRMGEPSǽGIVWRYVWIW
and community health workers.

Opportunities for capacity building of health care workers through formal

training, ECHO.

Opportunities for integration of TB treatment with service delivery points e.g.

Comprehensive care clinic, Maternal and child health services, nutrition services,
inpatient services, learning institutions and other areas such as workplaces

d) Is the facility serving large numbers of patients?

What are the issues experienced in high volume facilities?

ƽ For patients- longer waiting time, delay in service provision in the various service
delivery points, increased risk of infection transmission, inadequate contact with
health workers during consultation.

ƽ For health care workers- High potential for burn out due to high workload, are at
high risk of contracting infection, compromised quality of care.

Integrated Guideline for Tuberculosis, 261

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 12.5.2 What are some of the options available in
HMǺIVIRXMEXIHXVIEXQIRXERHGEVI$
E -EZMRKHMǺIVIRXMEXIHETTSMRXQIRXWGLIHYPIW

-IEPXL JEGMPMXMIW GER HIHMGEXI WTIGMǻG GPMRMG HE]W[MXL ǼI\MFPI ETTSMRXQIRX WGLIHYPIW
ERHSTIRMRKLSYVWXSWTIGMǻGTEXMIRXKVSYTWFEWIHSRXLIMVGPMRMGEPHIQSKVETLMGERH
psychosocial needs.

F -EZMRKHMǺIVIRXMEXIHGPMRMGEPQEREKIQIRXTPERW

-IEPXL JEGMPMXMIW VIUYMVI WTIGMǻG QEREKIQIRX TPERW JSV WTIGMǻG TEXMIRX KVSYTW IK
children and adolescents, drug resistant TB patients, TB/HIV co-infected patients, TB/
DM patients and so forth.

G )IWMKRSJHMǺIVIRXMEXIHTEXMIRXǼS[

-IEPXL JEGMPMXMIW GER HIWMKREXI WTIGMǻG TEXL[E]W JSV WTIGMǻG KVSYTW SJ TEXMIRXW IK
smear positive versus smear negative and stable patients versus unstable patients.

)MǺIVIRXMEXIH8'HVYKHIPMZIV]
)MǺIVIRXMEXIH HVYK HIPMZIV] MRGPYHIW HMWTIRWMRK HVYKW XS TEXMIRXW EW[IPP EW IRWYVMRK
continuous, reliable and quality supplies of drugs and other commodities for treatment
and care.

)MǺIVIRXMEXIHHVYKHIPMZIV]ETTVSEGLIWSǺIVWTIGMǻGERHGSWXIǺIGXMZISTTSVXYRMXMIWXS
MRRSZEXI8LI]GERHMǺIVXSQEXGLXLIRIIHWERHTVIJIVIRGIWSJWTIGMǻGTEXMIRXKVSYTW

8LI JSPPS[MRK UYIWXMSRW [MPP KYMHI XLI MHIRXMǻGEXMSR SJ STTSVXYRMXMIW MR HMǺIVIRXMEXIH
drug delivery

E ;LEXMWXLITVSǻPISJTEXMIRXWMRQ]JEGMPMX]$

&PP8'TEXMIRXWWLSYPHFIIZEPYEXIHJSVIPMKMFMPMX]XSVIGIMZIHMǺIVIRXMEXIHGEVI5VSǻPMRK
however, should continue during every clinic visit as a patient’s status may change
HYVMRKXVIEXQIRX5VSǻPMRKMWGSRHYGXIHYWMRKWIZIVEPTEVEQIXIVWXLEXMHIRXMJ]ETEXMIRX
as either stable or unstable. These Include;

1. History of Previous TB treatment

2. Clinical Presentation

3. Presence of comorbidities

4. Pregnancy

5. Adherence status

6. Demographic groups

7. Gender

8. Drug Resistance Pattern

262 Integrated Guideline for Tuberculosis,

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b) What barriers are patients and health service providers facing in drug delivery?

i. Patient barriers

ƽ 5L]WMGEPFEVVMIVWXSEGGIWWJSVHVYKVIǻPPW HMWXERGIXSXLIJEGMPMX]HMǽGYPXXVEZIP
conditions, poor availability of drugs);

ƽ 8MQIERHGSWXGSRWXVEMRXW IKVIQSXIPSGEXMSRGSRWXVEMRMRK[SVOLSYVWXVEZIP
cost, loss of income while accessing health services, long waiting times);

ƽ XMKQE JVSQ GSQQYRMX] JEQMP] SV WIVZMGI TVSZMHIV HYVMRK HVYK VIǻPPZMWMXW IK
PEGOSJTVMZEG]GSRǻHIRXMEPMX]SVVIWTIGX 

ƽ 1EGOSJXVIEXQIRXWYTTSVXJVSQTIIVWGSQQYRMX]SVJEQMP]

ĞĞũƐ Bå±ĮƒĚƐžåŹƽĞÏåƐŤŹŇƽĞÚåŹƐƱŹŹĞåŹžƐ

ƽ -MKLZSPYQISJGPMIRXWEXXLIJEGMPMX]PIEHMRKXSGSRKIWXMSRERHPIRKXL][EMXMRK
times for clinical appointments and at the pharmacy;

ƽ 1EGOSJLYQERVIWSYVGIWJSVTLEVQEG]QEREKIQIRXERHHMWTIRWMRK

c) What are the opportunities to adjust the current service-delivery model?

Health facilities should develop service delivery models that best address patient needs
and constraints, while working around the constraints of service providers, potentially
SǺIVMRKWIZIVEPGSQFMREXMSRSTXMSRWXSGPMIRXW

Any service delivery model is a combination of three factors, each of which has potential
for adjustment:

ƽ Who provides the serviceƳIKHSGXSVWGPMRMGEPSǽGIVWRYVWIWERHGSQQYRMX]

health workers

ƽ Where the service is provided – at various points in the health centers (regional
and district hospitals, health centers, dispensaries, etc) vs. distribution points in
communities or at home;

ƽ How often the service is provided – Facilities can vary the frequency of visits,
type of service provider, or service location to improve patient satisfaction. These
should improve case holding in care and better outcomes are observed.

&ZEMPEFPISTXMSRWJSVHMǺIVIRXMEXIHHVYKHIPMZIV]
1. Appointment spacing

Appointment spacing is an approach that can be applied based on whether the

patient is stable, distance to facility, number of patients served by the facility.

For stable patients’ appointment should be spaced 2 weekly in the intensive phase
and monthly in the continuation phase.

Integrated Guideline for Tuberculosis, 263

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  +EWXXVEGOMRKHVYKVIǻPPW

Facilities can adapt the patient’ pathways, based on the purpose of their visit and
eligibility to skip a few steps of the process. For example, stable TB patients with
good adherence record could be “fast-tracked” and access the pharmacy directly
JSVVIǻPPW&PXIVREXMZIP]XSJEWXXVEGOHVYKVIǻPPWTVITEGOIHHVYKWGERFIHSRIJSV
stable patients.

3. Decentralized drug delivery in communities

For stable and adherent patients living in remote areas where distances to facilities
are far, drugs should be given to patients for a longer duration for example one month
in the continuation phase or to community health volunteers who act as treatment
supporter for mobile populations. Appropriate and proper adherence counselling
and patient education is required to mitigate loss from care and treatment as well
EW MHIRXMǻGEXMSR SJ MRHMGEXSVW SJ TSSV XVIEXQIRX SYXGSQIW WYGL EW EHZIVWI HVYK
reactions. Linkage to their nearest health facility is also required should the patient
require any support.

 )MǺIVIRXMEXIH(EVI&TTVSEGLIWJSVTB Key

Populations
 8LI 0IR]E 3EXMSREP 8' XVEXIKMG 5PER  MHIRXMǻIW OI] TEXMIRX KVSYTW JSV 8'
GSRXVSP 8LIWI KVSYTW [IVI MHIRXMǻIH JSPPS[MRK E VMKSVSYW VIZMI[ TVSGIWW SJ GYVVIRX
epidemiological data in the country. Additionally, the needs of these groups are unique
ERHHITIRHSRXLIPSGEPGSRXI\X&WWYGLHMǺIVIRXMEXIHETTVSEGLIWWLSYPHXEOIXLIWI
into consideration during the design and implementation stages.

1. Men
Screening and testing

ƽ 4ǺIV MRXIKVEXIH SYX SJ JEGMPMX] 8' WGVIIRMRK ERH XIWXMRK MR [SVOTPEGIW WSGMEP
places e.g. entertainment spots.

ƽ &GXMZIGEWIǻRHMRKJSV8'MRLIEPXLJEGMPMXMIWQYWXIRKEKIQIRXSIRWYVIPMROEKI
to testing

Treatment and care

&PPIǺSVXQYWXFIQEHIXSIRKEKI[MXLXLITEXMIRXXSHIXIVQMRI[LMGLQSHIPSJGEVI
[SVOW FIWX XS IRWYVI XLIMV EHLIVIRGI FEWIH SR XLI TEXMIRXƶW TVSǻPI8LIWI WSPYXMSRW
include;

ƽ Clinic visits can be made without the need to miss work engagements

ƽ Longer appointments -2 weekly in intensive and monthly in the continuation.

ƽ Calling the facility in case of any concern rather than physically visiting a health
facility.

ƽ Integration of required services to provide a one-stop shop experience.

264 Integrated Guideline for Tuberculosis,

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Drug delivery model

7IWXVYGXYVI TEXMIRX ǼS[ XS IRWYVI QMRMQYQ XMQI WTIRX [MXLMR LIEPXL JEGMPMXMIW JSV EPP
stable patients

ƽ Where clinic visits interfere with work timings, consider drug collection outside
clinic timings where necessary.

ƽ +EWXXVEGOHVYKVIǻPPWJSVWXEFPIEHLIVIRXTEXMIRXW

ƽ Consider pre-packing patient medicines, prior to the clinic date

ƽ (SRWMHIVPSRKIVVIǻPPHEXIWJSVWXEFPITEXMIRXW(SQQYRMX]ZSPYRXIIVWGERWYTTSVX
MRHIPMZIVMRKHVYKVIǻPPW[MXLMRXLIGSQQYRMX][LIVIJIEWMFPI

2. Adolescents and youth (10-24 year olds)

&HSPIWGIRXW ERH ]SYXL EVI E WTIGMEP TEXMIRX KVSYT [MXL WTIGMǻG TL]WMGEP RIIHW XLEX
require addressing, notwithstanding evolving emotional and physical changes.
Majority of adolescents and youth in Kenya attend boarding schools and institutions
of learning, while many others though in day schools, may be uncomfortable to attend
the same clinics as adults due to stigma. Additionally, institutions of learning are mostly
overcrowded and have a higher risk of TB infection transmission.

Screening and testing

Out of facility TB screening and testing for adolescents and youth should be integrated
into the school health programs, institutions of learning and other social settings that
adolescents and the youth frequent. These include;

ƽ Schools and institutions of learning, particularly where a TB patient has been

MHIRXMǻIHMRERMRWXMXYXMSR

ƽ Church groups,

ƽ Sports and holiday camps

ƽ Sports activities.

Treatment and care

All health facilities should attempt to provide youth-friendly services where adolescents
and the youth can feel comfortable, and well supported towards treatment adherence.
An environment where adolescents can ask questions regarding their care and other
MWWYIWEǺIGXMRKXLIQQYWXFIGVIEXIH8LMWWYTTSVXGERFITVSZMHIHXLVSYKL

ƽ Peer support groups at facility level

ƽ Adolescent or youth peer educators at facility level who counsel, and provide
health education

ƽ =SYXLWTIGMǻGGPMRMGHE]W[LIVISRP]EHSPIWGIRXWERHXLI]SYXLEVIEXXIRHIHXS
particularly in large health facilities.

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 ƽ 8LSVSYKLIZEPYEXMSRSJMHIRXMǻGEXMSRSJGSRXEGXWXSIRWYVIGSRXEGXMRZMXEXMSRERH
management is conducted to reduce the risk of transmission

Drug delivery model

While the majority of adolescents and the youth attend institutions of learning such as
FSEVHMRKERHLMKLWGLSSPWXIGLRMGEPMRWXMXYXMSRWERHGSPPIKIWEPPIǺSVXQYWXFIQEHI
to ensure there is no interruption of these key activities due to the disease or clinic
attendance. Suggestions for drug models for this group include;

ƽ &PMKRMRKGPMRMGZMWMXWERHHVYKVIǻPPWXSLSPMHE]W

ƽ Where necessary engaging school nurses and institutional clinics as DOT

providers

3. Infants and Children below 10 years

Children below 10 years of age have unique needs and are considered unstable
TEXMIRXW -S[IZIV WTIGMǻG MRXIVZIRXMSRW GER FI XEMPSVQEHI XS JEGMPMXEXI GEWI ǻRHMRK
and management of TB in this patient group as shown below:

Screening and testing

ƽ Facility Targeted TB screening during scheduled immunization and nutritional

review clinics.

ƽ Targeted screening in boarding schools and enhanced linkage to the school

health program.

Treatment and care

ƽ Integrated TB treatment at Maternal and Child health services/nutrition services

where applicable.

ƽ -EZIWTIGMǻGGPMRMGHE]WJSVMRJERXWERHGLMPHVIR[LIVIHMǺIVIRXMEXIHQEREKIQIRX
plans and reviews can be done for the age group.

Drug delivery model

 Children and infants are considered unstable patients and should follow the weekly
scheduled appointments in the intensive phase and the fortnightly appointment
in the continuation phase for drug sensitive TB while for Drug resistant TB should
be directly observed therapy.

4. People who inject drugs

People who inject drugs are recognized as a high risk group for TB transmission and
non-adherence to treatment.

266 Integrated Guideline for Tuberculosis,

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Screening and testing

ƽ All attempts must be made to screen people who inject drugs for TB within their
natural and congregate settings which include Methadone Assisted Therapy
(MAT) clinics and Drop in centers (DiCES).

ƽ TB screening should be integrated into all services given to people who inject
drugs.

Treatment and care

ƽ People who inject drugs are considered unstable patients and their clinic
schedule should be daily.

ƽ )MǺIVIRXMEXIH QEREKIQIRX TPER [LMGL MRGPYHI RYXVMXMSREP WYTTSVX TW]GLS

WSGMEPGSYRWIPPMRKERHER]SXLIVWTIGMǻGWYTTSVXVIUYMVIHF]XLI5;.)WLSYPH
be integrated.

Drug delivery model

 Drug delivery for people who inject drugs should be as directly observed therapy
and should be integrated into the methadone administration schedule or as they
come for their daily support at the Drop in centres.

5. Health workers
Healthcare workers (HCWs) have a two- to three-fold increased risk of developing TB
compared with the general population due to frequent and prolonged exposure to
undiagnosed persons with TB or DRTB in the workplace. It is also estimated that in some
sub-Saharan countries the rate of HIV in HCWs is approximate to the rate in the general
population, placing these HCWs at an even greater risk of developing TB. In many low-
resourced settings, there are limited infection control measures in place to protect HCWs
in the workplace. HCWS should know their HIV status and be provided ART and IPT to
prevent TB, and all HCWs should be screened regularly for TB and adhere to infection
prevention and control measures.

Screening and testing

ƽ Due to the high risk of developing TB, health workers need to be screened for TB
at least twice a year. Integration of health worker screening into existing national
celebrations e.g as a build up to World TB day celebrations and World AIDS day
celebrations. (Refer to SoP on health worker screening)

ƽ Routine screening and testing for TB should be done any time a health worker
has any symptoms.

ƽ All HCWs with presumptive TB must be tested using GeneXpert, which will also
give information on drug susceptibility to rifampicin.

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 Treatment and care

ƽ ;LIVI TSWWMFPI LIEPXL JEGMPMXMIW WLSYPH HIHMGEXI WTIGMǻG GPMRMG HE]W JSV LIEPXL
[SVOIVW[MXL8'[MXLǼI\MFPIETTSMRXQIRXWGLIHYPIWERHSTIRMRKLSYVWXSWYMX
their needs.

ƽ -IEPXLJEGMPMXMIWVIUYMVIWTIGMǻGQEREKIQIRXTPERWJSVLIEPXL[SVOIVW8LMWQE]
MRZSPZISTIVEXMSREPM^EXMSRSJWXEǺGPMRMGW[MXLMRXIKVEXIHQEREKIQIRXSJLIEPXL
worker related issues be they mental health, physical health and substance
abuse.

Drug delivery model

ƽ )VYK VIǻPPW JSV EPP WXEFPI -(;W WIIOMRK XVIEXQIRX WLSYPH FI JEWX XVEGOIH XS
reduce time spent seeking care. In addition, the patient pathway followed by
XLMW GEXIKSV] SJ TEXMIRX QE] FI QSHMǻIH XS LEZI HVYK VIǻPPW HSRI HMVIGXP] EX
the pharmacy or other dispensing point without necessarily passing through the
clinical areas. This will reduce infection transmission as well as enhance client
experience.

ƽ &TTSMRXQIRXWJSVHVYKVIǻPPWJSVLIEPXL[SVOIVWQE]EPWSFIWTEGIHXSVIHYGI
frequency of clinic visits.

6. Rural communities
Persons living in rural communities face unique challenges in accessing TB care due
XS PSRK HMWXERGIW XS LIEPXL JEGMPMXMIW MREHIUYEXI EGGIWW XS 8' WIVZMGIW ERH ǻRERGMEP
challenges hence requiring cost cutting measures to ensure treatment access. The
following are key considerations and options for this populations.

Screening and testing options

ƽ Targeted screening during market days

ƽ Integration of TB screening with other outreach services.

ƽ &R]SXLIVGSRXI\XWTIGMǻGSTXMSREWTIVXLIMVPSGEXMSR

Treatment and care

ƽ For stable patients in rural communities, appointment schedules may be extended

to have longer intervals between clinical visits.

Drug delivery model

ƽ Engagement of community health volunteers (CHVs) to deliver medicines to

stable patients in rural communities.

ƽ Drug doses may be given in higher quantities to facilitate longer appointment

schedules

268 Integrated Guideline for Tuberculosis,

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7. People living in urban informal settlements
The National TB Prevalence Survey reported a higher burden of TB in urban (760 per
100,000 population) compared to rural settings (453 per 100,000 population), this is
GSRWMWXIRX[MXLVSYXMRI8'HEXE[LMGLWLS[WLMKLIVRSXMǻGEXMSRVEXIWMRXLIQENSVGMXMIW
To ensure that these persons receive appropriate TB care services, the following options
may be explored

Screening and testing

Out of facility Targeted TB screening which includes;

ƽ Periodic door to door TB Screening

ƽ Integration of TB screening with other outreach services

ƽ Screening for TB within hot-spots in informal settlements.

ƽ Strengthened contact management through community health workers.

Treatment and care

People who live in the urban informal settlement should also be assessed based on
demographics (e.g men), comorbidities and vulnerability such as PWID.

Based on this they can have:

ƽ )MǺIVIRXMEXIHGPMRMGGLIHYPIW+PI\MFPIETTSMRXQIRXWWGLIHYPIWPSRKIVWTEGMRK
of appointments for stable patients (2 weeks in the intensive and a month in the
continuation phase).

ƽ )MǺIVIRXMEXIHQEREKIQIRXTPER*EGLGEXIKSV]SJTEXMIRXWKVSYTWLSYPHLEZI
a tailored management plan which caters for all the needs of the group such as
WTIGMǻGGPMRMGWJSVGLMPHVIRQIRTEXMIRXW[MXLGSQSVFMHMXMIWERHEHSPIWGIRXW

Drug delivery model

ƽ Variable clinic appointment spacing for stable patients based on their needs

ƽ +EWX XVEGOMRK HVYK VIǻPPW JSV WXEFPI TEXMIRXW XS VIHYGI XMQI WTIRX MR XLI LIEPXL
facilities. Drugs can be pre-packed in advance.

ƽ Use of community health workers for drug delivery and as treatment supporters
where applicable.

8. People in congregate settings

TB in congregate settings is an area of focus to reach key groups in schools, work places,
prisons, refugee camps

Integrated Guideline for Tuberculosis, 269

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 Screening and testing

ƽ Regular symptom screening in large workplaces/ industries, schools, universities

and other educational institutions.

 Integration of TB in the workplace occupational health systems

 Regular screening of prisoners using the PF-10 form

 Linkage with the formal health system for sample transport and results relay

 Close management of contacts in collaboration with the TB program through

County and Sub-County TB coordinators

Treatment and care

Based on patients’ assessments and needs, they can have the following

 Scheduled appointments -Students who are in schools, universities and workers

their timings vary and need scheduled appointments based on availability.

 Workers in corporate settings should ideally receive care in an ethical and

acceptable setting, ideally, within the workplace occupational health set-up

 Flexible appointment timing to prevent loss of man-hours at work and schools

 )MǺIVIRXMEXIHQEREKIQIRXTPERXSWYMXXLIEHSPIWGIRXERH]SYRKEHYPXKVSYT
XSLEZIWTIGMǻGGPMRMGWJSV]SYXL[LMGLEVI]SYXLJVMIRHP]ERHGEXIVJSVXLIMVRIIHW
holistically.

Drug delivery model

'EWIH SR TEXMIRXWƶ EWWIWWQIRX ERH RIIHW XLI] GER LEZI HMǺIVIRXMEXIH HVYK QSHIP
below;

 Appointment spacing- have longer appointments for stable patients.

 +EWXXVEGOVIǻPPMRKSJHVYKWJSVWXEFPITEXMIRXWTVITEGOHVYKWMREHZERGI

 Decentralization of drug delivery to schools, universities and workplace where

we have health providers/ minder that can provide direct observation therapy.

9. Mobile populations (nomadic communities)

Screening and testing

 8EVKIXIH GSQQYRMX] WGVIIRMRK EX MHIRXMǻIH OVEEPW MR GSPPEFSVEXMSR [MXL OVEEP
leadership

 Integrate TB screening within outreach services in the

 Contact tracing

Treatment and care

 Appointment spacing-longer appointment times for stable patients

270 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
  Strengthening establishment of TB isolation facilities (‘manyattas’) in arid areas
for those willing to stay for the duration of treatment-ideal

Drug delivery model

 Fast tracking during clinic visits for those receiveing care in formal health
institutions

 Community decentralized model- Use of community volunteers for drug delivery

and as treatment supporter where applicable

10. Street Families

Screening and Testing

 Targeted screening in ‘bases’ where the families stay.

Treatment and Care

 Using the head of ‘bases’ for street families as DOT supporters and for follow up.

 Nutritional support at the facility for patients

 They should follow the standard treatment appointment schedule by the program
since they fall in the category of unstable patients

Drug Delivery Model

 Pre-packing of drugs and fast tracking for those with no issues.

Integrated Guideline for Tuberculosis, 271

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272 Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
CHRONIC LUNG
DISEASES 13

Introduction
Respiratory diseases account for more than 10% of all disability-adjusted life years
)&1=W ERH QEOI YT ǻZI SJ XLI XLMVX] QSWX GSQQSR GEYWIW SJ HIEXL .R 0IR]E
respiratory diseases account for at least 25% of the outpatient morbidity and are among
XLI ǻZI LMKLIWX GEYWIW SJ QSVXEPMX] 7IWTMVEXSV] HMWIEWIW EVI ER MQTSVXERX GEYWI SJ
morbidity and mortality. The most frequently occurring respiratory diseases that result
MRWMKRMǻGERXQSVFMHMX]ERHQSVXEPMX]EVITRIYQSRMEEGYXIVIWTMVEXSV]MRJIGXMSRW &7.
TB, asthma, chronic obstructive pulmonary disease (COPD) and lung cancer.

In recent decades, their incidence has continued to rise which can be attributed to a
rapid increase in a number of risk factors such as tobacco smoking habits in developing
countries, HIV epidemic, urbanization, industrialization, atmospheric pollution, and the
deterioration of socioeconomic conditions.

This chapter focuses on the following Chronic Lung Diseases:

1. Asthma

2. Chronic Obstructive Pulmonary Disease

3. Post Tuberculosis Lung Disease

a. 1YRKWGEVVMRK ǻFVSWMW

b. Bronchiectasis

c. Chronic Obstructive Pulmonary Disease (COPD)

d. Lung abscess

e. Aspergillus-related lung disease

f. Spontaneous Pneumothorax

4. Interstitial lung diseases

5. Lung cancer

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Leprosy and Lung Disease | 2021
 Table 13.1: Causes of chronic cough

Causes of chronic cough

ƽ Upper airway: ƽ Carcinomas-Lung cancer
ƽ Upper airway cough syndrome (formerly ƽ 5RIYQSGSRMSWMW
postnasal drip) ƽ (EVHMEGGEYWIW1IJXLIEVXJEMPYVI
ƽ Chronic allergic rhinitis  4XLIVW
ƽ 1S[IVVIWTMVEXSV]XVEGXGEYWIW ƽ ,EWXVSIWSTLEKIEPVIǼY\
ƽ .RJIGXMSRW8YFIVGYPSWMW'VSRGLMIGXEWMW (GERD)
ƽ .RǼEQQEXSV]&WXLQE(LVSRMG4FWXVYGXMZI ƽ MHIIǺIGXWSJGIVXEMR
Pulmonary Disease (COPD) medicines e.g. ACE inhibitors
e.g. Enalapril
ƽ &YXSMQQYRIEVGSMHSWMW.RXIVWXMXMEP1YRK
diseases

13.1 Asthma
)IǻRMXMSR
8LI ,PSFEP .RMXMEXMZI JSV &WXLQE ,.3& HIǻRIW EWXLQE EW E GLVSRMG MRǼEQQEXSV]
disease of the airways in which many cells and cellular elements play a role. The chronic
EMV[E]MRǼEQQEXMSRMWEWWSGMEXIH[MXLEMV[E]L]TIVVIWTSRWMZIRIWW &-7XLEXPIEHWXS
recurrent episodes of wheezing, shortness of breath, chest tightness and coughing
particularly at night or in the early morning. These episodes are usually associated with
widespread but variable airways obstruction within the lung that is often reversible
either spontaneously or with treatment.

8LIOI]GSQTSRIRXWSJXLMWHIǻRMXMSRMRGPYHI

ƽ 8LITVIWIRGISJEMV[E]MRǼEQQEXMSR

ƽ Airway hyper responsiveness which implies that the airways will narrow easily
and too much in response to various stimuli

ƽ Recurrent episodes of symptoms of wheezing, breathlessness, chest tightness

and coughing

ƽ Reversible airways obstruction that is demonstrable by changes in lung function

(Forced Expiratory Volume in 1 second and Peak Expiratory Flow) in response to
a broncho-dilating agent such as salbutamol.

274 Integrated Guideline for Tuberculosis,

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Figure 13.1 Summary of Airway Pathophysiologic Process in Asthma

Burden
,PSFEPP]ERIWXMQEXIHQMPPMSRTISTPIWYǺIVJVSQEWXLQE[MXLEREWWSGMEXIHQSVXEPMX]
of 383,000 annually. From the International Study of Asthma and Allergic Disease in
Childhood (ISAAC), Kenya has an estimated prevalence of 10% of the population with
asthma, approximately 4 million people. The prevalence of wheeze in the past 12 months
among 13- 14 year olds was 18% and 13.8 % in Nairobi and Eldoret respectively in the
year 2000 up from17.1% and 10.4 % in 1995. The prevalence of asthma in older children
between the ages of 12-14 years may be increasing.

Risk factors
Asthma is a heterogeneous disease and there are several phenotypes based on

ƽ Whether allergic or not

ƽ Control (poor control, controlled and brittle)

ƽ Time of onset (childhood or late in adulthood)

ƽ Occupational

ƽ Trigger(s)

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 Figure 13.2: Risk factors for Asthma

Clinical Presentation of asthma

A history of respiratory symptoms such as wheeze, shortness of breath, chest tightness
ERHGSYKLXLEXZEV]SZIVXMQIERHMRMRXIRWMX]ERHZEVMEFPII\TMVEXSV]EMVǼS[PMQMXEXMSR8LMW
is most likely asthma but Lung function test (spirometry) where available should be done.

Table 13.2 Typical and atypical presentation of asthma

Typical presentation Atypical presentation

ƽ Frequent episodes of cough, chest tightness, ƽ 2EMRP]MRGLMPHVIR

breathlessness and wheezing that vary in
ƽ 7IGYVVIRXEXXEGOWSJGSYKL
duration and severity
particularly in the evening and/or
ƽ Symptoms occur mainly at night and wake up at night, which do not respond to
patient, usually in the early hours of the morning symptomatic treatment
ƽ Symptoms disappear spontaneously or after ƽ (LIWXXMKLXRIWW[MXL[LII^MRKXLEX
bronchodilator use occurs only after exercise
ƽ Persistent breathlessness can occur in the most ƽ (PMRMGEPTEXXIVRWMQMPEVXSEREGYXI
severe form of asthma, due to progression from respiratory infection but frequently
VIZIVWMFPIXSMVVIZIVWMFPIEMVǼS[PMQMXEXMSR recurs during a short period
ƽ Severe progression is rare and linked to
irreversible airway remodeling
ƽ Several risk and trigger factors usually present

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Diagnosis of asthma
Listen to the patient (the clinical history is the most important in the diagnosis of asthma)

ƽ Is there recurrent or episodic wheeze, cough, chest tightness or shortness of

breath?

ƽ Are the symptoms particularly troublesome at night or early morning?

ƽ Are the symptoms triggered by factors such as dust, cold exposure, strong smells
or exercise?

ƽ .WXLIVIEGSRWMWXIRXVIWTSRWIXSEWXLQEWTIGMǻGXVIEXQIRX$

ƽ Is there a family history of allergy/atopy i.e allergic conjunctivitis, allergic rhinitis,

asthma, eczema and food (protein) allergy?

Obtain a Lung Function Test to assess airway hyper-responsiveness (measure FVC, FEV1
ERH5*+F]TMVSQIXV][LIVIEZEMPEFPI5IEOI\TMVEXSV]ǼS[QIXIV 5*+2MWGLIETIV
and should be used where there’s no spirometer.

ƽ .WXLIVIEMVǼS[PMQMXEXMSR +*:1/FVC less than 85 or diurnal variation in PEF)? FEV1/

FVC < 85% in children and 75% in adults is indicative of obstructive airway disease.

ƽ .W XLIVI E FVSRGLSHMPEXSV VIWTSRWI +*:1 or PEF improvement by greater than

12.5% (or 200mls), or 20% respectably, 30 minutes after inhalation of a short acting
bronchodilator)?

 ƽ 2IEWYVI 5*+ ZEVMEFMPMX] [MHI W[MRKW MR XLI 5*+ FIX[IIR QSVRMRK ERH IZIRMRK SV
[LIREX[SVOERHSǺ[SVO

ƽ )SIWXLI+*:1 drop below 20% with only small doses of inhaled bronchoconstrictors
such as Methacholine, Histamine or with exercise?

Diagnosis of asthma in children

The general principles for the diagnosis of asthma apply to children. Many preschool
children have frequent wheezing and most (over 50%) of those treated as asthma will not
have typical symptoms later on in life. Children with recurrent wheeze should be given
a trial of anti-asthmatic medication. Children with the following features are most likely
to be asthmatic:

ƽ Frequent episodes of chronic cough, chest tightness, breathlessness and wheeze

particularly experienced at night, early morning, or in response to exercise,
common allergens, emotions, laughter or occur in the absence of ‘common cold’
if they respond to asthma treatment.

ƽ Wheeze in between viral infection

ƽ A strong family history of asthma or allergic disease is also supportive of the

diagnosis of asthma in very young children.

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 +MKYVI)MEKRSWXMGǼS[GLEVXJSVEWXLQEMRGPMRMGEPTVEGXMGI

(PEWWMǻGEXMSRSJEWXLQE
8LI GPEWWMǻGEXMSR MW FEWIH SR WIZIVMX] SJ HMWIEWI XLYW  .RXIVQMXXIRX QMPH TIVWMWXIRX
moderate persistent and severe persistent asthma.

8EFPI(PEWWMǻGEXMSRSJEWXLQE

(PEWWMǻGEXMSR Symptoms Nocturnal PEF or FEV

symptoms
Intermittent < 1 time week ǷXMQIWEQSRXL > 80% predicted
Asymptomatic and normal Variability < 20%
PEF between attacks

Mild persistent > 1 time a week, but < 1 > 2 times a month > 80% predicted
time a day Variability < 20%-30%
Moderate )EMP]&XXEGOWEǺIGXEGXMZMX] > 1 time week 60-80% predicted
persistent Variability > 30%
asthma

Severe Continuous Limited Frequent > 60% predicted

persistent physical activity Variability > 30%
asthma

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Management of asthma
The aim of management is to achieve asthma control and to return patients to productive lives.

Goals of asthma care/management are to:

ƽ Achieve and maintain control of symptoms

ƽ Prevent asthma exacerbations

ƽ Maintain lung function as close to normal as possible

ƽ Maintain normal level of activity including exercise

ƽ &ZSMHEHZIVWIIǺIGXWSJEWXLQEQIHMGEXMSRW

ƽ 5VIZIRXHIZIPSTQIRXSJMVVIZIVWMFPIEMVǼS[PMQMXEXMSR

ƽ Maintain normal growth velocity in children

ƽ Prevent asthma mortality

8EFPI&WXLQE2IHMGEXMSRWEVIGPEWWMǻIHMRXSX[SFVSEHKVSYTW

Relievers They reverse broncho-constriction and relieve its symptoms. They include
rapid and short acting, rapid and long acting bronchodilators.
Short acting bronchodilators: Salbutamol
Controllers They are taken daily to keep asthma under control through their anti –
MRǼEQQEXSV]IǺIGXW
1SRK&GXMRK2&KSRMWXW 1&'&LEZIERXMMRǼEQQEXSV]IǺIGXWEVIYWIHMR
combination with inhaled corticosteroids for the long term control of asthma,
they also inhibit mast cell mediator release, plasma exudation and reduce
sensory nerve activation.
Beclomethasone Dipropionate
Budesonide
Ciclesonide
Fluticasone Propionate

Management of acute asthma

&GYXIEWXLQEMWGPEWWMǻIHEW

ƽ 2MPHEWXLQEEXXEGO

ƽ 2SHIVEXIEWXLQEEXXEGOERH

ƽ IZIVIEWXLQEEXXEGO

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280 Integrated Guideline for Tuberculosis,
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Management of chronic asthma
Routine care for asthma patients

Asthma is a chronic illness and therefore the clinical team and patients need to develop
a long term plan for the patient management. The Patient – Health Provider Partnership
include:

1. Personalized Education: Ensure the following is included in the patient education-

a. Basic information about the Disease

b. Medication including Relievers and Preventers

G5SXIRXMEPWMHIIǺIGXWSJQIHMGMRIW

d. Training on the medicine inhaler technique

e. Recognition of worsening asthma and actions to be taken

2. Self-monitoring of asthma control

a. Regular review to assess control and adjust treatment as may be necessary

F .HIRXMǻGEXMSR ERH EZSMHERGI SJ W]QTXSQ XVMKKIV JEGXSVW MRHSSV ERH SYXHSSV
pollutants)

3. A written asthma management plan

4. Regular assessment of patients for their symptom control.

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 Table 13.5: Assessment of asthma symptom control

In the past 4 weeks, has the patient had; Yes No

Daytime symptoms of asthma (cough, wheeze, shortness of breath
more than twice/week etc)?
Any night waking due to asthma?
Reliever needed more than twice/week?
Any activity limitation due to asthma?

Score: Well controlled - None of these, Partially controlled - 1-2

of these, Uncontrolled - 3-4 of these

Medication for chronic care

1SRK&GXMRK2&KSRMWXW 1&'&LEZIERXMMRǼEQQEXSV]IǺIGXWERHEVIYWIHMRGSQFMREXMSR
with inhaled corticosteroids (ICS) for the long-term control of asthma. They also inhibit
mast cell mediator release, plasma exudation and reduce sensory nerve activation. Anti-
MRǼEQQEXSV]XLIVET] .(JSVQWXLIFEGOFSRISJEWXLQEGSRXVSP

All asthma patients should be on inhaled corticosteroids. Bronchodilators should not

FIYWIH[MXLSYXGSQFMRMRK[MXL.(WMRGIEWXLQEMWERMRǼEQQEXSV]HMWIEWI+VIUYIRX
YWI SJ &'& GER PIEH XS I\GIWW HIEXLW HYI XS WMHI IǺIGXW ERH JEMPYVI XS EHHVIWW XLI
MRǼEQQEXSV]EWTIGX

Inhaler Devices
ƽ Pressurized Metered Dose Inhalers (pMDIs)
ƽ Breath Actuated MDIs
ƽ Dry Powder Inhalers
ƽ Soft Mist Inhalers
ƽ Nebulizers or wet aerosols
ƽ Volume Spacers with or without face masks to be used with pMDIs

Management of poor responders

ƽ 8LIǻVWXWXITMWXSI\GPYHIEPXIVREXMZIHMEKRSWI

ƽ The second is to consider and exclude comorbidities

ƽ The third Assess adherence to medication

ƽ 8LIJSYVXLWXITMRZSPZIWMHIRXMJ]MRKXLITEXXIVRSJMRǼEQQEXMSRERHVIWTSRWIXS
treatment. Innovative biological therapies can be used.

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Table 13.6: Other medications used in asthma management

Anticholinergics They are used for the treatment, especially in the acute care setting.
Ipratropium bromide is usually combined with a short acting B2 agonist
XåƚĩŅƋųĜåĹåaŅÚĜĀåųŸ They are used as add on therapy in patients who fail to achieve control.
Used with low dose inhaled corticosteroids or as alternatives to low
dose inhaled corticosteroids and in aspirin induced asthma (AIA).
It is useful in the presence of allergic rhinitis and asthma to relieve
both nasal and chest symptoms

„ƼŸƋåĵĜÏ They are recommended for patients with moderate to severe acute
Corticosteroids exacerbations of asthma. In some patients with steroid dependent
asthma the lowest possible dose of should be used

The cromones, Anti Refer to the National asthma Guidelines

IGE

8EFPI)MǺIVIRXMEPHMEKRSWMWSJEWXLQE

Non asthma causes of cough and or wheeze in Non asthma causes of cough and or wheeze
children in adults
ƽ Chronic rhino- sinusitis ƽ Tuberculosis
ƽ Recurrent viral respiratory tract infections ƽ Chronic bronchitis and COPD
ƽ Foreign body aspiration ƽ Bronchiectasis
ƽ ,EWXVSƳIWSTLEKIEPVIǼY\ ƽ Heart disease
ƽ Tuberculosis ƽ Airway obstruction e.g. lung cancer,
ƽ Congenital heart disease tracheal stenosis etc

ƽ (]WXMGǻFVSWMW
ƽ Bronchopulmonary dysplasia
ƽ Congenital malformations with narrowing of
the airways
ƽ Primary ciliary dyskinesia syndrome
ƽ .QQYRIHIǻGMIRG]
ƽ Bronchiectasis

8EFPI&TTVSEGLIW8S.HIRXMJ]MRK&WXLQE)MǺIVIRXMEPW

Diagnosis Evaluation
ŽŞŞåųeĜųƵ±Ƽ%ĜŸå±Ÿå ƽ Clinical ENT Examination
ƽ Adeno-tonsillar hypertrophy ƽ Sinus X-ray
ƽ Rhino-sinusitis ƽ CT Paranasal Sinuses
ƽ Post Nasal Drip ƽ ENT Specialist Referral

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 Diagnosis Evaluation
Congenital Structural Bronchial Disease ƽ Bronchoscopy
ƽ Tracheo- bronchomalacia ƽ CT Scan Chest
ƽ Cartilage Rings
ƽ Cysts
ƽ Webs
ųŅĹÏĘĜ±Ĭx‰ų±ÏĘå±ĬkÆŸƋųƚÏƋĜŅĹ ƽ CXR
ƽ Vascular Rings/ Slings ƽ CT Scan Chest
ƽ Enlarged Cardiac Chamber ƽ Echocardiogram
ƽ Lymph Node Enlargement from TB or Lymphoma ƽ Mediastinoscopy
)ĹÚŅÆųŅĹÏĘĜ±Ĭ%ĜŸå±Ÿå ƽ Chest X-ray
 Foreign Body /Tumor ƽ Bronchoscopy
)ŸŅŞĘ±čå±Ĭx„Ƶ±ĬĬŅƵĜĹč{ųŅÆĬåĵŸ ƽ Upper GI Studies/Barium Swallow
ƽ 7IǼY\ ƽ Upper Endoscopy
ƽ Uncoordinated Swallowing ƽ PH Probe
ƽ Laryngeal Cleft ƽ Milk Scan
ƽ Tracheo-esophageal Fistula

{ƚĬĵŅűųƼ„ƚŞŞƚų±ƋĜŅĹ ƽ Sweat/Genetic testing

ƽ Cystic Fibrosis ƽ Lung/Sinus Biopsy/Molecular
ƽ Primary Ciliary Dyskinesia Genetic Testing

ƽ IZIVI.QQYRSHIǻGMIRG]]RHVSQIW ƽ Complete Blood Count

ƽ Agammaglobulinemia ƽ Immunoglobulin Levels

ƽ Complement Levels
Miscellaneous ƽ Characteristic Viral Syndrome
ƽ Post Viral Wheeze ƽ Antigen Tests for RSV
ƽ Acute Bronchiolitis. ƽ Viral Cultures
ƽ Laryngo-Tracheobronchitis ƽ PCR
ƽ CXR
Chronic obstructive pulmonary disease ƽ Spirometry

Congestive heart failure ƽ Echocardiogram

ƽ Serum BNP
Pulmonary embolism ƽ Chest X-ray
ƽ Lower limb doppler ultrasound
ƽ CT pulmonary angiogram
ƽ Echocardiogram
ƽ Perfusion/ventilation scans
Tumors ƽ Contrast enhanced CT scan chest

Pulmonary eosinophilia ƽ Sputum eosinophilia

ƽ Elevated eosinophil counts in full
haemogram.

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Diagnosis Evaluation
ACE Inhibitor induced cough  Medication review and
discontinuation of ACE
inhibitors
Vocal cord dysfunction  Bronchoscopy
Laryngeal dysfunction  Laryngoscopy

(LVSRMG4FWXVYGXMZI5YPQSREV])MWIEWI (45)
Chronic Obstructive Airway Disease is a term used to describe progressive lung disease
that makes it hard to breathe. It includes chronic bronchitis and emphysema. It is
GLEVEGXIVM^IHF]TIVWMWXIRXEMVǼS[PMQMXEXMSRXLEXMWYWYEPP]TVSKVIWWMZIERHEWWSGMEXIH
[MXLERIRLERGIHGLVSRMGMRǼEQQEXSV]VIWTSRWIMRXLIEMV[E]WERHXLIPYRKXSRS\MSYW
particles or gases.

RISK FACTORS
ƽ Age and Sex: Elderly >40 years and Female > Male
ƽ Environmental factors:
 Active tobacco smoking
 Secondary tobacco smoking
 Indoor air pollution - bio fuels and coal
 Outdoor air pollution-also contributors to the lungs’ total burden of inhaled parti-
cles
ƽ Occupation exposure:
 Organic and inorganic dust
 Chemical agents and fumes
ƽ Genetic factors-
 IZIVI LIVIHMXEV] HIǻGMIRG] SJ EPTLE ERXMXV]TWMR &&8) XLI KIRI IRGSHMRK
matrix metalloproteinase-12 (MMP-12) and glutathione S-transferase have also
been related to decline in lung function or risk of COPD
ƽ 1YRKKVS[XLERHHIZIPSTQIRXƳER]JEGXSVXLEXEǺIGXWPYRKKVS[XLHYVMRKKIWXEXMSRERH
childhood (low birth weight, respiratory infections, etc.) has the potential to increase an
individual’s risk of developing COPD
ƽ SGMSIGSRSQMG WXEXYW TSZIVX] MW GSRWMWXIRXP] EWWSGMEXIH[MXL EMVǼS[ SFWXVYGXMSR ERH
lower socio-economic status is associated with an increased risk of developing COPD.
ƽ Asthma and airway hyper-reactivity - asthma may be a risk factor for the development of
EMVǼS[PMQMXEXMSRERH(45)
ƽ Infections-
- History of severe childhood respiratory infection has been associated with re-
duced lung function and increased respiratory symptoms in adulthood
 Post Tuberculosis lung damage
 Chronic bronchitis - may increase the frequency of total and severe exacerbations

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 Diagnosis of COPD

Consider COPD in a patient with:

ƽ Dyspnea that is progressive, persistent and worsens with exercise
ƽ Chronic cough which may be intermittent and productive or not productive
ƽ Chronic sputum production
ƽ Wheezing
ƽ History of exposure to risk factors which may include tobacco smoking, smoke from home
cooking and heating bio fuels, occupational dusts and chemicals
ƽ Patient with above symptoms and previously treated for Tuberculosis
ƽ Age of 40 years and above
ƽ Family history of COPD

Lung function testing: Spirometry

ƽ Spirometry is the Gold standard for clinical diagnosis and monitoring COPD
ƽ5SWXFVSRGLSHMPEXSV+*:+:(PIWWXLER GSRǻVQWXLITVIWIRGISJTIVWMWXIRX
EMVǼS[PMQMXEXMSR
ƽ8SHMEKRSWIQEREKIERHJSPPS[YT(45)TEXMIRXWSRIWLSYPHLEZIEGGIWWXS
Spirometryfacilities

Distinguishing asthma and COPD: a Practical approach to diagnosis of COPD

A patient with a chronic cough may have more than one disease. In case of a chronic
GSYKLǻVWXI\GPYHI8'PYRKGERGIVGLVSRMGFVSRGLMXMWLIEVXJEMPYVIERHTSWXMRJIGXMSYW
cough. Then consider asthma or chronic obstructive pulmonary disease (COPD) which
FSXLTVIWIRX[MXLGSYKLHMǽGYPX]MRFVIEXLMRKXMKLXGLIWXERH[LII^MRK

Table 13.9: If the cause of wheezing is not known, distinguish COPD and asthma as
follows

ASTHMA COPD
ƽ4RWIXFIJSVI]IEVWSJEKI ƽ Onset after 40 years of age
ƽ&WWSGMEXIHLE]JIZIVIG^IQEEPPIVKMIW ƽ Symptoms are persistent and worsen slowly
ƽ.RXIVQMXXIRXW]QTXSQW[MXLRSVQEPFVIEXL- over time
ing in between ƽ (SYKL[MXLWTYXYQWXEVXWPSRKFIJSVIHMǽGYPX
ƽ  ]QTXSQW [SVWI EX RMKLX IEVP] QSVRMRK breathing
with cold or stress
ƽ Client is or was a heavy smoker and/or had
ƽ5IVWSREPSVJEQMP]LMWXSV]SJEWXLQE TB
ƽ Previous diagnosis of COPD
Asthma likely COPD likely
(SRǻVQHMEKRSWMW,MZIVSYXMRIEWXLQEGEVI
ƽ (SRǻVQHMEKRSWMW,MZIVSYXMRI(45)GEVI

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8EFPI4XLIV)MǺIVIRXMEPWSJ(45)

Diagnosis Suggestive features

Congestive heart Chest X-ray shows a dilated heart, pulmonary edema

failure
5YPQSREV]JYRGXMSRXIWXMRHMGEXIZSPYQIVIWXVMGXMSRRSXEMVǼS[PMQMXEXMSR

Bronchiectasis Large volume of purulent sputum

Commonly associated with bacterial infection

Chest X-ray/CT scan shows bronchial dilatation, bronchial wall thickening

Tuberculosis Onset all ages

(LIWX<VE]WLS[WPYRKMRǻPXVEXIW

2MGVSFMSPSKMGEPGSRǻVQEXMSR

High local prevalence of tuberculosis

Obliterative Onset at a younger age, non-smokers

bronchiolitis
May have a history of rheumatoid arthritis or acute fume exposure
Seen after lung or bone marrow transplantation

CT on expiration shows hypodense areas

)MǺYWI Predominantly seen in patients of Asian descent

panbronchiolitis
Most patients are male and non-smokers

(LIWX<VE]ERH-7(8WLS[HMǺYWIWQEPPGIRXVMPSFYPEVRSHYPEVSTEGMXMIW
ERHL]TIVMRǼEXMSR

Management of COPD

Goals of COPD management

ƽ 8SVIPMIZIW]QTXSQW
ƽ 5VIZIRXHMWIEWITVSKVIWWMSR
ƽ 5VIZIRXERHXVIEXGSQTPMGEXMSRWERHI\EGIVFEXMSRW
ƽ 7IHYGIVMWOSJHIEXL

Assess COPD severity and the extent of exacerbation. The assessment is aimed
at determining disease severity, its impact on patient’s general health status, risk of
exacerbations and death (Suggested further reading: GOLD guidelines on COPD).

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 8EFPI(PEWWMǻGEXMSRSJWIZIVMX]SJ(45)FEWIHSR5SWXFVSRGLSHMPEXSV+*:1 (in
patients with FEV1/FVC <0.70)

GOLD 1 Mild COPD FEV1Ǹ TVIHMGXIH

GOLD 2 Moderate COPD  Ƿ+*:1 <79% predicted

GOLD 3 Severe COPD  Ƿ+*:1 < 49% predicted
GOLD 4 Very Severe COPD FEV1 < 30% predicted

Assess risk for exacerbations

Exacerbation of COPD is an acute event characterized by a worsening of the patient’s
respiratory symptoms that is beyond normal day-to-day variations and leads to a change
in medication. The best predictor of frequent exacerbations (2 or more per year) is a
history of previous treated events.

Management of COPD includes:

1. Smoking cessation: This has the greatest impact in reducing the disease progression.
This can be done through:
a) Patient counseling
b) Nicotine replacement therapy e.g. nicotine patches, nicotine gums, sublingual
tablets etc.
c) Institution of smoking prevention and tobacco control strategies (åüåŹƐƒŇƐc±ƒĞŇĻ±ĮƐ
‰ŇƱÏÏŇƐŇĻƒŹŇĮƐŤŇĮĞÏĞåž)

2. Prevention of occupational exposure

3. Reduction of exposure to indoor pollutants e.g. bio fuels in poorly ventilated houses

4. Physical exercise

5. Pharmacotherapy – the drugs used in the management of COPD are aimed at reducing
symptoms, frequency and severity of exacerbations and improving health status. They
include:
i. Inhaled bronchodilators
ii. Inhaled corticosteroids
iii. (SQFMRIHMRLEPIHGSVXMGSWXIVSMHFVSRGLSHMPEXSVXLIVET]MWQSVIIǺIGXMZIXLER
individual components. Antibiotics are not recommended except for treatment
of suspected bacterial infections.
iv. Mucolytic agents for patients with viscous sputum
v. Oxygen therapy - Long term administration of oxygen for > 15 hours per day has been
shown to increase survival in patients with severe COPD
vi. Palliative care/ hospice care is important for patients with advanced COPD which
is marked with deteriorating health status, increasing symptoms, frequent acute
exacerbations with frequent hospitalizations and associated comorbidities e.g.
cardiovascular diseases, malignancies and progressive respiratory failure

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Figure 13.4 Guide for the management of COPD based on severity of the disease

Key: X
a
ƐĝƐXŇĻďƐ
σĞĻďƐaƣžÏ±ŹĞĻĞÏƐ
Ļƒ±ďŇĻĞžƒØƐX

ƐĝƐXŇĻďƐ
σĞĻďƐ僱Ɛ
Ļƒ±ďŇĻĞžƒØƐF„ƐĝƐFĻ̱ĮåÚƐ
ŇŹƒĞÏŇžƒåŹŇĞÚžØƐ{%)ċĞĝ{ĚŇžŤĚŇÚĞåžƒåŹ±žåƐċƐĞĻĚĞÆĞƒŇŹžØƐc
ƐĝƐcĝ
ÏåƒDžĮÏDžžƒåĞĻåƐ

Routine COPD care

The aim of COPD care is to stop further deterioration of lung function and to recognize
and treat acute exacerbations early. COPD patients need to be reviewed regularly. At
each visit provide the following care:

ƽ QSOMRKGIWWEXMSR8LMWMWXLIQEMRWXE]SJGEVIQSOMRKGIWWEXMSRHVEWXMGEPP]VIHYGIW
the progression of disease. People are more likely to stop smoking if advised by a
health professional

ƽ &WWIWWWIZIVMX]SJ(45)ERHXVIEXEGGSVHMRKXSWIZIVMX]

ƽ *RWYVI STXMQEP HIPMZIV] SJ HVYKW F] IHYGEXMRK TEXMIRXW SR GSVVIGX YWI SJ MRLEPIVW
Check adherence to treatment and inhaler/spacer technique.

