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A community-based isoniazid preventive therapy for the prevention of

childhood tuberculosis in Ethiopia

Article  in  The International Journal of Tuberculosis and Lung Disease · September 2017

DOI: 10.5588/ijtld.16.0471

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INT J TUBERC LUNG DIS 21(9):1002–1007
Q 2017 Datiko et al
http://dx.doi.org/10.5588/ijtld.16.0471

A community-based isoniazid preventive therapy for the

prevention of childhood tuberculosis in Ethiopia

D. G. Datiko,*† M. A. Yassin,†‡ S. J. Theobald,† L. E. Cuevas†

*REACH Ethiopia, Hawassa, Southern Region, Ethiopia; †Liverpool School of Tropical Medicine, Liverpool, UK; ‡The
Global Fund to fight AIDS, Tuberculosis and Malaria, Geneva, Switzerland

SUMMARY

B A C K G R O U N D : Although children in contact with aged ,15 years and 3102 (12.7%) were aged ,5 years;
adults with tuberculosis (TB) should receive isoniazid 2949 contacts had symptoms of TB and 1336 submitted
(INH) preventive therapy (IPT), this is rarely imple- sputum for examination. Ninety-two (6.9%) were PTBþ
mented. and 169 had TB all forms. Of 3027 asymptomatic
O B J E C T I V E : To assess whether a community-based children, only 1761 were offered (and accepted) IPT due
approach to provide IPT at the household level improves to INH shortage. Of these, 1615 (91.7%) completed the
uptake and adherence in Ethiopia. 6-month course. The most frequent reason for discon-
M E T H O D S : Contacts of adults with smear-positive tinuing IPT was INH shortage.
pulmonary TB (PTBþ) were visited at home and C O N C L U S I O N : Contact tracing contributed to the
examined by health extension workers (HEWs). Asymp- detection of additional TB cases and provision of IPT
tomatic children aged ,5 years were offered IPT and in young children. IPT delivery in the community
followed monthly. alongside community-based TB interventions resulted
R E S U LT S : Of 6161 PTBþ cases identified by HEWs in in better acceptance and improved treatment outcome.
the community, 5345 (87%) were visited, identifying K E Y W O R D S : tuberculosis; children; preventive thera-
24 267 contacts, 7226 (29.8%) of whom were children py; health extension workers; Ethiopia

CHILDREN IN CONTACT with adults with smear- In 2010, we implemented a novel community-based
positive pulmonary tuberculosis (PTBþ) have a high approach to enhance TB case finding and treatment
risk of infection and disease progression; contact outcome in southern Ethiopia. This project trains
investigation is therefore critical for diagnosing female health extension workers (HEWs) to identify
additional cases and preventing vulnerable individuals individuals with symptoms of TB, collect sputum
from progressing from infection to overt disease. specimens and prepare and fix smears for examination
Nearly all National TB Control Programmes (NTPs) in ‘kebeles’ (equivalent to a village, with an average
recognise this risk and recommend screening contacts, population of 5000 people).8 HEWs are supported by
especially children, for the presence of symptoms. supervisors who transport the smears to the nearest
According to international recommendations, symp- diagnostic laboratory and bring the drugs to initiate
tomatic contacts should be investigated for active TB, treatment at home or at the kebele health post.
whereas asymptomatic children aged ,5 years should Contacts of adult TB cases are required to be screened
receive isoniazid (INH) preventive therapy (IPT).1 for TB. However, as it was unlikely contacts would
Although IPT reduces the risk of disease progres- attend the health facilities or bring their children for
sion,1 very few NTPs in low- and middle-income screening,8 we initiated contact tracing and the
countries (LMICs) implement this recommenda- provision of IPT in the community through HEWs.
tion.2,3 This is because INH is often unavailable, We report the acceptability of and adherence to IPT
staff have the perception that the risk of disease among children in contact with adults with PTBþ
progression is low, that monotherapy promotes the identified and managed in the community by HEWs.
risk of drug resistance if active TB is not excluded and
due to reluctance to take on additional work.4,5
METHODS
Parents are also reluctant to give pills to their
asymptomatic children and adhere poorly to the 6- This was a prospective community-based cohort
month course.3,6,7 study of individuals residing in a household of adults

