HAL Id: tel-03615102 https://tel.archives-ouvertes.fr/tel-03615102 Submitted on 21 Mar 2022 HAL is a multi-disciplinary open access archive for the deposit and dissemination of sci- entific research documents, whether they are pub- lished or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L’archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d’enseignement et de recherche français ou étrangers, des laboratoires publics ou privés. Designing a community intervention for tuberculosis household child contact management and assessing the feasibility of its evaluation in Cameroon and Uganda Anca Vasiliu To cite this version: Anca Vasiliu. Designing a community intervention for tuberculosis household child contact manage- ment and assessing the feasibility of its evaluation in Cameroon and Uganda. Human health and pathology. Université Montpellier, 2021. English. NNT : 2021MONTT078. tel-03615102
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HAL Id: tel-03615102https://tel.archives-ouvertes.fr/tel-03615102
Submitted on 21 Mar 2022
HAL is a multi-disciplinary open accessarchive for the deposit and dissemination of sci-entific research documents, whether they are pub-lished or not. The documents may come fromteaching and research institutions in France orabroad, or from public or private research centers.
L’archive ouverte pluridisciplinaire HAL, estdestinée au dépôt et à la diffusion de documentsscientifiques de niveau recherche, publiés ou non,émanant des établissements d’enseignement et derecherche français ou étrangers, des laboratoirespublics ou privés.
Designing a community intervention for tuberculosishousehold child contact management and assessing thefeasibility of its evaluation in Cameroon and Uganda
Anca Vasiliu
To cite this version:Anca Vasiliu. Designing a community intervention for tuberculosis household child contact manage-ment and assessing the feasibility of its evaluation in Cameroon and Uganda. Human health andpathology. Université Montpellier, 2021. English. �NNT : 2021MONTT078�. �tel-03615102�
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THÈSE POUR OBTENIR LE GRADE DE DOCTEUR
DE L’UNIVERSITÉ DE MONTPELLIER
En Biologie de la Santé
École doctorale CBS2
Unité de recherche UMI 233 TransVIHMI
Designing a community intervention for tuberculosis household child contact management and assessing the
feasibility of its evaluation in Cameroon and Uganda
Présentée par Anca VASILIULe 08 décembre 2021
Sous la direction du Dr Maryline Bonnet
Devant le jury composé de
Pr Christian Lienhardt
Pr Albert Faye
Dr Yap Boum II
Dr Joanna Orne Gliemann
Dr Maryline Bonnet
Membre du jury
Rapporteur
Rapporteur
Membre du jury
Directeur de thèse
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STUDY PROTOCOL Open Access
Community intervention for childtuberculosis active contact investigationand management: study protocol for aparallel cluster randomized controlled trialAnca Vasiliu1, Sabrina Eymard-Duvernay1, Boris Tchounga2, Daniel Atwine3, Elisabete de Carvalho1,
Sayouba Ouedraogo1, Michael Kakinda4, Patrice Tchendjou2, Stavia Turyahabwe5, Albert Kuate Kuate6,
Georges Tiendrebeogo1, Peter J. Dodd7, Stephen M. Graham8,9, Jennifer Cohn10, Martina Casenghi10 and
Maryline Bonnet1*
Abstract
Background: There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid
identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a
community-based intervention as compared to facility-based model for the management of children in contact
with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings.
Methods/design: This multicenter parallel open-label cluster randomized controlled trial is composed of three
phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is
checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with
enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory
phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment
by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The
community-based intervention includes identification and screening of all household contacts, referral of contacts
with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with
follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or
older (5–14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing
TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the
community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda.
Randomization was stratified by country and constrained on the number of index cases per cluster. The primary
endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample
size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of
children will complete the preventive therapy in the standard of care arm.
(Continued on next page)
© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you giveappropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate ifchanges were made. The images or other third party material in this article are included in the article's Creative Commonslicence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commonslicence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtainpermission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to thedata made available in this article, unless otherwise stated in a credit line to the data.
* Correspondence: [email protected] National Research Institute for Sustainable Development (IRD UMI
233 TransVIHMI- UM-INSERM U1175), Montpellier, France
Full list of author information is available at the end of the article
Vasiliu et al. Trials (2021) 22:180
https://doi.org/10.1186/s13063-021-05124-9
(Continued from previous page)
Discussion: This study will provide evidence of the impact of a community-based intervention on household child
contact screening and management of TB preventive therapy in order to improve care and prevention of
childhood TB in low-resource high-burden settings.
Trial registration: ClinicalTrials.gov NCT03832023. Registered on 6 February 2019
Keywords: Contact tracing, Preventive therapy, Pediatric tuberculosis, Community intervention, Tuberculosis
symptom screening, Cluster randomized controlled trial
BackgroundTuberculosis (TB) is an infectious disease causing inci-
dent cases of disease in around 10 million people world-
wide in 2018 [1]. The World Health Organization
(WHO) estimated that 11% of the TB cases in 2018 were
in children (< 15 years). However, a modeling study has
estimated that the pediatric caseload in high-burden
countries is as high as 15–20% of all TB cases [2]. The
mortality rate in undetected untreated children is esti-
mated to be 21.9% for children of all ages and rises to
43.6% in young children of less than 5 years [3]. Improv-
ing case detection and treatment of this high-risk group
of young children is particularly challenging due to diag-
nostic limitations and clinical overlap with other com-
mon severe diseases of infants and young children in
resource-limited settings.
Research has consistently shown that TB disease in
young children usually occurs soon after exposure
and infection, that the risk of disease if infected is
high, and that TB preventive therapy (TPT) can sig-
nificantly reduce the risk of disease following expos-
ure and infection [4]. A meta-analysis reported that
10% of young child contacts had TB disease at the
time of screening, and 35% had evidence of infection
[5]. A recent individualized participant meta-analysis
found that the effectiveness of tuberculosis prevent-
ive treatment (TPT) was 63% (95% CI 53–70%)
among all exposed children and 85% (95% CI 80–
89%) among those with evidence of infection [4].