Treatment of acute exacerbations

Lower respiratory tract infections (LRTI) occur commonly in patients with COPD. In
patients previously treated for Tuberculosis, repeat TB tests only if other TB symptoms
develop. If patient’s sputum increases or changes in color to yellow/green, treat for LRTI:

ƽ ,MZIHS\]G]GPMRIQKLSYVP]JSVHE]WSVEQS\MGMPPMRQKLSYVP]JSV
10 days.

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 ƽ ,MZI WLSVX GSYVWI SVEP TVIHRMWSRI QK HEMP] JSV  HE]W MJ TEXMIRX LEW WIZIVI
COPD

ƽ -MKL HSWI TK MRLEPIH GSVXMGSWXIVSMHW EVI IǺIGXMZI MR TEXMIRXW[MXL WIZIVI
COPD with more than 2 infective exacerbations per year

ƽ ,MZIMRǼYIR^EZEGGMRI]IEVP]ERHTRIYQSGSGGEPZEGGMRI]IEVP]

ƽ .HIRXMJ]ERHQEREKIGSQTPMGEXMSRW8VIEXǼYMHVIXIRXMSR[MXLEPS[HSWIHMYVIXMG

ƽ *RGSYVEKI TEXMIRX XS I\IVGMWI HEMP] IK[EPOMRK KEVHIRMRK LSYWILSPH GLSVIW
using stairs instead of lifts etc.

ƽ 7IZMI[TEXMIRXWIZIV]QSRXLWMJWXEFPI

 5SWX8YFIVGYPSWMW1YRK)MWIEWI 581)

The World Health Organization (WHO) estimates that 1.7 billion people are infected
with aũƐƒƣÆåŹÏƣĮŇžĞž globally and approximately 54 million people survived Tuberculosis
8'FIX[IIRERHEPSRI0IR]EJSVMRWXERGIRSXMǻIHTEXMIRXW[MXL8'
in 2018 and successfully treated 84% of them. There is increasing evidence of long-
XIVQVIWTMVEXSV]GSQTPMGEXMSRWJSPPS[MRK8'MRETVSTSVXMSRSJXLIWITEXMIRXWEǺIGXMRK
their quality of life. For many persons with tuberculosis, a microbiological cure is the
beginning, not the end of their illness.

5SWX8'1YRK)MWIEWI 581)MWHIǻRIHEWGLVSRMGVIWTMVEXSV]EFRSVQEPMX][MXLSV[MXLSYX
symptoms attributable, at least in part, to previous pulmonary TB.

There is evidence that over 60% of patients still have symptoms after completion
of TB treatment, over 80% have radiological sequalae, over 30% have spirometric
function test abnormalities and over 40% have bronchiectasis ŦaåďĚĥĞƭIØƐåƒƐ±ĮƐƞǑƞǑƐ
ËĚƒƒŤž×xxƒĚŇŹ±DŽũÆķĥũÏŇķxÏŇĻƒåĻƒxƆĂxƗxƞƌŁÌŧ.

Patients with PTLD may present with persistence of symptoms or decline in lung function
despite successful completion of treatment or cure.

Patients presenting with respiratory complaints and have recently completed

TB treatment (and who may be erroneously considered as TB relapse) should
be thoroughly evaluated for post-TB lung disease and/ or other forms of lung
conditions.

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Post TB lung disease may present as the following:
1. 1YRKWGEVVMRK ǻFVSWMW
2. Bronchiectasis
3. Chronic Obstructive Pulmonary Disease (COPD)
4. Lung abscess
5. Aspergillus-related lung disease
6. Spontaneous Pneumothorax

Clinical Presentation of PTLD

This is dependent on the type of lung impairment and presentation is varied. The key
presentation of PTLD is persistence of clinical symptoms or occurrence of new symptoms
e.g. cough, chest pains, breathlessness or decline in lung function despite successful
completion of PTB treatment.

Assessment for Post TB Lung Disease

Assessment of post TB Lung disease should begin with a baseline assessment at the
initiation of PTB treatment followed by regular assessment during and after successful
completion of PTB treatment.

Schedule of assessment:

After successful completion of treatment at Month 12, 18 and 24

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 Other radiological investigations as indicated:
Lung parenchyma diseases (Interstitial diseases) - High Resolution CT Scan
Cardiac involvement - Cardiac CT scan
Mediastinum, chest wall involvement - Chest CT Scan

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Table 13.12 Diagnosis - Possible Post TB Lung Disease clinical pattern

Compartment Clinical Pattern )IǻRMXMSRW

Airways Tuberculosis associated Airway obstruction (FEV1/FVC ratio < 0.7 or <LLN)
obstructive lung disease though primarily related small airway disease
Bronchiectasis (8HIǻRMXMSRIZMHIRGISJEMV[E]HMPEXEXMSR QSVI
than diameter of adjacent vessel, or non-tapering.
47(<7HIǻRMXMSRIZMHIRGISJVMRKERHXVEQPMRIW
Parenchyma Cavitations &KEWǻPPIHWTEGIIMXLIV[MXLMREREVIESJ
pulmonary consolidations, or surrounded by a thin
wall
Parenchymal destruction Extensive destruction of lung tissue, with a gas-
ǻPPIHWTEGISGGYT]MRKXLIZSPYQISJ>1 lobe
Fibrotic change Areas of parenchymal scarring, with associated
volume loss
Aspergillus related lung Evidence of aspergilloma on imaging or chronic
disease pulmonary aspergillosis on imaging and blood
testing
Pleural Chronic pleural disease
Evidence of pleural
thickening on CXR or CT
imaging
Pulmonary Pulmonary hypertension Elevated pulmonary arterial pressures as
vasculature estimated using doppler echocardiography or
measured at right heart catheterization

Other Other Other pathology not meeting the criteria above.

Ú±ŤƒåÚƐüŹŇķƐƒĚåƐŐžƒƐžDžķŤŇžĞƣķƐŇĻƐŤŇžƒƐ‰ƐĮƣĻďƐÚĞžå±žåƐŇĻƐIƣĮDžƐƞǑŐŁƐ

Management of Post TB Lung Disease conditions:

The management is dependent on the diagnosis.

 1YRKWGEVVMRK ǻFVSWMW

)IǻRMXMSR8LMGOIRMRKWGEVVMRKSVWXMǺRIWWSJPYRKXMWWYIQEOMRKMXPIWWIǽGMIRXMRXLI
ability to get oxygen into the bloodstream. There is normally associated volume loss.
Develops as a consequence of lung healing, e.g. from TB.

8LI WXMǺRIWW GEYWIW HMǽGYPX] MR PYRK I\TERWMSR PIEHMRK XS WLSVXRIWW SJ FVIEXL 8LMW
could be a sequelae of extensive tuberculous disease.

Clinical presentation:

„DžķŤƒŇķžĝ8LIW]QTXSQWHITIRHSRXLII\XIRXSJǻFVSWMW5EXMIRXWQE]FIEW]QTXSQEXMG
or experience dry cough. In severe cases- shortness of breath on exertion, decreased
I\IVGMWIXSPIVERGIǻRKIVGPYFFMRK

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 Clinical examination

Diagnosis:

±ÚĞŇĮŇďĞϱĮƐ±ŤŤå±Ź±ĻÏåƐ

ŇķķŇĻĮDžƐŇÏÏƣŹžƐ±ƒƐƒĚåƐ±ŤĞÏåžƐ±ĻÚƐƣŤŤåŹƐĮŇÆåžØƐƾЃĚƐĀÆŹŇĻŇÚƣĮ±ŹƐŇŤ±ÏЃĞåžƐ±ĻÚƐ±žžŇÏбƒåÚƐ
ĮŇžžƐŇüƐĮƣĻďƐƽŇĮƣķåũƐ)Įåƽ±ƒĞŇĻƐŇüƐƒĚåƐ±ÚĥŇĞĻĞĻďƐĀžžƣŹåƐŇŹƐĚĞĮƣķƐķ±DžƐÆåƐ±žžŇÏбƒåÚũƐ

„ϱŹĞĻďƐ±ŤŤå±ŹĞĻďƐÆåDžŇĻÚƐƌƐķŇĻƒĚžƐϱĻƐĚåĮŤƐÚĞžƒĞĻďƣĞžĚƐ±ÏƒĞƽåƐ‰ƐüŹŇķƐĚå±ĮåÚƐ‰ũƐ

Management:

ƽ 8LIVI MW RS GYVI ERH QEREKIQIRX MW XS VIPMIZI W]QTXSQW ERH VIHYGI JYVXLIV
lung scarring.

ƽ .RWIZIVIXIVQMREPGEWIWPSRKXIVQS\]KIRXLIVET]QE]FIVIUYMVIH

ƽ 8LIWITEXMIRXWWLSYPHFIVIJIVVIHJSVVIZMI[ERHWTIGMEPMWIHGEVIF]ETL]WMGMER

2. Bronchiectasis

)IǻRMXMSRThis is a chronic lung disease often secondary to an infectious process that

results in the abnormal and permanent distortion and widening of airways leading to
build-up of excess mucus. Mechanisms for pathogenesis of bronchiectasis are infection,
EMV[E]SFWXVYGXMSRERHTIVMFVSRGLMEPǻFVSWMW

Clinical presentation:

„DžķŤƒŇķž×

ƽ Cough and daily mucopurulent sputum production, often lasting months to years
(classic)

ƽ Blood-streaked sputum or hemoptysis from airway damage associated with

acute infection

ƽ Dyspnea, pleuritic chest pain, wheezing, fever, weakness, fatigue, and weight
loss

ƽ Rarely, episodic hemoptysis with little to no sputum production (i.e., dry

bronchiectasis)

Clinical examination

Diagnosis:

The diagnosis of bronchiectasis involves the following:

ƽ &GSQTEXMFPILMWXSV]SJGLVSRMGVIWTMVEXSV]W]QTXSQW IKHEMP]GSYKLERH
purulent sputum production)

ƽ 8IWXWVIGSQQIRHIHJSVEIXMSPSKMGEPXIWXMRKMREHYPXW

 )MǺIVIRXMEPFPSSHGSYRX

2) Serum immunoglobulins (total IgG, IgA and IgM)

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 3) Testing for allergic bronchopulmonary aspergillosis (ABPA)

4) Sputum culture for bacterial infection

5) Mycobacterial culture for NTM

&HHMXMSREPXIWXWQE]FIETTVSTVMEXIMRVIWTSRWIXSWTIGMǻGGPMRMGEPJIEXYVIWSVMRTEXMIRXW
with severe or rapidly progressive disease.

Radiological appearance:

Imaging plays a pivotal role in the diagnosis of bronchiectasis.

High-resolution computed tomography (HRCT) is the cornerstone in the radiological

HMEKRSWMWSJGPMRMGEPP]WYWTMGMSYWGEWIWERHXLIQSWXWIRWMXMZIERHWTIGMǻGRSRMRZEWMZI
method for diagnosing bronchiectasis. Additionally, the pattern of disease on HRCT may
IREFPISRIXSPMQMXXLIHMǺIVIRXMEPXSEWMRKPIJI[WTIGMǻGGEYWEXMZIIRXMXMIW

Figure 13.5: HRCT Chest (a) axial and (b) coronal images showing cystic and varicose
FVSRGLMIGXEXMGGLERKIW[MXLVIXVEGXMSRHYIXSǻFVSWMW

Ŧ±ŧƐB‰Ɛ±DŽбĮƐÏĚ垃Ɛ Ɛ Ɛ ƐƐƐ ƐƐƐƐƐƐƐƐƐƐƐƐƐƐƐƐƐŦÆŧƐB‰ƐŇŹŇĻ±ĮƐĚ垃

The CXR: This has a role largely in surveillance for intercurrent infection, progressive
lobar collapse or suspected development of cavitary disease in patients with known
bronchiectasis.

8LIEǺIGXIHMRHMZMHYEPWEVISJXIRRSVQEPSVWLS[RSRWTIGMǻGǻRHMRKW8LIOI]GLERKIW
to look for include parallel line opacities (tramtrack appearance), tubular opacities (mucus
plugging) and ring opacities (dilated end on bronchi). others are Lobar atelectasis and
GSQTIRWEXSV]L]TIVMRǼEXMSR

Management

Treatment is mainly aimed at reducing exacerbations. These are associated with

MRGVIEWIHEMV[E]WW]WXIQMGMRǼEQQEXMSRERHTVSKVIWWMZIPYRKHEQEKI

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 In addition, more severe and more frequent exacerbations are associated with worse
quality of life, daily symptoms, lung function decline, and mortality.

8LIG]GPIFIPS[WLS[WXLIHMǺIVIRXG]GPIWXLEXETEXMIRXKSIWXLVSYKL

Figure 13.6: Treatments for bronchiectasis according to the vicious cycle concept of
bronchiectasis

ƽ (LIWX TL]WMSXLIVETMWX 8LMW MRGPYHIW TSWXYVEP HVEMREKI ERH SXLIV QERIYZIVW
aimed at improving drainage of respiratory secretions.

ƽ &RXMFMSXMGW .RJIGXMZI I\EGIVFEXMSRW [MPP VIUYMVI ERXMFMSXMGW 'VSEHWTIGXVYQ

antibiotics like amoxicillin-clavulanate, metronidazole or clindamycin for
anaerobic infection.

 &RXMTWIYHSQSREPERXMFMSXMGPMOIGMTVSǼS\EGMRVHKIRIVEXMSRGITLEPSWTSVMR IK
ceftazidime) should be used when colonization with Pseudomonas is suspected.

ƽ .J LEIQSTX]WMW MW WIZIVI ERH PMJI XLVIEXIRMRK TEXMIRXW WLSYPH FI EHQMXXIH XS
hospital

for more specialized treatment

NB:ƐkĻÏåƐ±ƐÚбďĻŇžĞžƐĞžƐķ±ÚåØƐ)8)ƐƒŇƐ±ƐÏĚ垃ƐŤĚDžžĞÏбĻƐüŇŹƐüƣŹƒĚåŹƐžŤåÏбĮĞǍåÚƐϱŹå

 (LVSRMG4FWXVYGXMZI5YPQSREV])MWIEWI (45)

)IǻRMXMSR(45)MWGLEVEGXIVM^IHF]TIVWMWXIRXEMVǼS[PMQMXEXMSRXLEXMWYWYEPP]TVSKVIWWMZI
ERHEWWSGMEXIH[MXLERIRLERGIHGLVSRMGMRǼEQQEXSV]VIWTSRWIMRXLIEMV[E]WERHXLI
lung to noxious particles or gases.

TB disease can result into a COPD-like airway disease, at times called TB-associated
COPD.

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Clinical Presentation:

9WYEPP] MX TVIWIRXW [MXL GSYKL HMǽGYPX] MR FVIEXLMRK XMKLX GLIWX ERH [LII^MRK &
substantial number of TB patients develop post-tubercular airway disease or TB-
associated COPD.

Consider COPD in a patient with;

ƽ Dyspnea that is progressive, persistent and worsens with exercise

ƽ Chronic cough which maybe intermittent and productive or not productive

ƽ Chronic sputum production

ƽ Wheezing

ƽ History of exposure to risk factors which may include tobacco smoking, smoke
from home cooking and heating bio fuels, occupational

ƽ Dusts and chemicals

ƽ Patient with above symptoms and previously treated for Tuberculosis

ƽ Age of 40 years and above

ƽ Family history of COPD

Diagnosis:

Spirometry is the Gold standard for clinical diagnosis and monitoring COPD. Post
bronchodilator FEV1+:( PIWW XLER   GSRǻVQW XLI TVIWIRGI SJ TIVWMWXIRX EMVǼS[
limitation.

Management:

For detailed management refer to COPD section

 1YRKEFWGIWW

)IǻRMXMSR A lung abscess is a bacterial infection that occurs in the lung tissue. The
infection causes tissue death, and pus collects in that space. A lung abscess can be
challenging to treat, and it can be life threatening. Often seen in a patient with extensive
damage to the lungs after tuberculosis.

Clinical presentation:

„DžķŤƒŇķž×ƐThe most noticeable symptom of a lung abscess is a productive cough. The

contents that are coughed up may be bloody or pus-like, with a foul odour, fever of 38
degrees celsius or higher, chest pain, shortness of breath, sweating or night sweats,
weight loss, fatigue.

Clinical examination

Dullness on percussion and decreased or absent breath sounds with an intermittent

pleural friction rub (grating or rubbing sound) on auscultation, crackles may present.

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 Diagnosis:

Rule out TB and other infections by conducting sputum or pus analysis, CXR and/or CT.
Full blood count and/or a blood culture will support establishing the causative agent.

Management of abscess

ƽ &RXMFMSXMGXVIEXQIRXMWKMZIR8LIGLSMGISJERXMFMSXMGMWEMHIHF]XLIVIWYPXWSJETYW
culture-sensitivity test.

ƽ YVKMGEPMRXIVZIRXMSRQE]EPWSFIRIGIWWEV]

NB:ƐkĻÏåƐ±ƐÚбďĻŇžĞžƐĞžƐķ±ÚåØƐ)8)ƐƒŇƐ±ƐÏĚ垃ƐŤĚDžžĞÏбĻƐüŇŹƐüƣŹƒĚåŹƐžŤåÏбĮĞǍåÚƐϱŹå

5. Aspergillus-related lung disease

)IǻRMXMSRThis results from colonization of tuberculous cavities or bronchiectatic lesions

with the fungus Aspergillus.

Three distinctive patterns of aspergillus-related lung disease are recognized:

- Saprophytic infestation of airways, cavities and necrotic tissue

- Allergic disease including extrinsic allergic alveolitis, asthma, allergic

bronchopulmonary aspergillosis, bronchocentric granulomatosis and

- Chronic eosinophilic pneumonia.

They manifest depending on the underlying lung pathology and host immune status
into the following 5 types.

+MKYVI(PEWWMǻGEXMSRSJ&WTIVKMPPSWMW

Clinical presentation:

„ĞďĻžƐ±ĻÚƐ„DžķŤƒŇķž×Ɛ‰ĚåžåƐƽ±ŹDžƐÚåŤåĻÚĞĻďƐŇĻƐƒĚåƐžåƽåŹĞƒDžƐ±ĻÚƐƒDžŤåƐŇüƐĞĮĮĻåžžƐŇĻåƐÚåƽåĮŇŤžũ
‰ĚŹååƐÚĞžƒĞĻσƐƒDžŤåžƐ±ŹåƐīĻŇƾĻƐƾЃĚƐžŤåÏĞĀÏƐžĞďĻžƐ±ĻÚƐžDžķŤƒŇķžũ

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Table 13.13: Signs and Symptoms of Aspergillosis

Type of illness Signs / symptoms Predisposing condition

Allergic reaction ÎƐ 8åƽåŹ %åƽåĮŇŤžƐĞĻƐ±žƒĚķ±ƐŇŹƐÏDžžƒĞÏƐ

ĀÆŹŇžĞž
Ŧ±ĮĮåŹďĞÏƐ ÎƐ
ƐÏŇƣďĚƐƒĚ±ƒƐķ±DžƐÆŹĞĻďƐƣŤƐÆĮŇŇÚƐ
ÆŹŇĻÏĚŇŤƣĮķŇĻ±ŹDžƐ ŇŹƐŤĮƣďžƐŇüƐķƣÏƣž
±žŤåŹďĞĮĮŇžĞžŧ
ÎƐ œŇŹžåĻĞĻďƐ±žƒĚķ±

Aspergilloma ÎƐ cŇŹķ±ĮƐĞĻЃбĮĮDž )ķŤĚDžžåķ±ØƐƒƣÆåŹÏƣĮŇžĞžƐŇŹƐ

±Úƽ±ĻÏåÚƐž±ŹÏŇĞÚŇžĞžØ
ÎƐ
ƐÏŇƣďĚƐƒĚ±ƒƐŇüƒåĻƐÆŹĞĻďžƐƣŤƐ
ÆĮŇŇÚƐŦ̱åķŇŤƒDžžĞžŧ
ÎƐ œĚååǍĞĻď
ÎƐ „ĚŇŹƒĻåžžƐŇüƐÆŹå±ƒĚ
ÎƐ ŽĻĞĻƒåĻƒĞŇĻ±ĮƐƾåĞďĚƒƐĮŇžž
ÎƐ 8±ƒĞďƣå
Invasive aspergillosis „ĞďĻžƐ±ĻÚƐžDžķŤƒŇķžƐÚåŤåĻÚƐŇĻƐ FĻƐŤåŇŤĮåƐƾĚŇžåƐĞķķƣĻåƐžDžžƒåķžƐ
ƾĚĞÏĚƐŇŹď±ĻžƐ±ŹåƐ±ýåσåÚØƐ:åĻåŹ±ĮĮDž× ±ŹåƐƾå±īåĻåÚƐ±žƐ±ƐŹåžƣĮƒƐŇüƐ
ŦaŇžƒƐžåƽåŹåƐüŇŹķƐ±ĻÚƐ
ϱĻÏåŹƐÏĚåķŇƒĚåŹ±ŤDžØƐÆŇĻåƐ
fatal) ÎƐ 8åƽåŹƐ±ĻÚƐÏĚĞĮĮž
ķ±ŹŹŇƾƐƒŹ±ĻžŤĮ±Ļƒ±ƒĞŇĻƐŇŹƐ±Ɛ
ÎƐ
ƐÏŇƣďĚƐƒĚ±ƒƐÆŹĞĻďžƐƣŤƐÆĮŇŇÚƐ ÚĞžå±žåƐŇüƐƒĚåƐĞķķƣĻåƐžDžžƒåķƐƒŇƐ
Ŧ̱åķŇŤƒDžžĞžŧ ƒĚåƐÆŹ±ĞĻØƐĚå±ŹƒØƐīĞÚĻåDžžƐŇŹƐžīĞĻ
ÎƐ „ĚŇŹƒĻåžžƐŇüƐÆŹå±ƒĚ
ÎƐ Ě垃ƐŇŹƐĥŇĞĻƒƐŤ±ĞĻ
ÎƐ Bå±Ú±ÏĚåžƐŇŹƐåDžåƐžDžķŤƒŇķž
ÎƐ „īĞĻƐĮåžĞŇĻž

Table 13.14 Diagnosis of Aspergillosis

Diagnostic spectrum
Allergic bronchopulmonary aspergillosis Invasive aspergillosis Aspergilloma
(ABPA) (Chronic necrotizing
Aspergillus pneumonia)

Laboratory testing
a±ĥŇŹ× Demonstration of the
organism in sputum
Blood: ƐüŇŹƐ)ŇžĞĻŇŤĚĞĮбũ
ĝ„īĞĻƐƒåžƒƐĝƐŤŇžĞƒĞƽåƐŹåžƣĮƒƐüŇŹƐ
ũƐüƣķĞď±ƒƣž
ĝa±ŹīåÚƐåĮåƽ±ƒĞŇĻƐŇüƐƒĚåƐžåŹƣķƐ
ĞķķƣĻŇďĮŇÆƣĮĞĻƐ)ƐŦFď)ŧƐĮåƽåĮƐƒŇƐďŹå±ƒåŹƐƒĚ±ĻƐ
ŐǑǑǑƐFŽxÚX
ĝƐ
žŤåŹďĞĮĮƣžƐ{ŹåÏĞŤĞƒĞĻƐƒåžƒ×ƐŤŇžĞƒĞƽåƐ
ŹåžƣĮƒžƐüŇŹƐ
žŤåŹďĞĮĮƣžƐŤŹåÏĞŤĞƒĞĻžƐŦŤŹĞķ±ŹĞĮDžƐ
ĞķķƣĻŇďĮŇÆƣĮĞĻƐ:ƐËFď:ÌØƐÆƣƒƐ±ĮžŇƐ
ĞķķƣĻŇďĮŇÆƣĮĞĻƐ
ƐËFď
ÌƐ±ĻÚƐĞķķƣĻŇďĮŇÆƣĮĞĻƐ
aƐËFďaÌŧ

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 ĝMinor criteria ĝƐŤŇžĞƒĞƽåƐ
žŤåŹďĞĮĮƣžƐ
Ź±ÚĞұĮĮåŹďҞҏÆåĻƒƐ±žž±DžƐƒåžƒƐŹåžƣĮƒž
„ŤƣƒƣķƐƐÏƣĮƒƣŹåƐüŇŹƐ
žŤåŹďĞĮĮƣžƐĞĻƐžŤƣƒƣķƐ±ĻÚƐ
ƣĮƒƣŹåƐxƐžåĻžĞƒĞƽЃDž
Imaging

Chest radiography Chest radiography Chest radiography

ĝ8ĮååƒĞĻďƐŤƣĮķŇĻ±ŹDžƐĞĻĀĮƒŹ±ƒåž -š±ŹĞ±ÆĮåƐü屃ƣŹåžƐƾЃĚƐ ĝ
Ɛķ±žžƐĞĻƐ±Ɛ
ƽ±ŹĞ±ÆĮåØƐžŇĮЃ±ŹDžƐŇŹƐ ŤŹååDŽĞžƒĞĻďƐϱƽЃDžØ
ĝƐaƣÏŇĞÚƐĞķŤ±ÏƒĞŇĻ
ķƣĮƒĞŤĮåƐĻŇÚƣĮåž
ĝŽžƣ±ĮĮDžƐĞĻƐ±ĻƐƣŤŤåŹƐ
ĝÏåĻƒŹ±ĮƐÆŹŇĻÏĚĞåσ±žĞž
ƐĝƐ±ƽЃ±ŹDžƐĮåžĞŇĻž ĮŇÆå
ĝƐXŇÆƣĮ±ƒåÚƐĞĻĀĮƒŹ±ƒåØƐƾĚĞÏĚƐ̱žƐÆååĻƐĮĞīåĻåÚƐ
ĝƐ
ĮƽåŇĮ±ŹƐĞĻĀĮƒŹ±ƒåžƐƒĚ±ƒƐ ƐĝƐķ±ĻĞü垃åÚƐÆDžƐ
ƒŇƐ±ƐÏĮƣžƒåŹƐŇüƐŤåžƐŇŹƐ±Ɛ̱ĻÚƐĞĻƐ±ƐķЃƒåĻ
±ŹåƐĮŇϱĮĞǍåÚƐŇŹƐÆĞĮ±ƒåŹ±Į ±ƐÏŹåžÏåĻƒƐŇüƐ±ĞŹƐ
B‰ Ť±ŹƒĞ±ĮĮDžƐŇƣƒĮĞĻĞĻďƐ±Ɛ
ĝƐ%ĞýƣžåƐĞĻĀĮƒŹ±ƒåžƐ±žƐ
aƣÏƣžƐĀĮĮåÚƐÆŹŇĻÏĚĞ žŇĮĞÚƐķ±žžũ
ÚĞžå±žåƐŤŹŇďŹåžžåž

Źå±žƐŇüƐ±ƒåĮåσ±žĞž ĝƐaŇƽåķåĻƒƐŇüƐķ±žžƐ
B‰
ƾЃĚƐŤŇžĞƒĞŇĻ
ĝ̱Ź±ÏƒåŹĞžƒĞÏƐ̱ĮŇƐžĞďĻƐ
B‰
ŦĞũåũØƐ±ĻƐ±Źå±ƐŇüƐďŹŇƣĻÚĝ
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±ĻďĞŇĞĻƽ±žĞƽåØƐĞĻĀĮƒŹ±ƒåžƐ ϱƽЃ±ŹDžƐÚĞžå±žåƐ
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ÏŇĻžĞÚåŹåd)
ϱƽЃ±ŹDžØƐƾĚĞÏĚƐĞžƐ
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ĞĻü±ŹÏƒĞŇĻ

ƽ -MKLPIZIPWSJWTIGMǻGMQQYRSKPSFYPMR,EKEMRWX&WTIVKMPPYWMRFPSSH (SRǻVQEXSV]

test)

Management

ƽ 8LI SRP] IǺIGXMZI XVIEXQIRX MW WYVKMGEP VIQSZEP SJ XLI EWTIVKMPPSQE .R EHHMXMSR XS
surgical removal: Oral itraconazole may provide partial or complete resolution of
aspergillomas in 60% of patients.

ƽ &RXMJYRKEPQIHMGMRIGERFIYWIHJSVMRZEWMZITYPQSREV]EWTIVKMPPSWMW
e.g., Amphotericin B and voriconazole.

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6. Spontaneous Pneumothorax

)IǻRMXMSR It is the presence of air in the pleural cavity resulting in impairment of

oxygenation and

ventilation. It is a medical emergency and results from rupture of a TB cavity adjacent to

the pleura. It may be associated with formation of pus in the pleural space (empyema)
leading to a pyopneumothorax.

Clinical presentation:

„DžķŤƒŇķž×

ƽ &GYXISRWIXWLSVXRIWWSJFVIEXL

ƽ (LIWXTEMR

Diagnosis:

Pneumothorax is generally diagnosed using a chest X-ray. In some cases, a computerized

tomography (CT) scan may be needed to provide more-detailed images

Management:

ƽ 8LITEXMIRXWLSYPHFIEHQMXXIHXSLSWTMXEPJSVETTVSTVMEXIQEREKIQIRX

ƽ 9RHIV[EXIVWIEPHVEMREKI

c×ƐkĻÏåƐ±ƐÚбďĻŇžĞžƐĞžƐķ±ÚåØƐ)8)ƐƒŇƐ±ƐÏĚ垃ƐŤĚDžžĞÏбĻƐüŇŹƐüƣŹƒĚåŹƐžŤåÏбĮĞǍåÚƐϱŹå

13.4 Interstitial Lung Diseases (ILDs)

Interstitial Lung diseases (ILDs) also referred to as ÚĞýƣžåƐŤ±ŹåĻÏĚDžķ±ĮƐĮƣĻďƐÚĞžå±žåž are
a group of chronic conditions that generally present with the symptom of breathlessness.
8LI]PIEHXSPYRKXMWWYIHEQEKIERHYPXMQEXIP]ǻFVSWMWSVXMWWYIWGEVVMRK[MXLPSWWSJ
lung tissue elasticity. The lung loses its ability to supply oxygen to the bloodstream and
as the scarring progresses, one loses the ability to breath. ILDs can coexist with other
lung diseases.

Pathophysiology
8LI YRHIVP]MRK TEXLSPSK] MR XLI GSRHMXMSRW MW MRǼEQQEXMSR[MXL SV[MXLSYX ǻFVSWMW SJ
the alveolar walls which cause impaired gas exchange. The ILDs usually have a gradual
onset but can also present acutely.

Causes of ILDs
8LI.1)WEVIGPEWWMǻIHMRXSXLSWISJORS[RGEYWI EFSYX ERHXLSWI[LSWIGEYWIW
are unknown (about 65%).

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 For those with known causes, some known causes include:

ƽ Environmental factors which include exposure to air pollutants. These include

long-term exposure to asbestos, allergens e.g. from birds causes hypersensitivity
pneumonitis/ extrinsic allergic alveolitis

ƽ Autoimmunity - one’s own immune system attacks their body. This causes
HMWIEWIW[MXLKIRIVEPM^IHIǺIGXWMRXLIFSH][LMGLMRGPYHIXLIPYRKWSQISJ
these include Dermatomyositis, Rheumatoid Arthritis, Polymyositis, Systemic
Sclerosis/ Scleroderma, Systemic Lupus Erythematosus (SLE). Chest symptoms
QE] FI XLI ǻVWX WMKRWW]QTXSQW SJ XLIWI EYXSMQQYRI HMWIEWIW PSRK FIJSVI
other organ symptom manifestations.

ƽ Drug reactions - some drugs have been reported to cause ILDs in a small group
of people who take them over a long period of time. Some include; nitrofurantoin,
amiadorone

ƽ Sarcoidosis

ƽ Genetics

Some of the common ILDs include:

1. Those of known causes;

a. Pneumoconiosis (e.g. asbestosis, silicosis)

b. Post-infectious ILD

c. Iatrogenic ILD caused by drugs and/or radiation

d. Extrinsic allergic alveolitis (hypersensitivity pneumonitis)

e. ILD in Rheumatoid arthritis

f. ILD in SLE

2. Those of idiopathic causes;

a. Sarcoidosis

F .HMSTEXLMG .RXIVWXMXMEP 5RIYQSRMEW IK RSRWTIGMǻG MRXIVWXMXMEP TRIYQSRME

acute interstitial pneumonia, desquamative interstitial pneumonia, respiratory
bronchiolitis.

Signs and symptoms

The symptoms of ILDs appear gradually and they may not be apparent until the disease
MWJYPP]IWXEFPMWLIH8LITVSKVIWWMSRZEVMIWJVSQTIVWSRXSTIVWSRERHXLIHMWIEWIEǺIGXW
TISTPIHMǺIVIRXP]8LI]ZEV]JVSQQSHIVEXIXSWIZIVIERHQE]MRGPYHIXLIJSPPS[MRK

ƽ LSVXRIWWSJFVIEXLIWTIGMEPP]SRI\IVXMSR

ƽ (LVSRMGHV]SVLEGOMRKGSYKL

ƽ ;IMKLXPSWW

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 ƽ +MRKIVERHXSIGPYFFMRK

ƽ 9RYWYEPXMVIHRIWWXLEXTIVWMWXWJSVPSRK

ƽ )IGVIEWIHI\IVGMWIXSPIVERGI

ƽ (]ERSWMWMRWIZIVIGEWIW

ƽ (LEVEGXIVMWXMGMRWTMVEXSV]ƵZIPGVSƶGVEGOPIWSJXLIPYRKFEWIWSREYWGYPXEXMSRHYIXS
ǻFVSWMW

Diagnostic test

Í (LIWX<7E]ERH(LIWX(8WGER[LMGLWLS[WMKRWSJWGEVVMRKǻFVSWMWMRXIVWXMXMEPPYRK
markings, loss of lung volume.

ƽ 1YRKJYRGXMSRXIWXWTMVSQIXV]XSEWWIWWJSVPYRKVIWXVMGXMSR

ƽ 'PSSHXIWXHITIRHMRKSRWYWTIGXIHGEYWIIKEYXSMQQYRIERXMFSHMIWWGVIIRJSV
connective tissue disease.

ƽ 1YRKFMSTW]ƳFVSRGLSWGST]

Management of ILDs

Corticosteroids such as prednisone are be used with supportive oxygen therapy and
pulmonary rehabilitation

13.5 Lung Cancer

(ERGIV SJ XLI PYRKW MW ER MQTSVXERX HMǺIVIRXMEP HMEKRSWMW MR TEXMIRXW [MXL GLVSRMG
respiratory symptoms. Cancers in the lungs can be either primary or secondary. The
most common primary lung cancer is Non-small cell type (NSCLC) accounting for 80%
of all cases.

Predisposing factors include:

ƽ Smoking - both active and passive is responsible for up to 80 – 90% of cases

ƽ Asbestos exposure

ƽ Family history of lung cancer

ƽ Chronic lung diseases

ƽ Prior history of lung cancer

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 Diagnosis
Clinical presentation

Lung cancer does not usually cause symptoms in its early stages. Most patients will
TVIWIRX[MXLGPMRMGEPWMKRWSRǻVWXZMWMXFYXEQMRSVMX]  QE]FIHMEKRSWIHMRGMHIRXEPP]

]QTXSQWQE]FIHMVIGXP]VIPEXIHXSPSGEPIǺIGXW XYQSYVMXWIPJSVTVIWWYVIIǺIGXWSJ
XLIGERGIVSVXSIRHSGVMRISVQIXEWXEXMGIǺIGXW

Clinical symptoms of lung cancer

Clinical symptoms of lung cancer ƽLSVXRIWWSJFVIEXL

ƽ(LVSRMGGSYKL[MXLSV[MXLSYXLEIQSTX]WMW ƽ-SEVWIRIWWSJZSMGI
ƽ(LERKIWMREWQSOIVƶWGSYKL ƽ9RI\TPEMRIH[IMKLXPSWW
ƽ(LIWXTEMR ƽ+EXMKYI
ƽ;LII^MRK ƽ)]WTLEKME

Radiology diagnosis

a) Chest radiography - This is the initial imaging evaluation. Suggestive features may
include a pulmonary nodule, atypical region of consolidation with an alveolar
TEXXIVRGEZMXEXMRKPYRKQEWWTPIYVEPIǺYWMSRERHTPIYVEPRSHYPIWIRPEVKIHP]QTL
nodes. Most will show features of mass or enlarged lymph nodes. Others include
multiple nodes with cavitation due to necrosis of centrally located malignant tissue,
mediastinal mass, features of consolidation

b) (8 WGER  8LMW TVSZMHIW QSVI HIǻRMXMZI VEHMSPSKMGEP GVMXIVME JSV E RISTPEWXMG PYRK
lesion as well as staging of disease.

c) Others: MRI, Positron Emission Tomography (PET).

Tissue diagnosis

- Biopsy (obtained through bronchoscopy, mediastinoscopy, open biopsy etc)

- Fine Needle Aspirate cytology

- Sputum or thoracocentesis specimens can also be obtained for cytology

Management of Lung cancer

Early detection is key in cancer management and reduction in mortality.

The aim of management is to: Cure patients in early stages, reduce disease progression,
relieve symptoms and palliative care for advanced disease

The management of lung cancer is multidisciplinary. For detailed management plan for
Lung cancer, refer to the National guidelines for cancer management in Kenya.

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LEPROSY
14

KEY HIGHLIGHTS:
14.1 Introduction
Introduction:
 )IǻRMXMSRSJ Leprosy is an infectious bacterial disease caused by
Leprosy Mycobacterium Leprae. It is an Acid-fast-rod shaped
FEGMPPYW.XMWGPEWWMǻIHMRXSX[S
Leprosy is an infectious disease 1. Pauci-bacillary leprosy (PB):
caused by Mycobacterium leprae,
ƽ 5EXMIRXW[MXLXSL]TSTMKQIRXIHTEXGLIW
an acid-fast, rod-shaped bacillus.
ƽ OMRWPMXWQIEVWRIKEXMZI
8LI HMWIEWI QEMRP] EǺIGXW XLI
skin, the peripheral nerves, 2. Multibacillary leprosy (MB)
mucosa of the upper respiratory ƽ -EZIQSVIXLERTEXGLIWOMRWQIEVSJXIRTSWMXMZI
tract, and the eyes. Leprosy is Incubation period for Pauci-bacillary is between 2-5
curable and treatment in the early years and Multi-bacillary between 5-10years. It is a
stages can prevent disability. slow multiplying bacillus.
Cardinal signs for Leprosy
ƽ -]TSTMKQIRXIHVIHHMWLWOMRTEXGLPIWMSR[MXL
loss of sensation
14.1.2 Incubation
period ƽ *RPEVKIHSRISJQSVITIVMTLIVEPRIVZI
ƽ 5VIWIRGISJEGMHJEWXFEGMPPMMREWPMXWOMRWQIEV
The incubation period from
Treatment with Multi drug Therapy (MDT)-New
infection to clinical manifestations
update
is variable, it is shorter for Pauci
Treatment of leprosy include use of 3 drugs regimen
bacillary (PB) disease (in the
in all Leprosy patients.
order of 2–5 years) than for Multi-
ƽ Monthly Rifampicin for 6 months in PB and 12
bacillary (MB), in the order of
months in MB patients
5–10 years and sometimes much
ƽ )EMP](PSJE^MQMRIJSVQSRXLWMR5'ERHQSRXLW
longer.
in MB patients
ƽ )EMP])ETWSRIJSVQSRXLWMR5'ERHQSRXLW
in MB patients
NOTE: Rehabilitation of patients with leprosy should form a key
component in management and special consideration
should be taken when the Eye is involved.

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 14.1.3 Source of Infection
The main source of infection is usually untreated Multi bacillary leprosy patients who
are discharging bacilli via droplets from nose, mouth, during close and frequent contact.

14.2 Background
Epidemiology and History of Leprosy
Leprosy is one of the oldest documented diseases in the world. It is mentioned in the
Bible, Koran and other religious books. However, the description in these books may
include other dermatological conditions with similar manifestations.

Globally 208,619 cases of leprosy were reported in 2018 from 127 countries with the
majority of leprosy patients being found in South East Asia, Americas and Africa. In
the same year, Kenya reported 110 cases (80% were Multibacillary cases), of the cases
RSXMǻIH [IVIQEPIERHSRP] [IVIMRXLIEKIKVSYTSJ]IEVWMRHMGEXMRKXLEX
we could be missing cases in this age group. In the last 3 years Kenya has reported an
increased trend in leprosy cases among children under 15 years which is an indicator of
ongoing transmission in the community.

Kenya has had an upward trend of cases from 97 in 2016, 94 in 2017,110 in 2018 to 154
cases in 2019. Currently the majority of leprosy cases are reported in the following
GSYRXMIW MR 0IR]E 0MPMǻ 0[EPI -SQEFE] 0MWYQY ME]E ERH 'YWME )IWTMXI IǺSVXW XS
control leprosy cases, Kenya is still in the post elimination phase (point preference below
1/10,000 population).

5STYPEXMSR&ǺIGXIH
1ITVSW]EǺIGXWTIVWSRWMREPPEKIKVSYTWERHFSXLWI\IW.R0IR]EXLIEKIKVSYTQEMRP]
EǺIGXIHMWXLSWIEFSZI]IEVWSPHGSRXVMFYXMRKXSEFSYX SJXLIXSXEPGEWIW+EGXSVW
related to low socioeconomic status increase the risk of developing the disease.

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14.3 Mode of transmission and risk factors
Transmission of leprosy is poorly understood, the exact route of ƒŹ±ĻžķĞžžĞŇĻ for leprosy
is still uncertain at the present time. However, the inside lining of the nose and the mouth
is thought to be the main route through which the leprosy bacteria enter the human
body –the main portal of entry. When an untreated leprosy patient coughs or sneezes,
the droplets of mucus containing the Mycobacterium leprae (M.leprae) bacteria are
expelled into the air and can be inhaled by a susceptible person. Leprosy has a reservoir
in armadillos and a few other animals.

Up to 95% of patients exposed to M. leprae will not develop the disease, suggesting that
host immunity plays an important role in disease progression and control.

Infection follows prolonged contact with an infectious leprosy patient. Closeness of

contact is related to the dose of infection, which in turn is related to the occurrence
of disease. Contacts of MB cases are 5-10 times, and contacts of PB cases 2-3 times,
more likely to contract clinical leprosy than individuals in endemic communities with no
known contact with recognized cases.

14.4 Pathophysiology
The bacilli enter the body through the respiratory system by inhalation from an infected
individual. It invades the coolers areas of the body which are the skin, mucous membranes
and the peripheral nerves.

It has low pathogenicity where about 5% of infected people will develop signs and
symptoms of the disease. After entering the body, the bacilli migrate towards the neural
tissue and enter the Schwann cells. The bacteria can also be found in macrophages,
muscle cells and endothelial cells of blood vessels.

After entering the Schwann cells /macrophage the progress depends on the immune
status of the infected individual. The bacilli are slow in replication i.e. it takes about 12-14
days for one bacterium to divide into two within the cells. After replication it continues to
EǺIGXQSVIGIPPWERHYTXSXLMWWXEKIETIVWSRVIQEMRWJVIIJVSQWMKRWERHW]QTXSQW
of leprosy.

As the bacilli multiply, bacterial load increases in the body and infection is recognized by
the immunological system while the lymphocytes and histiocytes (macrophages) invade
XLI MRJIGXIH XMWWYI 8LI FEGXIVME HS RSX TVSHYGI ER] XS\MR FYX MRHYGIW MRǼEQQEXSV]
reactions that lead to injury of the nerve and consequent disability. Damage can occur
XSSRISVQSVISJXLIXLVIIGSQTSRIRXWSJXLITIVMTLIVEPRIVZI[MXLHMǺIVIRXWIUYIPEI

ƽ IRWSV]ǻFVIWPSWWSJWIRWEXMSR

ƽ 2SXSVǻFVIW[IEORIWWSVTEVEP]WMWMRMRRIVZEXIHQYWGPIW

ƽ &YXSRSQMGǻFVIWHV]RIWWERHL]TSTMKQIRXEXMSRSJXLIMRRIVZEXIHWOMR

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 At this stage clinical manifestation may appear as involvement of nerves with impairment
of sensation and or hypopigmented skin patch. If it is not diagnosed and treated in
the early stages, further progress of the diseases is determined by the strength of the
patient’s immune response.

14.5 Clinical presentation of disease

8LI GEWI HIǻRMXMSR JSV 1ITVSW] MW E TIVWSR[MXL GPMRMGEP WMKRW SJ PITVSW][LS VIUYMVIW
chemotherapy (MDT).

Leprosy should be suspected in people with any of the following symptoms or signs:

ƽ 5EPIL]TSTMKQIRXIHSVVIHHMWLTEXGLIWSRXLIWOMR XLIQSWXGSQQSRWMKRSJ

leprosy)

ƽ 1SWWSVHIGVIEWIWIRWEXMSRMRXLIWOMRTEXGL

ƽ 3YQFRIWWSVXMRKPMRKSJXLILERHWSVJIIX

ƽ ;IEORIWWSJXLILERHWJIIXSVI]IPMHW

ƽ 5EMRJYPSVXIRHIVRIVZIW

ƽ [IPPMRKWSVPYQTWMRXLIJEGISVIEVPSFIW

ƽ 5EMRPIWW[SYRHWSVFYVRWSRXLILERHWSVJIIX

Although the majority of leprosy patients have straightforward skin lesions which are
easy to see, experienced health care workers know that there is a great variety in the
WOMRPIWMSRWSJPITVSW]SQIWOMRPIWMSRWEVIZIV]HMǺYWIERHHMǽGYPXXSHMWXMRKYMWLJVSQ
normal skin: in these cases, the other symptoms and signs become important.

Hypopigmented/reddish patch with loss of sensation

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14.6 Diagnosis of Leprosy
Diagnosis of leprosy requires a high index of suspicion. A proper clinical history and
physical examination are critical in making a diagnosis of leprosy. It is diagnosed clinically
F]ǻRHMRKEXPIEWXONESJXLIJSPPS[MRKGEVHMREPWMKRWF];-4GPEWWMǻGEXMSR

)IǻRMXIPSWWSJWIRWEXMSRMRETEPI L]TSTMKQIRXIHSVVIHHMWLWOMRTEXGL

(2) Thickened or enlarged peripheral nerve, with loss of sensation and/or

weakness

of the muscles supplied by that nerve;

(3) Presence of acid-fast bacilli in a slit-skin smear.

Physical examination

This should be conducted in a room with good lighting. A thorough review of the systems
WLSYPHFIHSRILS[IZIVXLIJSPPS[MRKW]WXIQWWLSYPHWTIGMǻGEPP]FIVIZMI[IH

1. Skin

Look for hypo pigmented skin patches with loss of sensation using cotton wool to
conduct a light touch. Examine for nodules, look for dryness cracks and hair loss on the
patches and the eye brows lashes. Examine for muscle wasting. Ask the patient about
skin discoloration and duration of its presence, presence and duration of nodules.

2. Nervous and Musculoskeletal system

Systematically examine the peripheral nerves for nerve enlargement tenderness and
loss of function (autonomic, sensory and motor). Assess for weakness of muscles of
hands, feet and eyes as well as loss of sensation in these parts and unnoticed injuries in
the hands, feet and eyes

8LI JSPPS[MRK TIVMTLIVEP RIVZIW EVI YWYEPP] EǺIGXIH[MXL HMǺIVIRX GSRWIUYIRGIW ERH
must be examined.

Figure 14.6.1 (Sites where peripheral nerves can be palpated)

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 a. Facial Nerve

Facial nerve damage leads to facial palsy (weakness in the muscles of the face). Facial
palsy in leprosy it involve upper part of face due to selective involvement of zygomatic
branch of facial nerve by leprosy lesion.

;LIRXLISVFMXEPFVERGLMWEǺIGXIHXLITEXMIRX[MPPTVIWIRX[MXLHMǽGYPX]MRGPSWMRKXLI
eyes (lagophthalmos (rabbit-like eyes).

ƐƐƐƐƐƐƐX±ďŇŤƒĚ±ĮķŇž

b. Trigeminal Nerve

)EQEKIXSXLIXVMKIQMREPRIVZIPIEHWXSPSWWSJXLIFPMROVIǼI\VIWYPXMRKHV]RIWWERH
exposure keratitis. While examining the patient, observe for blinking.

The damage causes loss of sensation of the cornea leading to frequent injuries of the
GSVRIE F] JSVIMKR SFNIGXW 8LMW QE] VIWYPX MR MRJIGXMSR LIEPMRK [MXL ǻFVSWMW STEGMX]
formation and blindness. The eyes should always be examined for injuries.

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c. Great Auricular Nerve

8LIRIVZIYWYEPP]VYRWEGVSWWXLIRIGO.RPITVSW]XLIRIVZIIRPEVKIWERHEǻVQVSH
like structure may be seen and felt under the skin. There is usually no obvious loss
SJ JYRGXMSR 8LI IRPEVKIQIRX SJ XLMW RIVZI MW EPQSWX GSRǻVQEXMSR SJ XLI TVIWIRGI SJ
leprosy.

d. Ulnar nerve

The nerve runs in the olecranon groove in the medial aspect of the elbow joint. When
HEQEKIH MX PIEHW XS HV]RIWW MR XLI L]TSXLIREV IQMRIRGI XLI ǻJXL ǻRKIV ERH XLI
QIHMEPEWTIGXSJXLIJSVXL VMRKǻRKIVMXEPWSPIEHWXSPSWWSJWIRWEXMSRMRXLIWEQIEVIE
There is also wasting of the hypothenar eminence and clawing of the fourth and the
ǻJXLǻRKIVW8LIYPREVRIVZIEPWSWYTTPMIWXLIMRXVMRWMGQYWGPIWSJXLILERH8LIVIJSVI
damage results in ridging of the hand due to muscle wasting.

{±ĮŤ±ƒĞŇĻƐŇüƐƣĮĻ±ŹƐĻåŹƽå

e. Median Nerve

8LMW RIVZI VYRW HIIT YRHIV XLI ǼI\SV VIXMREGYPYQ WLIEXL MR XLI [VMWX ERH XLIVIJSVI
HMǽGYPXXSTEPTEXI;LIRMRǼEQIHMXMWTSWWMFPIXSIPMGMXXIRHIVRIWW[LIRSRITVIWWIW
over the anterior aspect of the wrist joint. Damage of the median nerve manifests as
dryness, cracking and loss of sensation in the thenar eminence, the thumb, the 2nd, 3rd

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 and the lateral aspect of the 4thǻRKIV8LIVIMWEPWS[EWXMRKSJXLIXLIREVIQMRIRGIERH
ridging of the dorsum of hand as seen in ulnar nerve damage. Wasting of the thenar
eminence leads to loss abduction resulting in ape thumb and clawing of the thumb 2nd
and 3rdǻRKIVW

f. Radial Cutaneous Nerve

8LIVIMWRSSFZMSYWPSWWSJJYRGXMSRFYXXLIRIVZIMWYWIJYPMRGSRǻVQMRKXLIHMEKRSWMW
of leprosy when enlarged. This nerve can be palpated on the lateral aspect of the distal
end of the radius proximal to the wrist.

g. Common Peroneal Nerve (lateral popliteal)

8LIGSQQSRTIVSRIEPRIVZIGERFIJIPXNYWXFIPS[XLILIEHSJǻFYPEFIPS[XLI
ORIIEVMWMRKJVSQXLITSTPMXIEPJSWWE8LMWRIVZIMWVIWTSRWMFPIJSVHSVWMǼI\MSRERH
IZIVWMSRSJXLIJSSX;LIRHEQEKIHMXPIEHWXSTPERXEVǼI\MSRERHMRZIVWMSRSJXLI
foot (foot drop). Observe the patients for evidence of foot drop while walking.

h. Posterior Tibia Nerve

Posterior tibia nerve is palpated below the medial malleolus. It is responsible for
autonomic sensory and motor functions of the foot. Damage leads to dryness and cracks
in the sole of the foot, loss of sensation wasting of the sole foot pad leading to the loss
SJXLIJSSXEVGL ǼEXJSSXVIWYPXMRKMRTPERXEVYPGIVW QIGLERMGEPYPGIVW

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 1EFSVEXSV])MEKRSWMWSJ1ITVSW]
The diagnosis of leprosy is mainly clinical, however Leprosy can also be diagnosed in
the lab (not a mandatory test), where in doubt.

