ASSESSMENT OF FACTORS AFFECTING CHILD ART ADHERENCE

AMONG CHILDREN ATTENDING JIMMA UNIVERSITY SPECIALIZED

HOSPITAL, ART CLINIC

BY:

MEKDES EYOB

RESEARCH PROPOSAL TO BE SUBMITTED TO JIMMA UNIVERSITY,

COLLEGE OF PUBLIC HEALTH AND MEDICAL SCIENCES,
DEPARTMENT OF NURSING IN PARTIAL FULFILLMENT FOR THE
REQUIREMENT OF BACHELOR OF SCIENCE DEGREE IN NURSING

DECEMBER 22, 2014

JIMMA, ETHIOPIA

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 JIMMA UNIVERSITY
COLLEGE OF PUBLIC HEALTH AND MEDICAL SCIENCES
DEPARTEMENT OF NURSING

ASSESSMENT OF FACTORS AFFECTING CHILD ART ADHERENCE AMONG

CHILDREN ATTENDING JIMMA UNIVERSITY SPECIALIZED HOSPITAL, ART
CLINIC

BY

MEKDES EYOB

ADVISOR: - Mr. ABEBE ABERA (RN, BSc, MSc)

DECEMBER 22, 2013

JIMMA, ETHIOPIA

ii
ABSTRACT

BACKGROUND: The introduction of combination antiretroviral therapy (ART) has resulted in

striking reduction in HIV related mortality. Despite increased availability of ART, children
remain a neglect population. This may be due to non adherence appears to be related to failure of
viral suppression, treatment failure and emergency of drug resistance strains of Human immune-
deficiency virus (HIV). This study determine the rates and factors associated with adherence to
Anti-retroviral drug therapy in HIV infected children who were receiving highly active anti-
retroviral therapy (HAART) in Jimma University Specialized Hospital (JUSH), Jimma, Oromia
Ethiopia in 2014
Objective: - to assess factors influencing child ART adherence.
Methods:-Hospital based cross-sectional study will be conducted in JUSH at ART clinic from
March 1st to April 1st 2014 G.C. Data will be collected by data collectors under supervision of
the researcher by using questionnaires and interviewing care givers of the children in the study
population. The data will be properly screened for completeness and internal consistency and it
will be analyzed manually by using scientific calculator and presented through frequency tables
and graphs.
Budget: -A total of 4,138.20 ETB will be required to conduct the study.
Conclusion and recommendation: based on the finding of the study appropriate conclusions
will be made and proper recommendations will be forwarded.
Key words: adherence, HIV, ART, HAART, JUSH, children, adherence self report, Pill count.

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ACKNOWLEDGMENT

First of all, I would like to thank Almighty God for giving me the patience, wisdom, knowledge
and strength I need to prepare this proposal and for always supporting me in every phase of the
work. I would also like to express my gratitude to Jimma University Department of Nursing for
timely arrangement of the title and assisting in preparing for the research proposal and also I
would like to give my heartfelt thanks and appreciation to my advisor Mr. Abebe Abera for his
unreserved cooperation and constructive comments.

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TABLE OF CONTENT

Contents
ABSTRACT.....................................................................................................................................i
ACKNOWLEDGMENT.................................................................................................................ii
TABLE OF CONTENT.................................................................................................................iii
List of Dummy Table.....................................................................................................................iv
LIST OF ABBREVIATIONS..........................................................................................................v
CHAPTER ONE..............................................................................................................................1
INTRODUCTION...........................................................................................................................1
1.1 Statement of the Problem...........................................................................................................2
1.2 Significance of the Study...........................................................................................................4
CHAPTER-TWO.............................................................................................................................5
2. LITERATURE REVIEW............................................................................................................5
CHAPTER THREE.........................................................................................................................7
Objective..........................................................................................................................................9
3.1 General Objective......................................................................................................................9
3.2 Specific Objectives....................................................................................................................9
CHAPTER FOUR...........................................................................................................................9
Methods and subjects.....................................................................................................................10
4.1 Study Area and period.............................................................................................................10
4.2 Study design ............................................................................................................................10
4.3 Populations...............................................................................................................................10
4.3.1 Source population.........................................................................................................10
4.3.2 Study population...........................................................................................................10
4.3.3 Inclusion Criteria...........................................................Error! Bookmark not defined.
4.4. sample size and sampling technique.......................................................................................10
4.4.1 Sample size determination............................................................................................10
4.5. Study Variables.......................................................................................................................11
4.6. Data Collection Process..........................................................................................................11
4.7.1. Data collection technique..................................................................................................11
4.8 Data Processing and Analysis..................................................................................................11
4.9 Data Quality Control Measures...............................................................................................11
4.10 Ethical Consideration.............................................................................................................11
4.11 Limitations.............................................................................Error! Bookmark not defined.
4.12 Operational Definitions..........................................................................................................11
CHAPTER FIVE........................................................................................................................13
TENTATIVE WORK PLAN........................................................................................................13
CHAPTER SIX..............................................................................................................................14
BUDGET SUMMARY.................................................................................................................14
REFERENCES..............................................................................................................................14
ANNEX:-1 Dummy Tables...........................................................................................................17
ANNEX:-2 QUESTIONNARIES.................................................................................................21