Therefore, the rapid identification and management
of exposed children in the households of TB disease
cases is a critical opportunity to detect, treat, and
prevent TB. Although recommended for decades,
household child contact screening and TPT have
been poorly implemented in high-burden and
resource-limited countries. For many years, children
were considered lower priority due to being less in-
fectious and therefore contributing less to TB trans-
mission than adults [6].
The WHO End TB Strategy and ambitious targets
for coverage of screening and TPT in the Global
Plan to End TB demonstrate political will and pro-
vide renewed opportunity to close the wide policy-
practice gap [7, 8]. The policy-practice gaps observed
in the screening and management of child contacts
are driven by health system and human resource
challenges as well as the many challenges faced by
families in bringing their children to the health facil-
ity [9–13]. In most low-resource countries, the index
case is asked to bring all child contacts to the health
facility for TB screening, and yet many barriers arise
when applying this recommendation such as schedul-
ing or financial challenges, transport costs, long
waiting periods in settings with risks of further ex-
posure, and families or even healthcare workers’ re-
luctance to apply these guidelines as they do not
always understand the rationale, potential benefits,
or risks when the child is well [13–17]. Community-
based household contact screening of children in the
household is likely to improve TB disease case de-
tection [8, 18–20].
The use of classical tuberculin skin test (TST) to iden-
tify child contact with TB infection who will benefit
from the TPT and the need of chest radiography (CXR)
in addition to symptom screening to exclude TB disease
before initiation of TPT have both operational challenge
that contributes to the lost proportion of child contacts
initiated on TPT for a long time [13]. However, there is
evidence that the additional yield of TB disease detection
from CXR in asymptomatic child contacts is extremely
low [9, 21–23]. In addition, WHO has recommended
since 2006 that high-risk child TB contacts—young (< 5
years) or are living with human immunodeficiency virus
(HIV) of any age—receive TPT after exclusion of TB dis-
ease without systematically confirming TB infection with
TST [24, 25]. Therefore, a symptom-based approach that
does not require further investigations for asymptomatic
child contacts could facilitate a more decentralized,
community-based implementation to initiate TPT in
asymptomatic children [8]. In addition, the recent WHO
recommendations [6] that include shorter TPT combin-
ation regimens (isoniazid and rifampicin or rifapentine
for 3 months) are associated with improved adherence
compared to the standard TPT regimen of isoniazid
monotherapy for at least 6 months and provide an im-
portant opportunity for increasing completion of TPT
[9, 26, 27]. Further, follow-up of children receiving TPT
at the household could further improve TPT completion
Vasiliu et al. Trials (2021) 22:180 Page 2 of 15
rates and could be easily integrated with activities to
support treatment of TB disease of the index cases in
the household.
There is no published study that has evaluated the im-
pact on the cascade of care of pediatric TB case detec-
tion and preventive therapy management of a
community-based approach compared to a facility-based
standard of care. We therefore aim to evaluate the im-
plementation of a community-based approach to child
TB contact screening and management in two TB-
endemic African countries.
MethodsStudy objective and endpoints
The primary objective of this study is to compare the
proportion of household child TB contacts eligible for
TPT who initiate and complete TPT under a facility-
based standard of care and under a decentralized
community-based intervention model of care for contact
screening and management.
The corresponding primary endpoint is the proportion
of child TB contacts < 5 years of age and HIV-infected
children of 5–14 years of age who are declared by the
index case and who initiate and complete the TPT.
The secondary objectives compare the aforementioned
models in terms of (i) cascade of care of TPT initiation
and completion in child contacts < 5 years or HIV-
positive children 5–14 years; (ii) cascade of care for TB
detection and treatment in all included contacts; (iii) tol-
erability and adherence in children initiated on TPT; (iv)
acceptability and feasibility of the two models by the
parents/guardians, health personnel, and community; (v)
the effect of the community-based intervention on the
number of adult contacts diagnosed with TB; and the
cost-effectiveness. The number of children and adults di-
agnosed with TB and the number of children initiated
on TPT will be also compared before and after the
intervention.
The secondary endpoints of the study are presented in
Table 1.
Study design
This is a two-arm parallel cluster randomized study
comparing two models of care for TB contact investiga-
tion and management. This study contains three phases:
1. Baseline phase (phase I) in which retrospective data
collection and register quality checks were done in
order to assess if the facility registers could be a
reliable source of documents for the study. During
this phase, there was also a baseline qualitative
assessment with adult TB patients who are parents
and stakeholders to better prepare the intervention
phase and assess the acceptability and feasibility of
the proposed activities.
2. Intervention phase (phase II) includes
implementation and participant recruitment in the
two models of care and study data collection.
3. Explanatory phase (phase III) contains the endpoint
analysis and reporting, a cost-effectiveness analysis,
and a post-intervention qualitative assessment with
adult TB patients who are parents and cluster stake-
holders to collect the acceptability of the imple-
mented package.
This research is known under the name of CONTACT
study (Community Intervention for Tuberculosis Active
Contact Tracing and Preventive Therapy) and represents
a research project embedded in a multi-country pediatric
TB implementation program called Catalyzing Pediatric
TB Innovations (CaP TB) led by the Elizabeth Glaser
Pediatric AIDS Foundation (EGPAF) and funded by
Unitaid.
Study setting
This study is conducted in two high TB incidence,
resource-limited African countries: Cameroon located
in West Africa and Uganda in East Africa, with im-
portant differences in programmatic delivery of TB
services. In Cameroon, TB care and management is
centralized. Only secondary-level health facilities have
TB laboratory diagnostic facilities and TB patients
can only access care and drugs from these health fa-
cilities. In Uganda, TB management is decentralized
to the primary healthcare level. In both countries, na-
tional guidelines [28, 29] at the time of this study de-
velopment recommended contact investigation and
screening as well as TPT with 6 months of daily iso-
niazid (6H) for eligible children. However, coverage of
TPT for eligible children below 5 years is low in both
countries. WHO recently reported that only 24% and
15% of eligible children were initiated on TPT in
2018 in Cameroon and Uganda respectively [1].