Correspondence to: Daniel G Datiko, REACH Ethiopia, Hawassa, Box 303, Southern Region, Ethiopia. e-mail:
[email protected]; [email protected]
Article submitted 22 June 2016. Final version accepted 4 May 2017.
 IPT in Ethiopian children 1003

who had been diagnosed with PTBþ in the Sidama were not tested with the tuberculin skin test or
Zone, in the Southern Nations Nationalities and interferon-gamma release assays, as these are not
Peoples’ Regional State (SNNPR) of Ethiopia. The locally available and are not indicated in the
project covered the entire zone, which has a Ethiopian TB guidelines.10 Parents and guardians of
population of 3.2 million residing in 19 rural districts the children were instructed to break the tablets into
and two town administrations. In this zone, three two (or four) pieces to provide the closest approxi-
hospitals and 104 health centres provide health mate dose possible. Parents of children aged ,2 years
services to 524 rural and 39 urban kebeles.9 The or unable to swallow tablets were advised to crush the
project was implemented under the Ethiopian Health pieces into a powder. Parents were advised on the
Extension Programme (HEP), which has been pro- symptoms of TB, the importance, purpose and side
viding health services at the village level since 2003. effects of IPT and to seek the HEWs for advice if the
The HEP trains women who have completed second- child developed symptoms or side effects. Adult
ary education for 1 year; HEWs are salaried cadres contacts received health education about TB, its
responsible for routinely conducting household visits transmission, symptoms and what to do if symptoms
to implement 16 basic health packages.10 developed in the future.
Adults with PTBþ reported here were diagnosed Index cases receiving anti-tuberculosis drugs and
between May 2011 and March 2013, as previously children receiving IPT were followed by HEWs and
described. Briefly, individuals with cough of 72 volunteer TB treatment supporters. Follow up com-
weeks were identified by HEWs during routine prised monthly home visits or visits at the health post
household visits. Symptomatic individuals were at the same time as the index case was receiving anti-
requested to provide two sputum specimens over 2 tuberculosis treatment. During each visit, parents/
consecutive days. Smears were prepared and fixed by guardians were asked by the HEWs about the
the HEWs and transported by supervisors to the presence of symptoms, adverse effects and adherence.
nearest laboratory. If the smear was positive, the Parents of children with minor side effects were
supervisor brought the anti-tuberculosis drugs to the advised to continue IPT and to immediately report
village and initiated treatment at home or at the any changes. Children with major IPT side effects or
health post, depending on the patient’s preference.8 TB symptoms were told to discontinue IPT and were
All household members were considered contacts referred to the nearest hospital, where they were
of the index case. The index cases were asked to list investigated and monitored. ‘Refusal to accept IPT’
all household members and their ages at the time the was defined as a parent refusing to initiate IPT. ‘IPT
supervisor or HEW visited the household to disclose discontinuation’ was defined as a child initiating IPT
the diagnosis of PTBþ and initiate treatment. This list but stopping the medication for .2 months contin-
was used to ask about the presence of symptoms uously in the absence of side effects or on medical
suggestive of TB among contacts. Houses of index advice.
cases reporting symptomatic household contacts not Parents or guardians were informed about the
present at the time of the first visit were revisited to importance of IPT and adherence, and children took
examine the contacts. However, asymptomatic con- their medication under their supervision. Parents or
tacts who were absent from the household at the time guardians visited their local health posts for refills
the list was prepared were not systematically revisit- and discussed any concerns about the medication,
ed. side effects and TB-related symptoms with HEWs or
Presumptive cases among contacts were defined as supervisors. Monthly meetings between HEWs,
individuals who reported having cough of 72 weeks supervisors and health centre staff were held to
with or without chest pain, shortness of breath, fever, discuss progress in the implementation of IPT in the
weight loss, failure to thrive or night sweats. community. Children receiving IPT were registered in
Presumptive cases able to expectorate were requested health post IPT registers, and data were updated
to submit sputum specimens. Children unable to monthly and at the time of drug refills.
produce sputum were referred to the nearest health Semi-structured questionnaires were used for
facilities for further clinical examination and chest X- symptom screening among household contacts. TB
ray (CXR). Transport subsidies were provided as and IPT registers were used to collect data related to
needed for household members who could not afford diagnosis for active TB and IPT outcomes. Question-
to travel to ensure they were able to access the naires were checked for completeness and consisten-
services. TB cases diagnosed among symptomatic cy; data were entered by a data officer into Excele
contacts were provided treatment in the same manner (MicroSoft, Redmond, WA, USA) and exported to
as the index cases. Children considered to have other SPSS for Windowse 20 (Statistical Package for the
infections were given broad-spectrum antibiotics and Social Sciences, Armonk, NY, USA). The main
were followed up by health facilities. outcomes of the study were the number of children
Asymptomatic children aged ,5 years were offered who completed 6-month IPT and the number who
6 months of INH at a daily dose of 5 mg/kg. Children discontinued or were lost to follow-up. Secondary
1004 The International Journal of Tuberculosis and Lung Disease