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List of Dummy Tables

Table 1:- Socio-demographic characteristics by age & sex of study subjects and their adherence
status, JUSH ART clinic, March, 2014.........................................................................................17
Table-2:- Frequency distribution of care –givers factors and child ART drugs adherence among
study subjects, JUSH ART Clinic, March, 2014...........................................................................17
Table 3:- Frequency distribution of characters of responsible person for the child ART drug
adherence among study subjects, JUSH ART Clinic, March, 2014..............................................18
Table 4:-frequency distribution of the child factor and ART drug adherence status among study
subjects, JUSH ART clinic, March, 2014......................................................................................18
Table 5:-frequency distribution of Disease and drug factor and child drug adherence status
among study subjects, JUSH ART clinic, March, 2014................................................................19
Table 6:-frequency distribution of the health care-providers estimate rate of child ART adherence
among study subjects, JUSH ART clinic, March, 2014................................................................20
Table 7:-Frequency distribution of Care-givers reports adherence rate of HAART among
children in JUSH ART clinic, March, 2014................................................................................200
Table 8:- Frequency distribution of type of child's illness & type of drug the child is taking (other
than ARV) among children in JUSH ART Clinic,March,2014.....................................................20

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LIST OF ABBREVIATIONS

AIDS -Acquired immunodeficiency syndrome

ANC -Antenatal -care
ARV -Anti retroviral.
JUSH -Jimma University Specialized Hospital
HAART -Highly active Anti retroviral therapy
HIV -Human immunodeficiency virus
IEC -Information, Education and Communication
MCH -Maternal and child health
MOH -Ministry of health
MTCT -Mother to Child Transmission
NGO -Non –Governmental Organization
PLWHA -People living with HIV/AIDS
PMTCT -Prevention of mother to child transmission
VCT -Voluntary Counseling and Testing
WHO -World health organization

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CHAPTER ONE

INTRODUCTION

Adherence is defined as taking medications or interventions correctly according to prescription.

There are different methods for assessing adherence and the level of adherence is specific not
only to places and patient groups but also to the method of adherence measurement used. They
include direct methods such as biologic markers and body fluid assays, or indirect methods such
as self-report, interview, pill counts, pharmacy records, computerized medication caps, and viral
load monitoring. While a combination of these methods may be employed, patient self-reports is
the most widely used given its ease of implementation and use of already existing resources. In
developing countries, pharmacy refill reports and self-reports are commonly implemented for
adults while caregiver reports are employed for children (1).

Adherence is the most important determinant of success of ART. Proper adherence determines
the biological, clinical and public health outcomes of treatment. Good adherence to ART
regimens is closely associated with the degree of viral suppression. Adherence is particularly
critical with antiretroviral drugs in treatment of pediatric HIV Infection where adherence of more
than 95% is necessary to maximize the benefit of ARVs. Studies on adherence in developed
world have demonstrated that higher level of drugs adherence is associated with improved
virological, immunological and clinical outcome. Despite the benefit of antiretroviral drugs in
pediatric HIV infection, there are consequences to non adherence including disease progression,
failure of viral suppression, decrease in CD4 cell count, drug resistance, risk of transmission of
resistant virus and limited treatment options. It is therefore important to identify children with
non adherence in order to intervene before developing drug resistance and treatment failure (2).

Without high level of adherence viral resistance and opportunistic infection can develop.
Despite the enormous benefit of near perfect adherence, studies in adult indicate that adherence
to antiretroviral therapy is frequently below 80%. For children within developed countries,
estimate of adherence to ART also indicate sub-optimal adherence. Furthermore, the best
strategy for measuring children adherence to ART has not been well defined. Because of expense
and lack of information on pediatric pharmacokinetic, direct- methods such as measuring plasma
drugs levels have rarely been used for children, even in high income countries. Care giver or
self-reports offer another set of challenges. Care-giver with varying degree of responsibility
directly affects the medication dosing, reporting of dosing, social, Psychological and economical
context in which adherence occur (3).

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 1.1 Statement of the Problem

HIV/AIDS is one of the most destructive epidemics the world has ever witnessed. In June 2000
an estimated 600,000 infants worldwide were infected with the virus bringing the total number of
young children living with HIV to over 1 million. The number was increased in Africa,
especially in sub-Saharan Africa countries. This lead to increased mortality in children under age
of 5 in regions most affected by the virus (4).

In 2007 an estimated 33.3 million people were living with HIV (PLHIV) in the world, while 2.5
million of these people were children under 15 years old, furthermore, 420,000 children under 15
years were newly infected with HIV. About 780,000 were being estimated to be in need of
antiretroviral therapy, ART. MTCT is by far the largest source of HIV infection in children
under age of 15 years. Ninety percent of 2-3 million HIV infected children in the world lives in
Sub-Saharan African but their adherence has not been well developed. Understanding children’s
adherence in resource limited setting presents a critical challenge because these setting have
limited option if viral resistance developed (5).

MTCT is contributing substantially to rising child mortality rates in many areas. Most studies
estimate the probability that an HIV –positive women's baby will have the virus ranges from
15% to 25% in an industrialized country and 25% to 35% in develop in countries. The most
efficient and cost-effective ways to tackle pediatric HIV globally is to reduce mother to child
transmission (MTCT). However everyday there are nearly 1,200 new infection in children under
15 years of age with more than 90% of these occurring in developing world and most being
associated with MTCT (6).
Among the factors that can influence treatment success or failure, research has identified high
adherence to ART regimen as the most important predictor of viral suppression, improved CD4+ T
Cell count, delayed progression to AIDS and patient survival. For ART to work effectively,
adherence is very crucial. The recommended optimal adherence level for ART to be effective is
above 95 percent. Any patient who misses more than 3 dosages in a one month treatment course is
considered to have achieved suboptimal adherence which is less than 95%. A level of adherence
which is greater than 95% (optimal adherence) suppresses viral replication and prevents the
development of resistance and treatment failure. However, ensuring a high level of adherence is very
difficult in cases of children on ART (7).