Description of the intervention
Facility-based model
This model implements a “passive” approach to the
screening and management of household contacts (see
definition in the “Study population” section) at the facil-
ity level as per current practice. Implementation follows
current National Tuberculosis Program (NTP) recom-
mendations, except that a 3-month regimen of daily
rifampicin-isoniazid (3RH) as a fixed-dose combination
(FDC) is offered as TPT to eligible child contacts. In the
context of the study, sites also benefit from additional
data collection and trainings with follow-up support for
the facility staff.
Vasiliu et al. Trials (2021) 22:180 Page 3 of 15
Table 1 Secondary endpoints of the CONTACT study
General secondary endpoints Detailed secondary endpoints
Cascade of care for the initiation and completion of TPT of child contacts < 5 years or HIV-infected 5–14 years and reasons of dropouts at different steps of the cascade
Number of screened children and proportion of children screened among child contacts < 5years or HIV-infected 5–14 years declared by the index case
Proportion of children potentially eligible for TPT: TB disease excluded
Proportion of children eligible for TPT after exclusion of contraindication to TPT
Proportion of children started on TPT among those eligible for TPT
Proportion of children who did not complete TPT among those started on TPT and reasons ofinterruptions
Cascade of care for TB detection of child contacts Proportion of children with symptoms suggestive of TB: presumptive TB
Proportion of presumptive TB cases investigated for TB
Proportion of children diagnosed with TB
Proportion of children with TB diagnosis who are started on TB treatment
Cascade of care for TB detection of adult contacts Number of adults screened and proportion of adults screened among household identifiedadult contacts
Proportion of adults with symptoms suggestive of TB: presumptive TB cases
Proportion of adults presumptive TB cases diagnosed with TB
Safety and treatment adherence for children under TPT Proportion of children with serious adverse events
Proportion of children with adverse events of interest: peripheral neuropathy, clinicalhepatotoxicity
Ratio of dose taken as indicated (ticked) on the treatment card by the parent/guardian overthe total number of doses to be taken by prescription
Endpoints at 6 months Treatment outcomes of children started on TB treatment
Proportion of children diagnosed with TB after initiation of TPT: during and after TPT
Proportion of children diagnosed with TB among those who were not started on TPT andwere not diagnosed with TB at baseline assessment
Before-after comparison for TB adult and pediatric cases and for TPT initiation and completion fromhealth facility registers
Number of patients diagnosed with TB and registered
Proportion of children among all patients diagnosed with TB and registered
TB treatment outcomes of patients (adults and children) diagnosed with TB and registered
Number of children started on TPT
Completion rate of children started on TPT
Acceptability and feasibility of the intervention Attitudes, willingness, and motivation to have a visit in their household
Myths, anticipated fears, stigma, and risks of having a visit in their household
Actual experiences with household visits
Perception of the disease, its risk, and the notion of prevention, including TPT
Description of critical events during house visits and how these were dealt with
Identification of main constraints
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Table 1 Secondary endpoints of the CONTACT study (Continued)
General secondary endpoints Detailed secondary endpoints
Fidelity of the study Proportion of delivered activities compared to the intended activities of the model
Cost-effectiveness of the intervention Costs of CHW/community nurse assessment and treatment
Costs of facility-based assessment and treatment
Other facility costs (overheads, diagnosis, hospitalizations)
Direct parent/guardian costs (related to care)
Indirect parent/guardian costs (unrelated to care, e.g., dissaving, travel costs)
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When a person is diagnosed with bacteriologically
confirmed pulmonary TB (index case), the facility staff
in charge of TB (TB focal person) asks the index case to
bring all household contacts with TB-related symptoms,
all young (< 5 years) child contacts or older (5–14 years)
child contacts living with HIV or exposed to HIV, irre-
spective of symptoms, to the health facility for evaluation
for TB disease or for eligibility for TPT. This facility-
based model is currently implemented in district hospi-
tals in Cameroon for child contacts under 5 years old,
but poorly applied for child contacts 5–14 living with
HIV. In Uganda, the NTP allows household contact tra-
cing when feasible but evaluation, TPT initiation, and
follow-up are required to be done at the facility. In prac-
tice, due to lack of transport, the household contact tra-
cing was poorly implemented. In both countries, at
facility, TB investigations include clinical examination,
sample collection for smear microscopy or Xpert MTB/
RIF testing, and CXR when available and indicated, i.e.,
Xpert is negative or not done. Any contact diagnosed
with TB is commenced on TB treatment, registered, and
provided with treatment support and follow-up as per
NTP guidelines. All sites are supported by the CaP TB
program reducing the risk of heterogeneity of diagnosis
and treatment of pediatric TB between sites and the two
countries. Asymptomatic children who are eligible to re-
ceive TPT as 3RH (or 6H if drug-drug interactions with
antiretroviral therapy preclude the use of rifampicin) are
initiated at the facility with monthly follow-up (Fig. 1).
The schedule of the facility-based model is presented in
Table 2.