Table 1 The yield of household contact screening and IPT provision in southern Ethiopia
All household Contacts with Symptomatic Children examined
members symptoms contacts examined* who initiated IPT Smear-positive TB TB all forms†
Age years n n (%) n (%) n (%) n (%) n (%)
0–4 3 102 75 (2.4‡) 74 (98.7§) 1 761 (58.2¶) 4 (5.4) 8 (10.8)
5–14 4 124 448 (10.9) 431 (96) NA 19 (4) 27 (6.3)
715 17 041 2 426 (14.2) 864 (35.6) NA 69 (8) 134 (15.5)
Total 24 267 2 949 (12.2) 1 336 (45.3) NA 92 (6.9) 169 (12.7)
* Number examined at the time of the household visits who submitted sputum.
†
Includes smear-negative and extra-pulmonary TB cases diagnosed among the contacts examined.
‡
Percentage of contacts with symptoms among all household members of the specific age group.
§
Percentage of contacts with symptoms who were examined.
¶
Percentage of children aged ,5 years who initiated IPT.
IPT ¼ isoniazid preventive therapy; TB ¼ tuberculosis.

outcomes were the number of children initiating IPT months for the 1730 asymptomatic children aged ,5
who developed minor and major side effects and the years (31 had data for age missing).
number of children diagnosed with TB or who died Only 472 (93.4%) of the 523 symptomatic children
during the 6-month follow-up. We conducted a aged ,15 years who were examined had symptoms
univariate analysis for categorical variables. P , recorded, compared with 100% of the 864 symp-
0.05 was considered statistically significant. Children tomatic adults who were examined. The most
aged ,5 years were categorised by age group to common symptoms identified in these children were
identify risk factors for IPT discontinuation. cough (66.3%), fever (63.8%), shortness of breath
The Federal Ministry of Health of Ethiopia, Addis (55.7%) and constitutional symptoms, including
Ababa, and the Southern Regional Health Bureau, night sweats, loss of appetite and weight loss. Only
Hawassa, Ethiopia, provided written support for the a few children had haemoptysis. These frequencies
implementation of the study. The study protocol was were similar to those recorded among symptomatic
submitted for consideration to the Liverpool School adults, except for cough, which was more common
of Tropical Medicine Ethics Committee, Liverpool, among adults (P , 0.01, Table 2).
UK. The Committee waived the need for ethics Of the 3027 asymptomatic children aged ,5 years
approval as it considered the project was implement- who were eligible for IPT, 1761 (58%) were offered
ing internationally accepted treatment. Parents were IPT (males 888, 50.4%; females 867, 49.4%; sex data
informed that the service was part of national TB were missing in 6). The remaining 1266 (42% of the
guidelines and that data monitoring was required to 3027 eligible) were not offered IPT due to INH
document the proportion of children who completed shortage. All parents who were offered IPT accepted
the treatment. the therapy.
In total, 1574 (89.3%) completed the 6-month
course of IPT (Table 3). Infants appeared to be more
RESULTS likely to discontinue IPT than those aged 1–2 years
A total of 10 066 PTBþ cases were notified from the and 3–5 years (89.0% vs. 90.8% and 92.1%,
Sidama Zone from November 2010 to March 2013. respectively), and to do so within 1 month of
Of these, 6161 (61%) had been identified by HEWs. prophylaxis initiation. However, the frequencies were
Contact tracing was mostly conducted for index cases small and did not reach statistical significance. The
identified by HEWs. A total of 5345 index cases proportion of children adhering to IPT at monthly
(53%) had their contacts enumerated, generating a intervals by age is shown in the Figure (age was
list of 24 267 household contacts. Of these, 7226
(29.8%) were children aged ,15 years, including Table 2 Most frequent symptoms reported among contacts of
3102 (12.7%) children aged ,5 years. A total of index pulmonary tuberculosis cases who submitted sputum (n ¼
1336)
2949 (12.2%) of the 24 267 contacts had symptoms
of TB, including 523/7226 (7.2%) children aged ,15 ,15 years 715 years
(n ¼ 472) (n ¼ 864)
years and 75/3102 (2.4%) children aged ,5 years. Of Symptoms n (%) n (%)
the 2949 symptomatic contacts, 1336 (45%) submit-
Presence of:
ted sputum for examination. Cough 313 (66.3) 844 (97.6)
Ninety-two (6.9% of 1336 symptomatic contacts Fever 301 (63.8) 562 (65)
Shortness of breath 263 (55.7) 539 (62.4)
with smear examination) had smear-positive PTB and Night sweats 226 (47.9) 369 (42.7)
169 (12.7%) had TB all forms (Table 1). The median Loss of appetite 208 (44.1) 369 (42.7)
age of the 75 symptomatic children aged ,5 years Weight loss 168 (35.6) 289 (33.4)
Blood in sputum 12 (2.5) 20 (2.3)
was 39 months (range 1–72) compared with 47
 IPT in Ethiopian children 1005