The importance of ART adherence makes accurate compliance assessment essential for effective
and efficient therapy and evaluation of treatment regimens. There are a number of key issues in
the study of ART adherence including having an accurate measure of adherence. Measurement
of adherence is usually based on Paterson’s pioneer study found that up to 95% adherence is
necessary for effective HIV viral suppression (8). This measurement is usually obtained by using
either a continuous or categorical variable constructed from patient self-reported adherence that
distinguishes “optimal” from “sub-optimal” adherence based on the 95% threshold.
Nevertheless, studies have demonstrated a significant relationship between self-report data and
viral load (9).

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Besides accurate measurement, other factors of importance in the study of ART adherence
include assessment of the impact of adherence on viral load and clinical outcome, identification
of the factors that affect adherence and effective interventions. Understanding the factors that
affect non-adherence could provide valuable information about patients most at risk. While some
factors determining non-adherence to ART may be similar across countries, others may be highly
contextual, and culture or country specific (10).

Botswana and Rwanda, have achieved universal access target (treatment coverage of 80% or
more of patients in need) at the end of 2009, while countries such as Ethiopia, Zambia, Namibia,
and Senegal are moving closer to the same target having covered 50–80% of patients in need of
treatment. According to recent studies, ART regimens require 70–90% adherence in order to be
effective. However, sustaining adherence to antiretroviral therapy (ART) over the long term
requires accurate and consistent monitoring. It is further challenged by various social and clinical
obstacles where inadequate suppression of viral replication by ART are resulting due to poor
adherence to therapy, low potency of the antiretroviral regimens, viral resistance to antiretroviral
medications, and pharmacokinetic interactions causing inadequate drug delivery. The
transmissibility of the antiretroviral resistant viruses from person to person further compounds
the problem as a clinical and public health challenge (11).

With regard to children, if the mother (or other caregiver) is infected, then she is struggling with
her own illness, psychosocial factors, medication regimens, and most often financial burden due
to expenses incurred on her own therapy, child’s therapy, and associated cost of medical
treatment. All of these produce negative influences on adherence .Factors such as age (especially
infancy and adolescence have a negative effect), refusal of treatment, knowledge of HIV status,
clinical stage, and depressive symptoms, male gender, and changes in health status
(improvement as well as deterioration) have also been identified as important factors which
affect adherence to HAART in pediatric patients. (12)

Antiretroviral adherence in young children and adolescents poses unique and formidable
challenges. Many of them are still largely dependent on a caregiver to take their medications.
Young children and adolescents may refuse to take medication especially as the reason for such
medication may not have been disclosed to them. Understanding the factors that influence
adherence is therefore very crucial in order for the health care provider to develop measures to
support and sustain patient’s adherence in the clinical care of HIV infected children. More so,
there are limited pediatric antiretroviral (ARV) formulations, hence the need to ensure high
levels of adherence and prevent drug resistance (13). Most studies have mainly addressed
adherence in the adult population. The aim of this study is to determine the adherence rates and
the factors influencing adherence to ARV treatment in pediatric population.

3
1.2 Significance of the Study
ART is life-long, therefore it is important to assess level of adherence and look for accuracy of
the methods currently used to assess adherence in children. This study will be carried out to
examine the adherence levels and different factors associated with adherence among HIV-
positive children receiving ART at JUSH ART Clinic.
Data from this study is useful to health managers such as those at the zonal and hospital level
and Social Welfare. The finding potentially enable Health managers and Social Welfare to
design better programmes to alleviate the problem of non-adherence to ARV in children and
serves as resource for new research on identified gaps.

4
CHAPTER-TWO
2. LITERATURE REVIEW
Adherence is the most important determinant of success of ART. Proper adherence determines
the biological, clinical and public health outcomes of treatment. Good adherence to ART
regimens is closely associated with the degree of viral suppression. Poor adherence can lead to
incomplete viral suppression, emergence of resistant viral strains, and treatment failure. Sub-
optimal adherence to ARVs is the most common cause of virologic failure of ART regimens. In
addition, non-adherence to one regimen can result in viral mutations that confer virus resistance
to many ARVs in the same class. Drug resistance might necessitate changing to another,
probably more expensive second-line drug regimen; yet, only a few treatment options are
available in developing countries. Furthermore, children have fewer treatment options than
adults due to the lack of suitable formulations. In the case of ART, an adherence level of 95% or
more is required in order to obtain a successful treatment outcome (14).

Several disclosure studies have been conducted in US .In a small survey of US care takers
biological and non-biological (foster, kin-ship or adoptive parents of children age<5 and older),
all care-givers said the best time to tell a child his or her HIV sero- status is around 10 or 11
years especially when the child ask questions about medication and clinical visits (15).

The study conducted to assess factors affecting adherence to ART regimens among HIV-
infected/AIDS-patients at TAKSIN Hospital in Thailand in 2012 found that sex, self-efficacy in
taking ART medicine and good patient-health care provider relationships were significantly
associated with increased adherence to ART regimens. Female gender, Self-efficacy and good
patient-healthcare provider relationship was associated with increased adherence to the ART
regimen (16).