Community-based model
The intervention model is a decentralized, “active” ap-
proach to the screening and management of household
contacts and is community-based. When an index case
is diagnosed with bacteriologically confirmed pulmonary
TB, the TB focal person asks whether s/he has child
contacts in the household, and if so, then asks whether
s/he is willing to receive a team in his/her household for
contact symptom screening. If they agree, then an ap-
pointment is made and a team comprising a trained
community health worker (CHW) and a research assist-
ant goes in the household to screen all contacts (chil-
dren and adults). If the index case does not have contact
children in their household, then s/he is not included in
the study, but contact investigation is done under rou-
tine care by the TB focal person. During the contact
screening visit, the contacts who present symptoms of
TB are referred to the health facility for TB investiga-
tions. Those who are asymptomatic and eligible for TPT
(i.e., < 5 years irrespective of HIV status or 5–14 years
and living with HIV) receive another visit by the TB
focal person or TB nurse to initiate 3RH (or 6H if drug-
drug interactions with antiretroviral therapy preclude
the use of rifampicin). The follow-up is done at the
household by the CHW after 1 week, 2 weeks, and then
monthly in order to rapidly identify the children who de-
velop TB symptoms in the community. The CHW col-
lects the TPT at the health facility before each
household visit and brings the remaining pills and docu-
ments back to the facility after the visit. During the
follow-up visits, the CHW repeats the TB symptom
screening, assesses the child’s TPT tolerability and ad-
herence, and assesses the presence of any critical sign. If
the child presents critical danger signs, tolerability prob-
lems, or TB symptoms, s/he is immediately referred to
the health facility for a clinician to consult them (Fig. 2).
The schedule of the community-based model is pre-
sented in Table 2.
Fig. 1 Facility-based model flowchart
Vasiliu et al. Trials (2021) 22:180 Page 6 of 15
Table 2 SPIRIT study schedule
Baseline phase Intervention phase Evaluationphase
Allocation* Siteassessment**
Enrolment ofindex cases
Enrolment ofcontact cases
Follow-up End ofstudy
Timepoint -2W 0 W1 W2 W4 W8 W12*** W24
Enrolment
Eligibility screen X X
Informed consent X X
Allocation X
Interventions
Facility-based arm X X X X X X
Community-basedarm
X X X X X X X X
Qualitativeassessment
X X
CEA X
Assessments
Identification ofcontact children
X
Children started onTPT
X
Children completedTPT
X X
Acceptability of theintervention
X X
TPT cost X
Abbreviations: W week, CEA cost-effectiveness analysis, TPT TB preventive therapy
*Allocation takes place before the intervention begins as the clusters are randomized and not the individuals
**The baseline phase takes place 3 months before the intervention phase
***Children started on 6months of isoniazid have 2 additional follow-up visits at week 16 and week 20
Fig. 2 Community-based model flowchart
Vasiliu et al. Trials (2021) 22:180 Page 7 of 15
Study population
Bacteriologically confirmed (by smear microscopy, Xpert
MTB/RIF, or TB loop-mediated isothermal amplification
(TB-LAMP) assays) index cases, > 15 years old who have
been diagnosed less than a month prior to inclusion and
declaring child contacts in the study catchment area, are
eligible. Exclusion criteria are known multi-drug resist-
ance (MDR), the index case being a prisoner, or TB pa-
tients from an already screened household from the
study.
Contacts sharing the same enclosed space for frequent
or extended periods of time with the index case or hav-
ing slept in the same bed during the last 3 months as per
the WHO definition of a contact case [24] are eligible
unless they are already on TPT or on TB treatment.
For the qualitative assessment, the study population is
represented by key informants (facility managers, health
staff, community health workers, and community
leaders) and by male and female TB patients, who are
parents/guardians.
Cluster selection and randomization
The study clusters are health facilities supported by the
CaP TB Program with TB diagnostic and treatment cap-
acity after an initial assessment taking into consideration
the number of bacteriological index cases identified from
January to December 2018 (minimum of 50). Priority
was given to rural, semi-rural, or semi-urban facilities as
there is less population movement than in an urban set-
ting with relatively easy access. In Cameroon, there were
mainly district hospitals because TB diagnosis is mainly
done at the secondary healthcare level, with ten clusters
selected from two regions (Central and Littoral regions).
In Uganda, as TB services are decentralized at the pri-
mary healthcare level, the ten clusters were primary
health centers in four districts in the South West region,
some with two facilities per cluster in order to reach the
minimum of 50 index cases per year.
The randomization was stratified by country, and in
each country, the 10 clusters have been allocated to one
of the study models by a covariate-constrained
randomization [30] taking into account the number of
bacteriologically confirmed TB cases from that cluster
the previous year. The randomization was performed by
a statistician from the central research team 3months
prior to the start of inclusions. Participants, healthcare
providers, study staff, and investigators are not blinded
to the allocation of the health facilities.
The cluster list can be found in the Supplementary
Material.
Criteria to discontinue the allocated intervention to a
cluster are the absence of recruitment in a cluster for
more than 2months or if the NTP proposes a similar
intervention that would bias the outcomes of the study.
TPT
The 3RH regimen uses the child-friendly formulation of
rifampicin (R) 75 mg/isoniazid (H) 50mg as a FDC [31]
for eligible child contacts of < 25 kg. This formulation is
procured and provided by the CaP TB project, as the
NTP has not yet recommended this regimen, but has ap-
proved its use in the context of the study. Prescription is
based on the body weight dose range as recommended
by WHO [32]. The body weight is measured at the TPT
initiation visit and at the TPT outcome visit for both
models, and in the facility-based model, it is measured at
every follow-up visit. For children of 25 kg or more, the
adult RH tablet is be provided. For children receiving an
antiretroviral treatment with protease inhibitors (as lopi-
navir/ritonavir), nevirapine or dolutegravir, 6H is used to
avoid the drug-drug interaction between R and these
antiretrovirals. Along with the TPT, 10 mg of daily pyri-
doxine (vitamin B6) is given to each child to prevent
peripheral neuropathy.
Study procedures
Symptom screening
Both models use the following symptoms [33] to assess
if the contact child has presumptive TB or not:
� Persistent non-remittent cough > 2 weeks
� Reported persistent fever > 10 days
� Reduced playfulness/lethargy/fatigue
� Wheezing > 2 weeks
� Night sweats > 2 weeks
� Documented or reported weight loss, loss of
appetite, or no weight gain (failure to thrive) in the
last month
� Malnourishment using Mid-Upper Arm Circumfer-
ence below 125 mm in children 6 months–5 years
old
The presence of at least one of these symptoms re-
quires TB investigations at the health facility.
