Public Health Action International Union Against Tuberculosis and Lung Disease

Health solutions for the poor

VOL 6 NO 4  PUBLISHED 21 DECEMBER 2016

Isoniazid preventive treatment among child contacts of adults

with smear-positive tuberculosis in The Gambia
U. Egere,1 A. Sillah,1 T. Togun,1,2 S. Kandeh,1 F. Cole,1 A. Jallow,3 A. Able-Thomas,3 M. Hoelscher,4
N. Heinrich,4 P. C. Hill,5 B. Kampmann1,6

http://dx.doi.org/10.5588/pha.16.0073
treatment.7 Not only is uptake poor, but adherence AFFILIATIONS
Setting:  Greater Banjul area of The Gambia. rates tend to be less than 30% among those who do
1 Vaccines and Immunity
Theme, Medical Research
Objectives:  To evaluate uptake, adherence and comple- commence IPT.8,9 The measurement of adherence can Council Unit–The Gambia,
tion of treatment among tuberculosis (TB) exposed chil- also be unreliable, relying heavily on reports from care
Banjul, The Gambia
2 Department of
dren in The Gambia when isoniazid preventive treatment givers, how often care givers return for more medica- Epidemiology and
(IPT) is delivered at home tion, and pill counts.10,11 Furthermore, interventions Biostatistics, McGill
University, Montreal,
Design: Child (age 5 years) contacts of adults with to improve IPT delivery frequently do not result in im- Quebec, Canada
smear-positive TB were prospectively enrolled. Following proved uptake, adherence and treatment comple- 3 National Leprosy and
Tuberculosis Control
symptom screening, tuberculin skin testing and clinical tion.12 A recent meta-analysis of the cascade of care for Programme, Kanifing, The
evaluation where indicated, those without disease were treatment of latent tuberculous infection (LTBI), Gambia
4 Centre for International
placed on daily isoniazid, provided monthly at home. Ad- which indicated where patients get lost in the system Health, Division of
herence was assessed by pill counts and IsoScreen™ for various reasons, focused primarily on adults.13 Infectious Diseases and
urine test. Tropical Medicine, Medical
As IPT implementation now has a higher priority Centre of the University of
Results: Of 404 contacts aged 5 years, 368 (91.1%) within the agenda for TB control,14 and as implemen- Munich, Munich, Germany
were offered IPT. Of the 328 (89.4%) for whom consent tation via TB clinics appears to be challenging, we de-
5 Centre for International
Health, Department of
was received and who commenced IPT, 18 (5.5%) veloped a home-based IPT programme among child Preventive and Social
dropped out and 310 (94.5%) remained on IPT to the contacts of recently diagnosed adult sputum
Medicine, University of
Otago, Dunedin, New
end of the 6-month regimen. Altogether, 255/328 chil- smear-positive TB cases and assessed its impact on up- Zealand
dren (77.7%, 95%CI 73.2–82.2) completed all 6 months, take, completion and adherence within the cascade of
6 Centre for International
Child Health, Academic
with good adherence. The IsoScreen test was positive in care in The Gambia. We also measured the isoniazid Department of Paediatrics,
85.3% (435/510) of all tests among those defined as hav- (INH) metabolites in urine to assess the reliability of Imperial College London,
London, UK
ing good adherence by pill count and in 16% (8/50) of our adherence measures.
those defined as having poor adherence (P  0.001). A CORRESPONDENCE
Uzochukwu Egere, Beate
cascade of care analysis showed an overall completion
rate with good adherence of 61% for all child contacts.
METHODS Kampmann
Vaccines and Immunity
Theme
Conclusion: Home-delivered IPT among child contacts Study sites Medical Research Council
of adults with smear-positive TB in The Gambia achieved The study was carried out in the Greater Banjul area of Unit–The Gambia
Atlantic Road, Fajara, P O
verifiable high uptake and adherence rates. System rather The Gambia between November 2013 and May 2015. Box 273
than patient factors are likely to determine the success of This is a mixed urban-to-rural area, including the capi- Banjul, The Gambia
IPT at national level. e-mails: uegere@mrc.gm,
tal city of Banjul, and has a population of approxi- bkampmann@mrc.gm
mately 700  000. The setting has been described
KEY WORDS
elsewhere.15