It is known that mothers tend to hide HIV infection status from their children and disclosure is
often delayed until adolescence. Reddi and colleagues show that only 7.9% children had been
made aware of their own HIV infection status in their study in South Africa. Disclosure of HIV
infection status is a critical step and has obvious implications for adherence. Starting the
disclosure process as early as 8-9 years of age and combining it with specific support, as
suggested (http://www.hivatis.org) may result in increased adherence in children. There are
similar reports that indicate lack of disclosure as predictors of poor adherence in adults (12)

The data in pediatric adherence to ARV is limited. Studies on adherence to ARV in children and
adolescent indicate that fewer than 50% of children and / or caretaker reported full adherence to
their regimens. A study conducted in Kampala Uganda reveals that only 72% of children aged 2-
18 years had adherence > 95% measured with home unannounced pill count compare to 89%
using 3 day self reported adherence and 94% using clinic –based pill count ( 17). While in a study
done in South Africa on adherence to ARV in young infants and children using medication
return 94% of children had good adherence. Another study in South Africa on pediatric
adherence using MEMS (medication event monitoring system) to monitor adherence show only

5
36% of patients achieved > 95% adherence in comparison to 91% of caregiver reporting
excellent adherence on visual analogue (18).

In a study conducted to assess factors influencing adherence to pediatric antiretroviral therapy in

Port harcourt, South- South Nigeria. A total of 213 caregivers and their children were
interviewed. The primary caregiver was the mother in 150 (70.4%). A total of 180 (84.5%)
caregivers had at least secondary education and 98 (46%) were older than 35 years. Ninety-seven
(45.5%) children had a co-morbidity which included tuberculosis 64(66%), chronic supurrative
otitis media 8(8.2%), dermatitis 7(7.2%), neurological 6(6.2%), renal 6(6.2%), sickle cell anemia
3(3.1%) and asthma 2(2.1%). Four (1.9%) children were on zidovudine/lamivudine/efavirenz
combination, 7 (3.3%) were on tenofovir/emtricitabine or lamivudine/ritonavir-boosted
lopinavir, 95 (44.6%) were on stavudine/lamivudine/nevirapine combination and 107 (50.2%)
were on zidovudine /lamivudine/nevirapine combination. Eighteen (8.4%) children have had
their status disclosed to them. Four (22%) were aged between 8 and 9years, 11 (61%) were
between 10years and 15years, while 3 (17%) were above 15years. One hundred and ninety-seven
(92.5%) caregivers had correct knowledge of the implication of non adherence whereas 16
(7.5%) did not. The commonest identified implications were that child will become ill again
(140), virus will be resistant (72), drugs may no longer work (52), child may die from the disease
(35) and viral load will rise (18) (19).

The study also showed that 162 (76.1%) children had adherence rates >95%, while 51 (23.9%)
had adherence rates less than 95%. Only126 (59.2%) were completely adherent (i.e. took 100%
of prescribed drugs in the past one month). The commonest caregiver-related reasons for missing
at least one dose of antiretroviral drugs were forgetfulness 48(55.2%), caregiver travelled 22
(25.3%) and drugs finished 16(18.4%), while the child related reasons were child refused drugs
10(11.5%), child slept 8(9.2%), and child vomited 8(9.2%). Sixty eight (31.9%) caregivers
reported missing clinic visits. The commonest reasons given were travelled 18(26.5%), caregiver
was ill 12(17.6%) and family problems 9(13.2%) (19)

In a study conducted to assess care-giver factors associated with adherence to antiretroviral

therapy in HIV infected children in Thika district Hospital in Kenya, 78 %( 157) of the children
were being cared for by their biological parents, 17% (34) by their guardians while 5% (9) were
under foster care. A lower rate of adherence was observed among parent caregivers (40%)
compared to guardians/foster parents (56%/44%). Twenty one (11%) of the caregivers had no
formal education, 44 (22%) had primary education, 71 (36%) had attained secondary level of
education, 64(32%) had university education. There was a statistically significant association
between the variables “caregiver’s education level” and adherence. Adherence rates increased
with increased primary caregivers‟ level of education (70%, less than 40% and 20% adherence
rate was observed in those who had University education, primary education and non formal
education respectively). 100% of the caregivers approved the use of ART and were willing to
continue administering the medication. However, only 77% knew that ARV’s reduced the
progression of HIV. 23% either believed it was a cure, meant for pain relief or had no idea of the

6
role played by ARVs. 92 %( 184) of the caregivers were able to identify the drugs the children
were taking. 16% could not identify the medication (20)

In a cross-sectional study of 170 children aged 2 to 18 years in Mulago Hospital, Uganda, by

Nabukeera et al, adherence to HAART was defined as taking >=95% of prescribed medication.
Adherence was assessed using three measures: three-day self-report from the caregivers, clinic-
based pill counts at enrollment, and home-based unannounced pill counts two to three weeks
later. Results were different for each measure, which was 88%, 94% and 72% respectively. The
majority of children had good adherence levels even when measured by unannounced pill counts.
Possible explanations for the higher adherence in this study could be about 82.4% of the children
had been on HAART for one year or less and were probably not yet fatigued with the medication
regimen; (14, 22) 91% of the children were taking medication with a simple twice daily dosing
schedule (Triomune and Duovir N); only 21% reported the presence of side effects; and the
majority of the children were receiving free therapy (only two children in the study were paying
for their ARVs). Furthermore, 81% of the children and 75% of caregivers reported that ART did
not interfere with daily life (14, 22).In this study the most common reason reported for missing
doses was forgetting n=46 (32%), “caregivers being away from home”, 21(14%) and “change in
daily routine”, 12 (8%) accounted for 54% of the reported reasons for missing doses. Several
studies have shown that forgetting is the most common reason reported for non-adherence (21).