For HIV-positive children, symptoms of any duration
are suggestive of TB and the child is immediately re-
ferred to the clinic. HIV testing is proposed for 5–14-
year-old children with unknown status using two rapid
tests, as per national HIV testing guidance. In the com-
munity model, the first test is done in the household
and if positive, the confirmation test is done at the
health facility as per national guidance.
In case a child presents a sign that is not yet suggestive
of TB due to its duration (ex: cough for less than 2
weeks), the screening is repeated after 2 weeks’ time.
In addition to the screening for TB symptoms, CHWs
have been trained to identify critical signs for urgent re-
ferral in case the child needs to be seen urgently by a
Vasiliu et al. Trials (2021) 22:180 Page 8 of 15
clinician. These signs are recommended by the Inte-
grated Management of Childhood Illness Handbook of
the WHO [34] and include lethargy or unconsciousness,
chest indrawing, difficulty breathing, sunken eyes, drink-
ing poorly or not drinking, seizures, severe wasting, se-
vere pallor, and edema of both feet.
Adherence assessment
The adherence is assessed at each follow-up visit in both
models of care using specific questions on how many
doses were missed in the last 4 days, by counting the
number of doses taken reported by the parent/guardian
in a TPT treatment card introduced by the study and by
verifying empty drug blister packs. Parent/guardian re-
ceived treatment adherence counseling at TPT initiation
and during follow-up based on treatment adherence.
Safety assessment
At each follow-up visit, the children are assessed for
TPT tolerability by CHW using a standard check list of
signs suggestive of hepatitis, peripheral neuropathy, and
rash that are classically associated with HR (nausea, loss
of appetite, vomiting, jaundice, dizziness, tingling, or
burning sensation in the extremities). In every cluster fa-
cility, a clinician was trained to act as a safety monitor
and examine children with problems of tolerability iden-
tified by the CHW. In case of serious adverse events, the
safety monitor immediately notifies the event to the
country principal investigator who informs the sponsor
and the ethics committee of the respective country. All
adverse events and serious adverse events are coded
using the Medical Dictionary for Regulatory Activities
(MedDRA) dictionary (version 22.1, September 2019).
On a 6-month basis, a safety data review is done by the
study management team that is then reported to the
sponsor and scientific advisory committee.
Sample size calculation
For the sample size calculation, we used an estimated
60% completion rate among the eligible children in the
facility-based arm based on a recent systematic review
[35] and a 10% difference in the community-based arm,
considered to be the minimal clinically relevant differ-
ence. We considered a cluster coefficient variability of
50% based on the variation in the number of bacterio-
logically confirmed index cases between the 20 clusters
in the year prior to the intervention. An intra-cluster
correlation of 0.01 was used. With these parameters, we
would need to include at least 1500 declared child con-
tacts by the index case who would be eligible to the TPT
to have a power of 85%. With a minimum of 1500 en-
rolled child contacts, we could maintain at least 80% of
power to detect a difference of 10% in the primary out-
come between the two arms assuming the proportion
with the primary outcome in the control arm ranges
from 60 to 70% and of the cluster coefficient variability
varies from 50 to 70%. The type I error rate α is conven-
tionally fixed at 0.05%. Based on national household sta-
tistics per country [36–38], we make the hypothesis of
one child under 5 years per household. Looking at the
index case TB registrations in the year prior to the inter-
vention, we estimate that it would be possible to include
1500 contact children in a 15-month period. Research
assistants in each cluster supervised that all bacterio-
logically confirmed index cases registered in the NTP
treatment register were screened for study eligibility to
achieve adequate participant enrolment to reach sample
size.
Data collection
Mixed methods of data collection, quantitative and
qualitative, are used. There were no specific plans to
promote participant retention to avoid biasing the trial
outcomes that the cascade of cares for contact screening
and management. The study reimburses participant’s
transportation in case for safety reasons only.
Quantitative data
Other than the facility registers, study-specific source
documents are used. The data for the primary and sec-
ondary objectives are collected by the TB focal person in
the health facilities and community health workers in
the community. There is one research assistant assigned
to each cluster health facility who enters data onto tab-
lets using the Research Electronic Data Capture (RED-
Cap) mobile application version 4.9.1, 6 February 2020.
Patients’ cost data are collected by research assistants in
the REDCap mobile application using an adapted version
of the patient cost tool developed by the WHO [39]. At
the health system level, data are collected through litera-
ture, source documents from the Ministry of Health, pri-
mary expenditure analysis, and procurement records by
the cost analysis researchers.
Qualitative data
The data for the qualitative assessment is collected by
the social researchers through in-depth interviews and
focus group discussions in English, French, or local lan-
guage with the help of a local qualitative research assist-
ant. Participants’ confidentiality and privacy are
respected throughout the study. During the baseline
phase of the study, a qualitative assessment of social de-
terminants has been performed to identify the percep-
tions of TB, prevention for child contacts, and obstacles
for treatment, acceptability, and feasibility of the pro-
posed intervention. Focus group discussions have been
organized with TB patients and in-depth interviews have
been conducted with health staff, facility managers,
Vasiliu et al. Trials (2021) 22:180 Page 9 of 15
CHW, and community leaders. During the implementa-
tion phase, data on concurrent acceptability is assessed
through periodic supervision meetings of the CHW. A
second qualitative assessment will be performed at the
end of the intervention focusing on the acceptability and
lessons learned. These activities are planned in both
models of care implemented in the study.
Process data
In the baseline phase, sites were assessed in terms of
quality of data collection in the registers and specific
practices that would require adjustments for study
organization of those sites. During the implementation
phase, recruitment logs are filled in by research assis-
tants to document study screening and enrolment
process with reasons of refusal.