T
adherence; IsoScreen; IPT;
he current elimination goals for tuberculosis (TB) prophylaxis; cascade of care
Participants
include a focus on individuals who are latently
Child contacts aged 5 years living in the same
infected with Mycobacterium tuberculosis to reduce the
household as adult sputum smear-positive TB cases
number of new TB cases and subsequent M. tuberculo-
were recruited. A household was defined as a group of
sis transmission.1 This strategy requires isoniazid pre-
individuals eating from the same pot and living in the
ventive therapy (IPT) or an alternative regimen. Initial
same building.16
targets are those at most risk of disease progression,
such as young children and human immunodefi- Symptom screening, tuberculin skin testing and
ciency virus (HIV) infected individuals in contact with clinical evaluation
an infectious adult with TB.2 Adults with newly diagnosed sputum smear-positive
The above World Health Organization (WHO) rec- TB were identified at the National Leprosy/TB Control
ommendations have not, however, been implemented Programme (NLTP) clinics and were asked for their
in most of the high-burden TB settings where IPT is consent to a household visit. After the project was ex-
most needed. In many places where IPT has been im- plained to the parents/care givers, written informed
plemented and evaluated, the impact is suboptimal consent was obtained. A standard symptom-screening
Received 29 August 2016
and the operational challenges are formidable.3–6 Con- questionnaire for TB was then administered to ascer- Accepted 12 October 2016
sidering the cascade of care as a whole, it is estimated tain if any child living in the same household had a
that, even where IPT is part of routine practice, only a cough of 2 weeks’ duration in association with at PHA 2016; 6(4): 226–231
minority of eligible children complete a course of least one of the following symptoms: weight loss, fail- © 2016 The Union
 Public Health Action IPT in The Gambia  227

ure to gain weight, fever or night sweats. The tubercu- take component of the cascade, the number of con- ACKNOWLEDGEMENTS
The authors are grateful to
lin skin test (TST) was performed using the Mantoux tacts of those TB cases who refused a home visit and the National Leprosy and
method (2 tuberculin units of purified protein deriva- the number of children with TB disease among those Tuberculosis Control
Programme of The Gambia
tive RT23, Statens Serum Institute, Copenhagen, Den- who had not been assessed in the clinic were esti- (Banjul), the childhood TB
mark) and read 48–72 h later. A positive TST was de- mated. This was performed by simple extrapolation of field team of the Medical
Research Council (MRC) Unit
fined as an induration of 10 mm, in line with WHO the average number of child contacts per case and the
(Banjul) and all the children
recommendations.17 Child contacts with symptoms rate of disease in those assessed to a rate of disease in and their families who
suggestive of TB and/or a positive TST were referred to those not assessed, rounded to the nearest whole num- participated in the study.
This work was funded by an
a dedicated childhood TB clinic for further evaluation. ber.13 Adherence was divided into three categories: MRC Programme grant to BK
All children diagnosed with TB disease were referred to good, reasonable and poor, if respectively 80%, 60– (MR/K011944/1). Research
at the MRC–The Gambia is
the TB clinics of the NLTP for DOTS-based treatment. 80% or 60% of the pills delivered each month had jointly funded by the UK
been taken.19 Treatment completion was defined as MRC (London, UK) and the
Isoniazid prophylaxis and follow-up UK Department for
consuming 80% of all pills prescribed in each of the International Development
All child household contacts aged 5 years in whom
6 months of prophylaxis.20 The proportion of children (DFID, London, UK) under
TB disease was excluded were provided with IPT at 10 the MRC/DFID concordant
with a positive IsoScreen test result was compared agreement, and is also part
mg/kg/day for 6 months, as recommended by the
among the adherence categories using the χ2 test. The of the European &
WHO,2 regardless of their TST result. Field workers de- Developing Countries
data are presented in frequencies, proportions and per-
livered the IPT to the homes of the children on a Clinical Trials Partnership
centages with their 95% confidence interval (CI). programme (The Hague, The
monthly basis and administered a brief questionnaire Netherlands) supported by
to capture missed doses, the reasons for missed doses the European Union.