In a study conducted in Vientiane, Lao PDR (People Democratic Republic-June 2013) non
adherence to the prescribed medication and dosage was reported by 39.1% PLHIV. The major
reasons given for non-compliance were being too busy and forgetfulness (97.0% vs. 62.2%
respectively). Forty three (12.4%) of the respondents reported having missed at least one medical
appointment. The reasons for this were given as being too busy (41.9%), lack of money to travel
to the health center (32.6%) or because the center was too far from their home (27.9%). One
hundred and eighty one (52.3%) patients reported having had experienced side-effects due to
their treatment. Of these, the most common symptom was a rash (42%), followed by headache or
dizziness (34.3%) and numbness (32.6%). In order to examine factors associated with
adherence, two groups were created. One consisted of those with an adherence score of ≥ 95%
(n=206, 59.5%). Participants with adherence scores of ≤ 95% (n=140, 40.5%) were allocated to a
non-adherence group. (22)

In a study conducted in Addis Ababa, by using pill count method of adherence measurement,
out of the 355 patients, 94 (26.5%) were non-adherent, with less than 95% adherence level, and
261 (73.5%) of them were adherent at a 95-100% adherence level. There were 6 (1.7%) patients
with 0-5% adherence level. The adherence levels ranged from 0% to 100%; the lowest, 0%
indicated that the patient did not take any pills during the preceding seven days and the highest
100% indicated that the patient took all pills prescribed for the past seven days. A higher number
of patients who were ART-adherent were found in WHO stage I (n=141; 57.8%) followed by
WHO stage II (n=56; 23.0%). There was a significant association between WHO HIV/AIDS
staging and adherence. The proportion of patients who adhered to treatment increased as the

7
WHO clinical stage decreased, indicating that when patients adhered to ART, the associated
severity of their illness could be reduced (23).

In another study, Patients who didn`t disclose their HIV status to their partners had 3.6 times
higher risk of being lost to follow-up. Patients who had their partner`s HIV status unknown had 5
times higher risk of getting lost to ART follow-up than those who had their partner`s HIV status
known (24).

8
CHAPTER THREE
OBJECTIVE
3.1 General Objective
To assess factors affecting child ART drug adherences at ART clinic in JUSH
3.2 Specific Objectives
1. To assess the level of ART adherence among children attending ART clinic of
JUSH
2. To assess factors affecting child ART drug adherences at ART clinic in JUSH March,
2014.

9
CHAPTER FOUR

4. Methods and subjects

4.1 Study Area and period

The study will be conducted in JUSH found in Jimma town from March 1 st to April 1st, 2014.
Jimma Town is found in Oromia regional state, Jimma zone, located 357km South-West of the
capital city, Addis Ababa. It has seventeen kebeles and a total population of 174,000. Out of the
total population, 49% are males and 51% are females. The existing health institutions are two
hospitals (JUSH and One Primary Hospital), 4 health centers, Twenty one medium clinics
(private), five higher clinic, and three NGO clinics.

JUSH is one of the oldest public health hospitals in the country. It was established in 1930 E.C.
by Italian Invaders for the service of their soldiers. Currently it is the only teaching and referral
hospital in the south-western part of the country. It runs an annual governmental budget of 25.06
million Birr with bed capacity of 450 and a total of more than 750 staffs of both supportive and
professional. It provides services for approximately 9000 inpatient and 80,000 outpatient
attendances per year coming from the catchment population.

JUSH, ART Clinic was established in 2002 E.C. at which time it started ART for adult PLWH.
Two years after its establishment, Pediatric ART was started. Currently there are 149(male 77
and female 72) children on ART at this treatment site. But the total children on Pre-ART and
ART are 815.At the beginning, the clinic had started with only one counselor and eleven peer
educators, but currently six counselors and eight peer educators are giving the service.

4.2 Study design

A hospital-based cross-sectional study will be carried out at the ART clinic of JUSH

4.3 Populations

4.3.1 Source population

All HIV-positive children age 0-14 years attending ART Clinic at JUSH
4.3.2 Study population

All 149 HIV-positive children age 0-14 years who are currently on ARV at JUSH,ART clinic at
the time of the study.

4.4. Sample size and sampling technique

4.4.1 Sample size determination
All 149 children who are currently attending ART clinic in JUSH will be assessed for their
adherence status.

4.5. Study Variables

4.5.1. Independent variables
 Age
 Marital status
 Ethnicity
10
  Religion
 Occupational status
 Educational status
 Annual Income
4.5.2. Dependent variable
 ART adherence

4.6. Data Collection Process

4.7.1. Data collection technique
Data will be collected from the care givers of the study children by using structured and semi
structured interviewer administered questionnaires which will be properly formulated and tested
before use.

4.8 Data Processing and Analysis

The data will be categorized, coded and manually manipulated after the data is collected and
analyzed by using scientific calculator then the data will be presented on the prepared dummy
table graphs and charts.

4.9 Data Quality Control Measures

Data collectors will be assigned from ART Clinic Nurses and one day training will be provided
to achieve common understanding on the questionnaire and on the objective of the study, the
questionnaire will be translated to Amharic /Afan Oromo and pretest will be conducted at
Shenan Gibe Hospital by taking 5% the sample size to identify potential problems with the
proposed study and instruments. Then, revisions will be made. Continuous supervision will be
made by the researcher during data collection and the collected data will be checked for
completeness and accuracy during data collection period.

4.10 Ethical Consideration

Before data collection, official letter of permission will be obtained from Jimma University
Nursing department to JUSH Administrator office which will be communicated to Nursing
Directors Office and thereby to Pediatric ART Clinic. The confidentiality of the respondents will
be assured.
4.11 Operational Definitions
Adherence to ART: - means taking the ARV medications prescribed at the “right time”, in the
“right doses” and in the “right way
Non-Adherence:-Means not following the prescribed treatment plan and includes missed or
delayed doses or failing to follow guidelines like, taking too little or too
much medication and taking it at incorrect times or Patient swallowed < 85 %
of the prescribed drug (lost ≥ 6 doses in the last one month Or > 9 doses in
the last two months)

Good adherence:-Patient swallowed >95% of the prescribed drug (lost ≤ 2 doses in the last
one month Or < 3 doses in the last two months)
Fair Adherence: - Patient swallowed 85-94% of the prescribed drug (lost 3-5 doses in the last

11
 one month Or 3-9 doses in the last two months)
Poor adherence: - Patient swallowed < 85 % of the prescribed drug (lost ≥ 6 doses in the
last one month Or > 9 doses in the last two months)
Primary Caregiver:- A person who has consistently assumed responsibility for the housing, health,
or safety of the child (individuals who administered at least 50% of the
child’s medication daily and bringing the child for clinic appointments).