Data management
A central data manager coordinates with local data man-
agers to ensure the data entry and verification according
to a Data Management Plan. There are three levels of
data checking and quality control: at data entry using re-
stricted value set or compulsory fields, at country-level
data management running weekly checks, and at
central-level data management with a monthly
consistency data check. The collected data is anon-
ymized by the use of unique study identification num-
bers and followed by the investigators through a
dashboard system developed at the central level. The
tablets used for the study are password-protected and
have an individual identification for each research assist-
ant. The tablet data is encrypted when sent to the server.
The study database is on a web-based platform provided
by REDCap [40, 41], protected by password, encrypted,
and hosted at the Institut de Recherche pour le Develop-
ment in Montpellier, France. The back-up of the data-
base is done on a daily basis on the server of the Institut
de Recherche pour le Development in Montpellier.
Quality management
Each country research team is composed of one study
coordinator, one clinical research assistant, and 8 re-
search assistants. All staff is trained on good clinical
practices, protocol, and study standard operating proce-
dures. Training of the country research teams took place
before the baseline phase and was done by the central
research team. CHW were selected based on criteria re-
garding their education, experience with community ac-
tivities, and acceptability by the community and capacity
for study activities. The site teams (TB focal person, TB
nurse, CHW, and safety monitor) were trained before
the intervention phase by the country research teams.
Each facility cluster has a clinician safety monitor trained
to consult children with tolerability complaints and
report adverse events. Standard operating procedures,
country-specific manuals of procedures (to take into ac-
count the implementation specificities of each country),
and a quality management plan were developed by the
central research team. Clinical research assistants per-
form internal data monitoring from the eCRF against
source documents on a monthly basis, and central site
monitoring is done every 3–4months. In addition, the
sponsor performs a yearly site monitoring.
The study is overseen by a steering committee involv-
ing all investigators including representatives of the na-
tional TB program with monthly calls to discuss study
inclusions, challenges, and decisions on study implemen-
tation and a scientific advisory committee composed by
experts in the field of pediatric tuberculosis and ran-
domized controlled trials with meeting twice a year to
discuss study progress, challenges, and safety review. A
country community advisory board is constituted to give
guidance on the implementation of the community ac-
tivities and support the study team on patient informa-
tion and communication.
Statistical analysis
Primary analysis
The denominator for the analysis of the primary end-
point is the number of child contacts < 5 years and HIV-
infected 5–14 years declared by the index case at the fa-
cility during the inclusion visit. Since discrepancies can
be expected between what is declared by the index case
and what is observed during contact screening, a sensi-
tivity analysis will be performed using as denominator
the number of children < 5 years of age and HIV-
infected children of 5–14 years of age identified during
the screening. An additional sensitivity analysis will be
performed including only participants that followed all
study procedures (per-protocol approach) among the de-
clared and then enrolled child contacts. Dropping out of
the cascade of cares and potentially being lost to follow-
up can be the consequence of the models of care under
evaluation. Therefore, lost to follow-up will be kept in
the primary outcome analysis. They will be removed
from the sensitivity per-protocol analysis.
A generalized linear mixed model with a binomial dis-
tribution and logit link function will be used to perform
individual-level analysis adjusting for clustering. The re-
gression model will include the fixed effect of treatment
assignation and country and one random-effect for the
cluster. A degree-of-freedom correction will be applied
(between-within method) to deal with the type I error
inflation due to the small number of clusters. The pri-
mary analysis will focus on the difference between the
two study arms adjusted for country, and a secondary
analysis will add an adjustment for unbalanced factors
(urban/rural, district size) identified in the baseline
Vasiliu et al. Trials (2021) 22:180 Page 10 of 15
assessment. For the analysis of the secondary outcomes,
a similar mixed model will be used with the same ran-
dom effects and correction method, focusing on each
endpoint of the cascade of care for initiation and com-
pletion of TPT and each endpoint of the cascade of care
for TB detection. The same model will be applied for
the sensitivity analyses.
The proportion of children notified in the facility TPT
register among all notified cases during the intervention
period will be compared between the two models of care
and will also be compared with the same proportions be-
fore intervention for the same time period (data col-
lected during the baseline assessment). The proportion
of confirmed TB among all pediatric notified cases and
the proportion of treatment completion will also be
compared between the two models and with the pre-
intervention period.
Qualitative assessment analysis
All transcripts from the in-depth interviews and focus
group discussions are transcribed in French if the activ-
ity was conducted in French and in English if the activity
was conducted in the local language or English. For the
analysis, an interim analysis process will be used. Major
themes from the interviews and focus groups will be
listed according to the objectives of the study before
starting the analyses (a priori codes) and will be enriched
if other themes will be found to be relevant to the study
objectives (inductive codes). The analysis will be done
using the software ATLAS.ti 8 2017.
Cost-effectiveness analysis
The two models of care will be analyzed and their cost-
effectiveness in each country assessed.
The analysis will be from the healthcare system’s and
the primary analysis will generate an incremental cost
per Disability-Adjusted Life Year averted for the inter-
vention model of care vs the standard of care, with a
mathematical model used to extrapolate effects observed
in the trial to a lifetime time horizon. Additional ana-
lyses will include reporting of patient costs incurred dur-
ing illness and care-seeking, and an asset-based wealth
quintile of participants, and generation of additional
measures of health impact (deaths and TB cases
averted).
Ethical aspects
Protocol approval
The study protocol has been submitted and approved by
two central Institutional Review Boards (IRBs): Advarra
IRB from the USA, which is the sponsor’s institutional
IRB, and WHO Ethics Research Committee. In addition,
the protocol was submitted and approved by the local
IRBs: Cameroon National Ethics Committee for Human
Health Research and Research Ethics Committee of the
Mbarara University of Science and Technology in
Uganda. In Cameroon, it has also been approved by the
Direction for Operational Research from the Ministry of
Health and in Uganda by the Ugandan National Council
for Science and Technology. Any change in the protocol
or to the informed consent form that affects the scien-
tific questions and study design or may affect a subject’s
willingness to continue participation in the study were
considered as amendment and are submitted to all pre-
viously described ethics committees after approval from
the scientific committee and the sponsor.