These following diagnostic methods are used in leprosy diagnosis:

1. Bacteriological
2. Histological
3. Molecular methods

1. Bacteriological

±ũƐ „ĮЃƐžīĞĻƐžķå±Źž

Smears can be taken from any area of the body that manifest leprosy like a patch a
RSHYPIEVIESJEREIWXLIWMESVMRǻPXVEXMSR.RTVEGXMGIWQIEVWEVIGSQQSRP]XEOIRJVSQ
ear lobes, one elbow, and a contralateral knee.

Slit skin smear Procedure is as follows:

NB-ƐƣžåƐďĮŇƽåžƐ±ĻÚƐåĻžƣŹåƐ±žåŤƒĞÏƐŤŹŇÏåÚƣŹåũ

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 b. c±ž±ĮƐžƾ±Æž

A special forceps is inserted into the nose to open it up and cotton swab used to scrap
materials from the nasal wall. The smears are then prepared on a microscope slide for
WXEMRMRK8LMWMWRSXVIGSQQIRHIHHYIXSXLITVIWIRGISJRSVQEPQ]GSFEGXIVMEPǼSVEMR
the nose.

2. Histology

Skin or nerve biopsies can be taken for histological examination using various histological
techniques like, ZN, FITES, etc.

 2SPIGYPEVXIGLRMUYIW

Molecular techniques can be used to detect genetic materials of M.leprae for example
PCR.

)MǺIVIRXMEP)MEKRSWMW

)MǺIVIRXMEP)MEKRSWMWVIPEXIHXSXLIWOMR

Some of the skin manifestations that may be confused with leprosy include; hypo pigmented
non-raised (macules) and raised lesion (plaques).
ƽNon-raised Hypo Pigmented Lesions (Macules)

1. Birthmarks (Nevus ;IPPHIǻRIH[LMXITEXGLIWXLEXEVITIVWMWXIRXJVSQFMVXLERH

Achromicus) increase in size with growth of the body. Hairs on the patches are also
depigmented.
ƞũƐšĞƒĞĮĞďŇƐŇŹƐ While in true leprosy there is only a partial loss of pigment of the skin, in
Leucoderma this condition, there is a total loss of pigment (skin is white), although in
the early stages of leukoderma, the patches are hypo pigmented and
GERFIGSRJYWIH[MXLMRHIXIVQMREXIPITVSW]8LIVIMWRSWIRWSV]HIǻGMX
in the patches.
ƗũƐ‰ĞĻå±ƐšåŹžĞÏŇĮŇŹ The neck and trunk are the prime sites. Generally, the lesions are
multiple and have no loss of sensation. Fungi can be seen under the
microscope.
4. Pityriasis Rosea Lessons manifest as small oval patches on the trunk. The scaly lesions
can be confused with leprosy but there is no loss of sensation.
ƽ Raised Hypo pigmented Lesions: (Papules / Plaques/ Nodules)
1. Seborrheic The lesions are yellow in colour and show coarse parakeratosis scaly
Dermatitis lesions which are common on the chest and back and they may coalesce
into larger polycyclic patches healing in the centre. Itching is usually mild.

2. Tinea Corporis These lesions, generally known as “Ringworm”, are usually present in the
groin and waist area. Unlike a leprosy patch, they are always itchy and
fungal elements can be seen under the microscope. There is no loss of
sensation.

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3. Psoriasis Silvery white patches of psoriasis have no sensory loss.

4. Kaposi’s sarcoma Kaposi’s sarcoma lesions are often found on the foot or leg. The lesions
are shiny, violaceous and nodular. Sensation is preserved.

5. Multiple Characterized by growth of non-cancerous tumours in the nervous

cåƣŹŇĀÆŹŇķ±ƒŇžĞž system. The commonest tumours are acoustic neuromas. The most
Common signs include hearing loss, ringing in the ears (tinnitus) and
problems with balancing. Some people may develop cataracts.
6. Diabetic ulcers This can often be confused with ulcers following neglected leprosy

)MǺIVIRXMEP)MEKRSWIWVIPEXMRKXSRIVZIW
ŐũƐšĞƒ±ķĞĻƐƐÚåĀÏĞåĻÏDž This may be seen in undernourished children and alcoholics. Loss of
sensation in the lower limbs can sometimes be experienced by those
WYǺIVMRKJVSQ:MXEQMR'VIWYPXMRKMRPIWMSRWMRXLITSWXIVMSVGSPYQRSJ
the spinal cord.

2. Toxic Neuritis Patients working in paint factories or other heavy metal industries
dealing with lead, arsenic etc. may develop a leprosy-like anaesthesia
and paralysis. Careful recording of case histories is essential.

3.Syphilitic Neuritis 8LMWMWERSXLIVHMWIEWIEǺIGXMRKXLITSWXIVMSVGSPYQRSJXLIWTMREPGSVH

resulting in lesions that lead to sensory loss. A careful case history needs
to be taken a V.D.R.L. test made.

4.Traumatic Neuritis A careful recording of case history may reveal physical injury to the nerve,
perhaps through an accident.

5.Diabetes Mellitus Many patients with ulcerated feet have been wrongly diagnosed as
having leprosy because peripheral neuritis in diabetes can result in loss
of sensation, particularly in the lower extremities which often produces
trophic or plantar ulcers. A careful physical examination will reveal
glycosuria and hyperglycaemia.
6.Bell’s Palsy This condition results from Facial Nerve involvement causing facial
paralysis and lagophthalmos.

14.9 Immunology of Leprosy

Not all leprosy infections result into development of leprosy disease. The occurrence is
dependent on one’s immunity. There are two types of immunity;

1. Humoral Immunity” or Antibody Mediated Immunity and

2. Cell-Mediated Immunity” (CMI).

Humoral immunity

In humoral Immunity, certain chemicals (antibodies) are generated by the body when it
MWMRZEHIHF]ERXMKIRW.RGIVXEMRX]TIWSJMRJIGXMSRERXMFSHMIWEVIIǺIGXMZIMRGPIERWMRK
the system of the toxins liberated by the invading organism. However, while humoral
.QQYRMX]MWZIV]IǺIGXMZIMRǻKLXMRKQER]JSVQWSJMRJIGXMSRMXLEWPMXXPIIǺIGXEKEMRWX

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 2PITVEI ERH GER MR JEGX  GEYWI QYGL WYǺIVMRK XLVSYKL QIHMEXMSR SJ X]TI  PITVSW]
reaction.

Cell-Mediated Immunity (CMI)

Some of the invading foreign bodies and their antigens stimulate the production of
GIVXEMRWTIGMEPHIJIRGIGIPPWEXXLIWEQIXMQIIWXEFPMWLMRKERMRǼEQQEXSV]VIEGXMSR
Cell-mediated immunity is essential for the body’s defences against such diseases
as tuberculosis, and leprosy. Where the antigens accumulate, immune cells mainly
lymphocytes collect at the site. In the case of leprosy, these are mainly the peripheral
GSSPIVRIVZIWERHQSVITEVXMGYPEVP]XLIRIVZIƶWGL[ERRGIPP1ITVEILEWEREǽRMX]
for the cooler areas of the body and this characteristic has a bearing on the types of
deformities that result from the invasion of M.leprae.

The smaller lymphocytes have no phagocytic property therefore cannot ingest/digest

the M. leprae, like the macrophages. The role of the lymphocytes is to secrete certain
chemicals which attract the larger macrophages to the site of antigen build-up and
assist the macrophages to engulf and digest the M.leprae. Cell-Mediated-Immunity
(CMI) is the protective immunity that the body needs against leprosy. Majority of humans
have this type of immunity however to varying degrees.

At one end of the “Immunological Spectrum” leprosy patients with a well-established

CMI have the form of the disease known as “Tuberculoid” leprosy, but they may have
little Humoral immunity. At the other end of the Immunological Spectrum, Lepromatous
leprosy is a complete opposite with a well-established Humoral Immunity but no CMI.
The latter is the infectious form of leprosy, the multi bacillary leprosy.

.QQYRSPSKMGEPWTIGXVYQERHGPEWWMǻGEXMSRSJPITVSW]
Although immunity, in most cases, helps the body’s defence against the invasion of
bacteria and their antigens, there are occasions when the body reacts violently to the M.
leprae antigens. This is called the “Leprae Reaction”. Reactions in leprosy are of several
types: “Type 1” and “Type 2”

Immunological Response and Deformity

Although tuberculoid leprosy patients, with strong CMI, may have few bacilli in their
FSHMIW XLEX XLI] GERRSX FI HIXIGXIH F] SVHMREV] QMGVSWGST] XLI] QE] WYǺIV WIZIVI
nerve damage due to the massive lymphocytic response, causing the nerves to swell 5
or more times the normal size.

On the other hand, Lepromatous, infectious patients, whose bodies may be teeming
[MXLQMPPMSRWSJ2PITVEIQE]WYǺIVVIPEXMZIP]PMXXPIRIVZIHEQEKI MRXLIIEVP]WXEKIW
because the lack of CMI means that there is no strong build-up of defence cells around
the nerves. Leprosy is a very enigmatic disease. Although it can look to be a highly
contagious disease, in actual fact, of all the communicable diseases, Leprosy (the
tuberculoid type) is the least contagious.

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(PEWWMǻGEXMSRSJ1ITVSW]
8LIVIEVIX[SQEMRGPEWWMǻGEXMSRWSJPITVSW]HMWIEWIFEWIHSRX[SGVMXIVME

1. The number of lesions as recommended by WHO

.QQYRSPSKMGEPERHGPMRMGEPJIEXYVIWEWTIVXLI7MHPI]/STPMRGPEWWMǻGEXMSR

;-4GPEWWMǻIWPITVSW]MRXSX[SKVSYTWJSVITMHIQMSPSKMGEPERHXVIEXQIRXVIEWSRW

Pauci-bacillary leprosy:

- Patients with 1 to 5 hypo pigmented patches

- Skin smears negative

Multibacillary leprosy (MB)

- Have more than 6 patches Skin smear often positive

- Patients with MB leprosy may present with plaques, macules, papules and or
RSHYPIW[MXLWOMRMRǻPXVEXMSR5EXMIRXW[MXLRIYVEPPITVSW]EVIGPEWWMǻIHERHXVIEXIH
as MB leprosy

8EFPI)MǺIVIRGIWFIX[IIR5'ERH2'1ITVSW]

c 5EYGMFEGMPPEV]c 5' 2YPXMFEGMPPEV]c 2'

Previously called ‰ƣÆåŹÏƣĮŇĞÚƭXåŤŹŇžDž XåŤŹŇķ±ƒŇƣžƭXåŤŹŇžDž
Severity Mild Can be extreme

(Without treatment, the patient will

die)
Unique Signs and MKRMǻGERXP]QMPHIV[MXLWOMR 1MSRPMOIJEGIHYIXSMRǼEQQEXMSR
Symptoms lesions and peripheral nerve (PISRMRIcJEGMIW), as well as nasal
enlargement as the only usual GEVXMPEKIHEQEKIGEYWMRKcsaddle-
signs, possibility of spontaneous nose deformitycFPMRHRIWWcdue
recovery to scarring of the eye can
VIWYPXcinfertilitycQE]VIWYPXMRQIR
Distribution of lesions Asymmetrical Symmetrical

c
Occurs When .RJIGXIHTIVWSRMWcablecXSQSYRX .RJIGXIHTIVWSRcunablecXSQSYRX
a robust, cell-mediated immune a cell-mediated immune response
response to the bacterium to the bacterium
)IǻRIHF];SVPH 1-5 patches associated with >5 patches associated with leprosy
Health Organization as leprosy
Is the person Infectious? No Possibly; bacterium is found in
high concentrations in respiratory
secretions and organs, but it is not
clear how it is spread to another
person

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 Prospects for Recovery Good Cure from disease possible,
however, underlying disease
complications (such as limb
damage due to infection) may
not be reversible or require
reconstructive surgery

)MWEFMPMX],VEHMRK
Leprosy is graded by assessing the feet, hands and the eyes as follows;

14.11.1 Hands and feet

Grade 0: no anaesthesia, no visible deformity or damage.

Grade 1: anaesthesia present, but no visible deformity or damage.

Grade 2: visible deformity or damage present.

14.11.2 The eye

Grade 0: No eye problem due to leprosy; no evidence of visual loss.

Grade 1: *]I TVSFPIQW HYI XS PITVSW] TVIWIRX FYX ZMWMSR RSX WIZIVIP] EǺIGXIH EW E
VIWYPXSJXLIWI ZMWMSRSVFIXXIV GERGSYRXǻRKIVWEXQ

Grade 2:IZIVIZMWYEPMQTEMVQIRX ZMWMSR[SVWIXLER MREFMPMX]XSGSYRXǻRKIVWEX

6 m) also includes lagophthalmos, iridocyclitis and corneal opacities.

14.12 Leprosy Management

14.12.1 Chemotherapy
8LIVI EVI  ǻVWX PMRI HVYKW YWIH MR PITVSW] QEREKIQIRX  7MJEQTMGMR (PSJE^MQMRI ERH
Dapsone.

Figure 14.12.1 (2018 WHO Leprosy Treatment Guidelines.)

Duration
Age Group Drug Dosage and frequency
MB PB
Rifampicin 600 mg Once a month
300 mg once a month and 50
Adult 12 months 6 months
Clofazimine mg daily
Dapsone 100 mg daily
Rifampicin 450 mg Once a month
Children 150 mg once a month, 50 mg
12 months 6 months
(10-14 years) Clofazimine on alternate days
Dapsone 50 mg daily

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 Rifampicin 10 mg/kg once a month
Children <10
100 mg once a month, 50 mg
years old or 12 months 6 months
Clofazimine twice weekly
<40 kg
Dapsone 2 mg/kg daily

Note; ‰ĚåƐƒŹå±ƒķåĻƒƐüŇŹƐÏĚĞĮÚŹåĻƐƾЃĚƐÆŇÚDžƐƾåĞďĚƒƐÆåĮŇƾƐċǑƐīďƐŹåŭƣĞŹåžƐžĞĻďĮåƐüŇŹķƣĮ±ƒĞŇĻƐ
ķåÚĞϱƒĞŇĻƐžĞĻÏåƐĻŇƐa%‰ƐÏŇķÆĞĻ±ƒĞŇĻƐÆĮĞžƒåŹƐŤ±ÏīžƐ±ŹåƐ±ƽ±ĞĮ±ÆĮåƐüŇŹƐÏĚĞĮÚŹåĻƐÆåƒƾååĻƐƞǑƐ±ĻÚƐ
ċǑƐīďØƐFƒƐƾŇƣĮÚƐÆåƐŤŇžžĞÆĮåƐƒŇƐüŇĮĮŇƾƐƒĚåƐĞĻžƒŹƣσĞŇĻžƐŇüƐƒĚåƐŇŤåŹ±ƒĞŇĻ±ĮƐķ±Ļƣ±ĮØƐ:ĮŇƱĮƐĮåŤŹŇžDžƐ
žƒŹ±ƒåďDžƐƞǑŐƌĝƞǑƞǑƐŇĻƐĚŇƾƐƒŇƐŤ±ŹƒĮDžƐƣžåƐŦaĝÏĚĞĮÚŧƐÆĮĞžƒåŹƐŤ±ÏīžƐüŇŹƐƒŹå±ƒķåĻƒƐŦƌǑŧ

(SQQSR)VYKMHI*ǺIGXWERH2EREKIQIRX
1. Dapsone

ƽ „ĮĞďĚƒĞĻďƐЃÏĚĞĻďƐŦ%±ŤžŇĻåƐžDžĻÚŹŇķåŧ

Reassure patients and treat symptomatically with an antihistamine.

ƽ
Ļ±åķб

Investigate for other causes of anaemia, and manage appropriately/ refer to a medical
SǽGIVSV8'1ITVSW]GSSVHMREXSVJSVJYVXLIVQEREKIQIRX

ƽ )DŽüŇĮбƒĞƽåƐÚåŹķ±ƒĞƒĞž

8LIWOMRMWMXGL]ERHPEXIVTIIPWSǺ8LITEXMIRXMWYWYEPP]ZIV]MPPXSTHVYKWMQQIHMEXIP]
ERHVIJIVXLITEXMIRXXSEQIHMGEPSǽGIVSV(81(SVRIEVIWXLSWTMXEP

ƽ 8ĞDŽåÚƐÚŹƣďƐŹå±ÏƒĞŇĻ

Stop drugs, the eruption will slowly clear after stopping.

2. Clofazimine (Laprene)

ƽ :±žƒŹŇĞĻƒåžƒĞĻ±ĮƐÚĞžƒƣŹÆ±ĻÏåžƐĻ±ƣžå±ØƐƽŇķЃĞĻďØƐ±ÆÚŇķĞĻ±ĮƐŤ±ĞĻžũƐGive drugs after

a meal.

ƽ åÚƐžīĞĻxåDžåž

8LITEXMIRXLEWRSGSQTPEMRXWEXEPPETEVXJVSQXLIGSWQIXMGIǺIGX8LMWMWELEVQPIWW
condition, reassure the patient and continue treatment

ƽ BDžŤåŹŤĞďķåĻƒ±ƒĞŇĻxÚ±ŹīåĻĞĻďƐŇüƐƒĚåƐžīĞĻ

3. Rifampicin

ÎƐ åÚƐƣŹĞĻå
Harmless, no action needed. Reassure the patient and continue treatment.

ÎƐ „DžķŤƒŇķžƐ±žƐüŇŹƐžåƽåŹåƐāƣ
Treat symptomatically and reduce the dosage to half until the symptoms have
disappeared

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 ƽ I±ƣĻÚĞÏå
XSTEPPHVYKWMQQIHMEXIP]ERHVIJIVTEXMIRXXSEQIHMGEPSǽGIVSV(81(

ƽ
Ļ±åķб
.RZIWXMKEXIJSVSXLIVGEYWIWSJEREIQMEQEREKIETTVSTVMEXIP]VIJIVXSQIHMGEPSǽGIV
or SCTLC for further management.

14.13 How to Conduct a Voluntary Muscle Testing and

Sensitisation Test (VMT/ST)
14.13.1 Sensation in hands and feet
Check the sensation in the palms of the hands and the soles of the feet, using a ballpoint
pen:

ƽ *\TPEMRXLIXIWXXSXLITEXMIRX

ƽ &WOXLIQXSGPSWISVGSZIVXLIMVI]IW

ƽ 8SYGLXLIWOMRZIV]PMKLXP][MXLXLIFEPPTSMRX

ƽ &WOXLITEXMIRXXSTSMRXXSXLITPEGI]SYXSYGLIH

ƽ 8IWXEQMRMQYQSJJSYVTSMRXWSRIEGLLERHERHJSSX

ƽ 3SXIER]EVIEW[LIVIXLITIRMWRSXJIPX

NB:.RXLITEPQSJXLILERHXLIWMHI[MXLXLIPMXXPIǻRKIVMWWYTTPMIHF]XLIYPREVRIVZI8LI
TEVX[MXLXLIXLYQFMRHI\ERHQMHHPIǻRKIVWMWWYTTPMIHF]XLIQIHMERRIVZI8LIWSPISJXLI
foot is supplied by the posterior tibial nerve.

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14.13.2 Check for Muscle Weakness
Examination of hands and feet for muscle weakness

1. Thumb up (tests the median nerve)

ƽ &WOXLITIVWSRXSTYXSYXXLIMVLERHTEPQYT
ƽ YTTSVXXLIMVLERHMR]SYVLERH
ƽ &WOXLIQXSTSMRXXLIXLYQFXS[EVHWXLIMVS[RRSWI
ƽ 8IWXXLIWXVIRKXLSJXLIXLYQFXSWXE]MRXLEXTSWMXMSR

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 2. Wrist back’ test of radial nerve function

'IPS[ ǻKYVI WLS[W XLI XIWX JSV VEHMEP RIVZI JYRGXMSR &KEMR ]SY EVI XIWXMRK JSV LS[
much resistance there is to pressure you apply, this time to the individual’s raised hand,
while you support the wrist.

ƗũƐXЃƒĮåƐĀĻďåŹƐŇƣƒƐŦƒåžƒžƐƒĚåƐƣĮĻ±ŹƐĻåŹƽåŧ
ƽ&WOXLITIVWSRXSTYXSYXXLIMVLERHTEPQYT
ƽYTTSVXXLIMVLERHMR]SYVLERH
ƽ&WOXLIQXSQSZIXLIPMXXPIǻRKIVSYX
ƽ8IWXXLIWXVIRKXLSJXLIPMXXPIǻRKIVXSWXE]MRXLEXTSWMXMSR

4. Foot up’ test of peroneal nerve function

The movement of the foot is due to muscles activated by the peroneal nerve and the
test for muscle power in this case is shown below. You apply pressure to the top of the
raised foot by trying to push it down. Can the person still lift up the foot against your
pressure?

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By testing the strength of the voluntary muscles (which means the muscles we can
QSZIEX[MPPIKMRSYVEVQWERHPIKW]SYGERǻRHSYXMJXLITIVWSRƶWRIVZIJYRGXMSR
MWRSVQEPSVLEWFIIR[IEOIRIHSVTEVEP]^IHF]PITVSW]8LIǻRHMRKWEVIVIGSVHIHEW
follows:

ƽ {±Ź±ĮDžǍåÚƐ(P): the muscle has lost all strength and cannot produce any movement;

ƽ Weak (W): there is some movement, but muscle strength is reduced;

ƽ „ƒŹŇĻď (S): the muscle strength is normal.

14.14 Management of Leprosy Complications

14.14.1 Leprosy Reactions
This results from an exaggerated immune response to body tissues due to the invasion
by M. leprae1ITVSW]VIEGXMSRWEVIGPEWWMǻIHMRXSX[SGEXIKSVMIW

ƽ 8]TIPITVSW]VIEGXMSR

ƽ 8]TIPITVSW]VIEGXMSR

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 Figure 14.14.1: Management of Leprosy reactions

Type Category Occurrence Management

Type 1 reactions Mild type 1 On skin only; there Baseline VMT/ST-(explain how
reactions, QE]cFIQMPHJIZIV to do this), paracetamol 2 tablets
and slight swelling TDS for 1 week and review after 1 If
IHIQESJXLIcPMQFW there is deterioration to moderate
or severe, treat as recommended
Moderate type 1 c&RYQFIVSJWOMRc Paracetamol, 2 tabs TDS for 2
reactions patches are involved, weeks and Chloroquine 2 TDS for 2
some of the nerves [IIOW(PMRMGEPVIZMI[XLIcTEXMIRX
are enlarged and do VMT/ST. If there is deterioration
XIRHIVFYXcRS to severe, treat as recommended
evidence of loss of
function.
Severe type 1 2SWXcSJEPPXLIcWOMR Admit and start long course
reactions TEXGLIWEVIEǺIGXIH Prednisolone, do 2 weekly VMT/
A number of nerves ST as you monitor.Start with 40mg
are enlarged, tender, OD for 2 weeks,30mg OD for 2
[MXLIZMHIRGISJPSWWc weeks,20mg OD for 6 weeks
of nerve function
Type 2 reaction Mild type 2 5EXMIRXLEWcXVERWMIRX 8VIEXEWcSYXTEXMIRX[MXLc
reactions ENL nodules; there is TEVEGIXEQSPKQcLSYVP]JSV
no nerve or systemic HE]WcVIZMI[ERHEGXETTVSTVMEXIP]
involvement.
Moderate type 2 Have generalized Treat with paracetamol at 1
reactions ENL with mild fever. KQcLSYVP]JSV[IIOWEWER
outpatient, review every week and
EGXcETTVSTVMEXIP]
Severe type 2 generalized ENL, high Put patient on short course
reactions fever (30-40oc) and TVIHRMWSPSRIXEVXcEXQK4)JSV
systemic involvement 3 days then, 40mg OD for 3 days
of organs. then, 30mg OD for 3 days then, 20
QKc4)JSVHE]WXLIRQKc4)
JSVHE]WXLIRQKc4)JSV
HE]WXLIRQKc4)JSVHE]W
Chronic c 8VIEXQIRXcVIUYMVIWVIMRMXMEXMRKXLIc
(recurrent) type 2 WLSVXGSYVWIWXIVSMHWXSKIXLIVc[MXL
reactions Clofazimine at a dose of 100mg
8hourly for 1 month then 100mg
BD for a month then 100mg OD
for 1 month. Thalidomide may be
given instead of Clofazimine for a
duration of 4 months

Note for severe type 1 reaction; FüƐƒĚåŹåƐĞžƐĻŇƐŹåžŤŇĻžåƐŇŹƐĻŇƐÏ̱ĻďåžƐĞĻƐƒĚåƐša‰x„‰ũƐ‰ĚåƐ

ƒŹå±ƒķåĻƒƐ̱žƐƐü±ĞĮåÚØƐœå±ĻƐƒĚåƐƐŤ±ƒĞåĻƒƐŇýƐ{ŹåÚĻĞžŇĮŇĻåƐÆDžƐŹåÚƣÏĞĻďƐƒŇƐŐĂķďƐƐk%ƐüŇŹƐƞƐƾååīžØƐ
ŐǑķďƐƐk%ƐüŇŹƐƞƐƾååīžƐ±ĻÚƐĂķďƐk%ƐüŇŹƐƞƐƾååīžØƐ
žžåžžƐüŇŹƐŹåÏŇĻžƒŹƣσĞƽåƐžƣŹďåŹDžØƐŹå̱ÆĞĮЃ±ƒĞŇĻƐ
±ĻÚƐĚå±ĮƒĚƐåÚƣϱƒĞŇĻƐŇĻƐƒĚåƐƐϱŹåƐŇüƐƒĚåƐƐåDžåžØƐ̱ĻÚžƐ±ĻÚƐüååƒØƐ
ƒƐƞǑķďƐk%ƐƌƐƐƾååīžØƐ±ĻÚƐ±üƒåŹƐƌƐƐ
ƾååīžƐŇüƐƐŤŹåÚĻĞžŇĮŇĻåØƐša‰x„‰ƐƐžƒĞĮĮƐžĚŇƾžƐĞķŤŹŇƽåķåĻƒƐĞĻƐĻåŹƽåƐüƣĻσĞŇĻØƐŇĻƒĞĻƣåƐƾЃĚƐƐƞǑķďƐ
{ŹåÚĻĞžŇĮŇĻåƐÚ±ĞĮDžƐƐ±ĻÚƐƞƐƾååīĮDžƐša‰x„‰ƐƐƣĻƒĞĮƐƐDžŇƣƐƐďåƒƐƐƗƐŹå±ÚĞĻďžƐŇüƐša‰x„‰ƐƒĚ±ƒƐƐ±ŹåƐžĞķĞĮ±ŹØƐ
åÚƣÏåƐ{ŹåÚĻĞžŇĮŇĻåƐƒŇƐŐĂķďƐƐk%ƐüŇŹƐƞƐƾååīžØƐŐǑķďƐƐk%ƐüŇŹƐƞƐƾååīžƐ±ĻÚƐĂķďƐk%ƐüŇŹƐƞƐƾååīžũ

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)MǺIVIRXMEPHMEKRSWMWSJPITVSW]VIEGXMSR
ƽ %ŹƣďƐŹå±ÏƒĞŇĻž:

Not common; usually accompanied by itching, which is not a typical feature of leprosy
reactions

ƽ kƒĚåŹƐϱƣžåžƐŇüƐĞĻā±ķķ±ƒĞŇĻ×

 MKRW SR XLI WOMR RSX GSVVIWTSRH [MXL PITVSW] TEXGLIW QSWXP] ǼEX PIWMSRW [MXL
hyperpigmentation.

ƽ XŇϱĮƐžåŤžĞž×

Will generally be localized to just one part of the body and the cause may be obvious
e.g. wound or insect bite.

14.14.3. Factors predisposing to leprosy reaction

1.
ĻƒƐĮåŤŹŇžDžƐƒŹå±ƒķåĻƒ: improved immunity & Ag-Ab complexes.

2. FĻƒåŹƐÏƣŹŹåĻƒƐĞĻüåσĞŇĻ× disrupt immunological balance between bacilli and host.

ƗũƐ{ĚDžžĞŇĮŇďĞϱĮƐü±ÏƒŇŹž×

- Stressful conditions due to stigma.

- Pregnancy.

- Puberty in males due to hormonal changes.

14.15 The Eye in Leprosy

8LII]IMWEǺIGXIHMRPITVSW]MRQEMR[E]W

1. Direct bacillary invasion

2. Leprosy reactions.

Direct bacillary invasion leads to a leproma, and exposure keratitis. Bacillary invasion of
the cornea, leads to vascularization of the cornea resulting in opacities and blindness.

14.15.1 Examining the eyes and eyelids

Testing for corneal sensation

Cornea is very sensitive to being touched in a healthy person, who will blink if something
touches it. Corneal sensitivity is lost in a person with leprosy. Observe the person’s blink
when talking to him/her. If the blink is normal, corneal sensation will be normal and
there is no need for the test. If there is no blink, the eye is at risk.

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 14.15.2 Management: initiation of MDT
ƽ 8]TIVIEGXMSRMRXLII]I

Type 1 reactions: facial nerve damage leads to inability to close the eye (lagophthalmos).

This results in exposure keratitis which leads to opacities & blindness. It exposes the eye
MRNYVMIWF]JSVIMKRSFNIGXWMRJIGXMSRWǻFVSWMWERHFPMRHRIWW

If the eyes are not active the muscle of orbicularis oculi atrophy leading to Entropion

)EQEKIXSXLIXVMKIQMREPRIVZIMWEWWSGMEXIH[MXLPSWWSJFPMROVIǼI\PIEHMRKXSI\TSWYVI
keratitis and blindness as discussed above.

There is also loss of corneal sensation which leads to unnoticed injury of the cornea and
secondary bacterial infection and ultimately blindness.

)ITSWMXMSR SJ &K&F GSQTPI\IW MRXS XLI GMPMEV] FSH] PIEHW XS EGYXI MRǼEQQEXMSR
(Iridocyclitis).

Iridocyclitis leads to increased intraocular pressure (Glaucoma) which can lead to

damage of the retina and blindness.

Glaucoma comes as result of anterior and posterior synechiae.

Signs and symptoms of Iridocyclitis

1. Perilimbal redness of the cornea

2. Pain in the eye

3. Blurred vision

4. Photophobia

5. Constricted pupil with poor reaction to light

6. In recurrent attacks of type 2 reaction the patient may develop premature

cataract.

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Management of Iridocyclitis

ƽ .VMHSG]GPMXMW.RMXMEPGEVI.RWXMPEXVSTMRII]IHVSTWMRXSXLII]I5EHXLII]I7IJIV
a patient for admission and further management.

ƽ FĻŤ±ƒĞåĻƒƐ ϱŹå: A patient should receive an ophthalmologist review where

available.

ƽ &XVSTMRI WYPTLEXI HVSTW VIPE\IW XLI MVMW QYWGPI QEOMRK XLIQ WLSVXIV XLYW
reducing the risk of attachment.

14.16 Foot Care in Leprosy

ƽ 7IKYPEVGLIGOYTSJWIRWEXMSRSJXLIJSSX
ƽ 7IKYPEVWSEOMRKSJXLIJSSXERHETTP]MRKTIXVSPIYQNIPP]SRXLIJSSX
ƽ YVKMGEPP]VIQSZIER]HIEHXMWWYIWJVSQXLI[SYRH
ƽ &ZSMH[EPOMRKFEVIJSSXIH
ƽ 9WISJ2(7WERHEPWXLMWJSSX[IEVLEWEXSYKLSYXIVWSPIWLSYPHRSXVYFEKEMRWX
toes. Where unavailable advise them to get appropriate footwear which has an
outer sole of 15-18mm thick and soft inner sole 18-22mm.
ƽ 9WIRSVQEPǻXXMRKWLSIW
ƽ *RGSYVEKIFIHVIWXERHIPIZEXIJSSXMRXLIEGYXITLEWI
ƽ 7IQSZIWPSYKLSVSXLIVHVEMRMRKTVSGIHYVIW

14.16.1 Causes of deformities in leprosy include:

ƽ M. leprae invasion: poor impulse transmission
ƽ 1SWWSJWIRWEXMSRYRRSXMGIHMRNYVMIW
ƽ )V]RIWWGVEGOMRK[SYRHWERHMRJIGXMSR
ƽ 5EVEP]WMW[EWXMRKHMWYWITSSVTSWXYVISVMQTVSTIVLERHPMRKSJSFNIGXW
ƽ 2IGLERMGEPMRNYVMIWJVSQ[SVOMRKXSSPW[VSRKJSSX[IEVERHKIRIVEPMRNYVMIW

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 (SQQSR)IJSVQMXMIW )MWEFMPMXMIW
1. Madarosis- loss of eyebrows and eyelashes

2. Lagophthalmus- leads to inability to close and open the eye voluntarily.

3. Collapsed nose (saddle nose)- leads to poor breathing in and out

4. Wrist drop – inability to extend the wrist

5. Ape thumb- leads to no thumb opposition and abduction

(PE[LERHƳMREFMPMX]XSǼI\XLITVS\MQEPQIXEGEVTSTLEPERKIEPNSMRXSJXLIth
and 5th ǻRKIVW ERH MREFMPMX] XS I\XIRH XLI HMWXEP QIXEGEVTSTLEPERKIEP NSMRXW SJ
XLIWIǻRKIVW

 +SSXHVSTƳMREFMPMX]XSHSVWMǼI\MSRERHIZIVXXLIJSSX

8. Claw toes – leads to injuries to the metatarsal heads and toes

9. Plantar ulcers.

14.18 Health Education to Patients on Leprosy

1. To take the drugs after a meal or in the evening just before going to bed if he feels
nausea after ingesting them

8SMRJSVQXLIWXEǺEXXLIGPMRMGMJXLI]MRXIRHXSXVEZIPSVQSZIXSERSXLIVEVIE

3. Tablets given are to be taken daily at the same time.

4. Drugs to be collected from the clinic every four weeks

5. Leprosy reactions can still develop after M.D.T. the reaction should not be treated
with a new course of MDT but other drugs will be used to treat them

6. Skin discoloration due to clofazimine

7. Urine discoloration due to rifampicin

8. When to report to the clinic as soon as he notices; -

ƽ YHHIR[IEORIWWSJQYWGPIW

ƽ 4RISVFSXLSJLMWI]IWEVIVIHERHTEMRJYP

ƽ 5EMRMRSRISJLMWPMQFW

ƽ 8LIETTIEVERGISJVIHW[SPPIRXIRHIVRSHYPIWMRXLIWOMR

ƽ &RHEWWSSREWTEXGLIWLEZIWXEVXIHXSFIGSQIVIHERHW[SPPIREKEMR

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14.19 Special Cases and their Treatment
1. Treatment during pregnancy and breast-feeding

The standard MDT regimens are safe, both for the mother and the child and therefore
should be continued during pregnancy and breast-feeding.

2. Treatment for patients also infected with HIV

Patients infected with HIV usually respond equally well to leprosy treatment as those
without HIV infection.

3. Treatment for patients with Leprosy and TB

5EXMIRXWWYǺIVMRKJVSQFSXL8'ERHPITVSW]VIUYMVIWXERHEVH8'XVIEXQIRXMREHHMXMSR
to the standard MDT. Hence, skip the monthly dose of rifampicin in the leprosy MDT
regimen. Once the TB treatment is completed, the patient should continue his/her MDT.

4. Leprosy and Malnutrition

(For further information, refer to the nutrition section in main document)

ƽ )S3YXVMXMSREPEWWIWWQIRX

ƽ 2EREKIEWTIVRYXVMXMSREPMRXIVZIRXMSRW

ƽ :MXEQMR&EXXLIWXEVXERHEXGSQTPIXMSRSJPITVSW]XVIEXQIRX

ƽ 5]VMHS\MRI,MZIRXSXLSWI[MXLTIVMTLIVEPRIYVSTEXL]XLVSYKLSYXXLIXVIEXQIRX
period

ƽ ,MZIJSSHWYTTPIQIRXWMJXLI'2.MW!QEREKIEWTIVXLIRYXVMXMSRMRXIVZIRXMSR
schedule.

ƽ '2.SJ#TVSZMHIRYXVMXMSREPGSYRWIPPMRKXSXLIGPMIRX

14.20 Leprosy Relapse

A patient should be diagnosed as a “relapse” if he/she has previously completed a
full course of MDT and returns 2 years later with signs of active leprosy (of the same
GPEWWMǻGEXMSR EW XLI SVMKMREP GPEWWMǻGEXMSR VIUYMVMRK GLIQSXLIVET] 7IPETWIW EJXIV E
complete course of MDT are very rare. A patient who has MB disease after being treated
EWE5'GEWIMWEQMWGPEWWMǻGEXMSRERHLEWXSWXEVX2'XVIEXQIRX

One or more of the following signs are indications of a relapse:

ƽ &GXMZIWOMRPIWMSRWETTIEVERGISJRI[WOMRPIWMSRW.RGVIEWIHIV]XLIQE VIHRIWW

in previously existing lesions.

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 ƽ 3I[RIVZIPIWMSRWIRPEVKIQIRXERHSVXIRHIVRIWWSJSRISVQSVIRIVZIW[LMGL
were previously normal.

NB: Leprosy relapse should not be confused with leprosy reaction. In relapse PCR and
slit skin smears will be positive while in reaction they will be negative.

Figure 14.20.1: Drug resistance leprosy

Area of the Recommendation

recommendation
Treatment of drug- Leprosy patients with rifampicin resistance may be treated using at least
resistant leprosy two of the following second-line drugs: clarithromycin, minocycline or a
UYMRSPSRI SǼS\EGMRPIZSǼS\EGMRSVQS\MǼS\EGMRTPYWGPSJE^MQMRIHEMP]
for 6 months, followed by clofazimine plus one of the second-line drugs
daily for an additional 18 months.

1ITVSW]TEXMIRXW[MXLVIWMWXERGIXSFSXLVMJEQTMGMRERHSǼS\EGMRQE]
be treated with the following drugs: clarithromycin, minocycline and
clofazimine for 6 months followed by clarithromycin or minocycline plus
clofazimine for an additional 18 months.
Prevention

Chemoprophylaxis Single-dose rifampicin (SDR) may be used as leprosy preventive

for contacts of treatment for contacts of leprosy patients (adults and children aged 2
patients with leprosy years and above), after excluding leprosy and tuberculosis (TB) disease,
and in the absence of other contraindications.
This intervention shall be implemented only by programmes that can
ensure:
(i) adequate management of contacts, and
(ii) consent of the index case to disclose his/her disease.

7ILEFMPMXEXMSR
1. Physical
This involves physical exercises, sometimes in line with pre- and post-operation
management of leprosy. It also includes vocational training and fabrication of adaptive aids.

Patients are encouraged to participate in recreational activities such as reading and

indoor games.

2. Economic empowerment
- Leprosy patients are encouraged to form groups and start income generating
activities.
- Those with vocational skills are supported to establish or start trades that will
make them self-reliant.
- Link them with disability programs at the County level

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3. Spiritual
- It helps in reducing stigma

- Encourage them to join their religious bodies of their choice

4. Surgical
This involves surgical procedures to correct the deformities:

ƽ2EHEVSWMW-EMVKVEJXMRK

ƽ1EKSTLXLEPQSW8EVWSVVLETL] 8IQTSVEPMWQYWGPIXIRHSRXVERWJIV 828

ƽ3EWEPGSPPETWI5SWXREWEPMRPE]KVEJX

ƽ;VMWXHVST;VMWXEVXLVSHIWMW

ƽ&TIXLYQF4TTSRIRWTPEWX]

ƽ(PE[LERH*\XIRWSVXSǼI\SVXEMPKVEJXYFPMQMWQYWGPIXVERWJIV

ƽ+SSXHVST8MFMEPMWTSWXIVMSVQYWGPIXVERWJIV 858

ƽ5PERXEVYPGIVW8VERWQIXEXEVWEPLIEHVIWIGXMSR

ƽOMRKVEJXMRK

ƽIUYIWXVIGXSQ]

ƽ&QTYXEXMSR

ƽ4VXLSTEIHMGETTPMERGIW

ƽ +SSX[IEV RSVQEP X]VI WERHEP [MXL QMGVSGIPPYPEV VYFFIV 2(7 7IJIV TEXMIRXW
with footwear needs to the rehabilitative department.

14.21.1 Prevention of Leprosy

E(LIQSTVSTL]PE\MWJSVGPSWIGSRXEGXWMWSǺIVIHMRLMKLFYVHIRGSYRXVMIW

F '(,ZEGGMREXMSRLEWEHSGYQIRXIHERHWYFWXERXMEPIǺIGXMRTVIZIRXMRKPITVSW]
and is therefore considered as an important tool for leprosy control

c) Health education

d) Early diagnosis, Prompt and adequate treatment.

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 14.22 Leprosy Active Case Finding
8LIJSPPS[MRKMRXIVZIRXMSRGERFIYWIHXSMRGVIEWIEGXMZIGEWIǻRHMRKJSVPITVSW]

1. Training and sensitization of health care workers on leprosy diagnosis and care

2. Build the capacity of communities to suspect leprosy and refer suspected cases
through Community health volunteers hence reducing stigma.

 (SYRXMIW XS GSRHYGX TSP]WOMR GPMRMGW MR XLI EǺIGXIH GSYRXMIW XS MHIRXMJ] XLI
missing leprosy cases- invite all persons with dermatological conditions to
come for medical check up

4. Actively conduct contact tracing for all leprosy patients diagnosed.

14.22.1 The role of community and community health

volunteers in Leprosy care
1. Suspect and refer leprosy patients to the health facilities

2. 4ǺIVXVIEXQIRXWYTTSVXXSPITVSW]TEXMIRXW

3. Support the leprosy patients to be integrated in the community

4. Assist in defaulter tracing/ retrieval

5. Support the leprosy patients in rehabilitation and wound care

6. Participate in health education meetings

7. Resource mobilization

8. Mobilise the community members to attend the poly skin clinic camps

14.23 Monitoring and Evaluation

Key indicators for monitoring progress

1. (EWI RSXMǻGEXMSR VEXI 8SXEP 3YQFIV SJ PITVSW] GEWIW RSXMǻIH HMZMHIH F] XLI
population per 100,000 in a given period.

2. Proportion of leprosy cases with grade 2 Disability detected

3. Proportion of children below 15 years detected

4. Proportion of children below 15 years with grade 2 Disability detected

5. 5VSTSVXMSRSJ2'GEWIWEQSRKXLIRI[GEWIWRSXMǻIH

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Treatment outcome indicators
1. Proportion of leprosy cases released from treatment- Number of leprosy cases
who have been released from treatment divided by the total number of leprosy
initiated on treatment

2. Proportion of leprosy patients lost to follow up- Number of leprosy cases lost to
follow up divided by the total number of leprosy cases detected.

3. Proportion of leprosy patients who have died.

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334 Integrated Guideline for Tuberculosis,
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PHARMACOVIGILANCE
15

)IǻRMXMSRWSJXIVQW OBJECTIVES:

Pharmacovigilance Striving for early detection

of any adverse reactions and
The science and activities related to enhancing the interactions.
quality, safety and rational the use of medicines
thereby improving patient care and public health.  .HIRXMǻGEXMSRSJVMWOJEGXSVWERH
possible mechanisms underlying
It involves the activities related to the detection, adverse reactions.
assessment, understanding, prevention and
QEREKIQIRXSJEHZIVWIIǺIGXWSVER]SXLIVTSWWMFPI Estimation of quantitative
EWTIGXWSJFIRIǻXVMWOEREP]WMW
patient to medicine related problems. and dissemination of information
needed to improve drug
prescribing and regulation.
8EFPI5LEVQEGSZMKMPERGIHIǻRMXMSRSJXIVQW

Term )IǻRMXMSR

Adverse event Any untoward medical occurrence that may present in a TB patient while
(AE) undergoing treatment with a pharmaceutical product, but which does not
necessarily have a causal relationship with this treatment.

Adverse drug A response to medicine that is noxious and unintended, including lack of
reaction (ADR) IǽGEG]ERH[LMGLSGGYVWEXER]HSWEKIERHGEREPWSVIWYPXJVSQSZIVHSWI
misuse or abuse of a medicine.

Causality The evaluation of the likelihood that a TB medicine was the causative
assessment agent of an observed adverse reaction.

Serious adverse An AE which either leads to death or a life-threatening experience; to

event (SAE) LSWTMXEPM^EXMSRSVTVSPSRKEXMSRSJLSWTMXEPM^EXMSR XSTIVWMWXIRXSVWMKRMǻGERX
disability; or to a congenital anomaly. SAEs that do not immediately result
in one of these outcomes, but which require an intervention to prevent it
from happening are included. SAEs may require a drastic intervention, such
as termination of the drug suspected of having caused the event.

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 Term )IǻRMXMSR

AE of special AE documented to have occurred during clinical trials and for which the
interest QSRMXSVMRKTVSKVEQMWWTIGMǻGEPP]WIRWMXM^IHXSVITSVXVIKEVHPIWWSJMXW
seriousness, severity or causal relationship to the TB treatment

AE of clinical AE that is either serious (SAE) or of special interest that leads to a

WMKRMǻGERGI discontinuation or change in the treatment, or judged as otherwise
GPMRMGEPP]WMKRMǻGERXF]XLIGPMRMGMER

Signal Reported information on a possible causal relationship between an

adverse event and a TB medicine, the relationship being unknown or
incompletely documented previously or representing a new aspect of a
known association

Why Pharmacovigilance is Importance

)MǺIVIRXFVERHWSJQIHMGMRIWQE]HMǺIVMRXLI[E]XLI]EVITVSHYGIHERHXLIMRKVIHMIRXW
that are used. Once marketed, the medicines are used by patients who have many
HMǺIVIRXHMWIEWIWSVEVIYWMRKWIZIVEPSXLIVHVYKWERH[LSLEZIHMǺIVIRXHMIXW[LMGL
QE]EǺIGXXLI[E]MR[LMGLXLI]VIEGXXSEQIHMGMRI

.R SVHIV XS TVIZIRX YRRIGIWWEV] WYǺIVMRK F] TEXMIRXW ERH XS HIGVIEWI XLI ǻRERGMEP
loss sustained by the patient due to the inappropriate or unsafe use of medicines, it is
essential that a monitoring system for the safety of medicines is supported by doctors,
pharmacists, nurses and other health professionals in the country. The Pharmacy and
poison board (PPB) are committed to improving drug safety through adverse drug
reaction monitoring. Through PPB pharmacovigilance programme and national TB and
Leprosy disease program (NTLD) adverse reactions should be reported daily.

All patient or their next of kin, health care workers, including doctors, dentists, pharmacists,
nurses and other health professionals are requested to report all suspected adverse
reactions to drugs especially when the reaction is unusual, potentially serious or clinically
WMKRMǻGERX.XMWZMXEPXSVITSVXEREHZIVWIHVYKVIEGXMSRXSXLITLEVQEG]ERHTSMWSRFSEVH
Pharmacovigilance programme even if you do not have all the facts or are uncertain that
the medicine is responsible for causing the reaction

'IRIǻXWSJ5LEVQEGSZMKMPERGI
The objectives of PV are;

ƽ 8S MQTVSZI TEXMIRX GEVI  WEJIX] MR VIPEXMSR XS QIHMGMRIW  EPP QIHMGEP  TEVE
medical interventions

ƽ 8SMQTVSZITYFPMGLIEPXL WEJIX]MRVIPEXMSRXSXLIYWISJQIHMGMRIW

ƽ 8S GSRXVMFYXI XS XLI EWWIWWQIRX SJ FIRIǻX LEVQ IǺIGXMZIRIWW ERH VMWOW SJ
medicines

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 ƽ 8STVSQSXIYRHIVWXERHMRKGPMRMGEPXVEMRMRK IǺIGXMZIGSQQYRMGEXMSRXSLIEPXL
professionals & the public.

Pharmacovigilance will cover the following components

The major components are;

ƽ )EXEGSPPIGXMSRERHEREP]WMW

ƽ .RXIVZIRXMSRWQEREKIQIRXVITSVX

ƽ 7ITSVXMRK

ƽ GEYWEPMX]EWWIWWQIRX

Data collection and analysis

What to collect is vital into understanding the cause of adverse reactions and addressing
the issues well. When a patient presents themselves at a facility, healthcare worker
should have time to record the following;

1. Take a proper history and do a proper examination

ƽ &JYPPHVYKERHQIHMGEPLMWXSV]WLSYPHFIHSRI

ƽ (ER XLMW EHZIVWI FI I\TPEMRIH F] SXLIV GEYWIW IK TEXMIRXƶW YRHIVP]MRK
disease, other drug/s, over-the-counter medicines or traditional medicines;
toxins or foods

ƽ .XMWIWWIRXMEPXLEXXLITEXMIRXMWXLSVSYKLP]MRZIWXMKEXIHXSHIGMHI[LEXXLI
actual cause of any new medical problem is. A drug-related cause should
be considered, especially when other causes do not explain the patient’s
condition

2. Establish time to understand the onset of drug reactions

ƽ SQI VIEGXMSRW SGGYV MQQIHMEXIP] EJXIV FIMRK KMZIR E QIHMGMRI [LMPI

other reactions take time to develop

ƽ 8LIXMQIJVSQXLIWXEVXSJXLIVET]XSXLIXMQISJSRWIXSJXLIWYWTIGXIH
reaction must be logical.

3. Do a thorough physical examination with appropriate laboratory investigations

ƽ +I[HVYKWTVSHYGIHMWXMRGXMZITL]WMGEPWMKRW

ƽ *\GITXMSRWMRGPYHIǻ\IHHVYKIVYTXMSRWWXIVSMHMRHYGIHHIVQEPEXVSTL]
acute extrapyramidal reactions

ƽ 1EF XIWXW EVI IWTIGMEPP] MQTSVXERX MJ XLI HVYK MW GSRWMHIVIH IWWIRXMEP MR
improving patient care or of the lab test results will improve management
of the patient

ƽ 8V] XS HIWGVMFI XLI VIEGXMSR EW GPIEVP] EW TSWWMFPI ERH [LIVI TSWWMFPI
provide an accurate diagnosis

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  *ǺIGXSJHIGLEPPIRKIERHVIGLEPPIRKIWLSYPHFIHIXIVQMRIH [LIRRIGIWWEV]

De-challenge = withdraw of drug

ƽ 7IWSPYXMSR SJ WYWTIGXIH &)7 [LIR XLI HVYK MW [MXLHVE[R MW E WXVSRK
although not conclusive indication of drug-induced disease.

ƽ .R GEWIW [LIVI E [MXLHVE[EP VIEGXMSR MW I\TIVMIRGIH E HIGLEPPIRKI MW

when the drug is again given to the patient.

ƽ Ƹ5SWMXMZIƹ HIGLEPPIRKI " MQTVSZIQIRX SJ VIEGXMSR [LIR HIGLEPPIRKI

occurs

Re-challenge = reintroducing the drug after a de-challenge.

ƽ 8LMWMWSRP]NYWXMǻEFPI[LIRXLIFIRIǻXSJVIMRXVSHYGMRKXLIHVYKXSXLI
patient outweighs the risk of recurrence of the reaction. This is rare. In
some cases, the reaction may be more severe on repeat exposure.

5. Check the known pharmacology of the Medicine.

ƽ .W XLI VIEGXMSR ORS[R XS SGGYV [MXL XLI HVYK EW WXEXIH MR XLI TEGOEKI
insert or other reference?