and any adverse events from the medication. To mea- RESULTS Conflicts of interest: none
declared.
sure adherence, pill counts were performed for all chil-
IPT uptake and characteristics of those
dren. An IPT card was specifically developed to record
commenced on IPT
the child’s weight and the number of unconsumed
Over the study period, 301/330 adults with sputum
doses of medication. All children were assessed every 3
smear-positive TB consented to contact tracing in their
months for 1 year; those with new symptoms sugges-
households. Altogether 404 children aged 5 years
tive of TB were referred to the childhood TB clinic at
and living in the same household as an adult index
the Medical Research Council (MRC) unit. A final
case were screened at community level. Of these, 163
home visit was made 1 year after INH completion to
symptomatic and/or TST-positive children were re-
ascertain post-IPT status.
ferred for further evaluation in the clinic, and 153/163
IsoScreen testing (94%) attended the appointment. Of this group, 26
In the first year of the study, consecutively recruited (16.9%) were diagnosed with active TB. The remaining
children on IPT were asked to provide a monthly urine 368 children were eligible for IPT and consent was
sample for a qualitative assessment of adherence using sought from their parent or legal guardian, of whom
the IsoScreenTM test (GFC Diagnostics Ltd, Oxford- 25 refused, 14 moved out of the study area after con-
shire, UK), a point-of-care colorimetric assay that de- senting and one child died of a brief febrile illness
tects INH and its metabolites utilising a disposable thought to be malaria in the first month of prophy-
plastic test device and the Arkansas method for metab- laxis (Figure 1). Of 328 children initiated on IPT, 50.6%
olite detection.18 Two ml of collected urine was in- were females; the median age (interquartile range
jected into a reaction chamber and mixed with the re- [IQR]) at recruitment was 2.3 years (IQR 1.3–3.4)
agents contained in an effervescent tablet for about (Table 1).
10 s. Dark blue/purple colouration appearing within 5
Completion of IPT
min indicates a positive result, i.e., the individual has
Of the 328 children commenced on IPT, 318 (96.9%)
taken INH within the previous 24–48 h. If no INH has
started within 1 month of the diagnosis of their re-
been taken, the colour of the urine remains un-
spective index cases. IPT was administered by the
changed, indicating a negative result. Care givers were
mothers in 92.3% (303/328) of the cases, by the fa-
informed about the monthly visits, but the actual days
thers in 2.4% (8/325), and by grandmothers and sib-
of the visit were unannounced. The results of the Iso-
lings in 0.9% of cases each.
Screen testing were recorded on the child’s INH card.
Eighteen of the 328 children dropped out of IPT,
Ethics approval leaving 310 children remaining on prophylaxis at the
Ethics approval for the study was obtained from the end of 6 months. There was no difference in the char-
joint Medical Research Council/Gambian government acteristics of those who dropped out and those who
ethics committee (Ref. L2012.E01), Banjul, The completed prophylaxis. A final 255 of the 328 children
Gambia. (77.7%, 95%CI 73.2–82.2) completed the 6 months of
IPT with good adherence.
Data analysis
Data were double-entered into an Access database (Mi- Adherence to treatment
crosoft Corp, Redmond, WA, USA) and verified using During the study period, 59 040 doses of IPT were dis-
consistency checks. All analyses were performed using pensed, of which 53  573 (90.7%) were consumed.
STATA/IC 13.1 (StataCorp, College Station, TX, USA). Based on pill counts, 78.9% (95%CI 74.5–83.2) of all
IPT implementation was assessed using a cascade of medications were consumed by children with good ad-
care approach. To provide a denominator for the up- herence, 15.4% (95%CI 11.5–19.3) by children with
 Public Health Action IPT in The Gambia  228