                                             

12
 CHAPTER FIVE

TENTATIVE WORK PLAN

Work Plan Proposal for assessment of factors that affect ART adherence among children at
JUSH,ART clinic, March, 2014

S. Activities Respo Period of performance(Year in G.C)

N nsible 2013 2014
perso

December
Novembe

February
October

January

March

April
r

1 Topic selection PI
2 Proposal writing PI
3 Submission of 1st PI
draft
4 Submission of 2nd PI
draft
5 Submission of final PI
draft
6 Identify and train PI
research assistants
7 Material collection PI
8 Data collection DC

9 Data processing and PI

analysis
10 Report writing PI
11 Final submission of PI
the result

13
 CHAPTER SIX

BUDGET SUMMARY

Budget proposal for assessment of factors that affect ART adherence among children at
JUSH, ART clinic, March, 2014
S.N Item Description Unit Quantity Unit price Total Price
A. Stationary
1 Computer paper Ream 2 100 200
2 Writing pads Pieces 5 10 50
3 Pen Pieces 5 2 10
4 Eraser Pieces 5 2 10
5 Pencil Pieces 5 2 10
6 Sharpeners Pieces 5 2 10
7 CD Rewritable (CD-RW) Pieces 2 25 50
8 Binding proposal & final Pieces 6 12 72
research document
Subtotal 412
B Personnel cost No of person No of Cost of Total cost
days days
1 Secretaries 1 2 100 200
2 Training of data collectors 3 1 50 150
3 Data collector 3 20 50 3000
Subtotal 3350
C Contingency (10%)  376.20
Grand Total (A+B+C)  4138.2

Summery
A. Stationary ……………...……..412.00
B. Personnel cost …………….…..3350.00
C. Contingency ………………….376.20
Grand Total ……………………….4138.20
Note:-The source of budget is from personal income of the principal investigator.

14
REFERENCES

1) AIDS Epidemic Update, Unite Nations Programme on HIV/AIDS (UNAIDS) and

World Health Organization (WHO), Geneva, Switzerland, 2009.
2) Adherence to ARV and its association with immune status among HIV infected children
aged 2-14 years in Dar es Salaam. By Frida W. Mghamba, MD October 2012
3) WHO/UNAIDS: Antiretroviral therapy of HIV infection in infant and children in resource
limited setting towards universal access: Recommendation for public Health
approach .Geneva 2006
4) Gortmaker SL, Hughes M, Cervia J, et al.: Pediatric AIDS Clinical Trials Group protocol
219 Team. Effect of combination therapy and adolescents infected with HIV-I N Engl J Med,
May, 2010 ;345(21): 1522-8
5) Erickson D, Mather W, Trager R, et al. Characteristic of the in vitro biotransformation of
the HIV reverse transcriptase inhibitor Nevirapine Drug metabolism. 2007; 27(14):1488-95.
6) WHO and UNICEF. Global HIV and AIDS progress report. November 2011
7) Africa network for the care of children affected by AIDS. A hand book of pediatric AIDS in
Africa. 2004.
8) Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, et al.: Adherence to
protease inhibitor therapy and outcomes in patients with HIV infection.Ann Intern
Med 2000, 133(1):21-30
9) Sabin LL, Desilva MB, Hamer DH, et al.: Barriers to adherence to antiretroviral medications
among patients living with HIV in southern China: a qualitative study. AIDS
Care 2008, 20(10):1242-50.
10) Visanou Hansana1*, Pattara Sanchaisuriya3, Jo Durham5, etal : Adherence to Antiretroviral
Therapy (ART) among People Living With HIV (PLHIV): a cross-sectional survey to
measure in Lao PDR ,2013
11) WHO, “Towards universal access: scaling up priority HIV/AIDS interventions in the health
sector: progress report 2010,” In: WHO, editor. Geneva, Switzerland, WHO, 2010.
12) Determinants of Adherence to Antiretroviral Therapy among HIV-Infected Patients in Africa
Ayalu A. Reda and Sibhatu Biadgilign Volume 2012 (2012), Article ID 574656, 8 pages
13) Monjok E, Smesny A, Okokon IB, et al.:  Adherence to antiretroviral therapy in Nigeria: an
overview of research studies and implications for policy and practice. HIV/AIDS - Research
and Palliative Care. 2010;2: 69-76. PubMed | Google Scholar
14) Factors Affecting ART Uptake, Adherence and Prevention of Transmission among HIV
Positive Children and Adolescents In Uganda, A Review of Literature Prepared by Dr.
Nicolette Nabukeera-Barungi For Joint Clinical Research Centre /Health Communication
Partnership, January 2007
15) Holtgrave DR: causes of the decline in AIDS deaths, United states, 1995-2002: prevention,
treatment or both/ Int J STD AIDS 2005, 16(12):777-81.