ƽ .JXLIVIEGXMSRMWRSXHSGYQIRXIHMRXLITEGOEKIMRWIVXMXHSIWRSXQIER
that the reaction cannot occur with that medicine.

6. Evaluate the suspected ADR after discontinuing the drugs or reducing the dose
and monitor the patient’s status. If appropriate, restart the drug treatment and
monitor recurrence of any adverse events.

Patient counselling
2IHMGMRITPE]WERMQTSVXERXVSPIMRQIHMGEPGEVI*ǺIGXMZIRIWWSJXVIEXQIRXHITIRHW
SRFSXLXLIIǽGMIRG]SJQIHMGEXMSRERHTEXMIRXEHLIVIRGIXSXLIXLIVETIYXMGVIKMQIR
Patient needs to be informed about potential ADRs and management strategies should
ER]SGGYVERHEHZMGIXSVITSVXER]WMHIIǺIGXMQQIHMEXIP]5EXMIRXRIIHXSYRHIVWXERH
that sometime people not all can get ADRs when taking medicine and that ADRs vary
JVSQTIVWSRXSTIVWSR2SWX&)7WSGGYV[MXLMRXLIǻVWXJI[[IIOWSJWXEVXMRKQIHMGEXMSR
and then improve after a few weeks or months.

;LEXHS]SYHSMJ]SYRSXMGIER]WMHIIǺIGXW$

ƽ .J]SY HIZIPST ER]&)7 VIXYVR XS XLI GPMRMG MQQIHMEXIP] ERH HMWGYWW[MXL]SYV
healthcare worker.

ƽ .JXLIWMHIIǺIGXWEVIQMPHXLIR]SYGERGSRXMRYIXEOMRK]SYVQIHMGMRIW[MXLSYX
missing any doses, and then discuss it with the clinician at your next appointment.

ƽ .JXLIWMHIIǺIGXWEVIFSXLIVMRK]SYXSSQYGLXLIRVIXYVRXSXLIGPMRMGMQQIHMEXIP]
even if you do not have a scheduled appointment, to discuss what to do next; you
can also call the clinic if you are not able to make it yourself immediately.

338 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Reporting
+EGMPMXMIW EVI I\TIGXIH XS VITSVX EPP &)7W ERH WMHI IǺIGXW XS TLEVQEGMWX (81(W ERH
SCTLCs for submission to PPB using the yellow forms through their website or email
ERHXS381)5JSVIRXV]MR8.'9 (LEVXSRHEXEERHMRJSVQEXMSRǼS[8LIEHZIVWIIZIRXW
and ADRs for DRTB to be recorded in the DRTB patient logbook and reported through
aDSM/ADR reporting tool (in TIBU) and PPB ADR reporting form (yellow form) (annex 1)

ƽ Report all ADRs to PPB via the PPB website (http://www.pv.pharmacyboardkenya.org/)

or via email [email protected]

 ;LIVIXLI[IFWMXIMWRSXEZEMPEFPI

- Fill out in the yellow form

- Submit a hardcopy to the sub-county Pharmacist

Methods of reporting in pharmacovigilance

a) Spontaneous reporting is the most common form of PV is spontaneous which
involves a health-care worker - or even the patient - reporting a drug-related reaction.
8LIIǺIGXMZIRIWWSJXLMWHITIRHWSRXLITEXMIRXZSPYRXIIVMRKXLMWMRJSVQEXMSRXSLIEPXL
care workers’ competence to recognize an event, and their motivation to report it.

b) Targeted spontaneous reporting uses a methodology that monitors and records all
SVEWTIGMǻGWIXSJWEJIX]GSRGIVRWMREHIǻRIHTSTYPEXMSRSJXVIEXIHTEXMIRXWIKHVYK
resistant TB patients on treatment.

c) Active PV is a more systematic and proactive form of safety surveillance. In active PV,
events are elicited as part of patient monitoring using a set of questions and an array of
PEFSVEXSV]GPMRMGEPXIWXWEXHIǻRIHTIVMSHWSJXMQIFIJSVIHYVMRKERHEJXIVXVIEXQIRX
Cohort event monitoring (CEM) is one of the standard methods of active PV which is used
to monitor adverse events in patients who receive a particular medication or treatment
regimen. Patients are followed up prospectively in groups and all adverse events are
registered during treatment and usually for a given time after its end. The CEM method
MWXLIJSVQSJEGXMZI5:[LMGLLEWFIIRFIWXHIǻRIHERHYWIHMRHMǺIVIRXWIXXMRKWFSXL
well-resourced and low income. Beyond its role as part of a risk management plan, CEM
can provide useful insights into the patterns of utilization and the adoption of a new drug
in clinical practice (e.g. acceptability by clinicians and patients).

.RJSVQEXMSRERHHEXEǼS[
The data received will be entered and analyzed at the National Pharmacovigilance Centre
at the PPB, supported by the Expert Safety Review Panel (ESRP). 9. The Pharmacy and
Poisons Board will review the reports received from all sources and advise on or take
the appropriate action. 10. Feedback to all levels of the system will be the responsibility
of PPB.

Integrated Guideline for Tuberculosis, 339

Leprosy and Lung Disease | 2021
 +MKYVI8LI&)7MRJSVQEXMSRERHVITSVXMRKǼS[GLEVX

ADRs reporting tools: (Annex 15, 16, 17)

ƽ Yellow form (PV 1) - form to capture all suspected adverse drug reactions

ƽ White card (PV 4) – Patient Alert card for life threatening drug reactions

ƽ Pink form (PV 6) - form for reporting poor quality medicinal products.

Causality assessment
In order to assess the likelihood that the suspected adverse reaction is due to the
medicine, the WHO has provided a list of causality assessment criteria for deciding on
XLIGSRXVMFYXMSRSJXLIQIHMGMRIXS[EVHWXLIEHZIVWIIZIRX8LIWIGVMXIVMEEVIHIǻRIH
as follows:

Certain: Clearly caused by the exposure. ‰ĚåŹåƐ ĞžƐ clear åƽĞÚåĻÏåƐ ƒŇƐ žƣďď垃Ɛ ±Ɛ ϱƣž±ĮƐ
ŹåĮ±ƒĞŇĻžĚĞŤƐ±ĻÚƐŇƒĚåŹƐŤŇžžĞÆĮåƐÏŇĻƒŹĞÆƣƒĞĻďƐü±ÏƒŇŹžƐϱĻƐÆåƐŹƣĮåÚƐŇƣƒũ

Assessment criteria;
ƽ (PMRMGEPIZIRXPEFXIWXEFRSVQEPMX][MXLTPEYWMFPIXMQIVIPEXMSRWLMTXSHVYKMRXEOI
ƽ (ERRSXFII\TPEMRIHF]GSRGYVVIRXHMWIEWISVSXLIVHVYKWGLIQMGEPW

340 Integrated Guideline for Tuberculosis,

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 ƽ 7IWTSRWIXS[MXLHVE[EPTPEYWMFPI
ƽ *ZIRXQYWXFIHIǻRMXMZITLEVQEGSPSKMGEPP]MQQYRSPSKMGEPP]
ƽ 5SWMXMZIVIGLEPPIRKIW MJTIVJSVQIH

Probable/ Likely: Likely to be related to the exposure. ‰ĚåŹåƐ ĞžƐ åƽĞÚåĻÏåƐ ƒŇƐ žƣďď垃Ɛ ±Ɛ
likely ϱƣž±ĮƐŹåĮ±ƒĞŇĻžĚĞŤƐ±ĻÚƐƒĚåƐĞĻāƣåĻÏåƐŇüƐŇƒĚåŹƐü±ÏƒŇŹžƐĞžƐƣĻĮĞīåĮDžũ

Assessment criteria;
ƽ (PMRMGEP IZIRX PEF XIWX EFRSVQEPMX] [MXL VIEWSREFPI XMQI VIPEXMSRWLMT XS HVYK
intake
ƽ 9RPMOIP]XSFIEXXVMFYXIHXSHMWIEWIHVYKWGLIQMGEPW
ƽ (PMRMGEPP]VIEWSREFPIVIWTSRWIXS[MXLHVE[EP HIGLEPPIRKI
ƽ 7IGLEPPIRKIRSXVIUYMVIH

Possible: May be related to the exposure. ‰ĚåŹåƐ ĞžƐ some åƽĞÚåĻÏåƐ ƒŇƐ žƣďď垃Ɛ ±Ɛ ϱƣž±ĮƐ
ŹåĮ±ƒĞŇĻžĚĞŤƐŦÆåϱƣžåƐƒĚåƐåƽåĻƒƐŇÏÏƣŹžƐƾЃĚĞĻƐ±ƐŹå±žŇĻ±ÆĮåƐƒĞķåƐ±üƒåŹƐ±ÚķĞĻĞžƒŹ±ƒĞŇĻƐŇüƐƒĚåƐ
ƒŹĞ±ĮƐķåÚĞϱƒĞŇĻŧũƐBŇƾåƽåŹØƐƒĚåƐĞĻāƣåĻÏåƐŇüƐŇƒĚåŹƐü±ÏƒŇŹžƐķ±DžƐ̱ƽåƐÏŇĻƒŹĞÆƣƒåÚƐƒŇƐƒĚåƐåƽåĻƒƐ
ŦåũďũƐƒĚåƐŤ±ƒĞåĻƒŷžƐÏĮĞĻĞϱĮƐÏŇĻÚЃĞŇĻØƐŇƒĚåŹƐÏŇĻÏŇķЃ±ĻƒƐƒŹå±ƒķåĻƒžŧũ

Assessment criteria;
ƽ (PMRMGEP IZIRX PEF XIWX EFRSVQEPMX] [MXL VIEWSREFPI XMQI VIPEXMSRWLMT XS HVYK
intake
ƽ (SYPHEPWSFII\TPEMRIHF]HMWIEWISVSXLIVHVYKWSVGLIQMGEPW
ƽ .RJSVQEXMSRSRHVYK[MXLHVE[EPQE]FIPEGOMRKSVYRGPIEV

Unlikely: Doubtfully related to the exposure. ‰ĚåŹåƐĞžƐlittle åƽĞÚåĻÏåƐƒŇƐžƣďď垃ƐƒĚåŹåƐĞžƐ±Ɛ

ϱƣž±ĮƐŹåĮ±ƒĞŇĻžĚĞŤ ŦƒĚåƐåƽåĻƒƐÚĞÚƐĻŇƒƐŇÏÏƣŹƐƾЃĚĞĻƐ±ƐŹå±žŇĻ±ÆĮåƐƒĞķåƐ±üƒåŹƐ±ÚķĞĻĞžƒŹ±ƒĞŇĻ

ŇüƐ ƒĚåƐ žƒƣÚDžƐ ŹåďĞķåĻŧũƐ ‰ĚåŹåƐ ĞžƐ ±ĻŇƒĚåŹƐ Źå±žŇĻ±ÆĮåƐ åDŽŤĮ±Ļ±ƒĞŇĻƐ üŇŹƐ ƒĚåƐ åƽåĻƒƐ ŦåũďũƐ ƒĚåƐ
Ť±ƒĞåĻƒŷžƐÏĮĞĻĞϱĮƐÏŇĻÚЃĞŇĻØƐŇƒĚåŹƐÏŇĻÏŇķЃ±ĻƒƐƒŹå±ƒķåĻƒŧũ

Assessment criteria;

ƽ (PMRMGEPIZIRXPEFXIWX[MXLMQTVSFEFPIXMQIVIPEXMSRWLMTXSHVYKMRXEOI

ƽ 4XLIVHVYKWGLIQMGEPWSVYRHIVP]MRKHMWIEWITVSZMHITPEYWMFPII\TPEREXMSRW

(SRHMXMSRYRGPEWWMǻEFPI8LIVIMWMRWYǽGMIRXMRJSVQEXMSR about the ADRs to allow for

an assessment of causality

Assessment criteria;
ƽ *ZIRXSVPEFSVEXSV]XIWXEFRSVQEPMX]
ƽ 2SVIHEXEJSVTVSTIVEWWIWWQIRXRIIHIHSV
ƽ &HHMXMSREPHEXEYRHIVI\EQMREXMSR

Integrated Guideline for Tuberculosis, 341

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 9REWWIWWEFPIYRGPEWWMǻIH 8LIVIMWMRWYǽGMIRXMRJSVQEXMSREFSYXXLI&)7WXSEPPS[
for an assessment of causality and more is expected.

Assessment criteria;

ƽ 2SVIHEXEMWIWWIRXMEPJSVTVSTIVEWWIWWQIRXSVEHHMXMSREPHEXEEVIYRHIV
examination.

In most cases there is some level of uncertainty as to whether the drug is directly
responsible for the reaction. Many of the questions above may remain unanswered or
may be contradictory, however this should not dissuade you, from reporting the reaction
to the {Pharmacy and poisons board and NTP}. A well-documented report which includes
MRJSVQEXMSREFSYXEPPXLIEFSZIQIRXMSRIHUYIWXMSRWGERTVSZMHIYW[MXLXLIǻVWXWMKREP
of a previously unknown problem.

ROLES AND RESPONSIBILITIES

The entire system of pharmacovigilance works with the support of each healthcare
provider, the regulatory bodies, the pharmaceutical industry, other stakeholders and
the public at large. Hence, each of these has an important role to play and responsibility
to bear: (See Annex 23: Roles of Commodities Security and Management Team)

Patient / Public

5EXMIRXW XS VITSVX ER] YREGGITXEFPI YRI\TIGXIH SV WYWTIGXIH EHZIVWI IǺIGX SJ
medicine dispensed to them.

Health Care Worker

Patient awareness of possible serious reactions, and development of a culture to report

reactions to clinics, will be essential for any pharmacovigilance system. Health facility
WXEǺTVSZMHIWERIWWIRXMEPPMROMRXLIHIXIGXMSRSJ&)7WEXXLITIVMTLIV]SJXLILIEPXLGEVI
system. The healthcare worker’s roles in the PV system are:
ƽ 5EXMIRXIHYGEXMSR
ƽ )IXIGXMSRERHETTVSTVMEXIGPMRMGEPQEREKIQIRX
ƽ 7ITSVXMRK
ƽ )SGYQIRXEXMSRXSQEMRXEMREGGYVEXIHSGYQIRXW
ƽ .RZIWXMKEXMSR[LIVIRIGIWWEV]
ƽ 5EXMIRXJIIHFEGO

Hospital pharmacist
ƽ 7IGIMZIVITSVXWJVSQXLILIEPXLGEVI[SVOIVWMRXLILSWTMXEPERHWIRHXLIQXSXLI
sub county pharmacist.
ƽ 7IZMI[XLITEXMIRXWD&)7TVSKRSWMWERHMRXIVZIRXMSRW
ƽ )IZIPSTETLEVQEGIYXMGEPGEVITPERJSVXLITEXMIRX 5(5
ƽ ,IRIVEXIEHVYKWYXMPMWEXMSRVIZMI[VITSVX

342 Integrated Guideline for Tuberculosis,

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 ƽ 2EREKIXLI-SWTMXEPTLEVQEGSZMKMPERGIFYHKIX
ƽ (LEMVXLILSWTMXEPTLEVQEGSZMKMPERGIGSQQMXXII
ƽ 2IQFIVSJXLIGPMRMGEPZMI[QIIXMRKWMRXLI-SWTMXEP+EGMPMX]

Clinical pharmacist specialist

ƽ .RMXMEXIMQQIHMEXIWLSVXXIVQMRXIVZIRXMSRWSJXLI&)7W
ƽ 7IZMI[XLITEXMIRXWD&)7TVSKRSWMWERHMRXIVZIRXMSRW
ƽ )IZIPSTETLEVQEGIYXMGEPGEVITPERJSVXLITEXMIRX 5(5
ƽ (SRHYGXXLIVETIYXMGWHVYKWQSRMXSVMRKVITSVXW 8)2
ƽ 2EREKIXLI282GPMRMGERH8)2FYHKIX
ƽ (SSVHMREXIJEGMPMX]QIHMGMRIWFEWIHSTIVEXMSREPVIWIEVGLERHGPMRMGEPXVMEPW
ƽ (LEMVXLIHVYKWYXMPMWEXMSRVIZMI[VITSVXW
ƽ 8VEMRMRKSJXLILIEPXLGEVIWXEǺ
ƽ 2IQFIVSJXLIGPMRMGEPVIZMI[QIIXMRKWMRXLILSWTMXEP

Sub County Pharmacist

ƽ 7IGIMZIVITSVXWJVSQLIEPXLGIRXVIWERHWIRH&)7VITSVXWJVSQHMWXVMGXXS55'SR
a monthly / weekly basis or on an ad hoc basis in an emergency.
ƽ .RMXMEXIMQQIHMEXIWLSVXXIVQMRXIVZIRXMSRWSJXLI&)7W
ƽ (SSVHMREXI XLI WYF GSYRX] VIZMI[W SJ XLI TEXMIRXWD &)7 TVSKRSWMW ERH
interventions.
ƽ (SSVHMREXI XLI TLEVQEGIYXMGEP GEVI TPERW JSV XLI TEXMIRX 5(5 VIZMI[W JSV XLI
sub county. Coordinate the therapeutics drugs monitoring reports (TDM) reviews
in the sub county.
ƽ +EGMPMXEXI MRZIWXMKEXMSRW JSV GEYWEPMX] EWWIWWQIRX MRMXMEXIH F] 55' [LIVI
necessary.
ƽ 8VEMRMRKSJLIEPXLGEVIWXEǺMRJEGMPMXMIW
ƽ 2IQFIVSJXLIGPMRMGEPVIZMI[QIIXMRKWJSV8'MRXLIWYFGSYRX]

County Pharmacist /Pharmacovigilance pharmacist specialist

The pharmacovigilance important roles of the county pharmacist (assisted by Pv

pharmacy specialist/clinical Pharmacist) are:
ƽ (SSVHMREXIEPPEGXMZMXMIWSJTLEVQEGSZMKMPERGIMRXLIGSYRX]
ƽ 8VEMRMRKSJLIEPXLGEVIWXEǺMRXLIGSYRX]
ƽ +EGMPMXEXI MRZIWXMKEXMSRW JSV GEYWEPMX] EWWIWWQIRX MRMXMEXIH F] 55' [LIVI
necessary.

Integrated Guideline for Tuberculosis, 343

Leprosy and Lung Disease | 2021
 ƽ 2EREKIERHGSSVHMREXIXLI5LEVQEGSZMKMPERGIMQTPIQIRXEXMSRERHGSSVHMREXMSR
budget in the county.
ƽ (LEMVXLIGSYRX]5LEVQEGSZMKMPERGIGSQQMXXIIW
ƽ (LEMVXLIGSYRX]GSQQSHMXMIWWIGYVMX]QIIXMRKW
ƽ (SSVHMREXIXLI(SYRX]VIZMI[WSJXLITEXMIRXWD&)7TVSKRSWMWERHMRXIVZIRXMSRW
ƽ (SSVHMREXI XLI TLEVQEGIYXMGEP GEVI TPERW JSV XLI TEXMIRX 5(5 VIZMI[W JSV XLI
county. Coordinate the therapeutics drugs monitoring reports (TDM) reviews in
the county.
ƽ (SSVHMREXI282GPMRMGEGXMZMXMIWMRXLIGSYRX]
ƽ 5VSZMHITSPMG]ERHVIKYPEXSV]MRXIVTLEWIFIX[IIRXLIGSYRX]ERHXLITVSKVEQ
and PPB respectively.
ƽ 2IQFIVSJXLIGSYRX]GPMRMGEPVIZMI[QIIXMRKWMR8'

Clinical Review Team

The clinical review team plays a central role in monitoring DR TB patients for ADRs. The
team ideally will consist of clinicians, pharmacists, nutritionists as well as the head nurse
or matron of the facility. Detailed follow-up of suspected drug reactions would be used
XSHIǻRIGEYWEPMX]8LIGPMRMGMER[LSWIIWXLITEXMIRXVITSVXWER]WYWTIGXIH&)7WXSXLI
PPB and National TB Program and contributes to public education on drug safety.

Pharmacy & Poisons Board (PPB)

The PPB will take responsibility for any regulatory action with respect to the implicated
QIHMGMREP TVSHYGXW 8LIWI EGXMSRW [MPP FI SǽGMEPP] GSQQYRMGEXIH XS XLI HVYK
manufacturers, who have liability for the drug. The PPB will:
ƽ 7IGIMZIVITSVXWJVSQLIEPXL[SVOIVWERHSXLIVWSYVGIW
ƽ )IZIPSTERHQEMRXEMR&)7HEXEFEWI
ƽ )IXIGX&)7WMKREPWERHXEOIRIGIWWEV]EGXMSRSRVIGIMZIHVITSVXW
ƽ YTTSVXXLIGPMRMGEPVIZMI[XIEQXSMRZIWXMKEXIVIPIZERX&)7VITSVXW
ƽ IRH&)7VITSVXWXS9TTWEPE2SRMXSVMRK(IRXVI
ƽ 5VSZMHIJIIHFEGOXSXLIYWIVWSRVITSVXIH&)7WXLVSYKLUYEVXIVP]RI[WPIXXIVW
ƽ *WXEFPMWLERHTVSZMHIWIGVIXEVMEXJSVXLI*\TIVXEJIX]7IZMI[5ERIP
ƽ &HZSGEG]8VEMRMRKERH*HYGEXMSR
ƽ 5VSZMHIWYTTSVXXS[LSPIW]WXIQ
ƽ (SQQYRMGEXMSR.*(.QTPIQIRXETTVSTVMEXI

344 Integrated Guideline for Tuberculosis,

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2EREKMRK&HZIVWI*ǺIGXWSJ&RXM8YFIVGYPSYW)VYKWWXPMRIQIHMGMRI
8EFPI&RXM8')VYKWEHZIVWIIǺIGXW

&HZIVWI*ǺIGX Drug(s) Probably Management

Responsible
Minor Continue anti-TB drugs, check drug doses
Gastrointestinal R, H, Z, RPT Rule out other causes
(Nausea, vomiting, Conduct liver function tests to rule out drug-
anorexia) induced hepatic dysfunction
Give drugs with small meals or just before bedtime
and advise patient to swallow pills slowly with
small sips of water.
If symptoms persist or worsen, consider the side-
IǺIGXXSFIQENSVERHVIJIVXSGPMRMGMERYVKIRXP]
(Joint Pain) Arthralgia Z &WTMVMRRSRWXIVSMHEPERXMMRǼEQQEXSV]HVYKSV
paracetamol
Mild itching rash H, RPT Treat with antihistamine
Prednisone may be added at 40mg/day and
tapered gradually as the rash clears
A topical cream may be added
Peripheral H Pyridoxine 100 - 200 mg daily
neuropathy
Orange/red urine, R Reassurance. Patients should be told when starting
tears, etc. treatment that this is normal.
Major Stop responsible drug(s) and refer to clinician
urgently
(Flushing reaction) E>Z>R>H Reassure patients and inform about avoiding
tyramine and histamine-containing foods (e.g. tuna,
Skin rash with or
cheese red wine) while receiving Isoniazid
without itching
.JǼYWLMRKMWFSXLIVWSQIXSXLITEXMIRXER
antihistamine may be administered to treat the
reaction
If persist, stop anti-TB drugs; give symptomatic
treatment and wait for resolution of symptoms
before rechallenge
Hepatitis Z > H > R >RPT Stop anti-TB drugs, wait for resolution of symptoms
and liver function tests before rechallenge
(R can also cause
asymptomatic
jaundice)
Visual impairment E Stop E and exclude other causes
(optic neuritis)
Shock, purpura, R Stop R
acute renal failure
Hypersensitivity H, RPT if severe reaction e.g. thrombocytopenia,
hypotension, discontinue treatment until the
reaction resolves. Refer to hospital

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 Recommended approaches to improving Pharmacovigilance
Monitoring for suspected drug-related problems should be part of normal patient
care. At every encounter, the responsible health-care professional should screen for
any suspected ADRs. During patient investigation the possibility of a medicine-related
problem should always be considered

ƽ &PPLIEPXLGEVITVSJIWWMSREPWMRZSPZIHMRTEXMIRXGEVIWLSYPHFIWIRWMXM^IHXSXLI
RIIHXSEWOEFSYXERHMRZIWXMKEXIEHZIVWIIǺIGXWEXIZIV]IRGSYRXIV

ƽ 8LIJSVQWERHVSYXIJSVXVERWQMWWMSRSJMRJSVQEXMSREVIXLIWEQIEWXLSWIYWIHMR
WTSRXERISYWVITSVXMRKFYXXLIJSVQWWLSYPHFIWYTTSVXIHF]WTIGMǻGKYMHERGI
GEWIHIǻRMXMSRWERH[VMXXIRTVSGIHYVIWSR[LIRXSGSQTPIXIXLIQERHHIXEMPW
on standardized reporting of drug names and ADRs

ƽ 8LIVITSVXMRKQE]TVMQEVMP]XEVKIXWIVMSYW&)7WVEXLIVXLERXLIRSXMǻGEXMSRSJER]
suspected reaction. TSR can be adapted to the safety question at hand. If the total
burden of drug-related problems in the exposed population is of interest, health
professionals can be instructed to report any suspected drug-related problem.
.JLS[IZIVXLIJVIUYIRG]SJEWTIGMǻGTVSFPIQWYWTIGXIHXSFIEWWSGMEXIH[MXL
XLIXLIVET]KMZIRMWXLIMQTSVXERXUYIWXMSRIKZMWMSRHMWSVHIVWEGEWIHIǻRMXMSR
for reporting can be given in the instructions to health-care professionals

ƽ 8LIVITSVXMRK[SYPHPEWXXLI[LSPIPIRKXLSJE8'XVIEXQIRXITMWSHI

ƽ 9RPMOI(*2XLIVIEVIRSFEWIPMRIQIEWYVIQIRXWRSVMWXLIVIER]EGXMZIJSPPS[
up of the members of the cohort and thus fewer resources would be required

ƽ 8LIRYQFIVSJ8'TEXMIRXWMRXLIXVIEXQIRXƸGSLSVXƹ[LSLEZIFIIRMRZIWXMKEXIH
would represent a denominator for calculation of simple frequencies of ADRs.

ƽ 8LIVSYXMRITEXMIRXVIGSVHWLSYPHMRGPYHIXLIUYIWXMSRƸYWTIGXIHEHZIVWIHVYK
reaction? YES or NO” ensuring that the possibility has always been considered.
The extent to which this information is recorded will also indicate whether ADR
monitoring has become a part of normal practice. If safety monitoring of each
patient is truly part of best practice and recording of whether the patient has
experienced a suspected problem or not is complete, the calculated reaction
frequencies may be close estimates of true incidence rates

Table 15.3: Indicators to monitor in Pharmacovigilance

Source of
Indicator .RHMGEXSVHIǻRMXMSR Frequency
data
Numerator: Number of ADRs
attributed to target treatment
Frequency of ADRs associated among patient on aDSM
Quarterly TIBU/PPB
with target treatment Denominator: Number of TB
cases included in aDSM during at
a given period

346 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Numerator: Number of MDR-TB
cases with one or more serious
The proportion of MDR-TB and
adverse events.
or RR patients with reported Quarterly TIBU/PPB
Denominator: Total number of
adverse drug event
MDR-TB cases reported in each
period.

ACTIVE DRUG SAFETY MONITORING AND MANAGEMENT (aDSM)

KEY HIGHLIGHTS

ƽ E)2GSQTPIQIRXWXLIIǺSVXWERHGETEGMX]SJXLII\MWXMRKTLEVQEGSZMKMPERGIW]WXIQW
present, to address gaps in safeguarding patient safety and help increase knowledge on
treatment regimens.

ƽ E)2MWERIWWIRXMEPGSQTSRIRXSRXLIQEREKIQIRXSJFSXLHVYKWIRWMXMZIERHHVYK
resistant TB done in a patient centered care approach to achieve the most desired able
XLIVETIYXMGFIRIǻXWFEWIHSRFIRIǻXVMWOEREP]WMWXSXLITEXMIRX

E)2MWHIǻRIHEWEGXMZIERHW]WXIQEXMGGPMRMGEPERHPEFSVEXSV]EWWIWWQIRXSJTEXMIRXW
while on treatment üŅų £%ě‰Ø Ņų ƵĜƋĘ ĹåƵ ‰ ÚųƚčŸ Ņų ĹŅƴåĬ a%ě‰ ųåčĜĵåĹŸ ƋŅ
ÚåƋåÏƋØĵ±Ĺ±čå±ĹÚųåŞŅųƋŸƚŸŞåÏƋåÚŅųÏŅĹĀųĵåÚÚųƚčƋŅƻĜÏĜƋĜåŸ. The recording and
ųåŞŅųƋĜĹč ±ÏƋĜƴĜƋĜåŸ Ņü ±%„a ŞųĜĵ±ųĜĬƼ Ƌ±ųčåƋ ƋĘå ŸåųĜŅƚŸ ±ÚƴåųŸå åƴåĹƋŸ Š„e)Ÿš ±Ÿ ±
ƱŸĜÏ ųåŧƚĜųåĵåĹƋţ ‰Ęå ±ŞŞųŅŞųĜ±Ƌå ±ĹÚ ƋĜĵåĬƼ ĵ±Ĺ±čåĵåĹƋ Ņü e%Ÿ ĜŸ ±Ĺ ĜĹƋåčų±Ĭ
ÏŅĵŞŅĹåĹƋŅü±%„a±ĹÚޱƋĜåĹƋϱųå

aDSM components

1. Clinical monitoring

ƽ EGXMZIERHW]WXIQEXMGGPMRMGEPERHPEFSVEXSV]EWWIWWQIRXHYVMRKXVIEXQIRXXS
detect drug toxicity and AE

2. Management of AEs in a timely manner (Access to ancillary drugs)

3. Systematic and standardized recording and reporting of AEs

ƽ )EXEGSPPIGXMSRXSMRGPYHIWEJIX]HEXE

ƽ &*WERH&*WSJWTIGMEPMRXIVIWXXSFIVITSVXIHXSXLI5TFERH8'TVSKVEQJSV
causality assessment

ƽ 7IKYPEVQIIXMRKWFIX[IIR8'TVSKVEQERHVIKYPEXSV]EYXLSVMXMIW

Levels of aDSM monitoring

There are three levels of aDSM monitoring that may be used in depending on the human
resource capacity, namely:

1. Core package: requires monitoring and reporting of all SAEs

Integrated Guideline for Tuberculosis, 347

Leprosy and Lung Disease | 2021
 2. Intermediate package: includes SAEs and AEs of special interest

&HZERGIHTEGOEKIMRGPYHIWEPP&*WSJGPMRMGEPWMKRMǻGERGI

ADR risk factors

ƽ &HZERGIHEKI
ƽ )MEFIXIWQIPPMXYW
ƽ 2EPRYXVMXMSR
ƽ &RIQME
ƽ 5VIKRERG]ERHPEGXEXMRKQSXLIVW
ƽ SXLIVQIHMGEXMSRW
ƽ &PGSLSPMWQ
ƽ 1MZIVJEMPYVI
ƽ (LVSRMGVIREPJEMPYVI
ƽ -.:MRJIGXMSR

8EFPI(PEWWMǻGEXMSRSJXLIWIZIVMX]SJXLIEHZIVWIWMHIIǺIGXW

Severity )IǻRMXMSR
Mild 8LIEHZIVWIIZIRXHSIWRSXMRXIVJIVIMREWMKRMǻGERXQERRIV[MXLXLITEXMIRXƶW
normal functioning.

Moderate The adverse event produces some impairment in the patient’s functioning but is
not hazardous to the health of the patient.

Severe 8LIEHZIVWIIZIRXTVSHYGIWWMKRMǻGERXMQTEMVQIRXSVMRGETEGMXEXMSRSJ
functioning.

Life- The adverse event causes extreme impairment of functioning, requiring

threatening hospitalization and if left untreated could result in the death of the patient.

&)7WSJGPMRMGEPWMKRMǻGERGI
&)7WSJGPMRMGEPWMKRMǻGERGIMRGPYHIWIVMSYW&HZIVWI)VYK7IEGXMSR &)7WHIǻRIH
as any untoward medical occurrence that is either (i) serious, (ii) of special interest, (iii)
leads to discontinuation or change in the treatment or (iv) otherwise judged as clinically
WMKRMǻGERX.XMRGPYHIWEXER]HSWI

ƽ 7IWYPXWMRHIEXLLSWTMXEPM^EXMSRWMKRMǻGERXHMWEFMPMX]MRGETEGMX]PMJIXLVIEXIRMRK 
congenital anomaly or a birth defect,

ƽ &*W SJ MRXIVIWX MR VIPEXMSR XS WIVMSYWRIWW WIZIVMX] SV GEYWEP VIPEXMSRWLMT XS XLI
DRTB treatment, pertaining to the following medical conditions: Peripheral

348 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 neuropathy, Myelosuppression, Prolonged QTcF interval, Optic nerve disorder
(optic neuritis), Hepatitis, Hearing impaired, Acute kidney injury, Hypokalemia and
Hypothyroidism.

Figure 15.2: Serious adverse reactions

Detection of ADRs and Adverse events

&)7W ERH EHZIVWI IZIRXW GER EǺIGX FSXL TL]WMSPSKMGEP ERH TEXLSPSKMGEP TEXL[E]W
QEOMRKXLIQHMǽGYPXXSHMWXMRKYMWL8LIWXIT[MWIETTVSEGLFIPS[MWVIGSQQIRHIHJSV
assessing ADRs;
a) Ensure the correct medication and dosing is prescribed to the patient
b) Verify that the onset of the suspected ADR was after the drug was taken, not
before and discuss carefully the observation made by the patient;
c) Determine the time interval between the beginning of drug treatment and the
onset of the event;
d) Evaluate the suspected ADR after discontinuing the drugs or reducing the dose
and monitor the patient’s status. If appropriate, restart the drug treatment and
monitor recurrence of any adverse events.
e) Analyse the alternative causes (other than the drug) that could on their own have
caused the reaction
f) Report any suspected ADR to the person nominated for ADR reporting in the
hospital or directly to the National PV Centre which is PPB.

Integrated Guideline for Tuberculosis, 349

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 Principles of management
ƽ *EVP]MHIRXMǻGEXMSRERHXVIEXMQQIHMEXIP] EHIUYEXIP]

ƽ 7YPISYXSXLIVGEYWIW

ƽ (SRWMHIVEHHMXMZISVTSXIRXMEXMRK*[MXLGSRGSQMXERXXLIVET]

ƽ (SRWMHIVHVYKHVYKMRXIVEGXMSR

ƽ +SV QMRSV ERH QSHIVEXI VIEGXMSRW ]QTXSQEXMG QEREKIQIRX VIGSQQIRHIH

algorithms, OTCs and ancillary medications)

ƽ +SVQSHIVEXIP]WIZIVIVIEGXMSRW7IHYGIHSWEKIJVIUYIRG]SJXLIWYWTIGXIH
drug.

ƽ IZIVI VIEGXMSRW 5EXMIRX LSWTMXEPM^IH ERH QEREKIH .J E VIHYGIH HSWI HSIW
not help to resolve stop and replace or immediate stoppage of all treatment or
removal of a drug from the regimen.

Clinical grading and management of adverse reaction of DRTB treatments

1. Peripheral Neuropathy
Possible anti-TB drug that causes neuropathy: Cs, Lzd, H,

Table 15.5: Grading peripheral neuropathy

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life-

Moderate threatening

Neurosensory
žDžķŤƒŇķ±ƒĞÏƐƾЃĚƐ „åĻžŇŹDžƐ±ĮƒåŹĝ „åĻžŇŹDžƐ±ĮƒåŹĝ %Ğž±ÆĮĞĻďƐžåĻžŇŹDžƐ

alteration (in- žåĻžŇŹDžƐ±ĮƒåŹ±ƒĞŇĻƐ ±ƒĞŇĻƐŇŹƐŤ±Ź±åžĝ ±ƒĞŇĻƐŇŹƐŤ±Ź±åžĝ ±ĮƒåŹ±ƒĞŇĻƐŇŹƐŤ±Źĝ
cluding paraes- ŇĻƐåDŽ±ķƐŇŹƐķĞĻĞĝ ƒĚåžĞ±ƐϱƣžĞĻďƐ ƒĚåžĞ±ƐϱƣžĞĻďƐ ±åžƒĚåžĞ±ƐϱƣžĞĻďƐ
thesia and painful ķ±ĮƐŤ±Ź±åžƒĚåžĞ±Ɛ ďŹå±ƒåŹƐƒĚ±ĻƐķĞĻĝ ĞĻ±ÆĞĮЃDžƐƒŇƐŤåŹĝ ĞĻ±ÆĞĮЃDžƐƒŇƐŤåŹüŇŹķƐ
neuropathy) ϱƣžĞĻďƐĻŇƐŇŹƐķĞĻĝ Ğķ±ĮƐĞĻƒåŹüåŹåĻÏåƐ üŇŹķƐƣžƣ±ĮƐžŇÏбĮƐ ƱžĞÏƐžåĮüĝϱŹåƐ
Ğķ±ĮƐĞĻƒåŹüåŹåĻÏåƐ ƾЃĚƐƣžƣ±ĮƐžŇÏбĮƐ ±ĻÚƐüƣĻσĞŇĻ±ĮƐ üƣĻσĞŇĻž
ƾЃĚƐƣžƣ±ĮƐžŇÏбĮƐ ±ĻÚƐüƣĻσĞŇĻ±ĮƐ ±ÏƒĞƽЃĞåž
±ĻÚƐüƣĻσĞŇĻ±ĮƐ ±ÏƒĞƽЃĞåž
±ÏƒĞƽЃĞåž
Monitor. If symp- Stop Cs and Stop Cs and Lzd. Stop Cs and Lzd.
toms improve Lzd (high dose If symptoms If symptoms
after 2 weeks, H). If symptoms improve after improve after 2
consider restarting resolve after 2 2 weeks con- weeks consider
Action these drugs. weeks, consider sider restarting restarting
restarting Cy- Cycloserine. Cycloserine.
Consider restart-
closerine.
ing Lzd at a lower Do not reintro- Do not reintro-
dose. Do not reintro- duce Lzd. duce Lzd.
duce Lzd.

350 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Symptomatic relief for peripheral neuropathy:

ƽ cŇĻĝžƒåŹŇĞÚ±ĮƐ ±ĻƒĞĝĞĻā±ķķ±ƒŇŹDžƐ ÚŹƣďž or acetaminophen helps alleviate

symptoms.

ƽ Tricyclic antidepressants have also been used successfully. Start amitriptyline

25 mg at bedtime. The dose should be increased to a maximum of 150 mg daily
for refractory symptoms.

ƽ CarbamazepineMWIǺIGXMZIMRVIPMIZMRKTEMRERHSXLIVW]QTXSQWSJTIVMTLIVEP
neuropathy.

2. Myelosuppression
Possible anti-TB drug causes: Lzd, Cfz,

NOTE:
If possible, the co-administration of amitriptyline and Lzd should be avoided due to poten-
tial risk of serotonergic syndrome. Symptoms of serotonergic syndrome include high body
XIQTIVEXYVIEKMXEXMSRMRGVIEWIHVIǼI\IWXVIQSVW[IEXMRKHMPEXIHTYTMPWERHHMEVVLSIE

Table 15.6: Grading Myelosuppression

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life

Moderate threatening
Absolute neutro- ŐǑǑǑƐôƐŐƗǑǑx ƆĂǑƐôƐŁŁŁxƐķķƗ ĂǑǑƐôƐƆċŁxķķƗ ĴƐĂǑǑxƐķķƗ
phil count ķķƗ
Haemoglobin*6 ŐǑũĂƐĝƐŁũĂƐďxÚX ŁũċƐĝƐíũǑƐďxÚX ƆũŁƐĝƐƌũĂƐďxÚX ĴƐƌũĂƐďxÚĮ
Platelets de- ŐǑǑũǑǑǑĝ ĂǑũǑǑǑĝŁŁũŁŁŁx ƞĂũǑǑǑĝċŁũǑǑǑxķķƗ ĴƞĂũǑǑǑxķķƗ
creased ŐƞċũŁŁŁxķķƗ ķķƗ
WBC decreased ƞũǑǑǑĝƞũĂǑǑx ŐũĂǑǑĝŐũŁŁŁxķķƗ ŐũǑǑǑĝŐũċŁŁxķķƗ ĴŐũǑǑǑxķķƗ
ķķƗ
Monitor careful- Monitor carefully, Stop Lzd imme- Stop Lzd
ly, and consider and consider re- diately. Restart immediately.
reduction of duction of dose at reduced dose Consider hae-
dose of Lzd of Lzd to 300mg once toxicity has motransfusion
(300mg daily or daily; decreased to or erythropoi-
600 mg thrice Grade 1. etin. Restart at
In case of Grade
weekly) reduced dose
Action 2 neutropenia, once toxicity
stop Lzd imme- has decreased
diately. Restart to Grade 1.
at reduced dose
once toxicity has
decreased to
Grade 1.

5
Hemoglobin should be interoperated with baseline hemoglobin value

Integrated Guideline for Tuberculosis, 351

Leprosy and Lung Disease | 2021
 Prolonged QTcF Interval
Possible anti-TB drug causes: Bdq, Mfx, Lfx, Cfz

Possible other causes:

ƽ 2ER] SXLIV HVYKW GER GEYWI 68 TVSPSRKEXMSR  IV]XLVSQ]GMR GPEVMXLVSQ]GMR

UYMRMHMRIOIXSGSRE^SPIǼYGSRE^SPIERXMTW]GLSXMGWLEPSTIVMHSPGLPSVTVSQE^MRI
risperidone, methadone and anti-nausea drugs that include ondansetron/
granisetron, domperidone,

 ,IRIXMGGEYWIWWYGLEWPSRK68W]RHVSQI L]TSXL]VSMHMWQ

Figure 15.3: Normal vs Prolonged Q-T intervals6

Note:Ɛ‰ĚåƐ}‰ƐĞĻƒåŹƽ±ĮƐĞžƐķ属ƣŹåÚƐüŹŇķƐƒĚåƐÆåďĞĻĻĞĻďƐŇüƐ}ĝƾ±ƽåƐƒŇƐƒĚåƐåĻÚƐŇüƐƒĚåƐ‰Ɛƾ±ƽåũƐFƒžƐ
ÚƣŹ±ƒĞŇĻƐƽ±ŹĞåžƐÚåŤåĻÚĞĻďƐŇĻƐƒĚåƐĚå±ŹƒƐŹ±ƒåũƐFƒžƐķ属ƣŹåķåĻƒƐķƣžƒƐÆåƐÏŇŹŹåσåÚƐ±ÏÏŇŹÚĞĻďƐ
ƒŇƐ ƒĚåƐ Ěå±ŹƒƐ Ź±ƒåũƐ FƒƐ ĞžƐ ŹåÏŇķķåĻÚåÚƐ ƒŇƐ ƣžåƐ ƒĚåƐ 8ŹåÚåŹĞÏбƐ ķåƒĚŇÚƐ ƒŇƐ ϱĮÏƣĮ±ƒåƐ ƒĚåƐ }‰Ï8Ɛ
Ŧ{̱Źķ±ÏDžũƣķ±ŹDžĮ±ĻÚũåÚƣŧ

8EFPI68G+5VSPSRKEXMSR QW,IRHIVGYXSǺW

QTc Prolongation (ms) Normal Borderline Abnormal

Men Ƿ 431- 450 >450
Women Ƿ 451-470 >470

352 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Table 15.8: Grading of prolonged QT interval

Grade 1: Mild Grade 2: Mod- Grade 3: Severe Grade 4: Life-threat-

erate ening
Prolongation of
žDžķŤƒŇķ±ƒĞÏØƐ
žDžķŤƒŇķ±ƒĞÏØƐ
žDžķŤƒŇķ±ƒĞÏØƐ }‰Ï8Ɛĕ÷ƐĂǑŐķžƐŇŹƐƐĕƐ
QTcF }‰Ï8ƐċĂǑƐôƐċíǑƐķžƐ }‰Ï8ƐċíŐƐôƐĂǑǑƐ }‰Ï8Ɛĕ÷ƐĂǑŐƐķžƐ ƌǑƐķžƐÏ̱ĻďåƐüŹŇķƐ
ķž ƾЃĚŇƣƒƐžĞďĻžx ƱžåĮĞĻåƐ±ĻÚƐŇĻåƐŇüƐ
kƐFĻÏŹå±žåƐ
žDžķŤƒŇķžƐŇüƐžåŹĞĝ ƒĚåƐüŇĮĮŇƾĞĻď×Ɛ‰ŇŹž±ÚåƐ
ĞĻƒåŹƽ±ĮƐ< 0.03 žåÏƐ kƐFĻÏŹå±žåƐĞĻƐ
ŇƣžƐ±ŹŹĚDžƒĚķб ÚåƐŤŇĞĻƒåžƐŇŹƐŤŇĮDžĝ
±ÆŇƽåƐƱžåĮĞĻå ĞĻƒåŹƽ±ĮƐǑũǑƗôƐ
ķŇŹŤĚĞÏƐƽåĻƒŹĞÏƣĮ±ŹƐ
ǑũǑĂƐžåÏƐ±ÆŇƽåƐ kƐFĻÏŹå±žåƐĞĻƐ
ƒ±ÏĚDžϱŹÚбƐŇŹƐžĞďĻžx
ƱžåĮĞĻå ĞĻƒåŹƽ±ĮƐdzƐǑũǑƌƐžåÏƐ
žDžķŤƒŇķžƐŇüƐžåŹĞŇƣžƐ
±ÆŇƽåƐƱžåĮĞĻå
±ŹŹĚDžƒĚķб
Monitor more Monitor more Stop the sus- Stop the suspect-
closely; at least closely; at least pected causative ed causative drug.
Action
weekly ECG weekly ECG drug. Hospitalize Hospitalize and
until QTcF has until QTcF has and replete elec- replete electrolytes
returned to grade returned to trolytes as neces- as necessary.
1 or less. grade 1 or less. sary.

Suggested Management strategy

1. Checking and eplenishing serum electrolytes

ƽ IVYQ TSXEWWMYQ 0 MSRM^IH GEPGMYQ MSRM^IH (E ERH QEKRIWMYQ 2K
should be obtained in the event a prolonged QT interval is detected.

ƽ 8LIGEYWISJEFRSVQEPIPIGXVSP]XIWWLSYPHFIGSVVIGXIH

ƽ ;LIRIZIVEPS[TSXEWWMYQMWHIXIGXIHMXWLSYPHXVMKKIVYVKIRXQEREKIQIRX[MXL
replacement and frequent repeat potassium testing (often daily or multiple times
a day) to correct the levels of potassium.

ƽ .J TSXEWWMYQ MW JSYRH PS[ EP[E]W GLIGO QEKRIWMYQ ERH MSRM^IH GEPGMYQ ERH
compensate as needed. (If unable to check, consider oral empiric replacement
doses of magnesium and calcium).

4. Optic Neuritis
Possible anti-TB drug causes: Lzd, E

Table 15.9: Grading of optic neuritis

Grade 1 Mild Grade 2 Grade 3 severe Grade 4 life-

Moderate threatening
Visual changes šĞžƣ±ĮƐÏ̱ĻďåžƐ šĞžƣ±ĮƐÏ̱ĻďåžƐ šĞžƣ±ĮƐÏ̱ĻďåžƐ %Ğž±ÆĮĞĻďƐƽĞžƣ±ĮƐ
(from baseline) ϱƣžĞĻďƐķĞĻĞķ±ĮƐ ϱƣžĞĻďƐďŹå±ƒåŹƐ ϱƣžĞĻďƐĞĻ±ÆĞĮЃDžƐ ĮŇžž
ŇŹƐĻŇƐĞĻƒåŹüåŹåĻÏåƐ ƒĚ±ĻƐķĞĻĞķ±ĮƐ ƒŇƐŤåŹüŇŹķƐ
ƾЃĚƐƣžƣ±ĮƐžŇÏбĮƐ ĞĻƒåŹüåŹåĻÏåƐƾЃĚƐ ƣžƣ±ĮƐžŇÏбĮƐ
±ĻÚƐüƣĻσĞŇĻ±ĮƐ ƣžƣ±ĮƐžŇÏбĮƐ ±ĻÚƐüƣĻσĞŇĻ±ĮƐ
±ÏƒĞƽЃĞåž ±ĻÚƐüƣĻσĞŇĻ±ĮƐ ±ÏƒĞƽЃĞåž
±ÏƒĞƽЃĞåž

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 Action Stop LZD Stop LZD Stop LZD Stop LZD
immediately if immediately if immediately if immediately if
there are any there are any there are any there are any
suspicion of suspicion of optic suspicion of optic suspicion of
optic neuritis. Do neuritis. Do not neuritis. Do not optic neuritis. Do
not restart. restart. restart. not restart.

Suggested management strategy

ƽ )SRSXVIWXEVXXLIWYWTIGXIHGEYWEXMZIHVYK 1MRI^SPMHSV*XLEQFYXSP

ƽ 7IJIVTEXMIRXWXSERSTLXLEPQSPSKMWXJSVJYVXLIVIZEPYEXMSRERHQEREKIQIRX

ƽ 4TXMGRIYVMXMWKIRIVEPP]MQTVSZIWJSPPS[MRKGIWWEXMSRSJSǺIRHMRKHVYKMJMXGER
be stopped early enough.

5. Hepatitis
Possible anti-TB drug causes: H, R, Z, Bdq,

Table 15.10: Grading of Hepatitis

Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life

threatening

ALT (SGPT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

AST (SGOT) ŐũƞĂƐôƐƞũĂƐDŽƐŽXc ƞũƌƐôƐĂũǑƐDŽƐŽXc ĂũŐƐôƐŐǑũǑƐDŽƐŽXc ĕƐŐǑũǑƐDŽƐŽXc

Continue treatment Continue treat- Stop all drugs, Stop all drugs,
regimen. Patients ment regimen. including anti-TB including anti-TB
should be followed Patients should drugs; measure drugs; measure
until resolution (re- be followed until LFTs weekly. LFTs weekly.
turn to baseline) or resolution (return Treatment may Treatment may
ACTION stabilization of AST/ to baseline) or sta- be reintroduced be reintroduced
ALT elevation. bilization of AST/ after toxicity is after toxicity is
ALT elevation. resolved. resolved.

Suggested management strategy

Reintroduce anti-TB drugs once liver enzymes return to normal level. Anti-TB drugs
should be reintroduced in a serial fashion by adding a new medicine every three to four
days. The least hepatotoxic drugs while monitoring liver function tests after each new
exposure.

(SRWMHIVWYWTIRHMRKXLIQSWXPMOIP]SǺIRHMRKHVYKTIVQERIRXP]MJMXMWRSXIWWIRXMEPXS
XLIVIKMQIR8LMWMWSJXIRXLIGEWIJSVT]VE^MREQMHIMJMXMWPIWWPMOIP]XSFIIǺIGXMZIF]
clinical history.

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6. Hearing Impairment
Possible anti TB drugs causing hearing impairment: Km, Am, Cm.