Table 3 Characteristics of asymptomatic children aged ,5 years who received IPT (n ¼ 1761)*
Treated for TB
Completed IPT Discontinued IPT on follow-up Died
(n ¼ 1574) (n ¼ 142) (n ¼ 3) (n ¼ 3)
Age, months, median (range) 36 (1–60) 48 (2–60) 24 (9.6–48) 9.6 (1–54)
Age group, years*
,1 (n ¼ 164) 146 (89.0) 15 (9.1) 1 (0.6) 2 (1.2)
1–2 (n ¼ 263) 239 (90.8) 24 (9.1) 0 0
3–5 (n ¼ 1190) 1096 (92.1) 93 (7.8) 0 1 (0.8)
Male:female (% male)† 802:766 (51.1)‡ 58:84 (40.8) 0:3 (0) 1:2 (33)
* Outcome data missing in 41.
†
Sex data missing for 6 children.
‡
Age data missing in 103.
IPT ¼ isoniazid preventive therapy; TB ¼ tuberculosis.

missing for 103 children). The most frequent reasons to initiate and monitor IPT, staff perception that the
for discontinuing IPT were INH shortage (n ¼ 133), risk of disease progression was minimal and the risk
the death of a parent or the index case (n ¼ 4) and side of developing drug resistance.12,17–20
effects (n ¼ 3). The main reported side effects of IPT We report our experience in implementing IPT at
included nausea and vomiting, which resolved the community level among children within the
spontaneously. One child developed symptoms com- framework of the Ethiopian Health Extension Pro-
patible with hepatitis and required hospitalisation. As gramme. Children and adults exposed to adults with
the hospitals do not have the diagnostic capacity to pulmonary TB were visited at home and questioned
exclude other common causes of jaundice, such as about the presence of symptoms; symptomatic
viral hepatitis, IPT was discontinued in this child as a individuals were asked to provide sputum samples.
precaution. A further six patients developed symp- Of the 7226 children aged ,15 years, 523 were
toms compatible with TB, and underwent CXR. reported to be symptomatic and 35 had TB. All
Three cases (0.17%) were diagnosed as having TB parents with children aged ,5 years visited by HEWs
and 3 (0.17%) died due to other medical illnesses (2 who were offered IPT accepted the therapy and
were malnourished and were considered to have attained high adherence, with .90% of the children
sepsis and 1, whose parents were infected with the completing the 6-month course. Despite the accept-
human immunodeficiency virus, developed abdomi- ability of the approach, an important shortcoming of
nal distension and severe oedema). the intervention was the major logistical problems
faced in procuring INH despite a close partnership
with the NTP. Before the intervention, the NTP had
DISCUSSION only implemented IPT at the health facility level and
Despite the universal recognition of the value of the on a small scale, and the relatively large scale of our
systematic screening and provision of IPT among project led to major national procurement problems.
children in contact with adults with TB,11–14 very few The government also requested proxy registrations of
NTPs in LMICs implement this service at the health the children at the nearest health centre before
facility level,12,15,16 and even fewer NTPs are able to releasing the INH. This resulted in bottlenecks and
provide the service at the community level in poor, a protracted process to release the drugs to the
remote and rural communities. Reasons for not community, which took several months to resolve.
implementing contact investigation and IPT range Our study had methodological limitations that
from lack of prioritisation by NTPs, logistical must be explained to facilitate interpretation. The
problems in securing INH supplies, the time required intervention was conducted under operational con-
ditions, with the purpose of developing a system to
provide TB services close to the community. As such,
we were limited by the amount of information that
could be collected to avoid overburdening the system.
We were unable to obtain sputum from about 55% of
the contacts who initially reported having symptoms.
This was due to contacts being unable to expectorate,
having no cough or because the symptoms resolved
before the HEW had examined them. Furthermore,
although children who could not expectorate were
Figure Proportion of children who adhered to IPT by age referred for CXR, not all parents were able to attend
group and month of treatment. IPT ¼ isoniazid preventive the clinic and some TB cases were likely missed. A
therapy. further limitation is the underrepresentation of
1006 The International Journal of Tuberculosis and Lung Disease