Informed consent
All consent forms used for the CONTACT study have
previously been approved by the central and local ethics
committees. Written informed consent is obtained from
index cases and contacts, who are informed of the study
objectives, procedures, and their risks and benefits. In
addition, children older than 7 years in Cameroon and 8
years in Uganda provide written informed assent. Partic-
ipants with incapacity consent through their legal repre-
sentative and illiterate participants consent through a
witness who is not part of study staff. Country-specific
informed consent forms are developed to allow for dif-
ferent standard of care specificities. For index cases, the
TB focal person collects the informed consent at the in-
clusion visit. For contacts in the facility-based model,
the TB focal person, assisted by the research assistant,
collects the informed consent. In the community-based
model, only the research assistant can collect the in-
formed consent. Consent for HIV testing is included in
the study consent form.
Individual consent is obtained by the researchers dur-
ing qualitative activities: focus group discussions and in-
depth interviews and also during the patient cost collec-
tion for the cost-effectiveness analysis.
Handling withdrawals
At any moment, a contact case can withdraw their con-
sent without any consequence for their care and their
data prior to the date of withdrawal are kept for analysis.
Their case management continues under the NTP
guidelines.
Confidentiality
Each participant has a unique study code. No directly
identifying data is entered into the database. An identifi-
cation log allows the research assistants to make the link
between the code and the name if needed and this log is
kept separately in locked study cabinets on site.
Vasiliu et al. Trials (2021) 22:180 Page 11 of 15
Dissemination
The trial results will be published in peer-reviewed med-
ical journals, preferably open access or guarantying an
open access according to international guidelines for
authorship. After approval by the scientific committee,
the final trial report will be sent to the sponsor, Unitaid,
the World Health Organization, and NTP officials.
DiscussionThe CONTACT study has several strengths and
limitations.
Strengths
Methodologically, the use of a randomized cluster-
controlled design ensures a good level of evidence. The
inter-cluster variability is taken into consideration by the
use of a covariate-constrained randomization of the
number of index cases per cluster. In addition, the study
is using a comprehensive mixed-methods approach that
looks at the study goal from different perspectives: quan-
titative, qualitative, and cost-effectiveness.
The intervention package was conceptualized in a very
pragmatic and realistic manner after discussion with
end-users, national TB program, and community repre-
sentative to ensure that it could be implemented by the
NTP at the end of the research period. In addition, the
intervention is evaluated in two countries with similar
TB burden, but very different health system organization
and level of community engagement that increases the
representativeness of the study results. In Cameroon, the
national system is very centralized whereas in Uganda
lower level health facilities are capacitated to do TB
diagnosis and follow-up. In Uganda, over the last 2 de-
cades, there have been several HIV-related interventions,
many of which have been implemented in the communi-
ties. The population is used to community activities and
a system of CHW is in place (called Village Health
Teams) and articulated by the Ministry of Health. The
package proposed by the CONTACT study has been in-
spired by the HIV and malaria community activities [42,
43] and integrates very well in the Ugandan context. Fi-
nally, all cluster facilities are supported by the CaP TB
program for TB diagnosis and treatment, which reduces
the risk of heterogeneity between the clusters and TB
detection endpoint assessment bias.
The study is constructed on the framework already ex-
istent in the health facilities and uses the health
personnel of these health facilities. The main strength is
represented by their training and experience in working
with TB, and the fact that they are already integrated in
the national system, no study additional staff was hired
for this purpose. The TB focal person and safety monitor
receive an incentive for filling study-specific documenta-
tion that is outside their usual work.
Limitations
Because the cluster sites were limited to the facilities
supported by the CaP TB project, it was not possible to
select more than 20 clusters. It was impossible to avoid
urban facilities, which increases the inter-cluster vari-
ability and may increase the risk of cluster contamin-
ation due to the more complex system of patients’
reference in cities as compared to rural settings. The
proportion of urban clusters is higher in Cameroon as
the two selected regions where the CaP TB project takes
place include the two biggest cities of the country. In
Uganda, some clusters comprise two health facilities to
allow for the necessary recruitment capacity and this op-
erational limitation may introduce more heterogeneity in
the measurement of the outcomes.
Another limitation is the reliability of source docu-
ments from facility registers as compared to study-
specific source documents, which can induce an infor-
mation bias and risk of missing data. To minimize this
limitation, a register data quality check was done during
the baseline period and in sites where inconsistencies
were found, a training on data collection was
recommended.
The training of facility personnel on the study proce-
dures, the reinforcement of the study source documents,
and the presence of research assistants is likely to in-
crease the quality of the facility-based as compared to
routine conditions and may have an effect on the ex-
pected difference of primary endpoint between the
community-based and the facility-based models. Also,
because the duration of the TPT is known to influence
the completion of the TPT, which is part of the primary
endpoint measure and because NTP was expected to
change their guidelines in the coming months, we intro-
duced the 3-month regimen in the facility-based model
as well. Therefore, the study standard of care does not
fully represent the current standard of care used in both
countries. The choice of a very operational and prag-
matic adherence measure likely to be well accepted by
NTP (recording of the dose intake on a treatment card)
relies on the parent/guardian’s understanding and reli-
ability in recording the dose intake and could potentially
introduce information bias or desirability bias. To pre-
vent this risk, the CHW and research assistants are
asked to systematically reconcile what is recorded by the
parent/guardian on the treatment card with the pills
remaining in the blisters. In the community-based
model, two extra visits after 1 and 2 weeks after starting
TPT were requested by the NTP to ensure that no child
with TB disease was missed by the symptom screening
done by CHW and to verify the tolerability. This results
in more frequent assessments of treatment adherence
and tolerability as compared to the monthly follow-up in
the facility-based model and could introduce an
Vasiliu et al. Trials (2021) 22:180 Page 12 of 15
observation bias that could affect the comparison of ad-
herence and safety between the two models.