Table 15.11: Grading Hearing impairment

Grade 0: Grade1: Slight Grade 2: Grade 3: Grade 4:

None Moderate Severe Profound
Decibel (dB) ƞĂƐÚƐŇŹƐĮåžž ƞƌĝċǑƐÚ ĚĞĮÚĝƐƐƗŐĝƌǑƐÃÚ ƌŐĝíǑƐÚ ĕíǑƐÚ
range
ÚƣĮƒĝƐċŐĝƌǑÃƐÚ
Severity No/ Slight Hears/ repeats Hears/ repeats Hears words cannot hear/
problems words in normal words in raised shouted into understand
Hears voice at 1 meter voice at 1 meter better ear shouted voice
Whispers

ÉĚåƐÚåžxžåƽåŹĞƒDžƐŇüƐĚå±ŹĞĻďƐĮŇžžƐĞžƐ±ĮžŇƐϱƒåďŇŹĞǍåÚƐÚĞýåŹåĻƒĮDžƐüŇŹƐÚĞýåŹåĻƒƐ±ďåƐďŹŇƣŤžƐ
ŦžååƐ±ĻĻåDŽŧũ

Suggested management strategy:

Perform a monthly assessment of hearing loss and balance. Audiometry is helpful in

detecting early high-frequency hearing loss that the patient may not even be aware of.
If the patient is experiencing hearing loss, stop the injectable and replace it with a non-
ototoxic drug. Even when non-ototoxic drugs are not available, stopping the injectable
can be considered based on the patient’s desire to maintain hearing. If moderate or
severe vertigo, tinnitus (ringing in the ears) or vestibular disturbances arise, with or without
WMKRMǻGERXLIEVMRKPSWWGSRWMHIVHIGVIEWMRKJVIUYIRG]SVWXSTTMRKXLIMRNIGXEFPIEKIRX

 &GYXI0MHRI].RNYV]+EMPYVI
Possible anti-TB drug causes: Aminoglycosides (Km, Am, Cm)

Table 15.12: Grading Acute kidney injury/Failure

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life

Moderate threatening
Acute Kidney GFR= 60-89 mL/ GFR= 45-49 mL/ GFR= 30-44 mL/ GFR= 15-29 mL/
Injury/ Chronic min min min min and <15 mL/
Kidney Disease min
Consider stopping Stop injectable Stop injectable Stop injectable
injectable until until creatinine until creatinine until creatinine
creatinine has has returned to has returned to has returned to
Action returned to baseline. baseline. baseline.
baseline. Consider Consider Consider
Consider restarting the restarting the restarting the
restarting the injectable at injectable at injectable at
injectable at lower frequency lower frequency lower frequency
lower frequency OR substitute OR substitute OR substitute
(e.g. MWF). with a non- with a non- with a non-
nephrotoxic drug nephrotoxic drug nephrotoxic drug
ÃƐ‰ĚåƐÆ垃Ɛķ属ƣŹåƐŇüƐīĞÚĻåDžƐüƣĻσĞŇĻƐĞžƐ:ĮŇķåŹƣĮ±ŹƐ8ĞĮƒŹ±ƒĞŇĻƐ±ƒåƐŦ:8ŧũƐ

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 Suggested management strategy:

Monitor serum creatinine and electrolytes frequently in patients receiving injectable.

Patients with pre-existing kidney disease, diabetes, or HIV are at high risk of injectable
nephrotoxicity and may be monitored more frequently.

Repeat electrolytes if necessary:

Injectable nephrotoxicity may be associated with injectable-induced electrolyte

wasting. For example, it is possible to see elevated creatinine and severe hypokalaemia/
hypomagnesemia at the same time. The aetiology of this phenomenon is unclear, but
it may occur more often in HIV co-infected patients. Discontinue the suspected drug
(usually the injectable). If the acute renal failure is severe, then stop all drugs. Follow
serum creatinine and electrolytes closely until the creatinine has returned to baseline
or has stabilized. Consider strict weight-based dosing of the injectable if the patient’s
weight is less than 50 kg. Suspend the injectable permanently if the nephrotoxicity recurs
despite intermittent dosing, and add additional anti-TB drugs to reinforce the regimen.

9. Hypokalemia
Possible anti-TB drug causes: Cm, Km, Am

Table 15.13: Normal values of potassium level and quantity of KCL required

Potassium level Normal value (3.5-5.0 Meq/L) Quantity of KCl

3.7 or more None
3.4-3.6 40 meq
3.0-3.3 60 meq
2.7-2.9 80 meq
2.4-2.6 80 -120 meq
2.0-2.3 60 meq IV and 80 meq PO
<2.0 60 meq IV and 100 meq PO

Table 15.14: Grading Hypokalaemia

Grade 1: Mild Grade 2: Grade 3: Severe Grade 4: Life

Moderate threatening
Hypokalaemia 3.4 - 3.0mmol/L 2.9 – 2.5 2.4 - 2.0 mmol/L < 2.0 mmol/L or
mmol/L or intensive abnormal potassium
replacement with paresis, ileus
therapy or or life-threatening
hospitalization arrhythmia
required

356 Integrated Guideline for Tuberculosis,

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 Continue Continue Consider stopping Stop injectable
injectable. injectable. the injectable temporarily.
temporarily.
Start oral Start Start IV potassium
Action
potassium aggressive Start IV potassium replacement therapy
replacement oral replacement in addition to oral.
therapy. potassium therapy in
Replace magnesium
replacement addition to oral.
Check serum and other electrolytes
therapy.
magnesium Replace as necessary.
and replace if Replace magnesium and
necessary magnesium other electrolytes
as necessary. as necessary.

8EFPIMHI*ǺIGXW7IPEXIHXS8')VYKWERH+SSH.RXEOI7IGSQQIRHEXMSRW

Food
Drug name Avoid 5SWWMFPIWMHIIǺIGXW
recommendation

To be taken I hr
Rifampicin before or 2 after food. Alcohol Nausea, vomiting, appetite loss
I hr before antacids
Taken 1 hr before or 2
Hepatotoxicity, Cutaneous,
Isoniazid hrs after food. Give B6 Alcohol
hypersensitivity, Peripheral Neuropathy
Supplement daily
To be taken with food Avoid
Ethambutol Arthralgia, Retro bulbar neuritis.
A alcohol
May be taken with Hepatotoxicity, Arthralgia, Nausea,
Pyrazinamide
food Vomiting
Take with or after
4ǼS\EGMR meals (Supplement Alcohol Abdominal discomforts, nausea
with Vit B6)
Ototoxicity: hearing damage, vestibular,
Can be taken without
Kanamycin (Km) disturbance, Nephrotoxicity: deranged
regard to food
renal function test
.RGVIEWIǼYMHMRXEOI
Ototoxicity: hearing damage, vestibular,
take with foods
Capreomycin disturbance, Nephrotoxicity: deranged
high in potassium
renal function test
(bananas, avocados)
Take with or
Paraaminosalicylic immediately after Gastrointestinal reactions Dizziness,
Alcohol
acid (PAS) JSSH.RGVIEWIǼYMH Headache, Depression, Memory loss
intake
Supplement with Dizziness, Headache, Depression,
Cycloserine Alcohol
vitamin B6 Memory loss
Take with or after
Avoid Abdominal Discomfort, Nausea,
Prothionamide meals (Supplement
Alcohol Vomiting
with Vit.

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 Take with or after Prolonged QT, Hepatotoxicity, Nausea,
Avoid
Bedaquline meals (Supplement vomiting, arthralgia, headache,
Alcohol
with Vit B6). itchiness,
Avoid foods rich in Myelosuppression, Lactic acidosis,
avoid
Linezolid tyramine (fermented optic and peripheral neuropathy, skin
alcohol
meat product, pickles) reaction
Serious Heart rhythm changes Nausea,
Vomiting, Dizziness, Insomnia, Upper
Absorption increased abdominal pain
Delanamide
after a standard meal
Anxiety, paraesthesia

Selected Serious Drug Interactions

Drug to drug interactions (DDIs) has recently received concern and increasingly
reported attention. With new interventions, large number of drugs are manufactured
and introduced into the market space every year, new interactions between medications
RIIHW XS FI QSRMXSVIH ERH VITSVXIH SQI GSQQSR HVYKW LEZI WTIGMǻG HVYKHVYK
interactions that may require dose adjustment or substitution of the ARV or the other
interacting drugs

Table 15.16: An overview of selected serious drug interactions

Antiretroviral Bedaquline Delanamide Rifapentine

Efavirenz Do not co-administer- No interaction No interaction
Reduces BDQ by 50%
Nevirapine No dose adjustment. Not expected Interacts
No dose adjustment
Rilpivirine Not expected Not expected N/A
Lopinavir/Ritonavir Increase BDQ Increase DLM Interacts
exposure: may lead to exposure: clinical
toxicity? relevance

Atazanavir/ritonavir/ No interaction Not studied, no Interacts with

Raltegravir & Dolutegravir expected interaction expected all except
Dolutegravir
Darunavir/ritonavir
Raltegravir No interaction Not studied, no No interaction
expected interaction expected
Dolutegravir

358 Integrated Guideline for Tuberculosis,

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COMMODITY
MANAGEMENT 16

The rational use of medicines, pharmaceutical and non-pharmaceutical including

nutrition commodities, requires that patients receive medicines appropriate to their
clinical needs, in doses that meet their own individual requirements, for an adequate
period of time, and at the lowest cost to them and the community.

Commodity management is a key component of rational drug use. It is the process of

developing a systematic approach to the entire usage cycle for a group of items. It
is used in ensuring that the Right product, of the Right quality, in Right quantities is
delivered at the Right time, at the Right place, to the Right customer.

Figure 16.1: Commodity logistics

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Leprosy and Lung Disease | 2021
 Figure 16.2: Commodity management cycle

+SVIGEWXMRKERH6YERXMǻGEXMSR
This is the process of estimating the quantities of medicines and other commodities
MRGPYHMRK RYXVMXMSREP WYTTSVX XLEX MW VIUYMVIH JSV E WTIGMǻG TIVMSH SJ XMQI MR SVHIV XS
IRWYVI YRMRXIVVYTXIH WYTTP] SJ GSQQSHMXMIW &GGYVEXI JSVIGEWXMRK ERH UYERXMǻGEXMSR
KYEVERXIIW GSQQSHMX] WIGYVMX] XLEX EPPIZMEXIW WLSVXEKIW ERH WXSGOSYXW EǺIGXMRK
WIVZMGI HIPMZIV] 6YERXMǻGEXMSR QIXLSHW MRGPYHI GSRWYQTXMSR FEWIH ERH QSVFMHMX]
based method.

 6YERXMǻGEXMSRQIXLSHWYWIHMR8'GSQQSHMXMIW
16.2.1 Consumption method
The consumption-based method uses historical data on the actual medicines dispensed
to patients to calculate the quantity of medicines that will be needed in the future. When
YWMRKXLIGSRWYQTXMSRQIXLSHJSVUYERXMǻGEXMSRSYXSJWXSGOTIVMSHWQYWXFIEHNYWXIH
in the calculation

16.2.2 Morbidity method

The morbidity-based method uses data about diseases and the frequency of their
occurrence in the population (incidence or prevalence) or the frequency of their
presentation for treatment.

360 Integrated Guideline for Tuberculosis,

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8LMW QIXLSH JSVIGEWXW XLI UYERXMX] SJ HVYKW RIIHIH JSV XLI XVIEXQIRX SJ WTIGMǻG
diseases, based on projections of the incidence of those diseases.

16.2.3 Flow of Logistics

TB commodities are ordered anytime for DRTB patients with drugs delivered in 48hours
by courier. The Facility consumption data report and request (FCDRR) tool is used for
GSQQSHMX]VITSVXMRKERHVIUYIWXMRK5PIEWIVIJIVXSǼS[GLEVXFIPS[

+MKYVIWLS[WXLIPSKMWXMGQEREKIQIRXMRJSVQEXMSRERHGSQQSHMX]ǼS[

16.3 Reasons for accounting for TB commodities

.XMWIWWIRXMEPJSVEPP8'GSQQSHMXMIWXSFIYXMPM^IHTVYHIRXP]EWIǺIGXMZIQEREKIQIRX
of commodities enables;

ƽ &GGYVEXIP]HIXIVQMREXMSRSJRIIHW

ƽ 5VIZIRXMSRSJWXSGOSYXW

ƽ 5VIZIRXMSRSJI\TMVMIW

ƽ 2MRMQM^EXMSRSJ[EWXEKI

ƽ 5VIZIRXMSRSJTMPJIVEKI

ƽ YWXEMREFPIJYRHMRKƲ

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 16.4 Stock keeping records
ƽ )IPMZIV]3SXIW&HSGYQIRXXLEXEGGSQTERMIWEWLMTQIRXSJKSSHWERHTVSZMHIW
a list of the products and their quantities

ƽ 'MRGEVHWƳ8LMWMWWXSVIƶWVIGSVHGEVHSJUYERXMXMIWSJETEVXMGYPEVGSQQSHMX]XLEX
records the quantities received, issued and balances the stocks of the commodity.

ƽ ƳMWEJSVQYWIHXSSVHIVEGSQQSHMX]JVSQXLIWXSVIXSTLEVQEG]SV
dispensing room. S12 is a form used to order a commodity from the warehouse to
the health facility store.

ƽ )EMP]EGXMZMX]VIKMWXIVWIK&1VIKMWXIVERH8EPP]WLIIXW

ƽ 47+-IEPXLJEGMPMX]QSRXLP]WYQQEVMIW

5EXMIRXTEGOERHWYTTP]FS\QEREKIQIRX
ƽ 5EXMIRX5EGO
A patient pack is the one every newly diagnosed DS-TB adult patient is allocated.
This pack contains the drugs the patient will use for the entire duration of TB
treatment. This pack should be titrated to ensure that it has the correct amount
of drugs that is equal to the duration that the patient will be on treatment. The
titration is done based on the patient weight at diagnosis and during the course
of treatment. If there are excess drugs following titration, these should be put
MRXS XLI WYTTP] FS\ .J XLIVI MW E HIǻGMX MR XLI TEXMIRX TEGO JSPPS[MRK XMXVEXMSR
the short fall is picked from the supply box. The adult patient pack contains 168
tablets of RHZE and 336 tablets of RH.

ƽ YTTP]'S\
The supply box is the one that contains TB drugs that are either an excess from
XLITEXMIRXTEGOSVXSFIYWIHXSǻPPXLIHIǻGMXMRXLITEXMIRXTEGO8LIWYTTP]FS\
can be used to provide drugs for patients on transit or to create a patient pack
in-case of drug shortages.

+SVTYVTSWIWSJXVEGOMRKSRILEWXSMRTYXXLIǻKYVIWSJHVYKWGSQMRKMRXSERH
leaving the supply box in the DAR for TB drugs.

362 Integrated Guideline for Tuberculosis,

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PATIENT SUPPORT,
HUMAN RIGHTS AND
SOCIAL PROTECTION
17

17.1 Introduction
The WHO End TB Strategy sets the required
interventions to end the global TB epidemic by
2035. Pillar one of the strategy adopts a patient- 1. Universal Health Coverage in TB,
Leprosy and Lung Health
centered approach that recognizes the individual
[LSMWWMGOEWXLIHMVIGXFIRIǻGMEV]SJ8'GEVIERH 2. Social protection through
strategies must be designed with this individual’s universal health coverage,
nutrition and human rights
rights and welfare in mind. The strategy, under Pillar
2 on Bold policies and supportive systems, places 3. Key social support
emphasis on ending TB through addressing social recommendations
determinants of TB, including poverty alleviation 4. Human Rights and TB, Leprosy
policies and social protection programs and putting and lung disease
Universal Health Coverage policies in place. The a. A rights-based approach to TB
National Strategic Plan for TB, Leprosy and Lung
b. Gender related barriers to TB
Disease (2019-2023) advocates for a more patient-
services
centred focus. Patient support includes support
from community and family members, health care c. The Constitution of Kenya and
protection of human rights
workers and from the health care system through
information, referral linkages, supplies of patient d. Human Rights and Unequal
commodities (nutritional commodities, medicines Access to TB Care and
Treatment
and equipment).
e. Criminalization of TB Status:
Involuntary Treatment,
Isolation, Detention and
Incarceration

f. Patients’ charter for

tuberculosis care

g. Guiding principles for

implementing TB control
activities at the workplace.

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 17.2 Universal Health Coverage in TB, Leprosy & Lung
Health
9RMZIVWEP -IEPXL (SZIVEKI 9-( MW HIǻRIH EW IRWYVMRK XLEX EPP TISTPI LEZI EGGIWW
XS XLI RIIHIH LIEPXL WIVZMGIW SJ WYǽGMIRX UYEPMX][LMPI EPWS IRWYVMRK XLEX XLI YWI SJ
XLIWIWIVZMGIWHSIWRSXI\TSWIXLIQXSǻRERGMEPLEVHWLMTW8LI,SZIVRQIRXSJ0IR]E
is committed to attaining UHC by 2021 through expansion of the population covered
with essential health services, strengthening and broadening the primary health care
system, increasing health resource base and leveraging on information technology.

Together with other United Nations member states, Kenya is working toward worldwide
universal health coverage by the year 2030.

KEY HIGHLIGHTS:

ƽ 9RMZIVWEP-IEPXL(SZIVEKILEWFIIRTMPSXIHMRGSYRXMIW .WMSPS0MWYQY3]IVM
and Machakos.

ƽ 8LI,SZIVRQIRXSJ0IR]EMWGSQQMXXIHXSEXXEMRMRK9-(F]XLVSYKL
expansion of the population covered with essential health services,
strengthening and broadening the primary health care system, increasing
health resource base and leveraging on information technology.

ƽ &WYVZI]GSRHYGXIHF]XLI3EXMSREP8'TVSKVEQMRJSYRHXLEX 
SJ8'EǺIGXIHLSYWILSPHWMRGPYHMRK SJ)78'EǺIGXIHLSYWILSPHW
experienced catastrophic cost.

17.2.1 Strategies towards Implementing UHC

1. Strengthening health systems in Kenya: Pooling of funds from NHIF in order to
WTVIEHXLIǻRERGMEPVMWOWSJMPPRIWWEGVSWWETSTYPEXMSR

2. Availability, accessibility and capacity building of health workers to deliver quality

people-centered integrated care.

3. Investing in primary health care which has been known to be the most cost
IǺIGXMZI[E]XSEGGIWWMRKIWWIRXMEPLIEPXLGEVI

4. Good governance, sound systems of procurement and supply of medicines,

health technologies, well-functioning health information systems and other
critical elements.

8LILIEPXLWIGXSVLEWMHIRXMǻIHXLIJSPPS[MRK9-(SFNIGXMZIW

1. Progressively increase the number of Kenyans accessing essential health services

 5VSKVIWWMZIP] I\TERH XLI WGSTI SJ XLI LIEPXL FIRIǻX TEGOEKI XLEX [MPP FI
accessible to all Kenyans

364 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 3. Increase the number of Kenyans covered under prepaid mechanisms (such as
health insurance, subsidies, direct government funding) to access health services

4. Increase the availability of quality essential interventions

5. Protect Kenyans from catastrophic health expenditures, and in particular the poor
and vulnerable groups

 *RLERGIIUYMX]ERHIǽGMIRG]MREPPSGEXMRKERHYWMRKVIWSYVGIW

7. Provision and maintenance of adequate health resources that will be appropriate

for the delivery of health services

8. Strengthen leadership and governance within the health sector

17.2.2 UHC and primary health care

Primary health care is an approach to health and wellbeing centered on the needs and
circumstances of individuals, families and communities. It addresses comprehensive
and interrelated physical, mental and social health and wellbeing. Primary health care
MWXLIQSWXIǽGMIRXERHGSWXIǺIGXMZI[E]XSEGLMIZIYRMZIVWEPLIEPXLGSZIVEKIEVSYRH
the world.

17.2.2.1 Key components to address at primary health care delivery

level:
i) Ensuring TB, Leprosy and other lung disease patients’ Ěå±ĮƒĚƐ ŤŹŇÆĮåķžƐ ±ŹåƐ
±ÚÚŹåžžåÚƐ ƒĚŹŇƣďĚƐ ÏŇķŤŹåĚåĻžĞƽåƐ ŤŹŇķŇƒĞƽåØƐ ŤŹŇƒåσĞƽåØƐ ŤŹåƽåĻƒĞƽåØƐ ÏƣŹ±ƒĞƽåØƐ
Źå̱ÆĞĮЃ±ƒĞƽåØƐ±ĻÚƐŤ±ĮĮбƒĞƽåƐcare throughout the life course, strategically prioritizing
key system functions aimed at individuals and families and the population as the
central elements of integrated service delivery across all levels of care;

ii) „Džžƒåķ±ƒĞϱĮĮDžƐ ±ÚÚŹåžžĞĻďƐ ƒĚåƐ ÆŹŇ±ÚåŹƐ ÚåƒåŹķĞĻ±ĻƒžƐ ŇüƐ Ěå±ĮƒĚ (including social,
economic, environmental, as well as people’s characteristics and behaviours)
through evidence-informed public policies and actions across all sectors; and

iii) )ķŤŇƾåŹĞĻďƐ ĞĻÚĞƽĞÚƣ±ĮžØƐ ü±ķĞĮĞåžØƐ ±ĻÚƐ ÏŇķķƣĻЃĞåž to optimize their health, as

advocates for policies that promote and protect the health and wellbeing, as
co-developers of health and social services through their participation, and as
self-carers and care-givers to others.

17.2.3 Role of counties in UHC

17.2.3.1 Planning for UHC

1. Ensure TB, leprosy and lung health are prioritized in the county integrated
development plan as part of county health systems strengthening to align to
UHC.

2. Develop roadmaps and annual work plans which incorporate TB, leprosy and lung
disease for UHC implementation for their respective counties. This should take

Integrated Guideline for Tuberculosis, 365

Leprosy and Lung Disease | 2021
 into account the planning horizon with regards to human resources and physical
infrastructure.

3. 5YXMRTPEGI[IPPHIǻRIHUYEVXIVP]MQTPIQIRXEXMSRTPERJSV8'PITVSW]ERHPYRK
disease.

4. Plan for and carry out annual and quarterly TB, leprosy and lung disease quarterly
review meetings and Rapid Response Initiative (RRI) reviews.

5. Develop learning platforms through collecting data and information on TB,

leprosy and lung disease for assessing the changes and impacts from the
implementation.

6. Review and strengthen the county referral systems for the TB, leprosy and Lung
HMWIEWITVSKVEQXSVIHYGIMRǼY\XSXLILMKLIVPIZIPJEGMPMXMIW

7. Put in place a clear guide and enforce the gatekeeping mechanism on TB, leprosy
ERHPYRKHMWIEWITEXMIRXWƶVMKLXWSRVIJIVVEPTVSGIWWIWXSEZSMHLMKLMRǼY\MR1IZIP
4 facilities as per the referral strategy.

8. Set up M&E units for TB, leprosy and lung disease within the Counties; put in
place strong expertise on M&E for the implementation of plans, for example
through RRIs, as well as collecting data/information for assessing the changes
and impacts from the implementation.

17.2.3.2 Communication for UHC

1. Create public awareness on the importance of taking care of one’s health
especially on patients who have developed signs and symptoms for TB, leprosy
and lung disease.

 (VIEXI TYFPMG HIQERH XS EGGIWW UYEPMX] ERH EǺSVHEFPI 8' PITVSW] ERH PYRK
health services.

3. Create public awareness on their right to health and the responsibility for their
own health including the importance of paying for national health insurance.

 )IZIPST45WSRERHXVEMRLIEPXLWIGXSVSǽGMEPWERHLIEPXLTVSZMHIVWSRLS[XS
respond to public and media concerns and/or allegations. Public communication
at the time of crisis should be done in a timely and transparent manner with
empathy.

5. Improve communication skills while providing TB, leprosy and lung disease
services

6. Communicate with all actors in a manner that they understand their rights,
VIWTSRWMFMPMXMIWERHSTTSVXYRMXMIWXSQE\MQM^IXLIFIRIǻXWSJ9-(

7. Strengthen public understanding of and demand for UHC by communicating

what achieving this goal would mean for individuals and communities; create
opportunities for citizens and communities to hold their leaders accountable.

8. Set up a structured system for TB, leprosy and lung disease patients channeling
their complaints, and receiving feedback on time.

366 Integrated Guideline for Tuberculosis,

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 9. Provide learning initiatives such as training and exchange visits to help counties
bridge communications gaps and reinforce UHC reform objectives.

10. Initiate messages and communicate through: billboards; radio; stories and
information on mass media (radio, newspaper, TV, etc.); and pamphlets for mass
distribution.

17.2.3.3 Expansion of the population covered by prepaid mechanisms

(subsidies, direct funding, insurance)
1. Provide TB and leprosy services at no cost to all the populations in L1 to L5 with
EZMI[XSIRWYVMRKǻRERGMEPTVSXIGXMSR

2. Strengthen advocacy, communication and social mobilization on the uptake of

health insurance for TB, leprosy and lung health services.

3. Encourage enrolment of households into a health insurance scheme with focus

SRSǺIVMRKWYFWMHMIWXSXLITSSVERHXLIZYPRIVEFPI

4. Institutionalize the biannual household registration including social mapping by

CHVs as prescribed in the Community Health Strategy.

5. Implement a standard incentive package for CHVs

17.2.3.4 Monitoring and evaluation

1. Collect and report TB, leprosy and lung disease statistics on DHIS and other
national reporting platforms

 7IKYPEVP]YTHEXIGSYRX]WTIGMǻGHEWLFSEVHWXSWLS[TVSKVIWW

3. Document and share best practices in TB, leprosy and lung disease for mutual
learning and replication

4. Continuously assess readiness and monitor improvement in preparedness to

deliver TB, leprosy and lung health services.

17.3 Social Protection

17.3.1 Background
8LI .RXIVREXMSREP 1EFSV 4VKERM^EXMSR HIWGVMFIW WSGMEP TVSXIGXMSR EW ƸREXMSREPP] HIǻRIH
sets of basic social security guarantees which secure protection aimed at preventing or
EPPIZMEXMRK TSZIVX]ZYPRIVEFMPMX] ERH WSGMEP I\GPYWMSRƹ8LMW HIǻRMXMSR GSZIVW TVSXIGXMSR
against:

ƽ ,IRIVEPTSZIVX]ERHWSGMEPI\GPYWMSR

ƽ 1EGOSJEǺSVHEFPIEGGIWWXSLIEPXLGEVI

ƽ 1EGOSJPEFSVQEVOIXTVSXIGXMSRW

ƽ 1EGOSJ[SVOVIPEXIHMRGSQI

Integrated Guideline for Tuberculosis, 367

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 KEY HIGHLIGHTS:

ƽ SGMEPTVSXIGXMSRMWEWIXSJMRXIVZIRXMSRW[LSWISFNIGXMZIMWXSVIHYGIWSGMEP
and economic risk and vulnerability, and to alleviate extreme poverty and
deprivation.

ƽ SGMEPTVSXIGXMSRGSRWMWXWSJTSPMGMIWERHTVSKVEQWHIWMKRIHXSVIHYGITSZIVX]
ERHZYPRIVEFMPMX]F]TVSQSXMRKIǽGMIRXPEFSYVQEVOIXWHMQMRMWLMRKTISTPIƶW
exposure to risks, and enhancing their capacity to manage economic and social
risks, such as unemployment, exclusion, sickness, disability and old age.

ƽ &WYVZI]GSRHYGXIHF]XLI3EXMSREP8'TVSKVEQMRJSYRHXLEX 
SJ8'EǺIGXIHLSYWILSPHWMRGPYHMRK SJ)78'EǺIGXIHLSYWILSPHW
experienced catastrophic cost

In 2017, Kenya’s Division of National TB Leprosy and Lung disease Program (DNTLD-P)
conducted a nationally-representative, health-facility based survey to assess the
magnitude and main drivers of costs incurred by TB patients in Kenya. The survey found
XLEX   SJ8' EǺIGXIH LSYWILSPHW MRGPYHMRK   SJ )78' EǺIGXIH LSYWILSPHW
experienced catastrophic costs. The median total cost borne by patients seeking
diagnosis and treatment per TB episode was Kshs 26,041.49. Median total cost of Kshs
25,874.00 and Kshs 145,109.53 was incurred as a result of an episode DS-TB and DR-TB
respectively. Direct non- medical costs due to nutrition and food supplements accounted
for 68.5% of expenses (Ksh 17,739.71).

8LIWIGSWXWLEZIFIIRMHIRXMǻIHEWFEVVMIVWXSEGGIWWMRKXLIJYPPWGSTISJ8'WIVZMGIW
To get by, 27.8% of TB patients used negative coping mechanisms like taking a loan, use
SJ WEZMRKW ERH WEPI SJ EWWIXW XS QIIX XLI I\TIRWIW 8LMW ǻRERGMEP LEVHWLMT VIWYPXMRK
JVSQHMVIGXERHMRHMVIGXGSWXW[LIREGGIWWMRKLIEPXLGEVIJSV8'QE]EHZIVWIP]EǺIGX
living standards and the capacity of households to pay for basic needs. Further, the
Kenya TB Patient Costs Survey, demonstrated the negative consequences faced by
TB patients including 63 percent lost jobs, nine percent of the household’s children
disrupted school and 36 percent faced social exclusion. These negative consequences
make TB patients less likely to present for care, complete testing, initiate and adhere
to treatment, leading to increased transmission of the disease, morbidity and mortality.

;MXL XLI ǻRHMRKW XLI )381)5 HIZIPSTIH E Ƶ0IR]E SGMEP 5VSXIGXMSR 5SPMG] JSV
Tuberculosis and Leprosy Patients 2018’. The overall goal of the policy is to “Reduce the
TVSTSVXMSRSJEǺIGXIHJEQMPMIW[LSJEGIGEXEWXVSTLMGGSWXWHYIXS8'ERHPITVSW]ƹ8LI
policy recognizes that social protection needs to be an integral part of TB and leprosy
prevention and care to achieve this target. It also proposes a comprehensive integrated
WSGMEPTVSXIGXMSRǼSSVJSVTISTPI[MXL8'ERH1ITVSW]XLEXMRGPYHIWGEWLXVERWJIVWJSSH
assistance, health insurance and advocacy of social security legal frameworks that cover
both formal and informal workers.

The Ministry of Health through DNTLD-P, began enrolling all DR-TB patients to the
National Hospital Insurance Fund (NHIF) scheme in 2017. A total of 310 newly diagnosed
)78' TEXMIRXW MRGPYHMRK QSRS VIWMWXERX 8' TEXMIRXW FIRIǻXXIH JVSQ 3-.+ WSGMEP

368 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
WYTTSVXMR&HHMXMSREPP])48WYTTSVXIVW[IVIWYTTSVXIHXSSǺIVGSQQYRMX]
DOT while 1,160 patients received monthly cash transfers of Ksh. 6,000 in the same year.

17.3.2 Social protection through universal health coverage,

nutrition and human rights
TB treatment is inextricably involved in a host of psychological, social, and economic
problems, these guidelines were developed to help providers establish and enhance
social support services in a TB clinic. The purpose of the guidelines is to help the worker
establish social services, develop a therapeutic alliance with clients, create an intake
form to identify barriers to TB, leprosy and lung disease treatment and formulate goals
to reduce those barriers and to increase client functioning, counsel and help clients
achieve their goals, form support groups, and lead or participate in case management.

Patient support under UHC, nutrition, gender and human rights are therefore aspects
that are cross cutting to ensure a comprehensive approach in the delivery of TB, leprosy
ERHPYRKLIEPXLMRXIVZIRXMSRW8LIETTVSEGLWLSYPHIRWYVIIǽGMIRGMIWERHIǺIGXMZIRIWW
in health programming. It therefore demands and calls for a multidisciplinary and multi-
sectoral collaboration in implementing the interventions.

Social protection for TB and leprosy patients is one way of demystifying the common
belief that these diseases are “poverty disease”. It plays a major role in restoring dignity
of individuals, households and communities and alleviates poverty, vulnerability and
social exclusion for both TB patients and their households.

17.3.2.1 Social Protection: What should a health care worker do?

All TB, leprosy and lung disease patients should be eligible for UHC, Social protection,
nutrition, gender and human rights services. In providing appropriate services, consider
eligibility criteria for the patients to be enrolled for the available support.

Psychosocial support - ongoing counselling for patients (ŹåüåŹƐƒŇƐ̱ŤƒåŹƐŐí×Ɛ
ÚƽŇϱÏDžƐ

±ĻÚƐŇķķƣĻĞϱƒĞŇĻƐüŇŹƐÚ僱ĞĮåÚƐďƣĞÚåĮĞĻåŧERHLSYWILSPHWMHIRXMǻGEXMSRERHVITSVXMRK
SJ EHZIVWI HVYK IǺIGXW8' XVIEXQIRX PMXIVEG] 2SRMXSVMRK ERH VITSVXMRK SJ8' LYQER
rights violations

Mental health - assess patients’ wellbeing and refer for psychological support, link to
social support groups/ structures in the community for adherence counselling, Assess
harmful alcohol and drug use and link for appropriate rehabilitation.

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 Table 171: Key Social Support recommendations of the Guidelines

Patient needs Refer to social protection support Link patient to social support services
MHIRXMǻGEXMSR FEWIHSRMHIRXMǻGEXMSRGVMXIVME
existing
Nutrition Refer to existing nutritional support Link for Supplementary/ therapeutic
Support system: support at facility level
ƽ YTTPIQIRXEV] +SV2SHIVEXI ƽ 1MROERHVIJIVJSVJSSHWIGYVMX] 
Acute Malnutrition) sustenance community systems/
programs e.g. Income Generating
ƽ 8LIVETIYXMGJIIHMRK +SVIZIVI
Activities, Food basket
Acute Malnutrition)
ƽ +SPPS[YTTEXMIRXWJSVTVSKVIWWERH
ƽ +SSHMRWIGYVMX]WYTTSVX
advise accordingly in every facility
(For Households with food
visit or review
insecurity)

Patient Psychological support -: Assess ƽ7IJIVXSETTVSTVMEXIWYTTSVXKVSYTW 

psycho-Social patient for Mental health status ŦƣžåƐ DOTS support
well being ±ŤŤŹŇŤŹĞ±ƒåƐƒŇŇĮžŧ
ƽ (SRWMHIVHMǺIVIRXMEXIHGEVIJSV
ƽ &HLIVIRGIWYTTSVXJSVTEXMIRX patient
and family
ƽ 7IJIVJSVI\TIVXEHZMGIERHJSPPS[
ƽ *ZEPYEXIJSV&HZIVWIHVYK up through a multidisciplinary team
reactions (Psychosis) (MDT)
ƽ &WWIWWERHJSPPS[YTSR ƽ 1MROXSTEXMIRXJEQMP]WYTTSVXKVSYT
Patient/family treatment literacy
ƽ +SPPS[YTTEXMIRXWJSVTVSKVIWWERH
advise accordingly in every facility
visit or review
Patient Social Support: Assess patient for ƽ 7IJIVERHPMROJSVVILEFMPMXEXMSR
psycho-Social social challenges services ensure patient consent and
well being sign on patient consent form
ƽ -EVQJYPHVYKYWIERHEPGSLSP
abuse ƽ 1MROXSETTVSTVMEXITEXMIRXWYTTSVX
groups
ƽ &GGIWWXSWSGMEPYXMPMXMIWIK
proper sanitation such as clean ƽ *RKEKIHMǺIVIRXWXEOILSPHIVW 2YPXM
water, proper housing, etc. sectoral approach)
ƽ (YPXYVEPERHVIPMKMSYWJEGXSVW ƽ YTTSVXGSYRWIPPMRKXSTEXMIRXERH
caregiver/family
ƽ +SPPS[YTTEXMIRXWJSVTVSKVIWWERH
advise accordingly in every facility
visit or review

370 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 Patient ƽ 2IHMGEPGSZIVJSVETTVSTVMEXI ƽ &HZMWISRMRHMZMHYEPTEXMIRX
support health services contributions to health insurances
for Cost or medical schemes for medical
of access services especially for DS TB, leprosy
to health ƽ (EWLXVERWJIVW and lung health services
services ƽ 5EXMIRXFIRIǻXTEGOEKIIK ƽ .QQIHMEXIPMROEKISJ)78'TEXMIRXW
Waiver, UHC, etc. or caregiver in the case of a minor,
to the Sub County/County level TB
Coordinators for enrollment in the
cash transfer program
ƽ 1MROTEXMIRXXS9-(FIRIǻXTEGOEKI
where available
ƽ +SPPS[YTTEXMIRXWJSVTVSKVIWWERH
advice accordingly in every facility
visit or review

Assess for ƽ &HHVIWWJEQMP]WYTTSVXJSV ƽ IRWMXM^ITEXMIRXERHJEQMP]SRTEXMIRX

human rights patient’s wellbeing charter and facility service charter
& gender
ƽ &HHVIWWKIRHIVVIPEXIH ƽ 7IJIVJSVHMǺIVIRXMEXIHGEVISR
issues
challenges gender related interventions
ƽ &HHVIWWXMKQEERH ƽ (SRWMHIV2)8ETTVSEGLWYGL
discrimination related as expert groups which include
circumstances, e.g. loss of Patients e.g. TB, Leprosy, Lung health
opportunities - job, school, Champions
community and health services
ƽ *RWYVIGSRǻHIRXMEPMX]ERHWIVZMGI
delivery in dignity for patients
ƽ .RGEWIWSJLYQERVMKLXWZMSPEXMSRW
link to available pro bono services for
legal advice e.g. KELIN, CREW, HIV
and AIDS tribunal, FIDA, etc.
ƽ 7IJIVXSXLI45WSR,IRHIV 
ƽ YTTP]ERHEGGIWWXS Human rights
appropriate commodities for the ƽ 2IERMRKJYPP]IRKEKIWXEOILSPHIVW
highest attainable standards of (TB Champions and advocates,
health (accessible, acceptable, (-28WMRIRWYVMRKIǽGMIRGMIWMR
EǺSVHEFPIERHSJKSSHUYEPMX] commodity supply at all levels of
ƽ (SRWMHIVVMKLXWSJ-IEPXLGEVI healthcare cascade for advocacy
worker purposes
ƽ *HYGEXIERHWIRWMXM^I-(;WSRXLIMV
rights, roles & responsibilities in TB
and related diseases
ƽ +SPPS[YTTEXMIRXJSVTVSKVIWWERH
advise accordingly in subsequent
facility visit/ reviews

Reference material: ĚƒƒŤž×xxƾƾƾũďŇŇďĮåũÏŇķxƣŹĮůŭ÷ĚƒƒŤž×xx

ƾƾƾũƾĚŇũĞĻƒxďåĻŇķĞÏžxŤƣÆĮĞÏxŤ±ƒĞåĻƒžƣŤŤŇŹƒx
åĻx¼ž±÷%¼ƣžƒ÷ŐĂíŐċíŁƞŐŐĂíŁǑǑǑ¼ƣžď÷
8}ĥc8Ł}žĥü%ƒďÆŤƌ¬šǍċĥĂƌƣ{£BcíŽƾ

Source:ƐŽƒ±ĀƒĞƐ„åŹ±ƐŇĻƐ„ŇÏбĮƐ{ŹŇƒåσĞŇĻƐŦƞǑŐƌŧ

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Leprosy and Lung Disease | 2021
 17.4 Human Rights and TB, Leprosy & Lung Disease
17.4.1 Background
Kenya is listed among the 30 high burden countries with a triple burden of TB, TB/HIV
and MDR-TB. Due to the infectious nature of TB, measures to prevent, manage, and
treat the disease have led to undesirable violations of human rights of TB patients. A
good example was the practice of arrest and detention in prisons of persons suspected
of having defaulted on their TB medication in Kenya. This necessitates the need for
advocacy to integrate a human rights based approach to TB prevention, management,
and treatment.

17.4.1.1 The Constitution of Kenya and protection of human rights

The Constitution of Kenya (CoK) has an expansive and progressive Bill of Rights that
sets the stage for the promotion and protection of the rights of all persons, including
persons with TB. Article 19 (1) provides that the Bill of Rights is an integral part of Kenya’s
democratic state and is the framework for social, economic and cultural policies. Article 10
of the CoK is particularly important to the TB response as it provides guidance in relation
to formulation and implementation of laws, policies, and strategies on TB prevention
and management. TB strategies in Kenya must be formulated and implemented in a
manner that respects the national values, especially through ensuring the participation
SJ8'EǺIGXIHGSQQYRMXMIW8LIQSWXTVSQMRIRXTVSZMWMSRSJXLI(S0MRXLI8'VIWTSRWI
is Article 43 that guarantees the right to the highest attainable standard of health. The
State is under an obligation to take legislative, policy and other measures, including the
setting of standards, to achieve the progressive realization of the right to health. By virtue
SJ&VXMGPI SJXLI(S0MRXIVREXMSREPMRWXVYQIRXWXLEX0IR]ELEWVEXMǻIHJSVQTEVXSJXLI
Laws of Kenya. These international instruments provide a sound framework and basis for
holding the government accountable where gaps exist at the domestic level.

The Health Act 2017 prescribes the right to health as:

i) Progressive access for provision of promotive, preventive, curative, palliative and

rehabilitative services;

ii) Right to be treated with dignity, respect and have their privacy respected;

iii) Right to informed consent;

MZ 7MKLXXSTVMZEG]ERHGSRǻHIRXMEPMX]EQSRKSXLIVW

The local government and leadership should ensure inclusion of and involvement of TB
champions and TB communities which is crucial to achieve better TB control outcomes.
The TB community is key in holding duty bearers accountable in provision of quality
TB and healthcare services. This also empowers the community to monitor service
delivery, take part in decision making processes and platforms in the community on
matters health and development and support in addressing wider social determinants
of TB in an integrated manner.

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&VXMGPI TVSZMHIW&PPXEXISVKERWERHEPPTYFPMGSǽGIVWLEZIXLIHYX]XSEHHVIWW
the needs of vulnerable groups within society, including women, older members of
society, persons with disabilities, children, youth, members of minority or marginalized
communities, and members of particular ethnic, religious or cultural communities.

Health providers on the other hand have, among other rights, the right to a safe working
environment that minimizes the risk of disease transmission. This is important in the
protection of HCWs in the TB response.

17.4.1.2 Key principles of human rights

Equality and Non-Discrimination: This principle emphasizes that one should not be
XVIEXIH HMǺIVIRXP] SR KVSYRHW SJ VEGI WI\ TVIKRERG] QEVMXEP WXEXYW LIEPXL WXEXYW
ethnic or social origin, colour, age, disability, religion, conscience, belief, culture, dress,
language or birth.

Universality of Rights: This principle focuses on the dignity of all human beings and
assumes that all human beings, irrespective of their circumstances or environments
have a right to equally enjoy all human rights.

Human Rights are Indivisible: This principle emphasizes the equal importance of
all human rights. It avoids the temptation to classify human rights into categories of
important and not important.

Human rights are interrelated: 8LMW TVMRGMTPI IQTLEWM^IW XLEX XLI JYPǻPPQIRX SJ SRIƶW
VMKLXSJXIRHITIRHW[LSPP]SVMRTEVXYTSRXLIJYPǻPPQIRXSJSXLIVW*\EQTPI+YPǻPPQIRX
SJXLIVMKLXXSLIEPXLQE]HITIRHMRGIVXEMRGMVGYQWXERGIWSRJYPǻPPQIRXSJXLIVMKLXXS
clean water & food, development, to education or to information.

Participation and Inclusion: All people have the right to participate in and access information
VIPEXMRK XS XLI HIGMWMSRQEOMRK TVSGIWWIW XLEX EǺIGX XLIMV PMZIW ERH [IPPFIMRK 7MKLXW
based approaches require a high degree of participation by communities, civil society,
QMRSVMXMIW[SQIR]SYRKTISTPIMRHMKIRSYWTISTPIWERHSXLIVMHIRXMǻIHKVSYTW

&GXSVWMRXLI-YQER7MKLXWǻIPH
Right or claim holder: The person who enjoys the human right and can claim for it. A
valid claim refers to the human right that can be enjoyed.

Duty bearer: A person or institution that is responsible to ensure that an individual obtains
his rights. In most cases the government is the ultimate duty bearer. But there may be
other duty bearers such as private actors and individuals. Correlative duty refers to
what the duty bearer must do in order to ensure that citizens obtain the rights.

17.4.1.4 A rights-based approach to TB

-YQER7MKLXWFEWIHZMSPEXMSRWERHXLIJEMPYVIXSJYPǻPPLYQERVMKLXWSFPMKEXMSRWMRGVIEWI
individuals’ vulnerability to contracting TB and reduce access to diagnostic, prevention
ERHXVIEXQIRXWIVZMGIW5ISTPIEǺIGXIHF]8'YWYEPP]WYǺIVEHSYFPIFYVHIRXLIMQTEGX
of the disease as well as the consequential loss of other rights. For key populations, due
to additional stigmatization, the burden is in fact triple.

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 KEY HIGHLIGHTS:

ƽ &LYQERVMKLXWFEWIHETTVSEGLXS8'EVXMGYPEXIWXLIVMKLXWSJTISTPI
living with and vulnerable to TB, including the rights to life, health, non-
discrimination, privacy, informed consent, housing, food and water.

ƽ 8LIETTVSEGLJSGYWIWSRXLIWSGMEPERHIGSRSQMGHIXIVQMRERXWSJXLIHMWIEWI

ƽ .XEVXMGYPEXIWXLIHSQIWXMGERHMRXIVREXMSREPPIKEPSFPMKEXMSRWSJKSZIVRQIRXW
and non-state actors to ensure quality testing and treatment for TB is available
and accessible without discrimination.

ƽ 8LIETTVSEGLEMQWXSGVIEXIERIREFPMRKPIKEPIRZMVSRQIRXJSVXLIVIWIEVGL
and development of new tools for managing TB.

A rights-based approach to TB is founded on respect for the dignity and autonomy of

TISTPIEǺIGXIHF]8'.XEVXMGYPEXIWERHTVSXIGXWMRHMZMHYEPJVIIHSQWERHIRXMXPIQIRXW
ERHMWFYMPXSRKSZIVRQIRXWƶSFPMKEXMSRWXSVIWTIGXTVSXIGXERHJYPǻPPXLIVMKLXXSLIEPXL
The approach focuses on the underlying determinants of TB through the lens of social,
economic and cultural rights.

&LYQERVMKLXWFEWIHETTVSEGLXS8'EPWSLEWGSQTSRIRXWVIPEXIHWTIGMǻGEPP]XSXLI
collection and use of data on TB key populations. Most importantly, the rights to privacy
ERHGSRǻHIRXMEPMX]SJEPPQIQFIVWSJOI]TSTYPEXMSRWQYWXFII\TPMGMXP]EGORS[PIHKIH
and protected during the collection and use of data. This is required under human
VMKLXWPE[ERHRIGIWWEV]XSIRWYVIIǺIGXMZIERHWYWXEMREFPIMRXIVZIRXMSRW.REHHMXMSR
countries must involve key populations in the design, implementation and evaluation of
HEXEGSPPIGXMSRERHYWIIǺSVXW

A rights-based approach requires that special attention be paid to the needs of groups
most vulnerable to TB in the design and implementation of health policies, including the
poor, people living with HIV, prisoners, migrants, women, children, and people who use
drugs. The approach also encourages and facilitates the active and informed participation
SJ EǺIGXIH MRHMZMHYEPW ERH GSQQYRMXMIW MR HIGMWMSRQEOMRK TVSGIWWIW EǺIGXMRK XLIMV
health. A rights-based approach has been applied successfully to HIV prevention and
XVIEXQIRXXLVSYKLSYXXLI[SVPH8LIQSFMPM^EXMSRSJEǺIGXIHGSQQYRMXMIWMRKVEWWVSSXW
campaigns has spurred research and development of new medicines and lowered the
prices of existing drugs. People living with HIV have claimed their rights to information in
EWMQTPMǻIHPERKYEKITEVXMGMTEXMSRERHMRJSVQIHGSRWIRXERH[SRKVIEXIVTVSXIGXMSRW
against discrimination through litigation and advocacy based on constitutionally derived
human rights.

17.4.1.5 Gender related barriers to TB services

8YFIVGYPSWMW EǺIGXW QIR ERH [SQIR HMǺIVIRXP] ITMHIQMSPSKMGEPP] FMSPSKMGEPP] ERH
socially. In order to eliminate TB, a TB response team must address the gender-related
barriers to accessing TB services and include key and vulnerable populations. Females

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are more likely to seek health care earlier and more frequently than males. However,
females face socio-economic barriers to accessing health services since they are usually
RSX EW IGSRSQMGEPP] IQTS[IVIH EW QIR&W E VIWYPX SJ ǻRERGMEP HMWEHZERXEKI WSQI
women have to request permission from their husbands so as to seek health services.
Money and power are barriers to health services for women. There is pressure for males
to be seen as strong and macho and this may hinder them from seeking health services
for TB, Leprosy or lung disease symptoms. Additionally, the labor task force in Kenya
MWPEVKIP]MRJSVQEPERHKIXXMRKXMQISǺ[SVOXSKSXSELIEPXLJEGMPMX]MWGLEPPIRKMRKJSV
casual laborers who are usually paid per day; this is a barrier to accessing health services
during work hours (8 am to 5 pm) and also violates the rights of the casual workers.
Majority of the casual laborers in the construction industry, factories and privately owned
public transportation systems are males. The lack of freedom to have permission from
GEWYEP PEFSV IQTPS]IVW JSV WYǽGMIRX XMQI XS WIIO LIEPXL WIVZMGIW [MXLSYX PSWMRK XLI
daily income is a major contributor to poor health seeking behavior in males in Nairobi.
&HHMXMSREPP]8'WIVZMGIWEVIYWYEPP]SRP]SǺIVIHMRXLIQSVRMRK

A study conducted by KELIN Kenya, Tuberculosis- A Gender Assessment in Kenya,

found out that there is a link between occupation and susceptibility to TB and gender.
Key populations for TB such as miners, Matatu crew, truck drivers and boda boda
riders are mostly men. Gender is an integral part in the delivery of TB services. In order
to have a holistic approach in responding to TB, the government both at the national
and county levels needs to embrace the human rights based approach in the delivery of
TB services. This will address any gender inequalities, discriminatory practices and any
unjust power relations, which may be at the core of TB service delivery.

The current Kenya National Strategic Plan (NSP) on Tuberculosis acknowledges that
gender inequalities can impact health risks, health seeking behaviour and responses
from health systems, which lead to poorer outcomes. The NSP acknowledges the need
to undertake responsive programming, which takes into account the prevailing gender
norms or undertakes a gender transformative programming, so as to mitigate harmful
gender norms that are barriers to accessing health services. It notes the necessity of
GSRHYGXMRKEGXMZIGEWIǻRHMRKMRGSQQYRMXMIWEǺIGXIHF]8'VIEGLMRKSYXXS[SQIR
and the poor, who do not have access to services without paying for transportation.

Integrating TB services into Reproductive Maternal and Child Health (RMNCH)-related

health services to facilitate access by women and girls is another priority within the NSP.
However, there are no interventions targeted towards men (who are disproportionately
EǺIGXIHF]8'MR0IR]EXSVIHYGIXLIMVFEVVMIVWXSEGGIWWMRK8'WIVZMGIW

The gender related barriers to TB diagnosis, prevention; treatment and care are at the
individual level and provider or health system level. Individual level barriers include:
health literacy, health seeking behavior, stigma, sociocultural (gender roles and status
MR XLI JEQMP] ǻRERGMEP XLI HMVIGX ERH MRHMVIGX GSWXW SJ WIIOMRK8' WIVZMGIW TL]WMGEP
(distance to TB services and access to transport) and treatment adherence ignorance.

Tuberculosis approaches and responses at the international level are anchored in

international and regional human rights instruments. These laws recognize that all
human beings have equal rights to access quality and timely health services, regardless
of their nationality, ethnic origin, sex, race, religion, or any other status and are built
around core human rights principles.

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 17.4.2 Human Rights and Unequal Access to TB Care and
Treatment
.X MW SJXIR IWTIGMEPP] HMǽGYPX JSV WSQI OI] TSTYPEXMSRW XS QSFMPM^I ERH HIQERH
realization of their rights. For example, migrants face challenges accessing health care
in host countries and, in some settings, may face deportation if diagnosed with TB.
2MRIVW [MXL 8' LEZI XLI XLVIEX SJ PE]SǺW FEWIH SR XLIMV LIEPXL WXEXYW ERH XLI] JEGI
challenges accessing continuous TB treatment and care. Prisoners often experience
increased risks of contracting TB due to poor prison conditions and many lack access
to good quality services while in detention. Upon release from prison, former prisoners
face complications seeking health care and adhering to treatment, as well as stigma
and discrimination in their communities. In many countries criminalization of People
Who Use Drugs contributes to long delays in diagnosis and lack of case management,
leading to treatment disruptions. PLHIV often have access to community support, but
the lack of integration of TB and HIV services continues to be a major challenge in the
areas of service delivery, human resources and supply of medicines and products.

17.4.3 Criminalization of TB Status: Involuntary Treatment,

Isolation, Detention and Incarceration
5ISTPI EǺIGXIH F] 8' GER FI WYFNIGXIH XS EVFMXVEV] ERH LEVQJYP QIEWYVIW WYGL EW
involuntary treatment, detention, isolation and incarceration.