15
16) Sujipittham T, Kulsomboon V. and Maleewong U. Factors affecting adherence to ART
regimens among HIV-infected/AIDS-patients at Taksin Hospital J Pub. Health Dev. 2012;
10(1): 29-39.
17) Nabukeera-Barungi N, Kalyesubula I, Kekitiinwa A, et al. Adherence to antiretroviral
therapy in children attending Mulago Hospital Kampala. Annal ofTropical Paediatric. 2007;
27:123-31.
18) Muller A, Bode S, Myer L, et al. Paediatric adherence to antiretroviral therapy in South
Africa measured by MEMS and its effect on treatment. 2007.
19) Rosemary Ugwu, Augusta Eneh:- Factors influencing adherence to paediatric antiretroviral
therapy in Portharcourt,South-SouthNigeria. The Pan African Medical Journal. 2013;16:30 
20) Linet Akinyi Arika ,care-giver factors associated with adherence to antiretroviral therapy in HIV
infected children: a case of Thika district hospital in Kenya, January 2011
21) Ministry of Health, Uganda, HIV/AIDS Surveillance Report. June 2004.
22) Visanou Hansana1*, Pattara Sanchaisuriya3, Jo Durham5, et al.: Adherence to Antiretroviral
Therapy (ART) among People Living With HIV (PLHIV): a cross-sectional survey to
measure in Lao PDR ,2013
23) Tefera Girma Negash, Personal Factors Influencing Patients’ Anti-Retroviral Treatment
Adherence in Addis Ababa, Ethiopia /June 2011
24) Agegnehu Tesfaye Amdeberhan, Risk factors for (Predictors of) loss to Antiretroviral
Therapy in Oromia, Ethiopia,May, 2010

16
ANNEX
ANNEX:-1 Dummy Tables

Table 1:- Socio-demographic characteristics by age & sex of study subjects and their
adherence status, JUSH ART clinic, March, 2014
Children`s Male Female Total
Age
Adherence Non Adherence Non Adherence Non
(years) *
Adherence Adherence Adherence

<3

3-5

6-8

>9

Total

*WHO

Table-2:- Frequency distribution of care –givers factors and child ART drugs
adherence among study subjects, JUSH ART Clinic, March, 2014

Variables Care-givers factors Adherence Non Adherence Totals

Frequency % Frequency % Frequenc %

y
Religion Muslim
Orthodox
Catholic
Wake feta
Protestant
Total
Marital Status Single
Married
Divorced
Widowed
Total
Occupational Farmer
status
Merchant
Gov. employee
NGO. Employee
Daily laborer
*others
Total
Educational Unable to read/write
status
Primary (1-8)
Secondary (9-12)

17
 Diploma and above
Total
Annual <9515
Income*
9515-33,660
>33,660
Total
Relationship with Biologic parent
the child
Non biologic parent

*EDHS 2011

Table 3:- Frequency distribution of characters of responsible person for the child
ART drug adherence among study subjects, JUSH ART Clinic, March, 2014
Variables Response Adherence Non Adherence Total

Frequency % Frequency % Frequency %

Yes
Primary care
giver No

Total

Non biologic Yes

parent
No

Total

Care-givers Yes
know when the
child started No
treatment
Total

Table 4:-frequency distribution of the child factor and ART drug adherence status
among study subjects, JUSH ART clinic, March, 2014
Variables Response Adherence Non-Adherence Total

Frequency % Frequency % Frequenc %

y
Children Know Yes
their sero-status
No

Total

Children’s HIV Yes

status disclosed to
others No

Total

Table 5:-frequency distribution of Disease and drug factor and child drug adherence
status among study subjects, JUSH ART clinic, March, 2014

18
 Disease/ Clinical marker Adherence Non- Total
Drug Adherence
factors
Freq % Freque % Fre %
uenc ncy que
y ncy
Duration <12
of
treatment 13-24
in month
24-36
>36
Total
WHO Sage I
clinical
Stage of Sage II
HIV
Sage III
disease
Sage IV
Total
CD4 <200
Count at
start of 200-499
treatment
>500
Total
Regimen 4a =
of HIV at d4t/3Tc/NVP
start 4b=d4t/3Tc/
EFN
4c=AZT/3Tc/
NVP
4d
=AZT/4TC/EFN
Total
Co- Yes
trimoxazol
e in take No
besides
Total
ART
Table 6:-frequency distribution of the health care-providers estimate rate of child
ART adherence among study subjects, JUSH ART clinic, March, 2014
Health care providers Adherence Non-Adherence Total
estimate of adherence
Frequency % Frequency % Frequency %
Good
Fair
Poor
Total

19
 Table 7:-Frequency distribution of Care-givers reports adherence rate of HAART
among children in JUSH ART clinic, March, 2014
Care givers Report in Adherence Non-Adherence Total
different days

Frequency % Frequency % Frequency %

To day

Yester day

Past 3 day

Past 7 day

Table 8:- Frequency distribution of child’s illness & type of drug the child is taking
(other than ARV)among children in JUSH ART clinic, March, 2014
Adherence Non-Adherence Total
Type of Childs illness since last
visit
Frequency % Frequency % Frequency %

Malaria

Pneumonia

Otitis Media

Diarrhea

Co-trimoxazole

Type of drug the

Amoxicillin
child is
taking(other than Anti-TB
ARV)
Other

JIMMA UNIVERSITY
COLLEGE OF PUBLIC HEALTH AND MEDICAL SCIENCES
DEPARTEMENT OF NURSING

ANNEX:-2 QUESTIONNARIES

Questionnaire to identify factors affecting child ART drugs adherence in JUSH at ART clinic in
Jimma town, Oromia, Ethiopia, March, 2013
Instruction
1. To be filled by the data collector at ART clinic under supervision of researcher.
2. Respondents need to be willing- full and have trust.
3. Any opinion will be kept confidential and names can be withheld.