selected age groups, as only 29.8% of the contacts separates the processes of treating the patient and
identified were children. This is in contrast to the preventing further disease in the family, potentially
national population statistics, which estimate that contributing to lower IPT uptake and adherence. In
44% of the population is aged ,15 years. This deficit the present study, we observed that initiating anti-
may reflect the working pattern of the HEWs, as tuberculosis treatment and IPT together creates a
household visits were conducted during working better mind imprint of the importance of adherence,
hours, and children may have been missed due to and that it is convenient for the parents to collect the
behaviour patterns, such as herding and school drugs at the same time as receiving treatment. This
activities. Finally, child-friendly formulations, such temporal association could be one of the reasons for
as those that have been recently developed, would the high adherence rates attained, in addition to the
have simplified the delivery of prophylaxis, but these client-friendly characteristics of the community-
were not available at the time of the study.21 The INH based approach implemented, but we were unable
dose used (5 mg/kg) might also have been too low, as to separate these factors.
the World Health Organization increased the recom- In conclusion, this innovative intervention demon-
mended dose to 7–10 mg/kg after the study had been strates that implementing community-based contact
implemented for 2 years. tracing and IPT provision among children is feasible
Despite these limitations, the approach presented under programme settings and can attain high adher-
here suggests that partnership with HEWs to provide ence and completion rates in the Ethiopian context.
community-based screening of contacts and IPT can
achieve a high degree of acceptance and adherence. Acknowledgements
To our knowledge, this is the highest adherence level The authors thank the Ministry of Health of Ethiopia (Addis
ever reported from this continent,7,22 suggesting that Ababa), the Southern Nations, Nationalities and Peoples’ Regional
a large component of the lack of acceptability and Health Bureau (Hawassa), the Sidama Zone Health Department
adherence reported by most studies may be the poor (Hawassa, Ethiopia) and District Health Officers, field supervisors,
health workers and Health Extension Workers of Sidama Zone for
accessibility of the service.
their support in the implementation of this project; and H Genzebe
Although these results are encouraging, a major for data entry and data management.
precondition for the provision of the service without The project was funded by the Canadian International Develop-
incurring major health service expenses was the ment Agency (Ottawa, ON, Canada) through the TB REACH
availability of community-based services, with the Initiative of the Stop TB Partnership, Waves I and III project
deployment of multipurpose HEWs at the village level. numbers T9-370-114 ETH and GAL W3/2013; the European and
Developing Countries Clinical Trials Partnership (The Hague, The
As these cadres are selected from and by the
Netherlands) (SP.2011.41304.021) and its co-funders (Medical
community, they are likely to remain in the village Research Council UK, London, UK; and Instituto de Salud Carlos
and have trusting relationships with the community. III, Madrid, Spain).
Several evaluations of the programme have demon- The funders had no role in study design, data collection and
strated their impact in other health areas,23,24 and the analysis, decision to publish, or preparation of the manuscript.
acceptability of TB packages.25 A further constraint is Conflicts of interest: none declared.
This is an open access article distributed under the terms of the
the inherent ineffectiveness of contact investigation as
Creative Commons Attribution License, which permits unrestricted
a method of early detection of TB cases, as secondary use, distribution, and reproduction in any medium, provided the
TB cases typically develop after a lag time of several original author and source are credited.
weeks in the first 2 years after infection. Asymptomatic
contacts could thus develop TB at a later time, and
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 IPT in Ethiopian children i