&GGSVHMRK XS ;-4 Ƹ.RZSPYRXEV] MWSPEXMSR I\GITX MR REVVS[P] HIǻRIH GMVGYQWXERGIW
WII FIPS[ JSV I\GITXMSREP GMVGYQWXERGIW ERH WTIGMǻG GSRHMXMSRW XLEX QYWX FI QIX
is unethical and infringes an individual’s rights to liberty of movement, freedom of
association, and to be free from arbitrary detention. It is unethical to isolate persons with
8'MJXLITIVWSRMWRSXGSRXEKMSYWSVMJMWSPEXMSRLSPHWRSGPIEVTYFPMGLIEPXLFIRIǻXXS
the community.’’

;-4 JYVXLIV WTIGMǻIW I\GITXMSREP GMVGYQWXERGIW [LIR MRZSPYRXEV] MWSPEXMSR GER FI
considered as the last resort for an individual who is:

M 0RS[RXSFIGSRXEKMSYWVIJYWIWIǺIGXMZIXVIEXQIRXERHEPPVIEWSREFPIQIEWYVIW
to ensure adherence have been attempted and proven unsuccessful

ii) Known to be contagious, has agreed to ambulatory treatment, but lacks the capacity
to institute infection control in the home, and refuses care at medical facilities

iii) Highly likely to be contagious (based on laboratory evidence) but refuses to

YRHIVKS EWWIWWQIRX SJ LMWLIV MRJIGXMSYW WXEXYW[LMPI IZIV] IǺSVX MW QEHI XS
work with the person with TB to establish a treatment plan that meets his needs.

And ALL of the following nine conditions must be met in order to justify any involuntary
isolation:

1. Isolation is necessary to prevent the spread of TB

2. *ZMHIRGIXLEXMWSPEXMSRMWPMOIP]XSFIIǺIGXMZIMRXLMWGEWI

3. Person with TB refuses to remain in isolation despite being adequately informed

of the risks, the meaning of being isolated and the reasons for isolation

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Leprosy and Lung Disease | 2021
 4. A person with TB’s refusal puts others at risk

5. All less restrictive measures have been attempted prior to forcing isolation

6. All other rights and freedoms (such as basic civil liberties) besides that of
movement are protected

7. Due process and all relevant appeal mechanisms are in place

8. Person with TB has, at least, basic needs met

9. The isolation time given is the minimum necessary to achieve its goals

Table 17.2: Examples of Human Rights Violations

Rights Examples of Violations

Right to Life ƽ .QTVMWSRIHSVSXLIV[MWIMRWXMXYXMSREPM^IHMRHMZMHYEPWJEGIE

disproportionate risk of TB infection, disease and death

ƽ 5ISTPI[LSYWIHVYKWTVMWSRIVWSXLIVQEVKMREPM^IHGSQQYRMXMIWQE]
be denied lifesaving TB treatment and face death

Right to the ƽ 5IVWSRW[MXL8'EVIHIRMIHEGGIWWXSUYEPMX]8'XVIEXQIRXERHGEVIMR

highest attainable prison
standard of
physical and ƽ 5IVWSRW[MXL2)78'EVIHIRMIHXEMPSVIHXLIVETMIWSJWIGSRHPMRIHVYKW
mental health ƽ ,SZIVRQIRXƶWJEMPMRKXSYXMPM^IHSRSVVIWSYVGIWXSGSRWXVYGXMWSPEXMSR
wards

ƽ 5ISTPI[MXL8'[LSFIPSRKXSEHHMXMSREPP]QEVKMREPM^IHKVSYTWEVI
discriminated against in TB care- given subpar treatment or denied care

Right to enjoy ƽ 5IVWSRW[MXL8'MRVIWSYVGIGSRWXVEMRIHWIXXMRKWQE]LEZIPMQMXIH

XLIFIRIǻXW EGGIWWXSLMKLUYEPMX]HMEKRSWXMGWIVZMGIWERHǻVWXERHWIGSRHPMRI
SJWGMIRXMǻG medicines for treatment
progress and its
ƽ 5SSVGSQQYRMXMIWEVIXIWXIH[MXLJEYPX]ERXMUYEXIHXIWXWERH
applications
consequently over-diagnosed and over-treated.

ƽ 7IWXVMGXMZIMRXIPPIGXYEPTVSTIVX]VIKMQIWPMQMXEGGIWWXSUYEPMX]EǺSVHEFPI
anti-TB medicines

Right to non- ƽ 5IVWSRW[MXL8'EVIVIJYWIHQIHMGEPXVIEXQIRXSVKMZIREPS[IVWXERHEVH

discrimination and of care
equality
ƽ 5IVWSRW[MXL8'EVIHIRMIHERHǻVIHJVSQNSFWFEWIHSRXLIMV8'WXEXYW
or TB history

Right to privacy ƽ .RJSVQEXMSREFSYXETIVWSRƶW8'WXEXYWMWHMWGPSWIHXLVSYKLTVSZMHIV

FVIEGLSJGSRǻHIRXMEPMX]ǼE[IHGSRXEGXMRZIWXMKEXMSRWSJTSSVHEXE
protections in surveillance systems

Integrated Guideline for Tuberculosis, 377

Leprosy and Lung Disease | 2021
 Rights Examples of Violations

Right to be free ƽ .RWXMXYXMSREPWIXXMRKWEVISZIVGVS[HIHSVTSSVP]ZIRXMPEXIHQEOMRKMX

from torture or more likely for individuals to contract TB.
cruel, inhuman
ƽ 5VMWSRIVWEVIRSXWGVIIRIHSVXIWXIHJSV8'ERHGERRSXEGGIWWQIHMGEP
or degrading
treatment and care for a TB diagnosis.
treatment or
punishment ƽ 4XLIVQIHMGMRIWWYGLEWWYFWXMXYXMSRXVIEXQIRXEVIRSXTVSZMHIHXS
people with TB who also use drugs in institutional settings

ƽ 5ISTPI[MXL8'[LSEVIHIXEMRIHEVISJXIROITXMRGSRHMXMSRWXLEXQE]
lack access to basic medical services Placing individuals who are
arbitrarily arrested in such conditions could constitute cruel, inhuman or
degrading treatment

Right to informed ƽ 5ISTPI[MXL8'EVIMRZSPYRXEVMP]XIWXIHJSV-.:

consent
ƽ 9RETTVSZIHQIHMGEXMSRVIKMQIRWEVIYWIHXSXVIEXTISTPI[MXL8'
without informing them

ƽ 5ISTPI[MXL8'EVIMRZSPYRXEVMP]WYQQSRIHJSVXVIEXQIRX

Right to ƽ 5ISTPI[LSEVIMPPMXIVEXIQE]LEZIPIWWORS[PIHKISJ8'ERHMXWWMKRW
information and symptoms

ƽ -IEPXLGEVI[SVOIVWJEMPXSEHIUYEXIP]I\TPEMRXSTIVWSRW[MXL8'[L]
adherence to TB medicine is important

ƽ &GSQTVILIRWMZIIHYGEXMSRTVSKVEQSR8'TVIZIRXMSRWMKRWERH
symptoms, cure
Right to freedom ƽ 5IVWSRWHMEKRSWIH[MXL8'[LSLEZIFIIRHIGPEVIHXSFIRSRGSQTPMERX
from arbitrary with TB treatment, are arrested
arrest and
ƽ 5IVWSRWEVVIWXIHJSVRSRGSQTPMERGI[MXL8'XVIEXQIRXEVIRSXTVSZMHIH
detention
with treatment while in detention or detained in environments that are
non-medical settings (prisons, holding cells, etc.)

Right to a fair trial/ ƽ .RHMZMHYEPW[MXL8'EVIHIXEMRIH[MXLSYXEHIUYEXINYWXMǻGEXMSRXLEXMXMW

due process the least restrictive alternative, strictly necessary or a measure of last
resort
Right to ƽ 5ISTPI[MXL8'ERHXLSWI[LSLEH8'LEZIPMQMXIHSTTSVXYRMX]XSLEZIE
participation say in designing programmes that aim to support them

ƽ (SQQYRMXMIWSJTISTPI[MXL8'EVIRSXWIIREWTEVXRIVWMRXLIǻKLX
against TB; peer-to-peer approaches are not common in TB care
programmes
Right to access ƽ 5ISTPI[MXL8'IWTIGMEPP]XLSWIJVSQQSWXQEVKMREPM^IHGSQQYRMXMIW
of an adequate, QE]RSXFIEFPIXSEǺSVHPIKEPEMHXSWIIOVIQIH]JSVXLIMVZMSPEXIHVMKLXW
IǺIGXMZIERH
prompt remedy/
representation

378 Integrated Guideline for Tuberculosis,

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17.4.4 Reporting human rights violations in TB
Persons with TB should be empowered to report human rights violations and receive
support including linkage to pro bono lawyers for legal aid if it is required.

Human rights violations should be reported to TB champions, health care workers or

CHVs who in turn should forward the reports to Sub County TB and Leprosy Coordinators.
The TB champions, health care workers and CHVs are also expected to , cases of stigma
related violation or discrimination at the facilities, community or HH levels as they
go about their work. Sometimes persons with TB may report violations to Non-State
Actors working in their communities. The SCTLCs aggregate the data, analyze it and link
perosons to the relevant tribunals or escalate to higher levels if need be for resolution.
Data will be reported to TIBU through the County TB and Leprosy Coordinator.

17.4.5 Human rights-based TB interventions

These include but are not limited to:

ƽ 8VEMRMRKJSV8'OI]TSTYPEXMSRWERH8'GSQQYRMX]XSMRGVIEWIE[EVIRIWWEFSYX
TB in relation to human rights.

ƽ .RXVSHYGMRKQSVIǼI\MFPILSYVWEXLIEPXLJEGMPMXMIWXLEXSǺIV8'WIVZMGIWWSEWXS
cater for those who work during the morning and day.

ƽ &HZSGEXMRK JSV GSPPEFSVEXMSR ERH MRXIKVEXMSR SJ WIVZMGIW 8' -.: QEXIVREP
neonatal and child health programmes and primary care services to collaborate
and integrate to maximise the entry point to TB care for women at all levels.

ƽ &HZSGEXMRKJSVFIXXIVHEXEGSPPIGXMSRVIKEVHMRK[SQIR&HZSGEXIJSVMQTVSZIH
recording and reporting of TB data, to be disaggregated by sex and age, including
for TB treatment initiation and outcomes.

ƽ 2SRMXSVMRK HSGYQIRXEXMSR ERH VITSVXMRK SJ LYQER VMKLXW ZMSPEXMSRW MRGPYHMRK

discrimination, gender-based violence and denial of healthcare services for TB

ƽ )IZIPSTQIRXSJGSQQYRMX]FEWIHQSRMXSVMRKSJLYQERVMKLXWMR8'

ƽ 7SYXMRI RIKSXMEXMSR QMXMKEXMSR SV JSVQEP GSQTPEMRXW XS GLEPPIRKI EGXMSRW SV
inaction of the authorities, state or non-state providers.

ƽ XVEXIKMGPMXMKEXMSRXSFVMRKEFSYXGLERKIWMRTSPMG]ERHPIKEPJVEQI[SVOW

ƽ )IZIPSTMRK WXVEXIKMG TEVXRIVWLMTW [MXL EXXSVRI]W PIKEP GPMRMGW LYQER VMKLXW

NGOs and academia.

ƽ 8VEMRMRKPE[]IVWERHLIEPXLGEVI[SVOIVWSR8'KIRHIVERHLYQERVMKLXW

ƽ 2EWWQIHMEGEQTEMKRW

ƽ (SRHYGXMRK EGXMZI GEWI ǻRHMRK MR GSQQYRMXMIW EǺIGXIH F]8' VIEGLMRK SYX XS
women and other economically disadvantaged who do not have means to access
services without paying for transportation.

ƽ 9XMPM^MRK XIVQMRSPSKMIW XLEX EVI MRXIVREXMSREPP] VIGSKRM^IH ERH EKVIIH XS F]
UNAIDS, World Health Organization, STOP TB and other such governing bodies

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 17.4.6 Patients’ charter for Tuberculosis care
The Patients’ Charter for Tuberculosis Care (The Charter) outlines the rights and
responsibilities of people with tuberculosis. It empowers people with the disease and
their communities through this knowledge. Initiated and developed by patients from
around the world, the charter makes the relationship with health care providers a
QYXYEPP]FIRIǻGMEPSRI

The Charter sets out the ways in which patients, the community, health providers (both
private and public), and governments can work as partners in a positive and open
VIPEXMSRWLMT[MXLEZMI[XSMQTVSZMRKXYFIVGYPSWMWGEVIERHIRLERGMRKXLIIǺIGXMZIRIWW
of the healthcare process. It allows for all parties to be held more accountable to each
other, fostering mutual interaction and a “positive partnership.”

17.4.6.1 Patients have the right to:

i. Care

The right to free and equitable access to tuberculosis care, from diagnosis through
treatment completion, regardless of resources, race, gender, age, language, legal status,
religious beliefs, sexual orientation, culture, or having another illness.

The right to receive medical advice and treatment which fully meets the new International
Standards for Tuberculosis Care, centering on patient needs, including those with
QYPXMHVYKVIWMWXERX XYFIVGYPSWMW 2)78' SV XYFIVGYPSWMWLYQER MQQYRSHIǻGMIRG]
virus (HIV) coinfections and preventative treatment for young children and others
considered to be at high risk.

8LIVMKLXXSFIRIǻXJVSQTVSEGXMZILIEPXLWIGXSVGSQQYRMX]SYXVIEGLIHYGEXMSRERH
prevention campaigns as part of comprehensive care programs.

ii. Dignity

The right to be treated with respect and dignity, including the delivery of services without
stigma, prejudice, or discrimination by health providers and authorities.

8LIVMKLXXSUYEPMX]LIEPXLGEVIMREHMKRMǻIHIRZMVSRQIRX[MXLQSVEPWYTTSVXJVSQJEQMP]
friends, and the community.

iii. Information

The right to information about what healthcare services are available for tuberculosis
and what responsibilities, engagements, and direct or indirect costs are involved.

The right to receive a timely, concise, and clear description of the medical condition,
with diagnosis, prognosis (an opinion as to the likely future course of the illness), and
treatment proposed, with communication of common risks and appropriate alternatives.

The right to know the names and dosages of any medication or intervention to be
TVIWGVMFIH MXW RSVQEP EGXMSRW ERH TSXIRXMEP WMHIIǺIGXW ERH MXW TSWWMFPI MQTEGX SR
other conditions or treatments.

380 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
The right of access to medical information which relates to the patient’s condition and
treatment and to a copy of the medical record if requested by the patient or a person
authorized by the patient.

The right to meet, share experiences with peers and other patients and to voluntary
counseling at any time from diagnosis through treatment completion.

iv. Choice

The right to a second medical opinion, with access to previous medical records.

The right to accept or refuse surgical interventions if chemotherapy is possible and to

be informed of the likely medical and statutory consequences within the context of a
communicable disease.

The right to choose whether or not to take part in research programs without compromising
care.

Z (SRǻHIRGI

The right to have personal privacy, dignity, religious beliefs, and culture respected.

8LI VMKLX XS LEZI MRJSVQEXMSR VIPEXMRK XS XLI QIHMGEP GSRHMXMSR OITX GSRǻHIRXMEP ERH
released to other authorities’ contingent upon the patient’s consent.

vi. Justice

The right to make a complaint through channels provided for this purpose by the health
authority and to have any complaint dealt with promptly and fairly.

The right to appeal to a higher authority if the above is not respected and to be informed
in writing of the outcome.

vii. Organization

8LIVMKLXXSNSMRSVXSIWXEFPMWLSVKERM^EXMSRWSJTISTPI[MXLSVEǺIGXIHF]XYFIVGYPSWMW
and to seek support for the development of these clubs and community-based
associations through the health providers, authorities, and civil society.

The right to participate as “stakeholders” in the development, implementation,

monitoring, and evaluation of tuberculosis policies and programs with local, national,
and international health authorities.

viii. Security

The right to job security after diagnosis or appropriate rehabilitation upon completion of
treatment.

The right to nutritional security or food supplements if needed to meet treatment

requirements.

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 17.4.6.2 Patients’ Responsibilities
i. Share Information

ƽ The responsibility to provide the healthcare giver as much information as possible

about present health, past illnesses, any allergies, and any other relevant details.

ƽ The responsibility to provide information to the health provider about contacts

with immediate family, friends, and others who may be vulnerable to tuberculosis
or may have been infected by contact.

ii. Follow Treatment

ƽ The responsibility to follow the prescribed and agreed treatment plan and to
conscientiously comply with the instructions given to protect the patient’s health,
and that of others.

ƽ 8LI VIWTSRWMFMPMX] XS MRJSVQ XLI LIEPXL TVSZMHIV SJ ER] HMJǻGYPXMIW SV TVSFPIQW
with following treatment or if any part of the treatment is not clearly understood.

iii. Contribute to Community Health

ƽ The responsibility to contribute to community well-being by encouraging others

to seek medical advice if they exhibit the symptoms of tuberculosis.

ƽ The responsibility to show consideration for the rights of other patients and
LIEPXLGEVITVSZMHIVWYRHIVWXERHMRKXLEXXLMWMWXLIHMKRMǻIHFEWMWERHVIWTIGXJYP
foundation of the tuberculosis community.

iv. Show Solidarity

ƽ The moral responsibility of showing solidarity with other patients, marching

together towards cure.

ƽ The moral responsibility to share information and knowledge gained during

treatment and to pass this expertise to others in the community, making
empowerment contagious.

ƽ 8LIQSVEPVIWTSRWMFMPMX]XSNSMRMRIǺSVXWXSQEOIXLIGSQQYRMX]XYFIVGYPSWMWJVII

17.4.7 Guiding principles for implementing TB control

activities at the workplace
Stigma and discrimination in TB act as barriers to accessing treatment care and support.
People who fear losing their jobs or being kicked out of school because of TB are less
likely to seek testing and treatment for the disease. As such, stigma and discrimination
are human rights vilations and lead to inequalities in population health.

All employers involved in TB prevention and care should respect the following guiding
TVMRGMTPIWJSV8'GSRXVSPEX[SVOTPEGIWIWTIGMEPP]XLILIEPXLWXEǺMRGSRXEGX[MXLXLI
EǺIGXIHIQTPS]IIW

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17.4.7.1 Protect Rights of employees with TB
ƽ Always respect the rights of employees with TB2EMRXEMRMRKXLIGSRǻHIRXMEPMX]
of medical conditions and TB/HIV medical records is crucial to giving employees
GSRǻHIRGIXSYRHIVKSXVIEXQIRX1EGOSJGSRǻHIRXMEPMX]GERPIEHXSHMWGVMQMREXMSR
EW[IPPEWHIPE]IHHMEKRSWMWERHXVIEXQIRX(SRǻHIRXMEPMX]QIERWXLEXSRP]XLI
WXEǺ HMVIGXP] MRZSPZIH MR XLI MRHMZMHYEP IQTPS]IIƶW QIHMGEP GEVI ERH ORS[ XLEX
employee’s TB/HIV medical status, have access to his or her records. Medical
WXEǺWLSYPHRIZIVHMZYPKIXLIQIHMGEPWXEXYWSJIQTPS]IIWXSER]SXLIV[SVOIV
or to the management. They should give guidance to line management only on
[LIXLIVIQTPS]IIW[MPPRIIHXMQISǺERH[LIXLIVXLIVIWLSYPHFIER]GLERKI
to their workload and tasks because of their health status. Options should be
SǺIVIH JSV )48 XLEX VIWTIGX XLI VMKLXW SJ XLI IQTPS]II [MXL 8' 8LIVI RIIHW
XSFIEGPIEVWXEXIQIRXSJTSPMG]SRXLIMQTSVXERGISJGSRǻHIRXMEPMX]MRGPYHMRK
XLI GSRWIUYIRGIW SJ FVIEOMRK GSRǻHIRXMEPMX] [LIVI 8'-.: LIEPXL WXEXYW MW
concerned.

ƽ 4ǺIVWSGMEP[IPJEVIFIRIǻXWXSIQTPS]IIW[MXL8'ERHXLIMVJEQMPMIW — Social
welfare provided to workers and their families can help patients complete their
XVIEXQIRX;IPJEVIFIRIǻXWQE]GSRWMWXSJJVIIXVIEXQIRXERHWIVZMGIWQEMRXEMRMRK
salary during treatment (or providing compensation for loss of income) and food
support. Importantly, to motivate the employee with TB to continue treatment,
social support should be adapted to the delivery and duration of the treatment.

ƽ Help employees with TB to tailor their workload/tasks to their state of health —

+SVEXPIEWXXLIǻVWXƳ[IIOWSJ8'XVIEXQIRXERIQTPS]II[MXL8'WLSYPHFI
on leave of absence, with DOT arranged for his or her convenience. The employee
QE]SJXIRXLIRVIWYQI[SVOMJRIGIWWEV][MXLEREHNYWXIH[SVOPSEHERHQSHMǻIH
XEWOWYRXMPǻXRIWWVIXYVRW+SVI\EQTPIMXQE]FITSWWMFPIJSVERIQTPS]II[LSMW
RSVQEPP]IRKEKIHMRLIEZ]PEFSYVXSHSSǽGI[SVOJSVEJI[QSRXLW

17.4.7.2 Ensure a safe workplace environment

ƽ Use education campaigns to decrease stigma ƴ *ǺIGXMZI LIEPXL IHYGEXMSR
campaigns should address negative attitudes towards people with TB.
Traditionally TB is viewed as a deadly disease of the poor, and the strong social
WXMKQE MX TVSZSOIW QEOIW MX QSVI HMǽGYPX JSV TISTPI[MXL8' XS WIIO HMEKRSWMW
and treatment. This can be countered by greater knowledge and understanding.
For example, education should stress that everyone is vulnerable to TB, that most
people with TB cease to be contagious after 2–4 weeks of treatment, and that
the disease is usually curable. Education campaigns should not only target TB
infected patients only but also the TB/HIV patients who face stigma many a times.

ƽ Develop and implement clear management policies — The employer’s policies

SRGSRǻHIRXMEPMX]HMWGVMQMREXMSRPIRKXLSJXMQISǺEPPS[IHJSVQIHMGEPXVIEXQIRX
ERHNSFQSHMǻGEXMSR[LIRRIGIWWEV]WLSYPHFIGPIEVP]SYXPMRIHERHQEHIIEWMP]
accessible. They should be clearly explained to employees with TB as soon as
WYGLIQTPS]IIWEVIMHIRXMǻIHERHWLSYPHIRWYVITVSQTXVIGSKRMXMSRERHVIJIVVEP
of TB presumptive employees. Reducing the delay between onset of symptoms
and diagnosis and treatment is crucial to decreasing the risk of TB transmission.

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 ƽ Implement environmental controls — Environmental control of TB refers to
implementing environment-associated interventions to prevent or reduce
airborne transmission from unsuspected cases or from diagnosed cases of TB
to non-infected employees. Most TB cases are result of airborne transmission of
infection. Environmental factors that enhance TB transmission are:

i) Small, enclosed spaces

MM &VIEW XLEX PEGO WYǽGMIRX ZIRXMPEXMSR XS GPIER XLI EMV XLVSYKL HMPYXMSR SV
removal of infectious droplet nuclei

iii) Ventilation systems recirculating air.

8LISZIVEPPSFNIGXMZISJGSWXIǺIGXMZIMRXIVZIRXMSRWMRXLI[SVOTPEGIWLSYPHXLIVIJSVI
be to control the spread of TB by minimizing the concentration of airborne infectious
HVSTPIXRYGPIM&GLMIZMRKXLMWVIUYMVIWW]WXIQWXLEXIRWYVIELMKLǼS[SJJVIWLEMVMRXS
the workplace environment. It also involves keeping away from other workers with active
TB until 2–4 weeks after starting treatment.

17.4.7.3 Use partnership for buy-in

Ensure collaboration with the DNTLD-P. Negotiate and implement TB control activities
with all partners. Additionally, it is particularly important to work with workers’ organizations
to maximize awareness and understanding of the disease and of the programme of
control activities.

17.4.7.4 Protecting Human rights in learning institutions and at

workplaces
M 7MKLXWZMSPEXMSRJSVEGLMPHGSRǻVQIHXSLEZI8'MRWGLSSP

1. 5YTMPWXYHIRXWGSRǻVQIHXSLEZI8'RIIHXSKSLSQIWIIOJSVXVIEXQIRXWSEW
not to expose other pupils to Tuberculosis.

2. 4RGI XLI HSGXSV GSRǻVQW XLEX XLI GLMPH MW RSPSRKIV MRJIGXMSYW XLI TYTMP SV
student needs to go back to school as he/she continues with medication.

3. If the school refuses to admit the pupil/student, this amounts to rights violation,
let the parent/guardian discuss this violation with the school principal.

4. If the school principal is reluctant to admit the child, the parent/guardian can
IWGEPEXIXLIZMSPEXMSRXSXLIWYFGSYRX]SǽGIVSJIHYGEXMSR

5. (SRXMRYIXSXLIGSYRX]IHYGEXMSRSǽGIVMJXLIZMSPEXMSRMWRSXVIWSPZIHEXXLIWYF
county level.

6. Report the issue to court if not resolved at the sub-county and county levels.

384 Integrated Guideline for Tuberculosis,

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ii. Rights violation at workplace

1. Patient/ worker needs to seek treatment so as to avoid putting the co-workers at

risk

2. ,SFEGOXS[SVOSRGIHSGXSVGSRǻVQWXLEX[SVOIVMWRSPSRKIVMRJIGXMSYW

3. If not re-admitted to work, seek to discuss with authority- senior management

4. If not resolved, report to the industrial and Labour court for wrongful termination

5. &XXLILMKLGSYVXTEXMIRXGERǻPIJSVHMWGVMQMREXMSRSRLIEPXLWXEXYWERHWIIOXS
be compensated

iii. Rights of Health Care Workers in the TB clinic

ƽ -IEPXLGEVI[SVOIVWWLSYPHLEZIEWEJI[SVOMRKIRZMVSRQIRXVIGIMZIEHIUYEXI
training and support, have adequately equipped facilities and access to quality
and regular supplies, including adequate protective measures and equipment,
and legal protection.

ƽ -IEPXLGEVI[SVOIVWWLSYPHFIWGVIIRIHJSV8'EXPIEWXX[MGIE]IEV

17.4.8 Leprosy and human rights

1ITVSW]EǺIGXWXLITSSVIWXERHQSWXHMWEHZERXEKIHQIQFIVWSJWSGMIX]5ISTPI[MXL
PITVSW]ERHXLIMVJEQMP]QIQFIVWWYǺIVWXMKQEERHHMWGVMQMREXMSRHYIXSHIITWIEXIH
misconceptions that have revolved around the disease throughout history. This is despite
PITVSW] FIMRK SRI SJ XLI PIEWX GSRXEKMSYW GSQQYRMGEFPI HMWIEWIW EǺIGXMRK LYQERW
People with leprosy undergo human rights violations including denial of access to work,
education and community life.

17.4.8.1 Principles and Guidelines for elimination of discrimination

EKEMRWXTIVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVW
Adopted in 2010, the Principles and Guidelines for elimination of discrimination against
TIVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVWSYXPMRIXLIFEWMGLYQERVMKLXWSJ
TIVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVWERHTVSZMHIXLIVIWTSRWMFMPMXMIW
of States to promote, respect, protect and ensure the full realization of all human rights
JSVEPPTIVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVW

{ŹĞĻÏĞŤĮåƐ Ő× 5IVWSRW EǺIGXIH F] PITVSW] ERH XLIMV JEQMP] QIQFIVW WLSYPH FI XVIEXIH
as people with dignity and are entitled, on an equal basis with others, to all the human
rights and fundamental freedoms proclaimed in the Universal Declaration of Human
Rights, as well as in other relevant international human rights instruments to which their
respective States are parties.

{ŹĞĻÏĞŤĮåƐ ƞ× 5IVWSRW EǺIGXIH F] PITVSW] ERH XLIMV JEQMP] QIQFIVW WLSYPH RSX XS FI
discriminated against on grounds of leprosy or having had leprosy.

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 {ŹĞĻÏĞŤĮåƐƗ×5IVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVWLEZIXLIWEQIVMKLXW
as everyone else with respect to marriage, family and parenthood

{ŹĞĻÏĞŤĮåƐ ċ× 5IVWSRW EǺIGXIH F] PITVSW] ERH XLIMV JEQMP] QIQFIVW LEZI E VMKLX XS
citizenship and obtaining identity documents.

{ŹĞĻÏĞŤĮåƐĂ×5IVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVWLEZIEVMKLXXSWIVZI
the public, on an equal basis with others, including the right to stand for elections and to
LSPHSǽGIEXEPPPIZIPWSJKSZIVRQIRX

Ɛ{ŹĞĻÏĞŤĮåƐƌ×5IVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVWLEZIEVMKLXXS[SVO
in an inclusive environment

{ŹĞĻÏĞŤĮåƐ Ɔ× 5IVWSRW EǺIGXIH F] PITVSW] ERH XLIMV JEQMP] QIQFIVW LEZI E VMKLX XS FI
admitted to schools or training programmes

{ŹĞĻÏĞŤĮåƐí5IVWSRWEǺIGXIHF]PITVSW]ERHXLIMVJEQMP]QIQFIVWLEZIEVMKLXXSHIZIPST
their human potential to the fullest extent, and to fully realise their dignity and self-worth

{ŹĞĻÏĞŤĮåƐ Ł× 5IVWSRW EǺIGXIH F] PITVSW] ERH XLIMV JEQMP] QIQFIVW LEZI E VMKLX XS FI
and should be, actively involved in decision-making processes regarding policies and
programmes that directly concern their lives.

386 Integrated Guideline for Tuberculosis,

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ADVOCACY AND
COMMUNICATION 18

18.1 Advocacy KEY HIGHLIGHTS:

Kenya’s health sector has recently undergone Patient - Key information

fundamental changes in structure and funding. The
ƽ *ǺIGXMZIIHYGEXMSRMWXLI
2010 Kenya Constitution Act changed the system of
cornerstone for achieving
governance from a centralized to a devolved system high treatment success rate.
with the county as the operational unit for the Ministry
of Health. Whereas development of health policies and
guidelines has remained at the national level, service )MǺIVIRXMEXIH
delivery has devolved to the 47 counties. The most Communication
important implication of this is that the management approaches
of health resources which devolved and placed under ƽ 8EVKIXGSQQYRMGEXMSR[MXL
the management of the county governments under WTIGMǻGGLERRIPWMWIWWIRXMEP
the leadership of the governors and the county health in TB control
I\IGYXMZIW8LMWWLMJXMRGSRXVSPSJQEXIVMEPǻRERGMEPERH
human resources from the national level to the county
PIZIPWQIERWXLEXEHZSGEG]IǺSVXWXSIRWYVIVIWSYVGIW
for TB, leprosy and lung disease Program must be
directed to the county level. The advocacy guideline,
XLIVIJSVIMHIRXMǻIWXLIGSYRX]PIZIPPIEHIVWLMTEWEOI]
target for both advocacy and communication to:

E VEMWI XLI TVSǻPI SJ 8' PITVSW] ERH PYRK HMWIEWIW EX
the county level and

(b) raise awareness of the need for prioritization of

resource allocation towards control of TB, leprosy and
lung disease. Every individual must feel empowered
and obligated to stop TB.

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Leprosy and Lung Disease | 2021
 The program will focus on three main types of advocacy to bolster political commitment,
leverage resources, and positively change policies and administrative guidelines:

ƽ Policy advocacy- to lobby national and county political leaders to increase

funding for TB programs and policy changes for smooth implementation of the
activities.

ƽ Program advocacy- to reach out to decision-makers and community partners

to boost their participation in local actions and program decisions to support TB
services.

ƽ Media advocacy - to put TB issues on the public agenda, prompt media to cover
TB related topics regularly and responsibly to raise awareness of TB problems
and solutions.

At the national level, the program head together with the Stop TB partnership will work
together on strategies to lobby parliamentary caucuses on TB, treasury, Ministry of
health and donor partners to ensure that resources are allocated for TB, Leprosy and
Lung Disease activities.

At the national level, the program head together with the various partners will work on
WXVEXIKMIWXSIRWYVIFVERHMRKSJXLI3EXMSREP8'5VSKVEQMRSVHIVXSVEMWIXLITVSǻPISJ
TB, Leprosy, and lung diseases both at the country and international level.

At the County level, County director of health / County Executive Committee (CEC) for
health and County Health Management Team (CHMT) will work on strategies to lobby the
County government to ensure that TB, Leprosy and Lung Disease activities are included
in the county integrated development plan and resources allocated in annual work plans
and budgets. The activities/events to be lobbied for consideration should include the
following but not limited to, World TB day, World Asthma, World and Leprosy day.

At the community level the community health extension workers together with
Community health volunteers and Civil society organizations will work on the strategies
to advocate for communities to demand for TB, Leprosy and Lung Disease treatment
and care at the community level.

At the National and County level, the private sector will be engaged to support the
implementation of Advocacy Communication and Community Engagement strategies.
The advocates should endeavor to reduce the cost of treating and caring for TB,
Leprosy and Lung disease through the waiver system, NHIF or other existing insurance
companies.

18.1.1 Planning for advocacy sessions

Planning for an advocacy campaign is a dynamic process. It involves identifying the issue,
developing solutions, building support, and bringing issues, solutions and political will
together to ensure that the desired change takes place. It includes the following steps;

1. Researching on the issues and setting objectives

2. Gathering evidence

388 Integrated Guideline for Tuberculosis,

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 3. Identifying target audience

4. Identifying allies

5. Developing message

6. Planning how to deliver the message

7. Raising resources

8. Monitoring and Evaluating the impact of advocacy activities

18.1.2 Strategies for Advocacy

ƽ Coalition building - Coalition building refers to alliance or partnership of the TB
program and other stakeholders in order to achieve a common purpose or to
engage in joint activity. It brings more expertise and resources to bear on complex
issues.

ƽ Dialogues - This an informal and amicable strategy that entails talking to a person
SVIRXMX]SJMRǼYIRGI[MXLEZMI[XSMRǼYIRGMRKSVTIVWYEHMRKXLIQ

ƽ Petitions - This is a strategy through which people are allowed to raise their
concerns or complaints to those in authority. In often cases, it is usually in writing
with the petitioners appending their signatures.

ƽ Processions - These are lawful and peaceful demonstrations with a view to

WIRWMXMWMRK SR ER MWWYI XLEX EǺIGXW XLI TYFPMG ERH SRI XLEX XLI] EVI RSX LETT]
with.

ƽ Public Interest Litigation - 8LMWMWEWXVEXIKMGGEWI[LMGLMWYWYEPP]ǻPIHXSEHHVIWW

issues of public concern or to advance human rights and equality

ƽ Picketing - This is a peaceful protest where members of the public congregate.

This is done to draw attention to a cause.

18.2 Communication
Health Communication is aimed at promoting health care seeking behaviour, prevention
in the community and promoting innovative patient-centered communication methods
in line with the 2019-2023 NSP and 2020 ACCE for TB, Leprosy and Lung Health.

Communication plays a vital role in changing knowledge, creating awareness/positive

attitudes and improving the practice of positive health behavior. It should aim to create
awareness at all levels in the care continuum; policymakers, health care workers,
community and patients, in order to change attitudes and behaviors leading to a Kenya
free of TB, Leprosy and reduced burden of lung diseases.

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 /YWXMǻGEXMSRJSVGSQQYRMGEXMSRWXVEXIKMIW
In the last few years, whilst a number of resources have been expended in the development
of various IEC materials, there still exists a huge gap in terms of TB awareness. According
to the prevalence survey (2016), it was found that there was limited awareness of the
cardinal signs and symptoms of TB, and many people either do not recognize these
symptoms as symptoms of tuberculosis, or do not take the requisite actions whenever
they experience them. This results in patient delays in seeking care and enhances
continued active transmission further compounding the TB menace.

Misconceptions, myths and stigma amongst populations also contribute highly to

poor health seeking behavior which is a huge impediment to TB care and treatment
due to its high correlation to HIV. This results in negative impact in drug adherence
for those already in care and further discourages screening and testing. According to
the Legal Environment Assessment for Tuberculosis in Kenya (KELIN, 2018), stigma has
led to limited uptake of TB preventive therapy (TPT) and other care services. Varying
knowledge and understanding of TPT among both the community and HCWs has also
LEQTIVIH YTXEOI .R EHHMXMSR XLI MRǼY\ SJ IRVSPQIRX MR PIEVRMRK MRWXMXYXMSRW [MXLSYX
commensurate infrastructure has led to limited infection prevention control measures.

18.2.2 TB related communications falls into three categories:

ƽ Mass media - this includes radio and or television advertising campaigns,
digital media and social media, websites, special events and behavior change
communication campaigns that reach a general and targeted audience.

ƽ Small media - also referred to as information, education, and communication

(IEC) approaches. It includes targeted channels, like brochures, posters, mobile
TLSRIWTLSXSKVETL]ZMHISMRXIVEGXMZIXLIEXIVERHXIWXMQSRMEPWXSVIEGLWTIGMǻG
groups.

ƽ Interpersonal communication - this includes counseling, one-on-one education

sessions, skills training, and presentations that target health workers and direct
supporters of TB patients and families.

18.2.3 The objectives of health communications should be

aimed at:
1. Increasing knowledge on TB disease and control services

2. Increasing knowledge on Leprosy and Lung diseases

3. Changing attitudes and behaviours of clients/patients (current and potential),

health providers, and the community (general population).

8SEGLMIZIXLMWKSEPQYPXMQIHMEERHXEVKIXIH HMǺIVIRXMEXIHGSQQYRMGEXMSRETTVSEGLIW
will be used. It will be combined with mass media, social media and interpersonal media
so that all key populations are reached.

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8LI XEFPI FIPS[ HIWGVMFIW HMǺIVIRXMEXIH (SQQYRMGEXMSR ETTVSEGLIW SR TVIZIRXMSR
treatment and care.

8EFPI)MǺIVIRXMEXIH(SQQYRMGEXMSRETTVSEGLIW

Audience Message Objective Channels

(Primary
target)
Caregivers Address Facts on TB (Leprosy/ To promote uptake Social Media
Lung Diseases) which include: of screening and
(Children Digital Media
testing
under 5years) What TB is: Prevention, symptoms
Mass Media (TV and
and modes of transmission. Reduce stigma
Radio)
surrounding TB
TB is curable and treatable: TB
Outreach programs
screening and treatment is free in Reduce the spread
(roadshows,
all government facilities. of TB
concerts, mobile
Anyone can get TB To increase screening)
treatment
Preventing the spread of TB Out of Home
adherence
messages (wall and
Myths and facts about TB
To ensure treatment matatu branding)
How is TB treated? Treatment success-rate
One on one
VIKMQIRERHWMHIIǺIGXWSJXLI
discussion
medication

Young men Address Facts on TB which To promote uptake Social Media

and women include: of screening and
Digital Media
(age 24-35) testing
What TB is: Prevention, symptoms
Mass Media (TV and
and modes of transmission. Reduce stigma
Radio)
surrounding TB
TB is curable and treatable: TB
Outreach programs
screening and treatment is free in Reduce the spread
(roadshows,
all government facilities. of TB
concerts, mobile
Anyone can get TB To increase screening)
treatment
Preventing the spread of TB Out of Home
adherence
messages (wall and
Myths and facts about TB
To ensure treatment matatu branding)
How is TB treated? success-rate

Women and What is TB? Prevention, To promote uptake Vernacular radio

men aged 65+ symptoms and modes of of screening and and TV
transmission. testing
Religious
TB is curable and treatable: TB Reduce stigma institutions
screening and treatment is free in surrounding TB
̱ķ±ž
all government facilities.
Reduce the spread
Community
Anyone can get TB of TB
outreach (religious
Preventing the spread of TB led mobile
screening, market
Myths and facts about TB
screening)
How is TB treated? Treatment
regimen

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 Audience Message Objective Channels
(Primary
target)
School / What is TB? Prevention, To promote Social media
University symptoms and modes of screening and
Digital media
students transmission. testing
Out of home
TB is curable and treatable: TB Reduce stigma
messages (festivals,
screening and treatment is free in surrounding TB
concerts)
all government facilities.
Reduce the spread
Peer to peer
Anyone can get TB of TB
outreach (training
Preventing the spread of TB students to reach
out to peers)
Myths and facts about TB
Radio
How is TB treated? Treatment
regimen
Peer to peer screening

Patients/ What is TB? Prevention, Increase awareness IEC materials

clients symptoms and modes of (Posters /
Promote adherence
transmission. brochures)
to medication
TB is curable and treatable: TB Social media
To promote uptake
screening and treatment is free in
of screening and Digital media
all government facilities.
testing
Health care
Anyone can get TB
Reduce stigma channels
Preventing the spread of TB surrounding TB
Health care workers
Myths and facts about TB Reduce the spread
Patient support
of TB
How is TB treated? Treatment groups
VIKMQIRERHWMHIIǺIGXWSJXLI
medication
Treatment Adherence

Key What is TB? Prevention, Increase awareness Outreach programs

populations symptoms and modes of (interpersonal
To promote
(refugees, transmission. communication)
screening and
prisoners and
TB is curable and treatable: TB testing
PLHIV)
screening and treatment is free in
Reduce stigma
all government facilities.
surrounding TB
Anyone can get TB
Reduce the spread
Preventing the spread of TB of TB
Myths and facts about TB
How is TB treated?

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Audience Message Objective Channels
(Primary
target)
Community/ What is TB? Prevention, Increase awareness IEC materials
Family symptoms and modes of (Posters/brochures)
To promote
Members transmission.
screening and Health care workers
TB is curable and treatable: TB testing
Digital media
screening and treatment is free in
Reduce stigma
all government facilities. Social media
surrounding TB
Anyone can get TB Mass media
Reduce the spread
Preventing the spread of TB of TB Outreach programs
(roadshows,
Myths and facts about TB
concerts, mobile
How is TB treated? Treatment screening)
VIKMQIRERHWMHIIǺIGXWSJXLI
Out of Home
medication
messages (wall and
matatu branding)
Health care Anyone can get TB Uptake of SOPs
workers and screening/TPT
Screen all patients Training forums
public health among HCWs
Importance of patient follow up Health care
Public Health Increase case
and management channels
4ǽGIVW detection
Continuous medical education IEC (Posters /
Ensure treatment
is key to TB management and brochures)
success rate
treatment
Digital media (TIBU,
Reducing the
Importance of contact tracing ECHO)
spread of TB
Importance of patient counseling Social media

Informal What is TB? Prevention, Patients’ referrals. Screening tools

Health symptoms and modes of
Reducing the Posters
Service transmission.
spread of TB.
Providers Trainings
How is TB treated? Treatment
(ISPs) Increase case
regime
detection.
Anyone who is symptomatic
Increase formal
should be referred to health
health-seeking
facility
behaviours.
Promote TB
treatment and
management.

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 Audience Message Objective Channels
(Primary
target)

Audience (Secondary Target)

Learning What is TB? Prevention, Increase knowledge Circulars from

institutions’ symptoms and modes of to be able to Ministry of Health
administration transmission. screen and identify and line ministries
and presumptive cases
TB is curable and treatable: TB Brochures
management
screening and treatment is free in Educate and
Trainings and
all government facilities. empower school
meetings
fraternity on TB
Anyone can get TB
management Out of home
Providing proper infrastructure messages (talking
To promote uptake
to stop the spread of TB walls)
of screening and
Myths and facts about TB testing services
How is TB treated? Reduce stigma
Importance Screening of surrounding TB
Students Reduce the spread
of TB

Private sector What is TB? Prevention, Increase knowledge Stakeholder forums

symptoms and modes of to be able to
Outreach programs
transmission. screen and identify
(workplace
presumptive cases
TB is curable and treatable: TB screening)
screening and treatment is free in
Brochures / posters
all government facilities.
Educate and
Pay slips
Anyone can get TB empower
leadership to Email signatures
Providing proper infrastructure
enforce TB Internal
to stop the spread of TB
management communication
Myths and facts about TB
structures
How is TB treated? Treatment
To promote uptake
regimen
of screening and
Screen all employees testing services
Resources and collaboration to Reduce stigma
ǻKLX8'ERH1YRKHMWIEWIW surrounding TB
Reduce the spread
of TB

Private Proper diagnosis of TB saves To include TB Meetings

Insurance money because of fewer doctor screening in health
Emails
companies visits and prescriptions care packages

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Audience Message Objective Channels
(Primary
target)

Funding The TB and Lung health situation Resource Reports

partners in the country, highlighting the mobilization
Emails
funding gaps and need for more
resources Case studies /
newsletters
Meetings
Documentaries

Champions What is TB? Prevention, Give champions and Trainings

and symptoms and modes of advocate correct
Meetings
advocates transmission. information about
TB to spread the Digital media
TB is curable and treatable: TB
message. Social media
screening and treatment is free in
all government facilities. Brochures
Anyone can get TB
Preventing the spread of TB
Myths and facts about TB
How is TB treated? Treatment
regimen

Line The importance of resource Allocate more Circulars

Ministries, mobilization resources towards
Posters
Governors, improving TB
There is a TB and lung health
President and lung health Digital Media
problem that needs to be
and local response Meetings
addressed
and national
leaders We need to work together to end Emails
Tb in Kenya Ministry
publications

Policymakers: The importance of resource Allocate more Meetings

Parliamentar- mobilization resources towards
Reports
ians, Senate, improving TB
There are TB and lung health
MPs and and lung health
problems that needs to be
MCAs response
addressed
We need to work together to end
TB in Kenya

DNTLD-P Importance of the communication Allocate more Emails

Program function in awareness creation resources both
Memos
Managers personnel and
Importance of resource
ǻRERGMEPXS[EVHW Meetings
mobilisation
demand creation WhatsApp
and awareness

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 Audience Message Objective Channels
(Primary
target)
DNTLD-P Importance of the communication The need Posters
TVSKVEQWXEǺ function in awareness creation JSVHMǺIVIRX
Meetings
departments to
Importance of sharing successes
work together to WhatsApp
and stories
create demand Emails
creation and
awareness Social media
Digital media

Opinion What is TB? Prevention, Mobilization to Inter-personal

Leaders: symptoms and modes of spread awareness communication
religious transmission. about TB and lung
Brochures / Posters
leaders, health
TB is curable and treatable: TB
community Banners
screening and treatment is free in
elders Out of home
all government facilities.
messages (wall
Anyone can get TB
branding)
Preventing the spread of TB
Training
Myths and facts about TB
The importance of mobilization
There are TB and lung health
problems that needs to be
addressed
We need to work together to end
TB in Kenya
CSOs and The TB response in Kenya is led Gaining technical Technical working
supporting by NTLD, with partners working support from groups
partners collaboratively partners
Meetings
Emails

Media What is TB? Prevention, Spread awareness Trainings (media

symptoms and modes of about TB engagement)
transmission.
To promote uptake Reports
TB is curable and treatable: TB of screening and
Digital media
screening and treatment is free in testing
all government facilities. Social media
Reduce stigma
Anyone can get TB surrounding TB
Preventing the spread of TB Reduce the spread
of TB
Myths and facts about TB
How is TB treated?
Why is TB a priority now? How
does TB impact Kenya

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Communication on Prevention (as per the table above)
The areas to focus on are:

ƽ Facts on TB (frequently asked questions on TB)

ƽ Facts on Leprosy (frequently asked questions on leprosy)

ƽ Facts on Lung Health (frequently asked questions on lung health)

18.2.4 Communication on Adherence to Treatment

The aim of the National TB, leprosy and lung Disease program is to successfully treat
at least 90% of all patients started on treatment. This can only be achieved by ensuring
good compliance to treatment. This can be done where there is a good communication
strategy for patients being started on medication. TB is curable if patients take a complete
and uninterrupted course of the appropriate medicines for treatment. However, poor
compliance with TB medication is a common problem. Treatment interruption presents
a problem for patients, for their family and community and for the health care personnel
caring for them.

Communication is key in improving patient adherence. Health care workers should

consider a variety of factors and implement strategies targeting underlying issues. The
strategies should include customizing and simplifying all learning and intervention
regimens, identifying and addressing barriers to adherence, ensuring patient support
WXVYGXYVIW EVI MR TPEGI JSV IEWI SJ GSQQYRMGEXMSR ERH MQTVSZMRK WIPJIǽGEG] ERH
health literacy among all key stakeholders.

HCW knowledge gap - There is a need to sensitize HCW to understand the implications
SJ8')72)7<)78'XVIEXQIRXGLEPPIRKIWERHTYFPMGLIEPXLVEQMǻGEXMSRW

18.2.5 Health Informational support

Any useful information that helps a person to solve problems and address sources of
stress e.g. training, IEC materials for patients should be shared through the patient’s
most preferred medium. The information should be on:

ƽ What healthcare services are available for tuberculosis and what responsibilities,
engagements, and direct or indirect costs are involved

ƽ How to receive a timely, concise, and clear description of the medical condition,
with diagnosis, prognosis (an opinion as to the likely future course of the
illness), and treatment proposed, with communication of common risks and
appropriate alternatives

ƽ The names and dosages of any medication or intervention to be prescribed,

MXWRSVQEPEGXMSRWERHTSXIRXMEPWMHIIǺIGXWERHMXWTSWWMFPIMQTEGXSRSXLIV
conditions or treatments

ƽ The access to medical information which relates to the patient’s condition and
treatment and to a copy of the medical record if requested by the patient or a
person authorized by the patient

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 ƽ 8LIRIIHXSQIIXERHWLEVII\TIVMIRGIW[MXLTIIVWERHSXLIVTEXMIRXWERHXS
voluntary counseling at any time from diagnosis through treatment completion

Patients have a responsibility to provide the healthcare givers with as much information
as possible about present health, past illnesses, any allergies, and any other relevant
details. The information should also include contacts with immediate family, friends, and
others who may be vulnerable to TB or may have been infected by contact.

The community has a right to access and understand information about TB, DR/MDR/
XDR-TB, its causes, its implications on their health, and the internationally recommended
standards and policies for prevention, diagnosis and treatment. People should participate
actively in decisions related to what is being done to their bodies and to the samples
obtained from their bodies, and why it is being done. This may help to instill trust in the
health system.

Some of the key interventions in reducing the non-adherence to treatment include:

1. Innovative health communication

2. Use of digital health platforms

3. Social support mechanisms

4. Health Education

5. Treatment plan

18.2.6 Patient Education and Informed Consent

All TB patients and their primary caretaker(s) should receive education about TB and its
treatment and the need for adherence. Adjustments in the attitudes and language used
by healthcare providers while delivering key information about the disease should be
applied.

ƽ Information and education interventions should commence as soon as diagnosis

is made and continue throughout the course of treatment.

ƽ Education can be provided by: physicians, nurses, community health workers

and other health care providers/stakeholders, Pharmacists, CHWs, Counsellors,
Peer educators, Social workers, DOT supporters and others.

ƽ Materials should be appropriate to the literacy levels of the patient and should be
gender, age and culturally sensitive.

ƽ All health care providers should adopt methods of ‘communicating with’ (and not
‘talking at’) patients and their caretakers

ƽ +SVTEXMIRXW[MXLPMXIVEG]PMQMXEXMSRWIǺSVXWWLSYPHFIYRHIVXEOIRXSYWIILIEPXL
tools based on audio or visual support.

ƽ Patient education should be continuous in the course of treatment

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18.2.7 Communication on Post TB treatment
2IERMRKJYPP] IRKEKI XLI[MPPMRK ERH GYVIH8' WYVZMZSVW MR IǺSVXW XS[EVHW E[EVIRIWW
creation and demand creation for TB health services, Leprosy and Lung Disease. This
can be through telling their stories of determination and using them as champions in
QIWWEKMRKFSXLSRPMRIERHSǾMRI

18.2.8 TB control challenges that can be addressed through

ACCE include
ƽ Delayed detection and treatment,

ƽ Lack of access to TB treatment,

ƽ )MǽGYPX]MRGSQTPIXMRKXVIEXQIRX

ƽ Stigma and discrimination that can prevent people from seeking care and
diagnosis,

ƽ Lack of knowledge and information about TB, leading to stigma, discrimination

and delayed diagnosis and/or treatment,

ƽ Misunderstandings and myths surrounding TB, including the belief that it is

“untreatable”,

ƽ Failure to understand the link between TB and HIV, with the view that having TB
means one has HIV,

ƽ Weak political support for TB programmes.