20
Objective: - In partial fulfillment of the requirement for the degree program Bachelor of Science
in Nursing.
Name of data collector ----------------------- sign ---------------- date---------------------
Name of supervisor ----------------------------- sign --------------------- date--------------------

Part -I
SOCIODEMOGRAPHIC CHARACTERISTICS OF THE RESPONDENTS
1. ID number of the child................................................................
2. Name of facility........................................................................
3. Date of interview........................................................................
4. Age................................................
5. Sex....................................................
6. CD4 count/ %........................
7. Distance of Health facility from your home------------------(hours)
SOCIAL DERMOGRAPHIC INFORMATION ON INFORMANTS /CARETAKER
8. Sex..........................
9. Age...........................
10. Education level
A. No education
B. Primary education (1-8)
C. Secondary education (9-12)
D. Tertiary Education (Diploma & above)
11. Occupational status
A. Farmer E. Day laborer
B. Merchant F. Unemployed
C. Government employee G. house wife
D. NGO –employee H. Others _________

12. Relationship with the child

A. Mother D. Non biologic parent
B. Father E. Other...............................
C. Aunt
13. Religion
A. Muslim C. Protestant
B. Orthodox D. Catholic e) other................................
14. Marital status
A. married D. Widowed
B. Single E. Others.........................
C. Divorced
15. When the child was first diagnosed? (Age-month...............years................) I don’t
know…….
16. For how long the child is on antiretroviral therapy? Month.............years.............

21
 17. Which medication is the child on/ Check on the card?
A. AZT, 3TC, NVP C. ABC, 3TC, NVP
B. d4T, 3TC, NVP D. Others.............................

18. Did the child suffer from any illness since last visit?
A. YES B. NO
If yes go to question no19.
19. IF YES WHAT
A. malaria D. diarrhea
B. pneumonia E. e)other...................
C. Otitis media

20. Does the child know his/her HIV status?

A. YES B. NO
21. What is your annual income?
A. < 9515ETB
B. 9515-33,660
C. >33,660
ASSESSMENT OF ADHERENCE AND NON ADHERENCE
1. Do you have medication with you? May I see them? Medication returned (amount)..........
A. <=5% of prescribed dose
B. >5%of prescribed dose
II) The dose per day....................................................................................
2. Please can you tell me when you give child medication?
A. Morning D. Morning and evening
B. Afternoon E. others...............
C. Evening
3. How many doses did the child miss taking yesterday?
A. None B. One dose C. Two dose
4. How many doses did the child miss taking day before yesterday?
A. None B. One dose C. Two dose
5. How many doses did the child miss taking 3 days ago?
A. None B. one dose C. two dose.
6. How many doses did the child miss taking 7 days ago?
A. None B. one dose C. two dose.
7. Are there any other medications the child is taking?
A. YES B. No
IF YES which medication
A. cotrimoxazole C. ant TB
B. amoxicillin D. other..................
8. I know it is difficult to take medication on daily basis, if you sometime miss a dose please
tell me what causes this to happen?
22
 A. Simple forgetful D. caretaker away
B. we travel E. bad taste
C. Child slept F. other....................................

9. Can you tell me what assisted you to give child medication on time and regularly?
A. Clock
B. individual
C. others.......
10. Did antiretroviral therapy have been changed since the child started on ARV?
A. YES
B. NO.
11. If YES why
A. adverse reaction
B. treatment failure
C. other
Part-II
Questionnaire which will be filled by health professional who is working at ART
Clinic in JUSH.
1. WHO clinical staging of HIV disease is one of clinical marker of HIV infected children. So
according to WHO staging how many of them will be adhered ART and not in each stage?

Stage I
A. In the last 7- days how many children was being adhered ----------
B. In the last 7- days how many children was being not adhered----------
Stage II
A. In the last 7-days how many children was being adhered-----------
B. In the last 7-days how many children was not being adhered-------
Stage III
A. In the last 7-days how many children was being adhered-------
B. In the last 7-days how many children was not being adhered ------
Stage IV
A. In the last 7-days how many children was being adhered --------
B. In the last 7-days how many children was not being adhered------
2. CD4 counts at the start of treatment
How many of children from selected group whose CD4 counts <200 are:-
A. Number of children those who adhered ----------
B. Number of children those who didn’t adhere ----------
3. How many of children from selected group whose CD4 counts 200-499
A. Number of children those who adhered------
B. Number of children those who didn’t adhere----
4. How many of children from selected group whose CD4 counts >=5oo
I. Number of children those who adhered--------

23
 II. Number of children those who didn’t adhere-----
5. Current CD4 counts
I. How many of the children from selected group whose CD4 counts <200
A) Number of the children those who adhered-------
B) Number of the children those who didn’t adhere-------
II. How many of the children from selected group whose CD4 counts 200-499
A) Number of children those who adhered---------
B) Number of children those who didn’t adhere-------
III. How many of the children from selected group whose CD4 counts >=500
A) Number of children those who adhered----------
B) Number of children those who didn’t adhere--------
6. Regimen recommended
IV. How many of children from selected group who took 4a= d4t/3TC/NVP
A) Number of children those who adhered---------
B) Number of children those who didn’t adhered -----
V. How many of the children from selected group who took 4b=d4t/TC/EFN
A)Number of children those who adhered------
B)Number of children those who didn’t adhere------
VI. How many of children from selected group who took 4c=AZT/3TC/NVP
A) Number of children those who adhered -------
B) Number of children those who didn’t adhere----------
VII. How many of children from selected group who took 4d=AZT/3TC/EFN
A) Number of children those who adhered--------
B) Number of children those who didn’t adhere------

24