RESUME
CONTEXTE : Les enfants en contact avec des adultes ans et 3102 (12,7%) d’entre eux avaient ,5 ans ; 2949
atteints de tuberculose (TB) devraient recevoir un contacts avaient des symptômes de TB et 1336 ont
traitement préventif par isoniazide (IPT), mais ceci est soumis un échantillon de crachats pour examen. En tout,
rarement mis en œuvre. 92 (6,9%) avaient une TBPþ et 169 une TB de forme
O B J E C T I F : Evaluer si une approche bas ée en variée. Sur 3027 enfants asymptomatiques, seulement
communauté fournissant l’IPT au niveau du foyer 1761 ont été invités à prendre l’IPT (et l’ont accepté) en
améliore la prise du traitement et l’adhérence en raison de ruptures de stock d’isoniazide. Parmi ces
Ethiopie. derniers, 1615 (91,7%) ont achevé les 6 mois de
M É T H O D E S : Les contacts des adultes atteints de TB traitement. La raison la plus fréquente de suspendre
pulmonaire à frottis positif (TBPþ) ont bénéficié d’une l’IPT a été la rupture de stock d’isoniazide.
visite à domicile et d’un examen par des agents de C O N C L U S I O N : La recherche des contacts a contribué à
vulgarisation sanitaire (HEW). Les enfants la détection de cas supplémentaires de TB et à la
asymptomatiques âgés de ,5 ans ont reçu l’IPT et ont fourniture de l’IPT aux jeunes enfants. La fourniture de
été suivis une fois par mois. l’IPT dans la communaut é parall èlement à des
R É S U LT A T S : Des 6161 cas de TBPþ identifiés par les interventions communautaires relatives à la TB a
HEW au sein de la communauté, 5345 (87%) ont été abouti à une meilleure acceptation du traitement et à
visités, ce qui a permis d’identifier 24 267 contacts : un meilleur résultat.
7226 (29,8%) contacts ont été des enfants âgés de ,15

RESUMEN
M A R C O D E R E F E R E N C I A: Los niños que están en refirieron sı́ntomas indicativos de TB y 1336 aportaron
contacto con adultos con diagnóstico de tuberculosis muestras de esputo para examen. Se detectaron 92 casos
(TB) deberı́an recibir el tratamiento preventivo con de TBPþ (6,9%) y 169 casos con todas las formas de TB.
isoniazida (IPT), pero esta norma no suele aplicarse. De los 3027 niños asintomáticos, se ofreció el IPT solo a
O B J E T I V O: Analizar si una estrategia de dispensación 1761 (y lo aceptaron) debido a la escasez de isoniazida.
comunitaria del IPT en los hogares mejorarı́a la De estos ni ños, 1615 completaron la pauta de
aceptación y la adherencia a este tratamiento en Etiopı́a. tratamiento de 6 meses (91,7%). La causa más
M É T O D O S: Los trabajadores de extensión sanitaria frecuente de abandono del IPT fue también la escasez
(HEW) visitaron en su hogar a los contactos de los del medicamento.
adultos con diagnóstico de TB pulmonar a baciloscopia C O N C L U S I Ó N: La localización de contactos contribuyó
positiva (TBPþ). Se propuso a los niños de edad ,5 años a la detección de casos adicionales de TB y mejoró la
el IPT y se practicó un seguimiento mensual. provisión del IPT a los niños pequeños. La dispensación
R E S U LT A D O S: De los 6161 casos de TBPþ, los HEW comunitaria del IPT aunada a otras intervenciones
visitaron a 5345 casos (87%) en la comunidad y contra la TB en la comunidad tuvo como resultado
reconocieron 24 267 contactos. De estos contactos, una mayor aceptación del tratamiento y mejores
7226 (29,8%) eran niños ,15 años de edad y 3102 desenlaces terapéuticos.
(12,7%) tenı́an ,5 años de edad. De los contactos, 2949

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