18.2.9 Each patient must understand what the treatment

entails:
ƽ )MǺIVIRXQIHMGMRIW

ƽ )YVEXMSR

ƽ 5SWWMFPIWMHIIǺIGXW

ƽ .QTSVXERGISJGSQTPIXMRKXVIEXQIRXERHXEOMRKIZIV]QIHMGMRIEWTVIWGVMFIH

ƽ 5SWWMFMPMX]SJ-.:GSMRJIGXMSRERHXVIEXQIRX

The educator must verify that the patient has fully understood the message by asking
the patient and the DOT supporter to explain the information in his/their own words.

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 18.2.10 Principles of patient education
ƽ 8LIǻVWX.*(WIWWMSRWLSYPHJSGYWSREGGITXERGISJXLIHMEKRSWMW 

ƽ &WWYQIXLEXIEGLTEXMIRX[MXL8'[MPPFI[SVVMIHEFSYXLEZMRK-.: YRPIWWXLI]
already know their status), and that not addressing this represents a missed
opportunity for HIV prevention and patient management.

ƽ *HYGEXMSRMWEHMEPSKYIRSXEPIGXYVI

ƽ .RZSPZI TEXMIRX GSQTERMSRW JEQMP] VIPEXMZIW ERH JVMIRHW MR XLI IHYGEXMSR
sessions to maximise retention and reinforcement.

ƽ &P[E]WIRGSYVEKIXLITEXMIRXERHLMWLIVGSQTERMSRWSVXVIEXQIRXWYTTSVXIVXS
ask questions.

ƽ 8LIIHYGEXSVWLSYPHXV]XSTYXLMQWIPJMRXLITSWMXMSRSJXLITEXMIRX

ƽ &PPS[WYǽGMIRXXMQIJSVIEGLWIWWMSR

ƽ 9WI WIZIVEP ETTVSEGLIW VITIEXMRK XLI WEQI QIWWEKIW KVSYT HMWGYWWMSR

MRHMZMHYEPHMEPSKYIPIEǼIXWǼMTGLEVXWIXG

ƽ 5VSZMHIXLITEXMIRXERHLMWGSQTERMSRW[MXLMRJSVQEXMSRPIEǼIXWMRXLIPERKYEKI
they can read and understand. Verify that the patient has understood the
message(s) by asking him/her to repeat the message(s) in his/her own words

ƽ &ZSMHTVSZMHMRKXSSQYGLMRJSVQEXMSREXXLIWEQIXMQI

ƽ 7ITIEXIHYGEXMSRWIWWMSRWMJTSWWMFPI

18.2.11 Key information

*ǺIGXMZI IHYGEXMSR MW XLI GSVRIVWXSRI JSV EGLMIZMRK LMKL XVIEXQIRX WYGGIWW VEXI ERH
preventing the spread of TB and reduce treatment defaulting.

Table 18.2: Summary of Key information

What patients ƽ 8'MWGYVEFPIMJXVIEXQIRXMWXEOIREWTVIWGVMFIH
and his/her DOT ƽ 8'XVIEXQIRXMWEZEMPEFPIJVIISJGLEVKIEXER]KSZIVRQIRXSVQMWWMSR
supporter needs health facility.
to know
ƽ 8'MWERMRJIGXMSYWHMWIEWIXLEXMWXVERWQMXXIHJVSQSRITIVWSRXSERSXLIV
by coughing, and appropriate cough hygiene reduces transmission.
ƽ 8LITEXMIRXQE]EPVIEH]LEZIMRJIGXIHSXLIVTISTPI[LSQE]EPWS
develop TB. The patient should therefore encourage other people with
whom s/he is in close contact to have themselves checked for TB
disease now and when become ill or display symptoms.
ƽ .XMWMQTSVXERXXSMHIRXMJ]E)48WYTTSVXIVERHHIXIVQMRI[LIVIERH
when medication will be administered.
ƽ &PPGPSWIGSRXEGXWYRHIV]IEVWSJEKIERH-.:MRJIGXIHGSRXEGXWEVIEX
LMKLVMWOSJWYǺIVMRK8'HMWIEWIMJMRJIGXIHERHGERFIRIǻXJVSQ858
ƽ 8LIHYVEXMSRSJMRMXMEPERHGSRXMRYEXMSRTLEWIWSJ8'XVIEXQIRXQYWXFI
explained (give the actual duration to the patient and verify that they
understand).

400 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ *\TPEMR[LMGLTMPPWWLI[MPPXEOIHYVMRKXLIJYPPXVIEXQIRXGSYVWI WLS[
and explain number, colour and frequency.
ƽ 4RGIXVIEXQIRX[MXLXLIWIQIHMGMRIWLEWFIKYRW]QTXSQWSJ8'
disease will disappear quickly; but the medicines still need to be
continued daily until the end of the prescribed treatment period.
ƽ +EMPYVIXSEHLIVIXSXLMWXVIEXQIRXQE]GEYWI8'HMWIEWIXSWXEVXEKEMR
with great risks for the health of the patient, because the second time
around the treatment is likely not to work as well. In particular, there is a
risk of developing drug resistance and transmitting the disease further to
others.
ƽ 'IGEYWISJXLIVMWOSJXVERWQMXXMRK8'XSXLIGSQQYRMX]MXMWXLITEXMIRXƶW
VIWTSRWMFMPMX]XSGSQTPIXIXLI8'XVIEXQIRXXLIǻVWXXMQI.RXIVVYTXMRK
treatment puts the community at risk.
ƽ TYXYQWQIEVI\EQMREXMSRWEVIVIUYMVIHEXGIVXEMRMRXIVZEPWXSQSRMXSV
the progress towards cure.
ƽ 8'ERH-.:EVIHMǺIVIRXHMWIEWIWFYX-.:MWGSQQSRMR8'TEXMIRXW
ƽ 8'GERFIGYVIHIZIR[LIR]SYLEZI-.:
ƽ .XMWMQTSVXERXJSVXLIRYVWISVHSGXSVERHXLITEXMIRXXSORS[XLITEXMIRXƶW
HIV status so that the patient can have access to better treatment,
including ART
During treatment
ƽ 7IIQTLEWMWIXLIRIIHJSVJSPPS[YTZMWMXWERHMRZIWXMKEXMSRW
ƽ 5EXMIRXWLSYPHMRJSVQXLIWXEǺEXXLIGPMRMG[LIRWLIMRXIRHWXSXVEZIP&R
adequate supply of medicines can then be given to cater for the period of
travelling
ƽ 5EXMIRXWLSYPHMRJSVQXLIWXEǺEXXLIGPMRMG[LIRWLIMRXIRHWXSQSZI
XSERSXLIVEVIE8LIGPMRMGWXEǺ[MPPXLIR[VMXIXLIXVERWJIVPIXXIVERHKMZI
advice as to where treatment can be continued
At the end of treatment
ƽ 8'QE]SGGYVEKEMRIWTIGMEPP]MJSRIMW-.:TSWMXMZI
ƽ 8LITEXMIRXWLSYPHVITSVXMQQIHMEXIP]XSXLI8'GPMRMG[LIRWLIRSXMGIW
similar symptoms, to be examined for recurrence of the disease.
ƽ .XMWMQTSVXERXXSQEMRXEMRELIEPXL]PMJIWX]PIIZIREJXIV8'XVIEXQIRX

What the ƽ 0IR]EMWSRISJXLI[SVWX8'ITMHIQMGWMRXLI[SVPH

community ƽ 8'MWGEYWIHF]X]TISJFEGXIVME KIVQWXLEXEVITEWWIHSRJVSQSRI
should know person to another through the air, and is not caused by witchcraft, dust,
sharing utensils or inheritance.
ƽ *ZIV]FSH][LSLEWEGSYKLSJER]HYVEXMSRSVLEWGSYKLIHYTFPSSH
should go to a clinic or hospital to have his/her sputum examined for TB.
ƽ 8'XVIEXQIRXMWJVIISJGLEVKIMRKSZIVRQIRXERHQMWWMSRLIEPXLJEGMPMXMIW
ƽ 8'GERFIGYVIHGSQTPIXIP]MJ]SYGSQIIEVP][LIR]SYEVIMPPERHXEOI
the treatment to the end.
ƽ 8'TEXMIRXW[LSEVIRSXSRXVIEXQIRXEVIWTVIEHMRK8'HMWIEWI[MXLMR
their families and communities.
ƽ 8'TEXMIRXWSRXVIEXQIRXEVIRSXMRJIGXMSYWERHHSRSXRIIHXSFIMWSPEXIH
or shunned; but rather need support and encouragement to complete
their treatment.
ƽ 8LIVIMWRSHERKIVMRFIMRKGPSWIXSE8'TEXMIRX[LSMWSR8'XVIEXQIRX
touching, sleeping, and sharing food or eating utensils is safe.

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 ƽ 8'ERH-.:EVIHMǺIVIRXHMWIEWIWFYX-.:MWGSQQSRMR8'TEXMIRXW2SWX
patients with TB in Kenya do not have HIV.
ƽ 8'GERFIGYVIHIZIR[LIRETIVWSRLEW-.:
ƽ &PP8'TEXMIRXWWLSYPHLEZIER-.:XIWXWSXLEXXLSWI[LSEVI-.:TSWMXMZI
should be treated for HIV.
ƽ (SQQYRMX]QIQFIVWWLSYPHMHIRXMJ]JVMIRHWERHGSPPIEKYIW[MXLGLVSRMG
cough, weight loss, and prolonged fever and advise them to be screened
and tested for TB as soon as possible.
ƽ 5ISTPIWLSYPHGSZIVXLIMVQSYXLW[LIRXLI]GSYKL GSYKLL]KMIRI
preferably with the inner part of the elbow, a handkerchief or tissue paper.
ƽ -SYWIWFEVVEGOWERHGSVVIGXMSREPJEGMPMXMIWERHTYFPMGXVERWTSVXWLSYPH
be kept clean and well ventilated, with windows kept open as much as
possible.
ƽ -SYWIWWLSYPHLEZI[MHI[MRHS[WJSVZIRXMPEXMSRERHWYRPMKLX
ƽ &ZSMHSZIVGVS[HMRKMRGSVVIGXMSREPJEGMPMXMIWLSWXIPWFEVVEGOWERHTVMZEXI
homes, if possible
What leadership ƽ .RGPYHI8'MRXLIMVLIEPXLEKIRHEERHIRWYVIXLEXXLILIEPXLEKIRHEMW
GERHSMRXLIǻKLX represented in every sector.
against TB ƽ XVIWWXLIMQTSVXERGISJǻKLXMRK8'[LMGLMWE[MHIWTVIEHHMWIEWIFYXMW
very curable.
ƽ &PPSGEXIWYǽGMIRXLYQERERHǻRERGMEPVIWSYVGIWXSǻKLX8'
ƽ 2IRXMSRXLIRIIHXSǻKLX8'MRTYFPMGEHHVIWWIW
ƽ XVIWWXLEX8'ERH-.:SJXIRKSXSKIXLIVFYXRSXEP[E]WERHXLEXIZIV]
HIV infected patient should be regularly screened for TB, while every
TB patient should be tested for HIV in order to access life- saving HIV
treatment if HIV positive
ƽ 'IWMRGIVIP]GSQQMXXIHXSǻKLXMRKTSZIVX]ERH-.:EWFSXLEVIJYIPMRK
the TB epidemic.
ƽ *RWYVIWSGMEPTVSXIGXMSRJSVTEXMIRXWJEQMPMIWERHGSQQYRMXMIWEǺIGXIH
F]8' XLI]QYWXFITVIZIRXIHJVSQWYǺIVMRKIGSRSQMGPSWWIWFIGEYWI
of TB.

402 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
ENGAGING COMMUNITIES,
PATIENTS, AND NON-
STATE ACTORS (NSA) IN TB,
LEPROSY, AND LUNG HEALTH
19
CARE SERVICES.

Target audience and purpose

This chapter on community engagement will be useful in implementing Tuberculosis
ERH1ITVSW]MRXIVZIRXMSRW.XTVSZMHIWEWMQTPMǻIHWXITF]WXITSTIVEXMSREPKYMHERGIXS
the community engagement and outlines the critical community-related processes that
would make implementing interventions successful and impactful. Further, it will support
the ministry of health, county government health departments, non-state actors, funding
agencies and research stakeholders, and the community at large as they participate in
implementation. Innovative community engagement strategies should also be adopted
and replicated in Leprosy & Lung health interventions.

0I]XIVQWERHHIǻRMXMSRW

Key term )IǻRMXMSR

Community These are the various members of the community, including but
Members not limited to: Patients, household members (adults and children),
community health workers, and community leaders.

Community The community refers to the level of care in which patients seek services
from the Community Health Volunteers/workers and Community Health
Extension Workers who provide preventive, promotional, and basic
curative care services while linking and referring community members for
the appropriate health services.

ŅĵĵƚĹĜƋƼŽĹĜƋ &ƸGSQQYRMX]YRMXƹEWHIǻRIHMRXLMWGSRXI\XGSQTVMWIWETTVS\MQEXIP]
1,000 households or 5,000 people who live in the same geographical
area, sharing resources and challenges. Each unit is assigned two
community health extension workers (CHEWs) and ten community health
ZSPYRXIIVW (-:W[LSSǺIVTVSQSXMZITVIZIRXMZIERHFEWMGGYVEXMZI
services. Each community unit is linked to a primary healthcare facility.

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 Community It is the mechanism through which households and communities
„Ƌų±ƋåčƼ strengthen their role in health and health-related development by
increasing their knowledge, skills, and participation.

The Household The household-level consists of individuals associated with and usually
LIEHIHF]XLILSYWILSPHLIEHSVGEVIKMZIV&PWSGERFIHIǻRIHEW
members of households and families who are both the primary targets
and implementers of level one services. They are responsible for the
HE]XSHE]YTOIITSJXLILSYWILSPHEǺEMVWEW[IPPEWTEVXMGMTEXMSRMR
community-organized health activities. They are in contact with the CHVs
and formal health system where they seek and utilize health services.
8LILSYWILSPHJSVQWXLIǻVWXPIZIPSJGEVIXLEXMWYRMZIVWEPP]EZEMPEFPI

Community Owned CORPS are persons that exhibit good leadership, have been in the
Resource Persons community for a relatively long time, and have a close relationship with
Šk{„š the community. They understand and believe in the health initiatives’
goals, their respective community (architecture) environment, systems,
ERHWXVYGXYVIWERHLIRGI[MPPPEVKIP]LEZIERMQTEGXERHMRǼYIRGISR
community behavior.

Community- This refers to the provision of TB services outside the premises of

Based TB, Leprosy formal health facilities (e.g., hospitals, health centers, dispensaries, and
and Lung Health clinics) in community-based structures (e.g., schools, places of worship,
„åųƴĜÏåŸ congregate settings) and homesteads.

cŅĹě„Ƌ±ƋåeÏƋŅųŸ 3&MWXLITYFPMGFIRIǻXSVKERM^EXMSRWMRGPYHMRK3SR,SZIVRQIRXEP
Šc„eŸš Organizations (NGOs), Civil Society Organizations (CSOs), and community-
based Organizations (CBOs). Faith-based Organizations (FBOs) and other
organizations supporting the community outside the government.

„Ƌ±ĩåĘŅĬÚåųŸĜĹƋĘå Stakeholders are those involved in program operations, management,

Community TVSKVEQWXEǺTEVXRIVWJYRHMRKEKIRGMIW5EXMIRXWSVGPMIRXWEHZSGEG]
KVSYTWGSQQYRMX]QIQFIVWERHIPIGXIHSǽGMEPW

Multi-sectoral Deliberate collaboration among various stakeholder groups (e.g.,

eŞŞųŅ±ÏĘŠa„eš government, civil society, and private sector) and sectors (e.g., health,
environment, and economy) to jointly achieve a policy outcome.

Multi-disciplinary .RZSPZIWHVE[MRKETTVSTVMEXIP]JVSQQYPXMTPIHMWGMTPMRIWXSVIHIǻRI
eŞŞųŅ±ÏĘŠa%eš problems outside of normal boundaries and reach solutions based on a
new understanding of complex situations.

Community Health A community health committee is a committee that comprises a group of

ŅĵĵĜƋƋååŠBš selected members who reside in the same community. This committee
provides leadership and oversight in the implementation of health and
other related community services within the community unit.

Community Health The CHV is a member of the local community he/she is selected to
šŅĬƚĹƋååųŠBšš serve in. A CHV is selected by the community and undergoes training
to prepare him/her to serve households that are organized as part of a
community health unit. The work of the CHV is supervised by the CHA/
CHEW.

404 Integrated Guideline for Tuberculosis,

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 Community Health The Community Health Assistant / Extension Worker (CHA / CHEW) is a
eŸŸĜŸƋ±ĹƋx)ƻƋåĹŸĜŅĹ formal employee of the County Government, forming the link between
œŅųĩåųŠBex the community and the local health facility.
B)œš

Community This is a community-based approach, through which households

„Ƌų±ƋåčƼ and communities take an active role in health and health-related
development issues through increased knowledge, skills, and
participation in health matters.

ENGAGE-TB This is an approach that seeks to shift the perspective of TB from

Approach only a medical illness to a more comprehensive socio-economic and
community problem. This approach facilitates the engagement of
various stakeholders in community TB activities.

Background
(SQQYRMXMIWEVIEXXLIJSYRHEXMSRSJEǺSVHEFPIIUYMXEFPIERHIǺIGXMZILIEPXLGEVI8LI
GSQQYRMX]LIEPXLETTVSEGLMWERIǺIGXMZIQIERWJSVMQTVSZMRKLIEPXLERHGSRXVMFYXMRK
to general socio-economic development. Globally, this approach has been recognized
EWERIǺIGXMZI[E]SJQEOMRKMQTVSZIQIRXWMRLIEPXLGEVIHIPMZIV]EW[IPPEWEHHVIWWMRK
the heavy burden of disease and therefore contributing to health and socio-economic
development. Engaging communities on health matters is central to the success of
any public health intervention. Thus, community engagement in TB, Leprosy, and lung
LIEPXLMRZSPZIWXLSWIEǺIGXIHMRYRHIVWXERHMRKXLIVMWOWGLEPPIRKIWXLI]JEGIEW[IPP
as involving them in acceptable response actions.

The WHO global post-2015 plan, endorsed at the World Health Organization (WHO),
World Health Assembly (WHA) in May 2014, set the target for ending TB by 2035. This
plan emphasizes four driving principles to end TB: žƒŹŇĻďƐ ÏұĮЃĞŇĻƐ ƾЃĚƐ cŇĻĝžƒ±ƒåƐ

ÏƒŇŹžƐ ±ĻÚƐ ŇķķƣĻЃĞåžØƐ {ŹŇƒåσĞŇĻƐ ±ĻÚƐ {ŹŇķŇƒĞŇĻƐ ŇüƐ Ěƣķ±ĻƐ ŹĞďĚƒžØƐ åƒĚĞÏžØƐ ±ĻÚƐ åŭƣЃDž.
Sustainable development goal 3.3 requires that by 2030, countries should have ended the
epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases (like Leprosy)
and combated hepatitis, water-borne diseases, and other communicable diseases.

In Kenya, Tuberculosis still remains a public health challenge despite the disease being
treatable, curable, and preventable. Despite the cost of diagnosis and medicine to treat
TB being free for patients in Kenya, men, women, and children are still becoming ill
and dying from TB every day. With this in mind, innovative community engagement
strategies must be integrated as part of TB interventions to avoid just waiting for patients
to present themselves at the health facilities for essential services. On the other hand,
1ITVSW] [LMGLMWEXXLITSWXIPMQMREXMSRTLEWIEGGSVHMRKXS;-4GSRXMRYIWXSEǺIGX
E WMKRMǻGERX RYQFIV SJ TEXMIRXW & LMKL TIVGIRXEKI SJ TEXMIRXW EVI TVIWIRXMRK [MXL
grade 1&2 disability attributed to delayed diagnosis. Deformities and disabilities often
contribute to stigmatization and/or discrimination against leprosy patients.

In order to adequately address such gaps and make further progress toward mitigating
the impacts of TB, Leprosy, and lung health, health care workers (HCWs) need to

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 understand the importance of engaging communities & non-state actors (NSAs) in
the implementation of respective interventions/activities. Increased and enhanced
collaboration between HCWs, communities & NSAs, will lead not only to improved
LIEPXLSYXGSQIWMR8'ERH1ITVSW] XLVSYKLXLITVSZMWMSRSJERIǺIGXMZIGSRXMRYYQSJE
care package to patients as they exist in the facilities) but also an improved quality of life.

Rationale and Goal for Engaging the Community and Non-

State Actors
Though diagnosed in clinics and hospitals, TB and Leprosy thrive in the community. The
TB prevalence survey of 2016 showed that there are still missing persons (40%) with TB.
&GXMSR MR XLI GSQQYRMX] MW XLIVIJSVI IWWIRXMEP MR XLI GSYRXV]ƶW IǺSVXW EKEMRWX8' ERH
Leprosy. It is therefore important to take a multi-sectoral approach and link community
action on TB and Leprosy with the work of the national and county level so that the
IǺSVXW SJ XLI LIEPXL W]WXIQW EVI I\XIRHIH GVIEXI HIQERH JSV UYEPMX] WIVZMGIW ERH
reach as many people as possible.

8LIVIEVIXLVIIGVMXMGEPEVIEWSJ8'ERHPITVSW]TVSKVEQQMRKXLEXEVIEREXYVEPǻXJSV3&W
(NGOs, CSOs, FBOs, etc.) community-level work. As NSAs are often already positioned
to serve as a bridge between the health system and the community, they are natural
GERHMHEXIWXSǻPPXLIWIVSPIW-IEPXLI\TIVXMWIMWRSXEVIUYMVIQIRXƴNYWXE[MPPMRKRIWWXS
learn the basics of TB/Leprosy and to link to available TB/leprosy services.

NSAs can assist in:

ƽ (EWIǻRHMRKSVGEWIHIXIGXMSR- As people go about their daily lives, at home,

work, and school, and participate in cultural, political, economic, and religious
EGXMZMXMIW XLIVI EVI QER] STTSVXYRMXMIW XS ǻRH SYX [LS QMKLX LEZI W]QTXSQW
of TB or Leprosy. Individuals and some groups in the community are in a good
position to help identify people with symptoms of TB/leprosy and link them to
LIEPXLGEVIWIVZMGIW(EWIǻRHMRKTVEGXMGIWEPWSLIPTǻRHTISTPI[LSLEZIFIIR
exposed to TB so that they can receive TB Preventive Therapy (TPT) for latent TB
infection.

ƽ Treatment support- TB and leprosy treatment entails taking pills regularly over
a stipulated period. This can present challenges, including experiencing side
IǺIGXW JSVKIXXMRK PSWMRK SV VYRRMRK SYX SJ QIHMGMRI ERH LEZMRK WSGMEP ERH
emotional complications. Treatment supporters help overcome these obstacles.
The medicine-taking routine is often easiest when integrated into the patient’s
everyday life. Historically in Kenya, TB/leprosy patients are expected to report
to a health facility every day, week, or every two weeks, depending on the type
of TB/leprosy being treated as well as their phase of treatment. Too often, the
patient doesn’t have the time, energy, and/ or resources to make that daily or
weekly or two weekly journey leading to poor adherence. This poor adherence
may lead to the patient not getting better, development of drug-resistant TB/
Leprosy in the face of continuing spread in the community.

406 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 ƽ Advocacy, communication, and social mobilization (ACSM) -ACSM activities
help build public knowledge and foster positive attitudes and practices that
GSRXVMFYXI XS IǺSVXW XS WXST 8' ERH 1ITVSW] YGL IǺSVXW EVI QSWX TS[IVJYPP]
organized “from the inside” by people who really know and belong to the
community. What wrong beliefs do people have about TB and Leprosy? What
keeps sick people from seeking help? What pressures, beliefs, and stigmas
might be getting in the way? (Stigma is the unfair disapproval or prejudice against
a person, in this case, because the person has or may have TB or Leprosy.) What
is the best plan of action to create positive change in this community at this time?

.RSVHIVXSW]RGLVSRM^IIǺIGXMZI8'ERHPITVSW]TEXMIRXGEVIERHWYTTSVXMRXIVZIRXMSRW
there is a need for enhanced collaboration and coordination between the HCWs,
communities, and NSAs. Involving the community and collaborating with its members
EVIGSVRIVWXSRIWSJIǺSVXWXSMQTVSZITYFPMGLIEPXLMRVIPEXMSRXS8'1ITVSW]ERHPYRK
health.

Community Engagement
This is the process of working collaboratively with and through groups of people
EǽPMEXIH F] KISKVETLMG TVS\MQMX] WTIGMEP MRXIVIWX SV WMQMPEV WMXYEXMSRW XS EHHVIWW
MWWYIW EǺIGXMRK XLIMV [IPPFIMRK (SQQYRMX] IRKEKIQIRX MW E TS[IVJYP ZILMGPI JSV
bringing about environmental and behavioral changes that will improve the health of
the community and its members. It often involves partnerships and coalitions that help
QSFMPM^IVIWSYVGIWERHMRǼYIRGIW]WXIQWGLERKIWVIPEXMSRWLMTWEQSRKTEVXRIVWERH
serve as catalysts for changing policies, programs, and practices.

Why Community Engagement for TB, Leprosy, and

Lung health?

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 Community engagement can also be seen as a continuum of community involvement.
The table below illustrates one way of thinking about such a continuum. Over time, a
WTIGMǻGGSPPEFSVEXMSRMWPMOIP]XSQSZIEPSRKXLMWGSRXMRYYQXS[EVHKVIEXIVGSQQYRMX]
involvement, and any given collaboration is likely to evolve in other ways as well. Most
notably, while community engagement may be achieved during a time-limited project,
it frequently involves — and often evolves into— long-term partnerships that move from
the traditional focus on a single health issue to address a range of social, economic,
TSPMXMGEPERHIRZMVSRQIRXEPJEGXSVWXLEXEǺIGXLIEPXL

+SVWYGGIWWJYPGSQQYRMX]IRKEKIQIRXXLIVIQYWXFIERIǺSVXXSMRGVIEWIXLIPIZIPSJ
community involvement, trust, and communication as shown below

Increasing Level of Community Involvement, Impact, Trust, and Communication Flow

INFORM CONSULT INVOLVE COLLABORATE SHARED LEADERSHIP

„ŅĵåÏŅĵĵƚ- More community Better communi- Community in- „ƋųŅĹčųåĬ±ƋĜŅĹŸĘĜŞ

nity Involve- involvement ty involvement volvement
ment

Provides the Gets information Involves more 8ŅųĵŸޱųƋĹåų- „ƋųŅĹčޱųƋĹåųŸĘĜŞ

community with or feedback from participation with ships with the structure is formed
information the community the community community on
on issues each aspect of
the project – from
development to
solution

Optimally %åƴåĬŅŞŸ Visibility of Partnership build- Broader health out-

established connections partnership ing, trust-building ÏŅĵ埱ųå±ýåÏƋĜĹč
communication established with broader communities.
and outreach increased coop- „ƋųŅĹčÆĜÚĜųåÏƋĜŅűĬ
channels eration trust built

Approaches Linked to Community Engagement

ƽ Social mobilization

ƽ Behavior change communication

ƽ Health education and promotion

Social Mobilization
8LMW MW XLI TVSGIWW SJ FVMRKMRK XSKIXLIV EPP WSGMIXEP ERH TIVWSREP MRǼYIRGIW XS VEMWI
awareness of and demand for health care, assist in the delivery of resources and services,
and cultivate sustainable individual and community involvement.

408 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
This process engages and motivates a wide range of partners and allies at national,
county, and local levels to raise awareness of and demand for a particular health
objective through dialogue.

Members of institutions, community networks, civic and religious groups, and others
[SVOMREGSSVHMREXIH[E]XSVIEGLWTIGMǻGKVSYTWSJTISTPIJSVHMEPSKYI[MXLTPERRIH
messages. Social mobilization seeks to facilitate change through a range of interrelated
and complementary players.

Social and behavior change communication (SBCC)

This is an interactive process with communities (as integrated with an overall program)
to develop tailored messages and approaches using a variety of communication
channels to develop positive behaviors; promote and sustain individual, community,
and societal behavior change; and maintain appropriate behaviors. It strategically
uses communication approaches to promote changes in knowledge, attitudes, norms,
beliefs, and behaviors. This process helps in analyzing the health problem in order to
HIǻRI FEVVMIVW ERH QSXMZEXSVW XS GLERKI ERH HIWMKR E GSQTVILIRWMZI WIX SJ XEMPSVIH
interventions that promote the desired behaviors.

Health Promotion and education

This is a set of principles that involve- equity, empowerment, practices encompassing
communication, capacity building, and politically oriented activities; aimed at enabling
GSQQYRMX]QIQFIVWXSKEMRQSVIGSRXVSPSZIVXLIMRǼYIRGISJXLIMVPMZIWERHXSMQTVSZI
their health.

ƽ Health promotion aims at engaging and empowering individuals and communities

to choose healthy behaviors and make changes that reduce the risk of developing
TB, Leprosy and other lung related morbidities. It enables people to increase
control over their own health. It covers a wide range of social and environmental
MRXIVZIRXMSRW HIWMKRIH XS FIRIǻX ERH TVSXIGX MRHMZMHYEP TISTPIƶW LIEPXL ERH
quality of life by addressing and preventing the root causes of ill health, not just
focusing on treatment and cure.

ƽ Health education EMQW XS TVSZMHI MRJSVQEXMSR XS MRǼYIRGI XLI TISTPIWƶ JYXYVI
decision-making on their health. It provides learning experiences on TB, Leprosy
and lung health while presenting information to target populations on particular
EWTIGXW SJ 8' 1ITVSW] ERH PYRK LIEPXL MRGPYHMRK XLI LIEPXL FIRIǻXWXLVIEXW
they face, and provides tools to build capacity and support behavior change in
an appropriate setting. Health education looks at the health of a community as a
whole, seeks to identify TB, Leprosy and lung health issues and their trends within
ETSTYPEXMSRERH[SVOW[MXLWXEOILSPHIVWXSǻRHWSPYXMSRWXSXLIWIGSRGIVRW

Integrated Guideline for Tuberculosis, 409

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 Principles of community engagement
i. Planning phase
ƽ Clarify purpose/goal.
ƽ Understand the community’s culture, perception, economic condition, social
networks, political and power structures, norms, values, demographic trends,
history, and past experience.
ƽ Establish relationships, build trust, work with formal and informal leaders, and
seek their commitment for mobilizing the community.
ƽ Map and leverage existing community engagement mechanisms, e.g., for TB,
Leprosy, Polio, immunization campaigns, HIV work, Red Cross volunteers, etc.

ii. Implementation Phase

ƽ (SPPEFSVEXI[MXLXLIGSQQYRMX]XSGVIEXIGLERKIERHMQTVSZILIEPXL
ƽ 7IGSKRM^IERHVIWTIGXHMZIVWMX]ERHIRWYVIXLEXXLIQSWXZYPRIVEFPIEVIVIEGLIH
and engaged.
ƽ .HIRXMJ]QSFMPM^IEWWIXWERHWXVIRKXLWMRHIZIPSTMRKXLIGSQQYRMX]ƶWGETEGMX]
and resources to make decisions and take action
ƽ 'ITVITEVIHXSVIPIEWIGSRXVSPEGXMSRW ERH MRXIVZIRXMSRW XS XLI GSQQYRMX] 'I
ǼI\MFPIXSQIIXXLIGLERKMRKRIIHW

Challenges Related to Community Engagement

ƽ 2EMRXEMRMRKGSQQYRMX]MRZSPZIQIRXSZIVXMQI
ƽ 4ZIVGSQMRK HMǺIVIRGIW FIX[IIR XLI LIEPXLGEVI XIEQ GSQQYRMX] MRHMZMHYEP
QIQFIVWSJXLIGSQQYRMX]ERHHMǺIVIRXMRǼYIRGIVW
ƽ ;SVOMRK[MXLYRMUYIIWTIGMEPP]ZYPRIVEFPISVLEVHXSVIEGLGSQQYRMXMIW
ƽ (SQQYRMXMIWMRHMZMHYEPQIQFIVWSJXLIGSQQYRMX]ERHLIEPXLGEVIXIEQWQE]
not perceive risk in the same ways.
ƽ (SQQYRMXMIWLEZIGSQTPI\WSGMEPH]REQMGWERHGLERKMRKTS[IVVIPEXMSRWLMTW
[LMGLMRǼYIRGILS[[IIRKEKIXLIQ

Know the community

ƽ Community structure
 Formal and informal
 4TMRMSRPIEHIVWERHMRǼYIRGIVW
ƽ Community dynamics
ƽ Power relationships
ƽ Sources of information
ƽ Beliefs and practices
ƽ Available resources
ƽ Other important aspects of the community

410 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
The Perception Trap in Relation to Community Engagement
The perception trap is real and can make or break a public health intervention. Distorted
ERH ǻ\IH TIVGITXMSRW EVI HERKIVSYW 4YV GSQQYRMXMIW EVI FIGSQMRK QSVI GSQTPI\
integrated, and agile, and that static points of view limit our ability to collect information,
synthesize it, and have meaningful engagement. Holding onto a narrow view means
the community, and we make mistakes because our actions are based on incomplete
knowledge. Convinced in our accuracy, we refuse to adjust our views or consider other
STXMSRW .RWXIEH SJ PMWXIRMRK XS HMǺIVIRX TSMRXW SJ ZMI[ [I TVIJIV XS LEZI SXLIVW NYWX
agree with us. When the community or we realize that those we are engaging have their
mind made up, we stop sharing information since it becomes a waste of their or our time.
How many ways do you see this image?

Optical illusions have several ways they can be perceived. How open are you? Apart
from the community-related perception traps, do you have some yourself? Just as we
get our eyes examined to see clearly, we must also test our perceptions. For as Thoreau
noted- “It’s not what you look at that matters, it’s what you see.” We must continually test
SYVTIVGITXMSRFIJSVI[IEGGITX[LEX[IWIIEXǻVWXKPERGIMWEPPXLEXXLIVIMWXSWIIEW
we engage communities on matters of health.

As one engages the community, it is worth putting into consideration some of the
perception traps that may exist in the community and upon self in order for these to be
addressed; below is an example of a perception trap related to TB-

TRAP 1 - Fear: TB= HIV + Death

ƽ Everyone who has TB has HIV

ƽ Everyone who has TB will die

ƽ TB is a curse or is due to being bewitched

TRAP 2 - Dismissal

ƽ Don’t want to know

ƽ )SRƶX[ERXXSFIPMIZI

ƽ )SRƶX[ERXXSEGGITX

TRAP 3 - Disbelief due to distrust

ƽ TB is not curable

ƽ 8'GERRSXFITVIZIRXIH

Integrated Guideline for Tuberculosis, 411

Leprosy and Lung Disease | 2021
 The table below provides a summary of important key points to remember during
community engagement

1. Communities must be at the heart of any public health intervention especially if we are
to end TB and Leprosy.

2. FƋĜŸÏųĜƋĜϱĬƋŅĩĹŅƵ±ĹÚƚĹÚåųŸƋ±ĹÚÏŅĵĵƚĹĜƋĜåŸĜĹěŅųÚåųƋŅåýåÏƋĜƴåĬƼƵŅųĩƵĜƋĘƋĘåĵ
in all phases of health interventions.

3. Multiple strategies and tactics should be used to engage communities

4. Community engagement is grounded in the principles of community organization:

fairness, justice, empowerment, participation, and self-determination.

5. To achieve successful collaboration with a community, all parties involved need to

strive to understand the point of view of “insiders,” whether they are members of a
neighborhood, religious institution, health practice, community organization, or public
health agency Key to developing such understanding is recognizing one’s own culture
and how it shapes one’s beliefs and understanding of health and illness.

6. Meaningful community participation extends beyond physical involvement to include

generation of ideas, contributions to decision making, and sharing of responsibility.

7. %åƴåĬŅŞĜĹč±ÏŅĹŸƋĜƋƚåĹÏƼØŅųÚåƴåĬŅŞĜĹčųåĬ±ƋĜŅĹŸĘĜŞŸƵĜƋĘÏŅĵĵƚĹĜƋƼĵåĵÆåųŸ
who have a stake in and support public health and health care, involves four “practice
elements”:

ƽ Know the community, its constituents, and its capabilities.

ƽ Establish positions and strategies that guide interactions with constituents.

ƽ Build and sustain formal and informal networks to maintain relationships,

communicate messages, and leverage resources

ƽ Mobilize communities and constituencies for decision making and social action

8. Building capacity to improve health involves the development of sustainable skills,

ųåŸŅƚųÏåŸØ±ĹÚŅųč±ĹĜDŽ±ƋĜŅűĬŸƋųƚÏƋƚųåŸĜĹƋĘå±ýåÏƋåÚÏŅĵĵƚĹĜƋƼ

9. Community Empowerment takes place at three levels: the individual, the organization
or group, and the community. *QTS[IVQIRXEXSRIPIZIPGERMRǼYIRGIIQTS[IVQIRX
at the other levels Furthermore, empowerment is multidimensional, taking place in
sociological, psychological, economic, political, and other dimensions

10. ŅĵĵƚĹĜƋƼåĹč±čåĵåĹƋŅüƋåĹĜĹƴŅĬƴåŸÆƚĜĬÚĜĹčÏŅ±ĬĜƋĜŅĹŸØÚåĀĹåÚ±ŸٱƚĹĜŅĹŅü
ŞåŅŞĬå±ĹÚŅųč±ĹĜDŽ±ƋĜŅĹŸƵŅųĩĜĹčƋŅĜĹāƚåĹÏåŅƚƋÏŅĵåŸŅűŸŞåÏĜĀÏŞųŅÆĬåĵţŰ
Coalitions can help the engagement process in a number of ways, including maximizing
XLIMRǼYIRGISJMRHMZMHYEPWERHSVKERM^EXMSRWGVIEXMRKRI[GSPPIGXMZIVIWSYVGIWERH
VIHYGMRKXLIHYTPMGEXMSRSJIǺSVXW8LIIǺIGXMZIRIWWSJGSEPMXMSRWLEWFIIRIZEPYEXIHSR
two distinct bases: how well the members work together, and what kinds of community-
level changes they bring about.

11. %ŅĹåƵåĬĬØƋĘåÏŅĵĵƚĹĜƋƼěåĹč±čåÚ±ŞŞųŅ±ÏĘϱĹåűÆĬåޱųƋĹåųŸĘĜŞŸƋŅÚåƴåĬŅŞ
programs and research “in ways that are consistent with a people’s and community’s
cultural framework”

412 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Community Engagement Themes and Activities
The goal of engaging HCWs, communities, and NSAs is to contribute to the achievement
of universal health coverage and comprehensive care in TB, Leprosy & lung health. This
goal can be realized through various approaches and activities as highlighted in the
table below.

Theme Activities
Prevention Awareness-raising, information, education & communication, behavior
GLERKIGSQQYRMGEXMSR '((MRJIGXMSRGSRXVSPMHIRXMǻGEXMSR 
training of providers & TB Champions / Advocates (Multi-sectoral &
Multidisciplinary Collaborative Engagement)

%Ĝ±čĹŅŸĜŸ Screening, contact tracing, sputum collection and transportation,

provider training

Referral Linking with clinics/community support systems, transport support

and facilitation, accompaniment, referral forms, and training of health
providers (Multi-sectoral & Multidisciplinary Collaborative Engagement)

Treatment Home-based supervision and patient support, adherence counseling,

adherence support stigma reduction, pill counting, training of providers, home-based
care and support, SMS reminders (Multi-sectoral & Multidisciplinary
Collaborative Engagement)

„ŅÏĜ±Ĭ±ĹÚ Cash transfer, insurance schemes (e.g. NHIF), nutrition support and
livelihood support supplementation, voluntary savings and loans, and inclusive market
ŠŸŅÏĜ±ĬŞųŅƋåÏƋĜŅĹš that extend choices and opportunities to the poor, training of health
care providers, income generation (Multi-sectoral & Multidisciplinary
collaborative engagement)

„ƋĜčĵ±ųåÚƚÏƋĜŅĹ Community theatres/ drama groups/ testimonies, partner/peer support

groups, community champions, sensitizing and training facility and
CHVs and community own resource persons (CORPs) (Multi-sectoral &
Multidisciplinary collaborative engagement)

Advocacy *RWYVMRKEZEMPEFMPMX]SJVIWSYVGIW LYQERǻRERGMEPWYTTPMIWIUYMTQIRX

etc.) and services, training of providers, addressing governance and
policies issues, working with community leaders (Multi-sectoral & Multi-
disciplinary collaborative Engagement)

The Three Basic Components of TB Programming

Ŧ‰ĚåžåƐϱĻƐÆåƐƒƾå±īåÚƐƒŇƐ±ŤŤĮDžƐƒŇƐĮåŤŹŇžDžŧ

1. Finding the people who may have TB and providing access to diagnosis. This is
known as case detection. It may be done through symptom screening or contact
tracing (tracking down people who have been exposed to someone with TB).
Typically, sputum (coughed-up mucus) samples produced by persons presumed
to have TB are taken to a laboratory for testing to facilitate a diagnosis. In some
places, chest x-rays are also used as part of screening for TB.

Integrated Guideline for Tuberculosis, 413

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 2. Ensuring that those who have TB receive a supply of quality-assured medicine,
begin treatment, and are able to take the entire course of medicine consistently
and completely.

3. Minimizing the spread of TB through prevention and infection control. Health

JEGMPMXMIWERHQIHMGEPWXEǺEPSRIGERRSXHSEPPSJXLMW[SVO8SVIEGLXLIKSEPSJ
eliminating TB in Kenya, more people and organizations need to get involved. We
need a wide variety of people, organizations, and groups to engage communities
and work together to help stop TB. As a team, we can prevent many people from
IZIVGEXGLMRKSVHIZIPSTMRKEGXMZI8'MRXLIǻVWXTPEGIEW[IPPEWLIPTXLSWISR
therapy complete treatment.

The above can apply to Leprosy as well as part of a broad strategy to eradicate Leprosy
in Kenya.

A Highlight of the Strategies for the Three Basic Components of TB Programming

&XITWXS(SQQYRMX](EWI.HIRXMǻGEXMSRERH)MEKRSWMW

1. Create awareness among community members to increase demand for TB, Leprosy,
and lung disease services through community outreaches, health talks, health
education, and/or prevention campaigns/initiatives

2. Identify persons with signs and symptoms of TB, Leprosy, and lung disease using
GSQQYRMX]WGVIIRMRKXSSP MRXIRWMZIGEWIǻRHMRK

3. Refer and link presumptive TB / leprosy cases to a health facility for further evaluation

4. Collect and/or ship sputum specimen to facilities (ƾĚåŹåƐ±ŤŤĮĞϱÆĮå)

5. Contact trace (use of facility TB/leprosy data to follow up on contacts of

FEGXIVMSPSKMGEPP]GSRǻVQIH8'TEXMIRXW QYPXMFEGMPPEV]PITVSW]TEXMIRXW

6. Address / reduce stigma related to the disease

B. Approaches for Patient Care and Support at Community Level

1. Implement a good DOTS program at the community

1.1. Advice the patient on the availability of community-based patient

management options (ambulatory services) for both drug-sensitive and
resistant TB and leprosy management

1.2. Provide DOT for Rifampicin based regimens at the household level

2. Promote the provision of social and livelihood support (social protection for TB,
leprosy patients), including but not limited to:

2.1. Nutrition support

2.2. Income-generation activities for the aged, orphaned and vulnerable children,
etc.

2.3. Stipends during the treatment period

414 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 2.4. Enrollment into NHIF for care support during and after the treatment period

2.5. Reintegrate TB patients into the community post-recovery, e.g., joining/

participating in the community activities

3. Refer/link patients for Psychosocial support (to existing community-based

program) providing care and support services including:

3.1. Counseling

3.2. Patient follow up to ensure completion of treatment

3.3. Establish support groups in the community and link patients

accordingly

3.4. Home visits by community health volunteers to ensure adherence to

medication and nutritional therapy

3.5. Tracing of patients who might interrupt treatment

3.6. Post-treatment support for former patients and their household

4. Link and/or refer to leprosy patients (those with disability grade 1&2) for
rehabilitative services (social, surgical, etc).

C. Approaches for Infection Prevention and Control at the Community Level

1. Provide health education for the patient, family and community on how to minimize
disease transmission at the household level

2. Ensure timely vaccination for all children with BCG. BCG vaccination at birth or in the
ǻVWX]IEV SJ PMJI TVSZMHIW TVSZIR TEVXMEP TVSXIGXMSR EKEMRWX 1ITVSW] 4VKERM^EXMSRW
should actively encourage government health services to maintain high coverage.

3. Promote the provision of TPT for children exposed to infectious cases.

Coordination of TB and Leprosy Interventions in the

Community
National and County Governments

Engagement with the government and active participation with them is crucial for the
successful implementation of TB and Leprosy interventions. Government formulates
and oversees policy implementation.

Community-Based Approaches

Community Mapping: A mapping exercise should be conducted every six months to

locate administrative boundaries, discern the community’s own resource persons,
identify the community-based health interventions, including maternal and child health
WIVZMGIW EZEMPEFPI LIEPXL JEGMPMXMIW WIVZMGIW SǺIVIH LIEPXLWIIOMRK FILEZMSVW ERH

Integrated Guideline for Tuberculosis, 415

Leprosy and Lung Disease | 2021
 potential barriers to accessing health care services. These will guide in program design
and delivery.

Focus Group Discussions: FGDs should be conducted to initiate discussions around the
CHV program, address any issues arising from the mapping exercise, and develop a
desirable relationship with key community stakeholders in order to secure and sustain
the community’s interest in all aspects of the program. These consultations should be
used to discuss health issues in the community and ask about existing TBAs and health
leaders. It is also useful to visit the homes of the TBAs to understand the scope of their
work and the homes of community members to learn from whom they already seek
health advice and services. Community dialogue can culminate into community action.

Community Face-to-Face Sensitizations: It also helps to manage expectations and

prepare the community for new interventions. It is good to share plans with the community
prior to the rollout to help them prepare and clarify any questions they may have. CHVs
serve as the gatekeepers, and once they are known by the community members, they
can be used to prepare the community for any other new interventions.

Community sensitization should meet the following objectives

1. To provide background information about the CHV program.

2. To discuss the health status of the community and the need to improve health
outcomes.

3. To respond to and address any concerns that may arise during such community
entry activities.

4. To seek community approval for the recruitment of CHVs and their participation
in the program.

5. To seek collaboration with partner/referral health facilities and schools in the

area of coverage.

6. To identify existing community structures to work with.

7. To hold face to face meetings with local leaders’/opinion leaders.

Establishing criteria that respect equity

Each program needs to develop standards that CHV must meet. CHVs who are from
the same community as their clients are uniquely situated to build trusting relationships
[MXLXLIMVGPMIRXW4XLIVUYEPMǻGEXMSRWORS[PIHKIWOMPPWEFMPMXMIWERHI\TIVMIRGIJSPPS[
the criteria for the selection of community health volunteers.

Determining Roles and Responsibilities: Each program needs to develop a job

HIWGVMTXMSR [MXL WTIGMǻG VSPIW VIWTSRWMFMPMXMIW ERH EGXMZMXMIW JSV (SQQYRMX] -IEPXL
;SVOIVW2SWXNSFHIWGVMTXMSRWEVIWTIGMǻGXSTVSKVEQRIIHWVIWSYVGIWERHXLIWIVZMGI
package to be delivered by the CHVs. However, the engagement of CHVs shall align
with the ministry of health and county and sub-county guidelines.

416 Integrated Guideline for Tuberculosis,

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Some qualities of a CHV

1. Must be of age

2. Preferably a resident of the area or community being served

3. Selected by the community

4. Be committed to the role

5. Be able to read and write

6. A community mobilizer

7. Have knowledge of health issues, system, and development

8. Understand the local language

9. &FPIXSMRǼYIRGITISTPIJSVGLERKI

10. )IQSRWXVEXIGSRǼMGXVIWSPYXMSRWOMPPW

11. Be culturally sensitive

Supervision of TB Activities in the Community

Systematic supervision is a necessary part of a successful CHV program. It is imperative

XLEX(-:WLEZIGPIEVI\TIGXEXMSRWERHEVIVIKYPEVP]WYTTSVXIHERHQIRXSVIHEWXLI]JYPǻPP
XLIKSEPWSJXLI(-:TVSKVEQ*ǺIGXMZIWYTIVZMWMSRMWORS[RXSMQTVSZIXLIORS[PIHKI
and skills of CHVs and the quality of care provided to patients and raise awareness of
the CHV role, thus legitimizing CHVs and their work in the eyes of community members.
&QSHIPSJWYTIVZMWMSRLEWFIIRWYKKIWXIHEWEKYMHIXSIǽGMIRXWYTIVZMWMSR

The 360 Supervision Model

The steps in the model are as follows:

1) CHV Dashboard: CHV supervisors review the CHV performance data, which
tracks speed, quantity, and quality of care.

2) Patient Feedback Audit: CHV supervisors conduct home visits to families visited
by the CHWs in their absence in order to collect performance feedback.

3) CHV Shadowing: CHV supervisors visit households alongside CHVs in order to

directly observe the CHV providing care during home visits.

4) One on One Feedback: CHV supervisors sit down with their CHVs to collaboratively
set goals and identify areas of strength and areas of improvement. They should
discuss individual and aggregate performance, logistical challenges, and
solutions, and the supervisor should ensure that all CHVs have and know how to
use job aids, counseling cards, and smartphones.

Start-up Costs for a CHV Program: Start-up costs may be variable from program to
program depending on the design and the service package and can include many
components such as planning costs, training costs, CHV Kits, equipment, basic

Integrated Guideline for Tuberculosis, 417

Leprosy and Lung Disease | 2021
 supplies/consumables, airtime, uniforms, and development of any needed physical
infrastructure (e.g., meeting spaces, information technology infrastructure, payroll, and
human resources systems.

The Roles of Community Stakeholders in TB, Leprosy & Lung Health Disease Control

Community Health Committee (CHC)

ƽ 8LIGSSVHMREXMSRERHQEREKIQIRXSJXLI(-9ERHMXW[SVOJSVGIWLEPPFIHSRI
by a

ƽ (-( E KVSYT SJ QIQFIVW WIPIGXIH F] XLI GSQQYRMX] 8LI GSQQMXXII WLEPP
include:

ƽ &TVIWGVMFIHRYQFIVSJ[LMGLRSXQSVIXLERX[SXLMVHWWLEPPFIJVSQXLIWEQI
gender.

ƽ Representation from religious and cultural groups within the context.

ƽ Representation from youth and people with disabilities.

The members must reside in the community they are selected to serve. They will serve a
three-year term that is renewable once unless agreed by the community. The CHC shall
choose its chairperson and shall have at least one, and at most two, CHVs. If a member of
the CHC is selected to be a CHV, they cease to be in the CHC unless representing CHVs. The
CHA shall be the technical advisor and secretary to the CHC. The treasurer shall be a CHV.
The chairperson shall become a co-opted member of the link health facility committee.
8LI(-(WLEPPFIXLIǻVWXSVKERXSFIGSRWXMXYXIHMRXLIIWXEFPMWLQIRXSJE(-9

The roles and responsibilities of the CHC shall include:

ƽ Provision of leadership and oversight in the implementation of health and another

related community service.

ƽ Preparation and presentation of the CHU annual work-plans and operational

plans to the link facility health committee.

ƽ Planning, coordinating, and conducting community dialogue and health action

days.

ƽ Working with the link facility to promote facility accountability to the community.