Challenges
This is an implementation research which is highly
dependent on the health system policy and organization.
One of the many challenges to be taken into account is
the change of the country guidelines during the imple-
mentation of the protocol as these changes require most
of the time a protocol amendment with implications on
study procedures and organization. Other challenges are
related to shortages of TB medication, stock-outs of
Xpert MTB/RIF cartridges that affect the identification
of bacteriologically confirmed index cases at facility level
and staff availability or turn over. The 3RH and 6H TPT
drugs were provided by the study to prevent the risk of
shortage. One cluster in Cameroon had to be changed
after approval of the study protocol due to an unantici-
pated concurrent community-based intervention that
could bias the study outcome measure. Additionally, in
both countries, following the request from the NTP that
TPT should be initiated by a nurse, the implementation
of the intervention package could not rely on CHW only
as initially planned and has to involve facility nurses
moving to patients’ household. The same applies to HIV
testing that cannot be done by trained CHW in
Cameroon.
Constant communication with the CaP TB program
team and the NTP team at higher and lower levels is
crucial to anticipate any operational issue and find solu-
tions to ensure the continuity of study activities accord-
ing to the protocol. It also reinforces the level of
ownership by the NTP and prepares the future scale-up
of the intervention. The cost-effectiveness and qualita-
tive research components focusing on acceptability and
potential barriers such as stigma around tuberculosis
and its association to HIV bring crucial information for
future scale-up.
The CONTACT study will bring new evidence of al-
ternative ways for tuberculosis contact management in a
more convenient manner for children and their families
with an expected impact on TPT uptake, treatment
completion, and increase of case detection.
Study status
The study completed the first phase and participants’
enrolment started on 14 October 2019. Enrolment is ex-
pected to be completed in December 2021. The current
study protocol version is version 3.0: 24 June 2019.
Abbreviations
3RH: 3 months of rifampicin and isoniazid daily; 6H: 6 months of isoniazid
daily; CaP TB: Catalizing Pediatric TB Innovations; CHW: Community health
worker; CONTACT (study acronym): Community Intervention for Tuberculosis
Active Contact Tracing and Preventive Therapy; CXR: Chest radiography;
EGPAF: Elizabeth Glaser Pediatric AIDS Foundation; FDC: Fixed-dose
combination; H: Isoniazid; HIV: Human immunodeficiency virus;
IRB: Institutional Review Board; MedDRA: Medical Dictionary for Regulatory
Activities; MDR TB: Multidrug-resistant TB; NTP: National Tuberculosis
Program; R: Rifampicin; REDCap: Research Electronic Data Capture;
TB: Tuberculosis; TB-LAMP: TB loop-mediated isothermal amplification;
TPT: Tuberculosis preventive therapy; TST: Tuberculin skin test; WHO: World
Health Organization
Supplementary InformationThe online version contains supplementary material available at https://doi.
org/10.1186/s13063-021-05124-9.
Additional file 1. List of participating clusters.
Acknowledgements
This study is funded by Unitaid. Unitaid accelerates access to innovative
health products and lays the foundations for their scale-up by countries and
partners. We would like to thank Unitaid, EGPAF, the research teams, and the
study collaborators in the two countries.
Authors’ contributions
AV participated in the design of the study, protocol writing, and writing of
the manuscript. SED participated in writing the statistical details of the
protocol. SO participated in the data management aspects of the protocol
writing, and BT and DA participated in the study design and data collection.
EdC participated in the data collection and quality control. MK, PT, ST, and
AKK participated in the study design, and GT participated in the design and
data collection for the qualitative assessment. PJD participated in the study
design for the cost-effectiveness assessment. SG, MC, and JC participated in
protocol writing and study design. MB is the Coordinating Investigator and
supervised the protocol writing, data collection, and writing of the manu-
script. All authors read and approved the final manuscript.
Authors’ information
Not applicable
Funding
Unitaid is funding the CaP TB project through EGPAF. For the CONTACT
research study, EGPAF is using the funding through IRD. The funding
document available with the submission of this manuscript is the letter
between EGPAF and Institut Buisson Bertrand, a management center for the
IRD. The funding body has no role in study design, data collection, or writing
the manuscript. EGPAF (Dr Appolinaire Tiam, Elizabeth Glaser Pediatric AIDS
Foundation, 1140, Connecticut Av. Suite 200, NW, Washington, DC 20036) is
the sponsor of the trial.
Availability of data and materials
The research team at the IRD (Institut de Recherche pour le Développement)
in Montpellier, France, will have access to the final trial dataset from both
countries.
Ethics approval and consent to participate
The CONTACT study has been approved by the WHO Ethics Research
Committee, Advarra Institutional Review Board, and each local Research
Committee from Cameroon and Uganda. The approval letters are attached
to the submission. Informed consent will be obtained from all study
participants.
Consent for publication
Not applicable
Competing interests
The authors declare no competing interests.
Author details1French National Research Institute for Sustainable Development (IRD UMI
233 TransVIHMI- UM-INSERM U1175), Montpellier, France. 2Elizabeth Glaser
Pediatric AIDS Foundation, Yaoundé, Cameroon. 3Epicentre Research Center,
Vasiliu et al. Trials (2021) 22:180 Page 13 of 15
Mbarara, Uganda. 4Elizabeth Glaser Pediatric AIDS Foundation, Mbarara,
Uganda. 5National Tuberculosis and Leprosy Program, Kampala, Uganda.6National Tuberculosis Program, Yaoundé, Cameroon. 7School of Health and
Related Research, University of Sheffield, Sheffield, UK. 8Centre for
International Child Health, University of Melbourne and Murdoch Children’s
Research Institute, Royal Children’s Hospital, Melbourne, Australia.9International Union Against Tuberculosis and Lung Disease (The Union),
Paris, France. 10Elizabeth Glaser Pediatric AIDS Foundation, Geneva,
Switzerland.
Received: 14 August 2020 Accepted: 11 February 2021
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