tive by IsoScreen, compared to 0–25.0% of those with poor adher-

ence (Table 3). Across the three adherence categories there was a
significant trend in IsoScreen positivity (P  0.002) in each
month of IPT.
Of 314 responses to the adherence questionnaire adminis-
tered among care givers, 247 (78.7%) stated that the main reason
for failure to administer the pills was forgetfulness. The second
major reason, given by 30 (9.6%) of the care givers, was travel.
Other reasons included the child being sick (11 [3.5%]), refusing
medication (7 [2.2%]) and misplacement of the medications (5
[1.6%]).
Side effects
No side effects were reported throughout the study period.
One-year follow-up
Of the 310 children who completed their course of IPT, 12 (3.9%)
were lost to follow-up at 1 year after IPT. One child aged 18
months died of a sudden febrile illness not related to INH or TB.
FIGURE 1  Flow chart of screening and recruitment of children on
One child who dropped out of IPT in the first month developed
INH prophylaxis. INH = isoniazid; TB = tuberculosis.
clinically diagnosed TB by the ninth month of follow-up. All the
other children remained well.
reasonable adherence, and 5.6% (95%CI 3.1–8.1) by children with
Cascade of care summary analysis
poor adherence. Table 2 shows the monthly adherence of chil-
To identify where improvements may be needed in the contin-
dren on IPT as determined by pill count. Less than 10% of chil-
uum of care of child contacts eligible for IPT, we used a cascade of
dren on prophylaxis in any month had poor adherence. Overall,
care approach, as summarised in Figure 2. We estimated uptake
the proportion of children with positive IsoScreen test results was
and completion of IPT among all eligible children in the house-
similar to the proportion with good adherence: good adherence
holds of the 330 adults with TB approached during the study. Af-
by pill count was 77.4% (95%CI 74.2–80.6) compared to 76.6%
ter excluding 27 children with TB disease (26 diagnosed after clin-
(95%CI 73.4–79.8) with positive urine test results.
ical evaluation and one estimated from among those who failed
The proportion of children with good adherence remained
to attend the clinic), 418 children remained eligible for IPT, of
high, at 76.2% in the first month, and increased gradually over
whom 328 (78.5%) accepted IPT and 255 (61%) completed 6
time to 83% in month 6. Spot urine samples were collected from
months of IPT with good adherence.
the first 141 children recruited into the study, and 658 episodes of
pill counts and urine tests were carried out simultaneously.
Among these children, 85.3% (435/510) of all tests among those DISCUSSION
defined as having good adherence by pill count were positive,
In this study, we implemented and evaluated a home-based IPT
compared to 16% (8/50) of tests among those defined as having
programme in The Gambia. Uptake of IPT was high (78%), and
poor adherence (P  0.001). Over the 6 months of IPT, 80.6–
77.7% of all child contacts who initiated IPT completed the
93.3% of those with good adherence by pill count were also posi-
6-month course with good adherence. A further 15.4% had rea-
sonable adherence, and 5.6% had poor adherence. We also found
TABLE 1  Characteristics of children placed on INH prophylaxis that pill count reliably reflected adherence in this population.
The most frequent reason for non-adherence was forgetfulness.
Characteristics n (%) The cascade of care analysis showed that approximately 61% of
Age at recruitment, years, median [IQR] 2.3 [1.3–3.4] the estimated original number of contacts eligible for IPT com-
Weight at recruitment, kg, median [IQR] 11.3 [9–13.3] pleted 6 months of IPT with good adherence, and provides in-
Females 167 (50.9) sight into the potential public health impact of the programme.
TST result Adherence is a major determinant of efficacy of IPT.21 High IPT
  Negative (10 mm) 265 (80.8) uptake in The Gambia is encouraging as the country moves to ex-
Ethnicity pand these services nationwide. In high TB burden countries, the
 Mandinka 155 (47.3) proportion of those commencing and completing at least 4
 Fula 58 (17.7) months of IPT is approximately 15%,6,7 and even in research con-
 Jola 59 (18.0) ditions adherence to unsupervised IPT in high-burden countries
 Wolof 27 (8.2) has been relatively low. Good adherence to IPT was achieved by
 Other 29 (8.8) approximately 24% in South Africa,4,22 25.6% in Indonesia8 and
Relationship to index case 32.5% in Southern Ethiopia.9 In contrast, in another research
 Child 108 (33.2) study conducted in Guinea Bissau, West Africa, where IPT was
 Sibling 18 (5.5) also delivered to the homes of child contacts for 9 months, the
 Other* 166 (51.1) proportion achieving good adherence according to pill counts
  Not related 33 (10.2) was 76%,20 similar to our study. Interestingly, when INH was de-
livered at home to children in Ethiopia, adherence was very poor,
* Includes cousin, nephew, niece or other extended family member.
with only 33% of children taking their medications for up to 4
INH = isoniazid; IQR = interquartile range; TST = tuberculin skin test.
 Public Health Action IPT in The Gambia  229