ƽ Holding quarterly consultative meetings with the link facility health facility
committee.

ƽ Creating an enabling environment for implementation of community health

services.

ƽ Resource mobilization for sustainability.

418 Integrated Guideline for Tuberculosis,

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TB Treatment Supporters (e.g., Peers, family members, friends, etc.)

ƽ Provision of DOT (Directly Observed Treatment) to ensure compliance and

adherence of treatment

ƽ Provide psychosocial support, e.g., counseling, etc

ƽ Provide nutritional support

ƽ Follow up if any problems occur or if the patient does not adhere to treatment
schedules

ƽ *RWYVIVIKYPEVVIǻPPVITPIRMWLQIRXSJHVYKW

ƽ Ensure medicines are stored in a dry and cool place (away from heat and direct
sunlight) in the house and away from children

ƽ Alcoholics & Drug users

Community Health Volunteer (CHV)

ƽ Create awareness on TB, Leprosy & Lung Health and available services to the
community

ƽ Identify, screen, and refer presumptive TB/leprosy clients to the health facility
and follow up on the outcome

ƽ Support patients on treatment and adherence

ƽ Tracing of treatment interrupters and patient contacts

ƽ Refer TB patients on treatment for follow-up sputum smears

ƽ Record and report information using the standard tools

ƽ Identify complications, including adverse drug reactions, and refer as needed

ƽ Participate in periodic review meetings organized by the CHEW

ƽ Promote infection prevention and control interventions at the Household/

community level

 Link patients to support groups

 Perform nutrition assessment e.g., weighing patients, using mid-upper-arm

circumference (MUAC), etc., and referring appropriately

Note: ‰ĚåžåƐ±ÏƒĞƽЃĞåžƐ±ŹåƐ±ÏĚĞåƽåÚƐķ±ĞĻĮDžƐƒĚŹŇƣďĚƐĚŇķåƐƽĞžĞƒžØƐƱŹ±Ǎ±žØƐåƒÏũ

Community Health Assistants/Extension Workers (CHAs/CHEWs)

CHAs/CHEWs are directly in contact with the CHVs/Community Health Committee

(CHC). They are the link between the community and the local health facility. Other roles
include:

1. Participate in the selection, training, and support of Community Health Volunteers

(CHVs) and Community Health Committees (CHCs)

Integrated Guideline for Tuberculosis, 419

Leprosy and Lung Disease | 2021
 2. Being the secretary to the CHC and the custodian for CHC meeting minutes

3. Plan and build the capacity of CHVs

4. IRWMXM^IXLI(-:WSRWMHIIǺIGXWQSRMXSVMRK TLEVQEGSZMKMPERGI

5. Monitor the management of TB & leprosy patients in the community

6. Generate and collate data for decision making

7. Link the community and the health facility for action

8. Organize community health activities, including dialogue days and health action
days

9. Organize periodic review meetings with the CHVs

10. Organize and conduct school health activities (TB, Leprosy, lung health)

11. Provide support supervision to CHVs

12. *RWYVITEXMIRXWEVIETTVSTVMEXIP]RSXMǻIHERHQSRMXSVIHEXXLIGSQQYRMX]

13. Receives reports from the CHC / CHV and forward them to the HRIO

14. Coordinate/Link community-based interventions with non-state Actors

Facility-based CHEW

1. 4ZIVWIIXLIMHIRXMǻGEXMSRSJGSQQYRMX]LIEPXLZSPYRXIIVW (-:W

2. Plan and build the capacity of CHVs.

3. IRWMXM^IXLI(-:WSRWMHIIǺIGXWQSRMXSVMRK TLEVQEGSZMKMPERGI

4. Organize health outreach service in collaboration with community-based CHEW

5. Monitor the management of TB, leprosy patients in the Facility

6. Generate and collate data for decision making.

7. Link community and the health facility for action

8. Organize periodic review meetings with the CHVs.

9. Initiate referrals of patients and clients to the community

10. Generate community reports and forward them to the sub-county HRIO/ TB
coordinator

Health Care Workers

1. Conduct CMEs within their facilities on TB, Leprosy, and lung health

2. Screening of presumptive cases (TB, Leprosy) patients

3. .HIRXMǻGEXMSRSJTEXMIRXWMRXIVVYTXMRKXVIEXQIRXERHRSXMJ]MRKXLI(-*;

4. Health educate patients diagnosed with TB, Leprosy, and other lung diseases

5. 2SRMXSVMRKTEXMIRXWJSVWMHIIǺIGXWERHVITSVXMRKEGGSVHMRKP] TLEVQEGSZMKMPERGI

420 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 6. Monitor the management of TB, leprosy patients in the community

7. Ensure proper documentation in the TB/leprosy tools

8. Generate and collate data for decision making

9. Link the community and the health facility for action

10. Organize periodic review meetings with the CHVs

11. Provide support supervision to CHVs

12. *RWYVITEXMIRXWEVIETTVSTVMEXIP]RSXMǻIHERHQSRMXSVIH

Non-State Actors (NSA)

1. Empower communities to participate in matters relating to their own health

2. Mobilize communities to participate in resource mobilization for their livelihood

3. Advocate for budget allocation and mobilize resources for sustainability

4. .RǼYIRGISXLIVWXEOILSPHIVWXSIQFVEGI8'PITVSW]EGXMZMXMIWMRXLIMVVSYXMRIW

5. Support and participate in the implementation of TB, leprosy control activities

6. Promote behavior change through various channels of communication to reduce

stigma and discrimination

7. Identify and work with key populations

8. Facilitate implementation of TB Intensive Case Finding (screening, referral, and

testing)

9. Support and participate in home-based care activities

10. Promote treatment adherence through peer support groups, education, and
individual follow-up

11. Promote the provision of social and livelihood support to TB / leprosy patients
(e.g., stipends/ food, income-generation activities for the aged, orphaned and
vulnerable children, etc)

12. Promote patients’ rights and responsibilities

13. Promote infection prevention and control interventions at the community level

Note:Ɛ FĻüŇŹķ±ƒĞŇĻƐ ŇĻƐ ĚŇƾƐ ƒŇƐ åýåσĞƽåĮDžƐ åĻď±ďåƐ cŇĻĝžƒ±ƒåƐ
ÏƒŇŹžƐ xƐ „kžƐ ĞĻƐ ‰Ɛ ÏŇĻƒŹŇĮƐ
±ÏƒĞƽЃĞåžƐϱĻƐÆåƐüŇƣĻÚƐĞĻƐƒĚåƐ)c:
:)Ɛ‰ƐďƣĞÚåĮĞĻåũ

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 Field Processes
A Sample Community Outreach Field Process

1) Courtesy call to the CDH or the nearest CHMT representative by the team lead.
The rest of the team may go directly to the screening area.

2) People who have been mobilized are taken through Health Education on TB,
and their concerns responded to. The number of people attending the health
education forum becomes the denominator for the screening population.

3) Outreach teams assemble and strategically position themselves to facilitate free

TEXMIRXǼS[

4) Everyone present is screened by the clinician through the use of the TB screening
criteria and their details documented.

5) &R]FSH] VIWTSRHMRK EǽVQEXMZIP] XS ER] SJ XLI WGVIIRMRK UYIWXMSRW MW JYVXLIV
investigated by the clinician (Presumptive TB Patients).

6) TB presumptive patients are recorded in the presumptive register and may be

sent for Chest X-Ray. (NB: chest X-rays will only be done to those with the request
form from the clinician).

7) Those with abnormal chest x-ray outcomes are referred for Gene X-pert test.

8) Those who are diagnosed to have TB either through clinical diagnosis or

FEGXIVMSPSKMGEP GSRǻVQEXMSR WLSYPH FI TYX MR XLI 8' VIKMWXIV ERH MRMXMEXIH SR
treatment.

a) Those with normal chest X-ray outcomes are investigated by the clinician for
other chest conditions.

b) Those who test negative for Gene X-pert (MTB-Negative / MTB not detected)
are further evaluated and managed accordingly.

c) Those who test positive for Gene X-pert (MTB-Positive / MTB detected) are
initiated on treatment according to the National TB treatment guidelines and
recorded in the TB4 register of the nearest health facility.

9) The TB positive patients are then linked to the SCTLC for further follow up, contact
tracing, and social support (support groups, NHIF for DRTB patients).

A Sample Process for a Targeted Mobile X-ray Outreach

1) Counties make their request to be supported with the mobile digital X-Ray
machine/s to the Head of NTLD-P.

2) 7IUYIWXWJVSQIMXLIV(81(LEZIXSFIWYTTSVXIHF]WSQINYWXMǻGEXMSR

Outreaches target vulnerable populations and those in congregate settings. Some of

the key populations targeted include; people who abuse drugs, prison inmates, factory
workers, people in learning and training institutions, those living in informal settlements,
among others.

422 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
 3) 8LI-IEH381)5ETTVSZIWSVHMWETTVSZIWXLIVIUYIWXWFEWIHSRNYWXMǻGEXMSR

4) The Head NTLD-P will source for funding from partners.

5) 8LIXIEQPIEZIWJSVEǻIPHSYXVIEGL

Monitoring Community Engagement

WHO has developed a minimum set of standardized indicators to help monitor

contributions made by communities (particularly CHVs) whether supported by the
government or by partners.

NB: ŽƒĞĮĞǍ±ƒĞŇĻƐ ŇüƐ ƒĚåƐ ‰Ɛ
8Ɛ Ŧ
σĞƽåƐ ±žåƐ 8ĞĻÚĞĻďŧƐ Ú±ƒ±Ɛ ƒŇŇĮžƐ ±ĻÚƐ ÏŇķķƣĻЃDžƐ ŇƣƒŹå±ÏĚƐ
Ú±ƒ±ƐāŇƾƐÏ̱Źƒžx„k{žƐƾĞĮĮƐÆåƐĚĞďĚĮDžƐŹåÏŇķķåĻÚåÚ

The following are the additional activities on monitoring of community engagement

that can be carried out by community health extension workers and community health
volunteers:

ƽ Continuous capacity building of CHVs and Champions/advocates from other

sectors

ƽ Ensure accurate and orderly record-keeping of community tools

ƽ Ensuring presumptive cases reaching the facility is entered into the presumptive/
contact investigation register (where applicable)

ƽ Emphasize and utilize the “remarks” column in the various tools to indicate referral
to/from the community for proper analysis

ƽ Periodically document on the community engagement, multi-sectoral / multi-

disciplinary best practices

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424 Integrated Guideline for Tuberculosis,
Leprosy and Lung Disease | 2021
MONITORING &
EVALUATION 20

20.1 Introduction
Monitoring is the routine tracking of service and program performance. It is a continuous
process intended to provide information on the extent to which a program is achieving
MXWXEVKIXW[MXLMRWTIGMǻIHTIVMSH

*ZEPYEXMSR MW E XMQI WTIGMǻG EWWIWWQIRX SJ VIWYPXW XLEX GER FI EXXVMFYXIH XS TVSKVEQ
activities. It uses routine monitoring data and, often, indicators that are not collected
through routine information systems. A well designed evaluation should allow for the
GEYWIWSJJEMPYVIXSEGLMIZIMRXIRHIHVIWYPXWXSFIMHIRXMǻIH8LMWGERFIEGLMIZIHF]
all health workers at all levels utilizing the information collected routinely to improve
service delivery with the aim of achieving the set targets.

20.2 Recording and Reporting

Recording and reporting program of data is vital for Monitoring and Evaluation of the
Program. Data forms part of the general health information system, which aims to:

ƽ *RWYVI E GSRXMRYYQ SJ GEVI MRJSVQEXMSRWLEVMRK [MXL TEXMIRXW ERH XVERWJIV SJ
information between health facilities,

ƽ *REFPIQEREKIVWEXHMǺIVIRXPIZIPWMRXLI)3815XSQSRMXSV5VSKVEQTIVJSVQERGI
in a standardized and internationally comparable way, and

ƽ 5VSZMHIXLIFEWMWJSVTVSKVEQQEXMGERHTSPMG]HIZIPSTQIRX

Establishment of a reliable recording and reporting system is an essential part of the

End TB strategy. These guidelines are accompanied by forms, registers and reporting
templates that are designed for paper-based and electronic recording and reporting
systems.

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 ƽ&PPHEXEGSPPIGXMSRWXSVEKIERHYWIWLSYPHFIMREGGSVHERGI[MXLHEXETVSXIGXMSREGXSJ
parliament 2019.

ƽ*ZIV]LIEPXLGEVITVSZMHIV[LSXVIEXW8'LEWETVSJIWWMSREPVIWTSRWMFMPMX]XSVIGSVHERH
report all cases he or she treats

ƽ&GGYVEXIOIITMRKSJVIGSVHWSJEPPMRHMZMHYEPTEXMIRXWERHQEMRXIRERGISJVIKMWXIVWEVI
minimum requirements that need to be met by all health care workers involved with the
diagnosis and treatment of tuberculosis patients.

ƽ8YFIVGYPSWMW 8'GEWIVIGSVHMRKERHVITSVXMRKXSSPMWMQTSVXERXJSVQSRMXSVMRKIZEPYEXMRK
and collecting information on each newly reported case of TB disease (TB Surveillance)
at either health facility, region, county and nationally.

Note: 8'MWERSXMǻEFPIHMWIEWIYRHIVXLI5YFPMG-IEPXL&GX(ETERHXLIVIJSVIEPP8'
(EWIW HMEKRSWIHF]XLITYFPMGSVTVMZEXIWIGXSVQYWXFIRSXMǻIHXSXLI24-

Figure 20.1 Monitoring and evaluation log framework

426 Integrated Guideline for Tuberculosis,

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20.3 Data Management

Figure 20.2 Data management levels for TB in Kenya

ƽ +EGMPMX]8'PITVSW]ERHPYRKHMWIEWIHEXEQE]PEVKIP]FIVIGSVHIHMRXLIWXERHEVH
recording and reporting tools provided by the MOH. While electronic reporting at the
facility level is acceptable and encouraged, conformity to the standards provided by
the MOH through its reporting framework and health information system policy is
mandatory for each electronic tool handling TB, Leprosy and Lung disease data.

ƽ &GGYVEXIVIGSVHWSJMRHMZMHYEPTEXMIRXWERHQEMRXIRERGISJVIKMWXIVWEVIQMRMQYQ
requirements that need to be met by all healthcare workers involved with the
diagnosis and treatment of tuberculosis, leprosy and lung disease patients. It is
the responsibility of the facility in charge (I/C) with training and technical support
(supervision) from the County and Sub county coordinators to ensure that recording
of details about patients is done properly and correctly. The number and design of
cards, forms and registers has been limited and kept as simple as possible to enable
the DNTLD-P to have good patient care and monitoring of performance at all levels.

ƽ &PPTEXMIRXWHMEKRSWIHMRLIEPXLGEVIJEGMPMXMIWWYTIVZMWIHF]XLI)381)5QYWXFI
registered at the start of treatment.

NOTE:8'MWERSXMǻEFPIHMWIEWIYRHIVXLI5YFPMG-IEPXL&GX(ETERHXLIVIJSVIEPP8'
(EWIW HMEKRSWIHF]XLITYFPMGSVTVMZEXIWIGXSVQYWXFIRSXMǻIHXSXLI24-

Integrated Guideline for Tuberculosis, 427

Leprosy and Lung Disease | 2021
  &VGLMZMRK (SRǻHIRXMEPMX]
ƽ 8LIJEGMPMX]MWI\TIGXIHXSXEOITVIGEYXMSRWEKEMRWXǻVISXLIVEGGMHIRXWERHGVMQMREP
EGXWXLEXQE]EǺIGXWXSVIHHEXEEXXLIJEGMPMX]+SVGSQTYXIVFEWIHVIGSVHWVIWTSRWMFPI
.(8SǽGIVWMRGSRNYRGXMSR[MXLXLIJEGMPMX]MRGLEVKI WWLSYPHIRWYVITVSTIVEVGLMZMRK
and accessibility of the data. Because of data sensitivity, appropriate security against
YREYXLSVM^IH EGGIWW ERH QSHMǻGEXMSR WLSYPH FI MRWXMXYXIH  TEVXMGYPEVP] [LIVI E
provider fails to comply with privacy standards prescribed by the health information
system policy or any existing or proposed health law or knowingly violates patient
privacy. In line with the principles of information privacy, data collected for TB,
PITVSW]ERHPYRKHMWIEWIWF]XLILIEPXL[SVOIVWWLEPPFIWXSVIHGSRǻHIRXMEPP] PSGO
 OI]  5EWW[SVH TVSXIGXIH 8LMW WLEPP FI HMǺIVIRX JVSQ XLI TSPMGMIW SR QIHMGEP
records management.

Care should be exercised to ensure data integrity and data should be safeguarded
EKEMRWXYREYXLSVM^IHEGGIWWERHYWI(SRǻHIRXMEPMX]WLSYPHFIIRWYVIHEXEPPPIZIPWERH
any breech of this should be reported to relevant authorities.

Data analysis and use for decision making at all levels

HCWs at all levels should carry out routine basic data analysis in order to inform
management on progress and quality of care provided to the patients. Some of the
recommended analysis and quality checks at the facility are:

ƽ 2SRXLP] ERH UYEVXIVP] XVIRHW SJ 8' PITVSW] ERH PYRK HMWIEWIW HMEKRSWIH ERH
started on treatment

ƽ 8VIEXQIRXSYXGSQIW GSLSVXEREP]WMWTIVUYEVXIV

ƽ &+'QMGVSWGST]TSWMXMZMX]VEXIWJSVRI[ERHJSPPS[YTXIWXW

ƽ ,IRI<TIVXYXMPM^EXMSRVEXIW

ƽ ,IRI<TIVXTSWMXMZMX]VEXIW

ƽ ,IRI<TIVXIVVSVVEXIW

ƽ 5VSTSVXMSRWSJIPMKMFPITEXMIRXWHSRI)8

ƽ 5VSTSVXMSRWSJGLMPHVIRYRHIV]IEVWHMEKRSWIH[MXL8'

All operations research activities should be done in line with guidelines from the ethics
committees and requirements of NACOSTI adhered to. HCWs are encouraged to utilize
readily available data to diagnose any service delivery bottle necks and recommend
solutions to the management.

428 Integrated Guideline for Tuberculosis,

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 7SPIWERH7IWTSRWMFMPMXMIW
8'MWERSXMǻEFPIHMWIEWIIZIV]LIEPXLGEVITVSZMHIVLEWTVSJIWWMSREPVIWTSRWMFMPMXMIWXS
record and report the cases.

County TB and Leprosy coordinator (CTLC)

ƽ 5VSZMHISZIVWMKLXSJ8'PITVSW]ERHPYRKLIEPXLTVSKVEQQMRKMRGSYRX]

ƽ 'YMPHGETEGMX]SJ(81(WERH-(;WXLVSYKLQMGVSXIEGLMRKWSRNSFQIRXSVWLMT
facility CMEs and by availing of job aids, SOPs and guidelines

ƽ (81(WYTTSVXWYTIVZMWMSR

ƽ &ZEMPVIGSVHMRKERHVITSVXMRKXSSPW

Sub-county TB and Leprosy coordinator (SCTLC):

ƽ 5VSZMHISZIVWMKLXSJ8'TVSKVEQQMRKMRWYFGSYRX]

ƽ 'YMPH GETEGMX] SJ -(;W XLVSYKL QMGVSXIEGLMRKW SRNSF QIRXSVWLMT JEGMPMX]

CMEs, and by availing of job aids, SOPs and guidelines

ƽ -(;WYTTSVXWYTIVZMWMSR

ƽ &ZEMPVIGSVHMRKERHVITSVXMRKXSSPW

ƽ 3SXMJ]EPP8'TEXMIRXW

ƽ *RWYVITVSTIVHSGYQIRXEXMSRMWHSRI

HCW at all SDPs

ƽ (PMRMGEPIZEPYEXMSRJSV8'HMEKRSWMW LMWXSV]XEOMRKTL]WMGEPI\EQ

ƽ 2EOIW1EFVIUYIWXWERHVIJIV8'GEWIWJSV,IRI<TIVXWQIEVQMGVSWGST] (<7
as appropriate)

ƽ .RXIVTVIXPEFVIWYPXWERHQEOIEHMEKRSWMWEWETTVSTVMEXI

ƽ XEVXXVIEXQIRXMRMXMEXMSRERHGSRXEGXQEREKIQIRX

ƽ 2SRMXSVWMHIIǺIGXWVIGSVHERHVITSVX

ƽ )SGYQIRXEXMSRMRXLIETTSMRXQIRXGEVHWVIGSVHGEVHWERH8'VIKMWXIVW

Laboratory personnel

ƽ (EVV]SYX1EFSVEXSV]MRZIWXMKEXMSRERHVIPE]VIWYPXWFEGOXSXLIVIJIVVMRKGPMRMGMERW

ƽ +SPPS[YTGSRǻVQIH8'TEXMIRXWSRHMEKRSWMWXSVIXYVRJSVXVIEXQIRXMRMXMEXMSR

ƽ )SGYQIRXEXMSRSJPEFVIUYIWXJSVQERHVIKMWXIVW

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 Table 20.1 Data collection tools for TB in Kenya

No Name of Tool Purpose Location Filled By

1 Tuberculosis It is an ICF cards Used for Community CHV

screening/Contact screening TB in the community
tracing form at
community level

2 Community Referral Used to refer presumptive Community CHV

Form TB cases, contact tracing and
treatment interrupters from
community to the facility for
diagnosis and treatment

3 Patient Appointment Used to record clinic appointment TB clinic Clinician

Diary details for patients on TB treatment

4 Treatment Interruption Used to track patients who have Facility CHV

Tracing Form for defaulted TB treatment.
Community Health
Volunteers

5 Facility Summary Tool This is a summary tool used to Facility Clinician

for Facility-Based record summary ACF data in a
Active Case Finding facility from all the departments
per month

6 Departmental This is a summary tool used to Facility Clinician

Summary Tool for record summary ACF data per
Facility -Based Active department per month
Case Finding

7 MDR Lab Investigation This is a form used to request for Facility Clinicians
Request Form further lab investigation for a DR-
TB patient before and during the
treatment course

8 AFB/GeneXpert / It is a case listing for all pulmonary Lab 1EFSǽGIVW

Culture Register TB patients sent for AFB
microscopy and gene xpert tests
done in the lab.

9 EQA Analysis Form This is used to record the EQA Lab 1EFSǽGIVW
results by the lab

10 EQA Summary Form Used to collect microscopy Lab 1EFSǽGIVW

EQA performance by the Lab
coordinator

11 Laboratory Support It is a duplicated checklist booklet Lab 1EFSǽGIVW

Supervision Checklist used by the lab coordinator to
conduct supervision to the facilities
doing smear microscopy

12 Workload Summary Used to collect monthly laboratory Lab 1EFSǽGIVW

Form data for microscopy, Xpert data,
Culture data

430 Integrated Guideline for Tuberculosis,

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No Name of Tool Purpose Location Filled By
13 EQA Sampling Sheet Used by the TB coordinator to Lab TB Coordi-
sample slides for EQA controls nator

14 Patient referral form Used for referring presumptive TB Other Clinicians

to TB clinic cases from other service delivery service
points e.g. HIV clinic, medical delivery
clinics among others to TB clinic points
outside TB
Clinic

15 Asthma Register It is Asthma Case listing register Outpatient/ Clinicians

which summarizes key variables for Chest Clinic
tracking Asthma patient progress.

16 Asthma Record Card 8LIGEVHMWǻPPIHF]LIEPXL[SVOIV Outpatient/ Clinicians

and acts as patient clinical record Chest clinic
card used for clinical notes during
treatment

17 Patient Appointment The card is used for scheduling Patient Clinicians

Card (TB, TPT, DRTB, treatment appointments and acts
Leprosy and Asthma) as a treatment reminder to the
patient.

18 Bin Card This card is used to monitor stock Pharmacy/ Pharmacist

of commodities in facility store or Store
pharmacy

19 S11 This form is in triplicate and is used Pharmacy/ Pharmacist

to issue out commodities to various Store
service delivery points within the
facility

20 Intensive Case This form is used both for TB, and HIV Clinicians
Finding /TPT Card screening for TB among the clinic
at-risk population (both adults
and children) and recording TPT
information for eligible patients

21 TPT/Contact It is a Case listing which TB and HIV Clinicians

Management Register summarizes key variables for listing clinic
and management of contacts of
FEGXIVMSPSKMGEPP]GSRǻVQIH58'
and TPT patient progress and
outcomes.

22 Patient Record Card 8LIGEVHMWǻPPIHF]LIEPXL[SVOIV TB Clinic Clinicians

and acts as patient clinical record
card used for clinical notes during
treatment

23 Facility TB Treatment It is a TB Case listing which TB Clinic Clinicians

Register (TB 4) summarizes key variables for
tracking TB patient progress and
outcomes

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 No Name of Tool Purpose Location Filled By
24 Culture/DST Log To capture patients whose samples TB clinic Clinicians
book have been sent for culture and DST
and results

25 AFB/GeneXpert/ Used to request for AFB/Gene TB Clinic Clinicians

Culture request form xpert/culture/DST for DR TB
surveillance

26 DR TB Patient Log Individual patient management TB clinic Clinicians

book booklet that records all information
regarding the patient.

29 DR TB Register DRTB Case listing which TB clinic Clinicians

summarizes key variables for
tracking patient progress and
outcomes

30 DR TB baseline and Baseline and follow-up request TB clinic Clinicians

follow up test request form for DR TB patient.
form

31 Pharmacovigilance Reporting a Suspected Adverse TB Clinic Clinicians

Reporting Tools Drug Reaction
(Yellow)

32 Pharmacovigilance Reporting a Suspected Poor- Pharmacy/ Pharmacist

Reporting Tools (Pink) Quality Medicinal Product Store

33 Pharmacovigilance The card given to patient who Patient Clinicians

alert card (White) developed ADR

34 Leprosy record card 8LIGEVHMWǻPPIHF]LIEPXL[SVOIV TB Clinic Clinicians

and acts as patient clinical record
card

35 Leprosy register It is a leprosy case listing which TB Clinic Clinicians

summarizes key variables for
tracking TB patient progress and
outcomes

36 Monthly Data Chart It’s a monthly summary chart that TB Clinic Clinicians
shows facility performance in
various indicators

37 Facility Referral/ This a form used to refer a drug TB Clinic Clinicians

Transfer form for Drug resistant TB patient from one
Resistant (DR TB) facility to another

38 Facility Referral/ This a form used to refer a drug TB Clinic Clinicians

Transfer form for Drug sensitive TB patient from one
Sensitive (DS TB) facility to another

39 Presumptive TB Used to record all presumptive TB TB Clinic, Clinicians

Register GEWIWMHIRXMǻIHMRELIEPXLJEGMPMX] CCC,
for the purpose of intensifying case outpatient
ǻRHMRK and inpatient
departments

432 Integrated Guideline for Tuberculosis,

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No Name of Tool Purpose Location Filled By
40 Patient referral form Used for referring patients for TB clinic. Clinicians
from TB clinic. management of other conditions
than TB

41 Facility Daily Activity To monitor the use of the TB and TB clinic/ Clinician
Drug Register DR-TB drugs on a daily basis Pharmacy

42 FCDRR It’s a reporting tool for consumption TB clinic/ Pharma-

of TB, and DR TB drugs Pharmacy cist/
Clinician

8EFPI.RHMGEXSVHIǻRMXMSRQIEWYVIQIRX

Below are some of the indicators which can be tracked at the service level.

Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of

data

Drug susceptible TB

Proportion of pre- Numerator: Number of presumptive TB Quarterly TIBU/Pre-

sumptive TB cases cases tested sumptive
(with respiratory Denominator: Total number of people pre- Register/KHIS
symptoms) with lab- sumed to have TB
oratory investigation
for TB

Number of people 3YQFIVSJ)8'TISTPI EPPJSVQWRSXMǻIH Quarterly TIBU

RSXMǻIH[MXL8' EPP
forms)

(EWIRSXMǻGEXMSR Numerator:3YQFIVSJTISTPIRSXMǻIH[MXL Yearly TIBU/KNBS

rate (CNR) TB (all forms)
Denominator: Total projected population of
a county per year

Sputum conversion Numerator: No. of bacteriologically con- Quarterly TIBU

rate at the end of ǻVQIHGEWIW[MXLERIKEXMZIWQIEVVIWYPXEX
intensive phase the end of the intensive phase
Denominator: Total number of bacteriologi-
GEPP]GSRǻVQIHGEWIWWXEVXIHSRXVIEXQIRX

Proportion of noti- Numerator:3YQFIVSJRSXMǻIH8'GEWIW Annual Annual report

ǻIH8'GEWIWIZEP- with nutritional assessment
uated for nutritional Denominator:8SXEPRYQFIVSJRSXMǻIH8'
support cases

Proportion of eligi- Numerator: Number of malnourished (Se- Annual Annual report

ble malnourished ZIVIERH2SHIVEXITEXMIRXWSǺIVIHETTVS-
TB cases who re- priate nutritional support
ceived appropriate Denominator: Total number of assessed TB
nutrition support cases who required nutritional support

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 Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

Mortality rate Numerator: Number of deaths among noti- Annual Annual report
among malnour- ǻIH8'GEWIW[LSEVIQEPRSYVMWLIH
ished TB patients Denominator:8SXEPRYQFIVSJRSXMǻIHQEP-
nourished TB cases

Treatment success Numerator: Total number of patients with Quarterly TIBU

rate (all forms); Per- outcomes cured and treatment completed
centage of TB cases Denominator: Total number of patients
successfully treated RSXMǻIH

Cure rate for bacte- Numerator: No. of bacteriologically con- Quarterly TIBU
riologically con- ǻVQIH58'GEWIW[MXLEGYVISYXGSQIEX
ǻVQIHTYPQSREV] the end of treatment
TB cases (both New Denominator: Total number of bacteriologi-
and Relapse) GEPP]GSRǻVQIH58'GEWIWRSXMǻIH

TB death rate (All Numerator: Total number of TB patients Annual TIBU

forms of TB) with Died outcome in the register
Denominator: Total number of patients
RSXMǻIH

Lost to follow-up Numerator: Total number of TB patients Annual TIBU

(All forms of TB) with a lost to follow-up outcome in the
register
Denominator: Total number of patients
RSXMǻIH

Programmatic Management of Drug Resistance TB

Proportion of noti- Numerator:3SSJRSXMǻIH8'GEWIWXIWXIH Quarterly TIBU

ǻIH8'TEXMIRXW[LS with a WRD as the initial Diagnostic test
receive DST Denominator:8SXEPRYQFIVSJRSXMǻIH8'
cases

Number of TB cases Number of TB cases with RR-TB and/or Quarterly TIBU/ TB4/
with Rifampicin-re- 2)78'RSXMǻIHXSXLI3EXMSREP8'TVSKVEQ DRTB register
sistant TB (RR-TB)
and/or MDR-TB
RSXMǻIH

Number of cases Number of cases with RR-TB and/or MDR- Quarterly TIBU/DRTB
with RR-TB and/or TB that began second-line treatment register
MDR-TB that began
second-line treat-
ment

Treatment success Numerator: Total number of DRTB patients Quarterly TIBU

rate; Percentage of with outcomes cured and treatment com-
DRTB cases suc- pleted
cessfully treated Denominator: Total number of DRTB pa-
XMIRXWRSXMǻIH

434 Integrated Guideline for Tuberculosis,

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Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

Childhood TB

Proportion of chil- Numerator:3YQFIVSJRSXMǻIHGLMPHVIR ! Quarterly TIBU

dren with TB among years) with TB
RSXMǻIH8'5EXMIRXW Denominator:8SXEPRYQFIVSJRSXMǻIH8'
cases

Pediatric TB treat- Numerator: Number of pediatric TB cases Quarterly TIBU

ment success rate who cured or completed treatment
Denominator:8SXEPRYQFIVSJRSXMǻIHTIHM-
atric TB cases

Proportion (%) of Numerator: Total number of under 5 chil- Quarterly TIBU

children under 5 dren household contacts put on TPT. De-
household contacts nominator: Total number of children under 5
put on TPT household contacts who are eligible for TPT

Proportion (%) of Numerator: Total number of household Quarterly TIBU

household contacts contacts 5+ years old put on TPT. Denomi-
over 5 put on TPT nator: Total number of household contacs
5+ years old who are eligible for TPT

Active Case Finding c c c

Numerator: number of people who are Monthly

presumptive
Number screened Denominator: Total number of patients visit- OPD registers
for TB ed health facility (MOH 204)

Numerator: Number of people screened for Monthly

TB
Number of pre- Denominator: Total number of patients OPD registers
sumptive cases screened for TB (MOH 204)

Numerator: number of people with pre- Monthly

Number of pre- sumptive cases investigated for TB
sumptive TB cases Denominator: Total number of patients presumptive
investigated for TB screened for TB register/TIBU

Numerator: number of cases bacteriologi- Monthly

Number bacterio- GEPP]GSRǻVQIH
PSKMGEPP]GSRǻVQIH Denominator: Total number of presumptive presumptive
with TB cases investigated for TB register/TIBU

Numerator: number clinically diagnosed Monthly

with TB
Number clinically Denominator: Total number of presumptive presumptive
diagnosed with TB TB cases investigated register/TIBU

c c c

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 Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

TB/HIV

Proportion of reg- Numerator: number of TB patients with Quarterly TIBU

istered TB patients documented HIV status (Positive and Neg-
(all forms) with doc- ative)
umented HIV status
Denominator:8SXEPRYQFIVSJRSXMǻIH8'
patients

Proportion of HIV - Numerator: number of HIV positive TB pa- Quarterly TIBU

positive TB patients tients started on ART
started on ART Denominator:8SXEPRYQFIVSJRSXMǻIH8'
patients who were HIV Positive

Treatment success Numerator:3YQFIVSJRSXMǻIH-.:TSWM- Quarterly TIBU

rate among HIV- tive TB cases who got cured or completed
positive TB cases treatment
Denominator:8SXEPRYQFIVSJRSXMǻIH-.:
positive TB cases

Proportion of PLHIV Numerator: Number of PLHIV initiated on Quarterly MOH731/

initiated on TB Pre- TB Preventive Therapy KHIS
ventive Therapy Denominator: Total number of PLHIV on
care

Proportion (%) of Numerator: Total number of PLHIV initiated

PLHIV initiated on TPT 6 months before who successfully
on TPT who have completed TPT during the reporting period
completed a course Denominator: Total number of PLHIV initiat-
of TPT ed on TPT 6 months before.

Public Private Mix

Proportion of no- Numerator: Number of TB cases (all forms) Quarterly TIBU

XMǻIH8'GEWIW EPP XLEXEVIRSXMǻIHF]TVMZEXILIEPXLJEGMPMXMIWXS Yearly
forms) contributed the National TB Program
by non-national TB Denominator: Number of TB cases (all
program providers JSVQWRSXMǻIHXSXLI3EXMSREP8'5VSKVEQ
– private/non-gov-
ernmental facilities

Number of counties Number of counties engaging the informal Annual ISP providers
engaging the infor- sector providers in TB care and prevention reports
mal sector provid-
ers in TB care and
prevention

Proportions of peo- Numerator: Number of people with TB Quarterly TIBU/ Facility

ple with TB referred referred by private/NGO facilities registers
by private/NGO
Denominator: Total number of people with
facilities
8'RSXMǻIH

436 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

Human Rights and Gender

Number of lawmak- Number of lawmakers, law enforcement Annual Annual re-

ers, law enforce- agents and HCW sensitized on human ports
ment agents and rights and gender by the TB program and
HCWs sensitized on other partners.
human rights and
gender

Proportion of Numerator: Number of patients with TB Annually Annual re-

people with TB reached legal literacy (know your rights) ports
reached with legal campaigns to improve legal and human
literacy (know your rights literacy
rights) campaigns Denominator: Number of TB patients noti-
to improve legal ǻIH
and human rights
literacy

Number of Govern- Number of Government/legal stakeholders Annualy Annual re-

ment/legal stake- sensitized on human rights dimensions of ports
holders (Ministries, TB, leprosy and lung diseases.
national human
rights
institutions, Gender
Commission and Of-
ǻGISJXLI4QFYHW-
men) sensitized
on human rights
dimensions of TB,
leprosy and lung
diseases.

Number of people Number of TB, Leprosy and lung disease Yearly Reports
who face human patients who received disease related legal
right violations services
provided with TB,
leprosy and lung
diseases related
legal services

Supply Chain & aDSM

Reporting rates for Numerator; Number of TB central stores Monthly TB Allocation

central stores on TB reporting on TB medicine tool
medicine Denominator; Total number of TB central
stores

Reporting rates for Numerator; Number of TB diagnostic sites Monthly TB Allocation

central stores on reporting on lab commodities tool
laboratory com- Denominator: Total number of TB diagnos-
modities tic sites

Integrated Guideline for Tuberculosis, 437

Leprosy and Lung Disease | 2021
 Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

Number of ADRs 3YQFIVSJ&)7GEWIWRSXMǻIHXSXLI55' Quarterly PPB

reported to PPB

Proportion of coun- Numerator: Number of counties stocking Bi-annual Report

ties stocking Lung PAL commodities
Health commodities Denominator: Total number of Counties

Proportion of Lung Numerator: Number of PAL essential drugs Bi-annual Report

Health essential in the Essential list
drugs in the Essen- Denominator: Total number of PAL Essential
tial list drugs

Proportion of health Numerator: Number of health facilities with Bi-annual Report

facilities with the the minimum PAL equipment
minimum Lung Denominator: Total number of facilities
Health equipment

Leprosy

Proportion of noti- Numerator:3YQFIVSJRSXMǻIHPITVSW] Annual TIBU

ǻIHPITVSW]TEXMIRXW cases with disability grade 2
with disability grade Denominator:8SXEPRYQFIVSJRSXMǻIHPIT-
2 rosy cases

Proportion of noti- Numerator:3YQFIVSJRSXMǻIHGLMPHLSSH ! Annual TIBU

ǻIHPITVSW]GEWIW 15 years) leprosy cases
who are children Denominator:8SXEPRYQFIVSJRSXMǻIHPIT-
rosy cases

Diagnostics

EQA Coverage (Lab- Numerator: Number of laboratories en- Quarterly EQA Work-
oratories) rolled in EQA book
Denominator: Total number of laboratories

Unsatisfactory EQA Numerator: Total number of labs with un EQA feed- Quarterly
(laboratories) acceptable performance back form reports
Denominator: Total number of labs partici-
pating in EQA

Proportion of Gene Numerator: Total number of gene xpert EQA feed- Quarterly
Xpert sites enrolled sites enrolled for EQA back form reports
in EQA Denominator: Total number of gene xpert
sites

Gene Xpert utiliza- Numerator: Total Number of test done per AFB/Gene Quarterly
tion Rate machine xpert regis- reports
Denominator: Total number of test expect- ter/LIMS
ed based on machine modules capacity

Gene Xpert positiv- Numerator: Number of positive test results AFB/Gene Quarterly
ity rate Denominator: Total test done using Gene xpert regis- reports
xpert ter/LIMS

438 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

Gene Xpert error Numerator: Total Number of errors record- AFB/Gene Quarterly
rate ed xpert regis- reports
Denominator: Total test done using Gene ter/LIMS
xpert

Community TB

Proportion of Numerator: Number of bacteriologically Quarterly TIBU/Contact

bacteriologically GSRǻVQIH58'TEXMIRXWERHGLMPHVIRYRHIV management
GSRǻVQIH58'TE- 5 visited for contact tracing register
tients and children Denominator: Total number of bacterio-
under 5 reached for PSKMGEPP]GSRǻVQIH58'GEWIWERHGLMPHVIR
household contact under 5
tracing

Proportion of con- Numerator: Number of contacts of bacteri- Quarterly TIBU/Contact

tacts of bacteriolog- SPSKMGEPP]GSRǻVQIH58'GEWIWXVEGIHERH management
MGEPP]GSRǻVQIH58' screened for TB register
cases traced and Denominator: Total number of contacts of
screened for TB FEGXIVMSPSKMGEPP]GSRǻVQIH58'GEWIW

Proportion of peo- Numerator: Number of people with TB ref- Quarterly TIBU

ple with TB referred ered by CHVs and ISP
by community Denominator: Total number of DSTB pa-
health volunteers tients all forms
and Informal Service
Providers

Number of of Number of community actors capacity built Quarterly Quarterly

community actors on community TB segregated by type reports
(Civil society orga-
nizations (CSOs),
community based
organizations
(CBOs), community
health volunteers
(CHVs), community
health extension
workers (CHEWs),
religious leaders
and other communi-
ty leaders) capacity
built on community
TB through various
mechanisms

Number of out- Number of outreaches targeting Key popu- Quarterly Quarterly

reaches targeting lation for TB in the community reports
Key population for
TB in the commu-
nity

Integrated Guideline for Tuberculosis, 439

Leprosy and Lung Disease | 2021
 Indicator .RHMGEXSVHIǻRMXMSR Frequency Source of
data

Number of key pop- Number of key populations screened for TB Quarterly Quarterly
ulations screened in the community through outreaches reports
for TB in the com-
munity through
outreaches

Lung Health

Number of pa- This indicator provides an absolute Monthly Asthma

tients screened for number of patients screened for Asth- register/OPD
Asthma ma in a particular month Register

Number of health- Number of healthcare workers trained Quarterly Training Data-

care workers on Lung health base
trained on Lung
health

Proportion of PTB Numerator: No of PTB patients Quarterly TB register

patients screened screened for PTLD
for PTLD
Denominator: Total no of PTB patients
started on treatment.

Proportion of PTB Numerator: No of PTB patients diag- Quarterly TB register

patients diagnosed nosed with PTLD
with PTLD
Denominator: No of PTB patients
screened

Proportion of PTB Numerator: No of PTB patients diag- Quarterly TB register

patients diagnosed nosed with COPD
with COPD
Denominator: No of PTB patients
screened

440 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
ANNEXES

&RRI\1MWXSJ(SRXVMFYXSVW

1. Dr Elizabeth Onyango Head, DNTLD-P 21. Mercy Nyangaresi DNTLD-P

2. Dr Carol Asin DNTLD-P 22. Jacqueline Limo DNTLD-P
3. Dr S. K. Macharia DNTLD-P 23. Samuel Misoi DNTLD-P
4. Dr Philip Owiti DNTLD-P 24. Mbetera Felix DNTLD-P
5. Dr Jacqueline Kisia DNTLD-P 25. Mutisya Mueke DNTLD-P
6. Lilian Kerubo DNTLD-P 26. Moses Kigen DNTLD-P
7. Nduta Waweru DNTLD-P 27. Josphat Mutua DNTLD-P
8. Drusilla Nyaboke DNTLD-P 28. Glory Muthuri DNTLD-P
9. Abdille Farah DNTLD-P 29. Martin Githiomi DNTLD-P
10. Dr. Handson Bota DNTLD-P 30. Adano Godana DNTLD-P
11. Wesley Tomno DNTLD-P 31. Martin Githiomi DNTLD-P
12. Nkirote Mwirigi DNTLD-P 32. Timothy Kandie DNTLD-P
13. Samuel Misoi DNTLD-P 33. Richard Kiplimo DNTLD-P
14. Rhoda Pola DNTLD-P 34. Aiban Rono DNTLD-P
15. Jeremiah Okari DNTLD-P 35. Nelly Mukiri Head, NTRL
16. Dr. Okotu Boru DNTLD-P 36. Zipporah Mwongera NTRL
17. Dr.Kiogora Gatimbu DNTLD-P 37. Peter Mwangi NTRL
18. Dr. Evans Kituzi DNTLD-P 38. Beatrice Kinaiya NTRL
19. Dr Abdullahi Omar DNTLD-P 39. Dr. Irungu Karuga MoH FELTP
20. Mary Nyagah DNTLD-P 40. Dr. Muthoni Karanja NASCOP

Integrated Guideline for Tuberculosis, 441

Leprosy and Lung Disease | 2021
 41. Anthony Wachira NASCOP 69. Stella Omulo CHS TB ARC
42. Dr. Martin Mwangi MOH-NCD 70. Wandia IKua CHS TB ARC
43. Nicholas Njeru KMTC 71. Evelyne Nganga CHS TB ARC
44. Fiona Muhiri KEMSA 72. Patrick Angala CHS TB ARC
45. Dr. Jane Ong’ang’o KEMRI 73. Rose Wandia CHS TB ARC
46. Dr. Beatrice Mugi KEMRI 74. Diana Kagwiria CHS TB ARC
47. Dr. Veronica Manduku KEMRI 75. Kennedy Muimi CHS TB ARC
48. Dr. James Wagude Siaya County 76. Dennis Oira CHS TB ARC
49. Franklin Mwenda Kirinyaga 77. Dr. Virginia Karanja CHS NAISHI
County
78. Dr. Margaret Wanaina CHS NAISHI
50. Hiram Mathenge Nyeri County
79. Dr. Brenda Mungai CHS
51. Francisca Mukami Tharaka Nithi
80. Anne Munene Amref Health Africa
County
in Kenya
52. Paul Lodi Busia County
81. John Mungai Amref Health Africa
53. Dr Job Okemwa Turkana County in Kenya
54. Dr. Natasha Uchi Makueni 82. Najma A Salim CHAI
County
83. Philip Muchiri CHAI
55. Dr. Asmahani Ndaisi Kajiado County
84. Dr Sam Muga KCCB Komesha TB
56. Dr. Ngugi Peter Isiolo County
85. Michael Macharia KCCB Komesha TB
57. Elizabeth Mueni Nairobi County
86. Dr. Herman Weyenga CDC
58. Michael Mwalimu Nairobi County
87. Dr. Andrew Owuor KNH
59. Dr. Victor Kibe NCD – Nairobi
88. Dr. Diana Marangu University of Nairobi
60. Prof Lisa Obimbo UON Pediatrics
89. Rahab Mwaniki KANCO
61. Dr Diana Marangu UON Pediatrics
90. Lucy Ghati KELIN
62. Dr Jackie Oliwa UON Pediatrics
 *VMG1YKEOE ,7YǺ2IHME 
63. Dr Eunice Omesa WHO Technologies Ltd
64. Dr. Lorraine Mugambi-Nyaboga CHS TB ARC 92. Frida Njogu Consultant
65. Dr Simon Wachira CHS TB ARC 93. Dr. Joel Kangangi Karimi Consultant
66. Duncan Barkebo CHS TB ARC 94. Dr Chakaya Muhwa Respiratory Society
of Kenya (External
67. Ann Masese CHS TB ARC
Reviewer)
68. Godana Mamo CHS TB ARC

442 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Annex 2: TB Diagnostic Algorithm (Adults)

TB SCREENING AND DIAGNOSTIC ALGORITHM

+47(-.1)7*3Ǹ10yrs AND ADULTS
GeneXpert is the recommended initial test for TB diagnosis. However, where a facility has no GeneXpert, smear microscopy
SHOULD BE USED as another sample is collected & referred for GeneXpert.
TB LAM should be used where indicated among PLHIV as per guidelines. TB LAM SHOULD NOT be used as an alternative to GeneXpert testing.

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MOH/DNTLDP/TBSDXALG/01
September 2020

Integrated Guideline for Tuberculosis, 443

Leprosy and Lung Disease | 2021
 Annex 3: TB Diagnostic Algorithm (Children)

ALGORITHM FOR PULMONARY TB DIAGNOSIS IN

CHILDREN

History of For all children presenting to a health facility ask for the following suggestive symptoms:
ƽ (SYKL
presenting
ƽ JIZIV
illness ƽ TSSV[IMKLXKEMR
ƽ PIXLEVK]SVVIHYGIHTPE]JYPRIWW
Suspect TB if the child has two or more of these suggestive symptoms.
Ask for history of contact with adult/adolescent with chronic cough or TB within the
last 2 years

Clinical *\EQMRIXLIGLMPHERHGLIGOJSV
ƽ 8IQTIVEXYVI# JIZIV
evaluation
ƽ ;IMKLX XSGSRǻVQTSSV[IMKLXKEMR[IMKLXPSWWGLIGOKVS[XLQSRMXSVMRKGYVZI
ƽ 7IWTMVEXSV]VEXI JEWXFVIEXLMRK
ƽ 7IWTMVEXSV]W]WXIQI\EQMREXMSRƳER]EFRSVQEPǻRHMRKW
*\EQMRISXLIVW]WXIQWJSVEFRSVQEPWMKRWWYKKIWXMZISJI\XVETYPQSREV]8'

Investigations Obtain specimen* for Xpert MTB/RIF (and culture when indicated**)
Do a chest Xray (where available)
Do a Mantoux test***(Where available)
Do a HIV test
)4SXLIVXIWXWXSHMEKRSWII\XVETYPQSREV]8'[LIVIWYWTIGXIH

Diagnosis 'EGXIVMSPSKMGEPP] Clinical Diagnosis of PTB:

GSRǻVQIH8' Child has two or more of the following suggestive symptoms:
Diagnose if ƽ 5IVWMWXIRXGSYKLJIZIVTSSV[IMKLXKEMRPIXLEVK]
specimen is zXƒƉƋƵŅƉŅųƉĵŅųåƉŅüƉƋĘåƉüŅĬĬŅƵĜĹč×ƉƉ
positive for
ƽ 5SWMXMZIGSRXEGXEFRSVQEPVIWTMVEXSV]WMKRWEFRSVQEPR(<7
MTB positive Mantoux
Note:.JXLIGLMPHLEWGPMRMGEPWMKRWWYKKIWXMZISJ*58'VIJIVXS
EPTB diagnostic table

Treatment Treat for TB as follows:

ƽ&PPGLMPHVIR[MXLFEGXIVMSPSKMGEPP]GSRǻVQIH8'
ƽ&PPGLMPHVIR[MXLEGPMRMGEPHMEKRSWMWSJ8'
3'.RGLMPHVIR[LSHSRSXLEZIER<TIVXVIWYPXSVXLIMV<TIVXVIWYPXMWRIKEXMZI
but they have clinical signs and symptoms suggestive of TB they should be
treated for TB

&PPJSVQWSJ8' *\GITX8'QIRMRKMXMWFSRIERHNSMRX8'8VIEXJSVQSRXLW 
7->*7-
8'QIRMRKMXMWFSRIERHNSMRX8'8VIEXJSVQSRXLW 7->*7-

TIGMQIRQE]MRGPYHI*\TIGXSVEXIHWTYXYQ GLMPH#]IEVWMRHYGIHWTYXYQREWSTLEV]RKIEP
aspirate and gastric aspirate. &XXIQTXXSSFXEMRWTIGMQIRMRIZIV]GLMPH

**Do a culture and DST for the following children:

1. Rifampicin resistance detected by the Xpert test
2. Refugees and children in contact with anyone who has Drug Resistant TB
3. Those not responding to TB treatment
4. Those with Indeterminate Xpert results
*** This may include IGRA in facilities where it is available
9WI.2(.KYMHIPMRIWXSGPEWWMJ]WIZIVMX]SJHMWIEWI
# Refer to the table on diagnosis of Extra-pulmonary TB

MOH/DNTLDP/CPTBDXALG/01
September 2020

444 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Annex 4: CAGE and CAGE AID Scoring Introduction and
Scoring Sheet (Alcohol Abuse)

Integrated Guideline for Tuberculosis, 445

Leprosy and Lung Disease | 2021
 Annex 5: CAGE-AID Alcohol Abuse Screening
Questionnaire

446 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Annex 6: CRAFFT Screening Tool for Adolescent
Substance Abuse

Integrated Guideline for Tuberculosis, 447

Leprosy and Lung Disease | 2021
 Annex 7: CRAFFT Screening Tool: Scoring and
Interpretation

448 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
Annex 8: PHQ-9 Questionnaire

Integrated Guideline for Tuberculosis, 449

Leprosy and Lung Disease | 2021
 Annex 9: PHQ-9 Patient Depression Scoring tool

450 Integrated Guideline for Tuberculosis,

Leprosy and Lung Disease | 2021
&RRI\.QQYRI7IGSRWXMXYXMSR.RǼEQQEXSV]
Syndrome (IRIS)

Integrated Guideline for Tuberculosis, 451

Leprosy and Lung Disease | 2021