TABLE 2  Adherence to INH prophylaxis determined by monthly pill count

Patients on IPT at
end of month Good Reasonable Poor
(N = 328) adherence adherence adherence
Month n n (%) n (%) n (%)
1 323 246 (76.2) 49 (15.2) 28 (8.8)
2 316 245 (77.5) 49 (15.5) 22 (6.9)
3 316 245 (77.5) 53 (16.8) 18 (5.7)
4 302 235 (77.8) 51 (16.9) 16 (5.3)
5 311 252 (81.0) 52 (16.7) 7 (2.3)
6 310 259 (83.6) 36 (11.6) 15 (4.8)
INH = isoniazid; ITP = isoniazid preventive therapy.

months.9 More site-specific research is required to identify the ity of the IsoScreen test decreases with the passage of time from
best locally applicable approach to optimise adherence.23 ingestion of the medication.24 Similarly, some poorly adherent in-
The understanding and willingness shown by carers, especially dividuals may have taken IPT prior to their IsoScreen test. As the
mothers, to administer IPT provides a potential solid base for pro- day for IsoScreen testing was not announced in advance, how-
grammatic home-delivered IPT. As the project is now being trans- ever, it is unlikely that differential bias was introduced. A negative
ferred to the government programme, the priority is to enable IsoScreen result has been reported in fast acetylators;25 we did not
sustained delivery of INH to homes of child contacts. In the cur- assess acetylator status.
rent organisation of the health system in The Gambia, commu- In summary, the uptake of and adherence to IPT in our study
nity health workers and assistants living within the communities were high by international standards, suggesting that system
play a major role in public health. It is intended to provide train- rather than patient factors will be the main determinants of suc-
ing for this group to deliver IPT—and monitor IPT delivery—to cess when IPT management is transferred to be fully operational
homes of contacts at minimal or no additional cost to the NTP, as under the NLTP. IPT was highly acceptable to care givers and
they are already involved as TB treatment supporters to the index children in The Gambia, and home delivery will present an op-
cases. portunity for health education on TB and other topics of public
The use of IsoScreen enabled us to objectively assess whether health importance, such as malnutrition, sanitation and oral re-
pill counts are a reliable way to assess adherence in The Gambia, hydration. Training of health workers in childhood TB and IPT
and we found excellent agreement. Our results should be inter- will be required to ensure success.26,27 The cascade of care sum-
preted with caution, however, as some of the negative test results mary showed that there are opportunities for improvement for
came from individuals with good adherence by pill count but the IPT programme to have maximal public health impact. Fur-
who had missed doses only in the most recent days. The sensitiv- ther studies could explore the reasons why some households do
not uptake IPT and whether an intervention to reduce care giver
forgetfulness, such as cell phone text reminders,28 could be
TABLE 3  Adherence by pill count and urine test result in the beneficial.
IsoScreen™ cohort
Month of Adherence Patients Positive IsoScreen
prophylaxis* category N (%) n/N (%)
1 (n = 120) Good 97 (80.7) 82/97 (85.5)
Reasonable 11 (9.2) 4/11 (36.4)
Poor 12 (10.1) 2/12 (16.7)
2 (n = 141) Good 105 (74.5) 90/105 (85.7)
Reasonable 25 (17.7) 14/25 (56.0)
Poor 11 (7.8) 1/11 (9.1)
3 (n = 134) Good 103 (76.9) 83/103 (80.6)
Reasonable 19 (14.2) 12/19 (63.2)
Poor 12 (8.9) 4/12 (33.3)
4 (n = 107) Good 87 (81.1) 74/87 (85.1)
Reasonable 14 (13.2) 9/14 (64.3)
Poor 6 (5.7) 0/6 (0)
5 (n = 96) Good 75 (78.1) 66/75 (88.0)
Reasonable 16 (16.7) 13/16 (81.3)
Poor 5 (5.2) 0/5 (0)
6 (n = 60) Good 45 (75) 42/45 (93.3)
Reasonable 11 (18.3) 8/11 (72.7)
Poor 4 (6.7) 1/4 (25.0)
* The IsoScreen test was used only during the first 12 months of the study in the
same children; the number of children willing to give urine declined substantially FIGURE 2  Cascade of care of child contacts eligible for IPT. IPT =
despite the dropout rate remaining very low. isoniazid preventive therapy.
 Public Health Action IPT in The Gambia  230

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Contexte  :  Région du Grand Banjul en Gambie. le TPI. Sur ces 328 enfants, 18 (5,5%) ont abandonné et 310 (94,5%)
Objectifs  :  
Evaluer la couverture, l’adhésion et l’achèvement du sont restés sous TPI jusqu’à la fin du 6e mois. Au total, 255/328
traitement parmi des enfants exposés à la tuberculose (TB) en enfants (77,7% ; IC95% 73,2–82,2) ont achevé les 6 mois de
Gambie quand le traitement préventif par isoniazide (TPI) est donné traitement avec une bonne adhésion. Le test IsoScreen a été positif
à domicile. chez 85,3% (435/510) de tous les tests parmi ceux définis comme
Schéma  :  Les enfants âgés de 5 ans, contacts d’adultes atteints de ayant une bonne adhésion par le comptage des comprimés et chez
TB à frottis positif, ont été enrôlés de manière prospective. Après 16% (8/50) de ceux définis comme ayant une adhésion médiocre
dépistage sur les symptômes, test cutané à la tuberculine et (P  0,001). L’analyse de la « cascade des soins » a montré, pour tous
évaluation clinique quand cela était indiqué, les enfants non malades les enfants contacts, un taux de bonne adhésion d’ensemble de 61%.
ont été mis sous isoniazide, fourni une fois par mois à domicile. Conclusion  :  L’administration à domicile du TPI à des enfants contacts
L’adhésion a été évaluée par un comptage des comprimés et par un d’adultes atteints de TB à frottis positif en Gambie a abouti à une
test urinaire IsoScreen™. bonne couverture et à un bon taux d’adhésion, tous deux vérifiables.
Résultats  :  Sur 404 contacts âgés de 5 ans, 368 (91,1%) ont été Ce sont les facteurs de système plutôt que ceux liés au patient qui
invités à bénéficier du TPI, et 328 (89,4%) ont consenti et commencé sont susceptibles de déterminer le succès du TPI au niveau national.
 Public Health Action IPT in The Gambia  231

Marco de referencia:  La zona del Gran Banjul en Gambia. a recibirlo (89,4%). De este grupo, 18 niños abandonaron el
Objetivos: Evaluar la aceptación del tratamiento preventivo con tratamiento (5,5%) y 310 recibían aun el medicamento al final del 6
isoniazida (TPI), su cumplimiento y su compleción por parte de los mes (94,5%). De los 328 niños, 255 terminaron los 6 meses de
niños expuestos en Gambia, cuando se suministra el tratamiento en tratamiento, con un cumplimiento satisfactorio (77,7%; IC del 95%
los hogares. de 73,2 hasta 82,2). La prueba IsoScreen fue positiva en el 85,3%
Método: Se incluyeron en el estudio de manera prospectiva los (435/510) de los casos definidos con cumplimiento adecuado según
niños menores de 5 años de edad que eran contactos de un adulto el recuento de comprimidos y en el 16% (8/50) de los casos cuyo
con diagnóstico de tuberculosis (TB) y baciloscopia positiva. Luego cumplimiento se consideró deficiente (P  0,001). El análisis de la
de la detección sistemática a partir de los síntomas, se practicaron la trayectoria asistencial reveló que en todos los contactos la tasa global
prueba cutánea de la tuberculina y la evaluación clínica cuando de compleción con cumplimiento satisfactorio fue 61%.
estaban indicadas; en caso de ausencia de enfermedad activa se inició Conclusión: El TPI suministrado en el hogar a los niños que son
el tratamiento diario con isoniazida, la cual se suministraba en el contactos de un adulto con diagnóstico de TB y baciloscopia positiva
hogar cada mes. Se evaluó el cumplimiento en función del recuento alcanza altas tasas de aceptación y de cumplimiento que se pueden
de los comprimidos y la prueba IsoScreen™ en muestras de orina. verificar. Los factores que determinan el éxito del TPI a escala nacional
Resultados: En los 404 contactos menores de 5 años de edad, se dependen del sistema de salud y no del paciente.
ofreció el TPI a 368 niños (91,1%) y 328 lo aceptaron y comenzaron

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