Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04494516 |
Other study ID # |
IRB00237243 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 4, 2021 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
July 2023 |
Source |
Johns Hopkins University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This qualitative study is designed to elicit the perspectives of relevant stakeholders to
adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention
treatment (TPT) initiation for child TB contacts, to design its implementation strategy and,
post intervention, to assess lessons learned for future scale up. Participants will include
policy makers and health system managers, nurse and physician providers, community health
team members, and child caregivers of TB-exposed children. Stakeholders will be asked to
participate in two interviews, one prior to the cluster randomized trial assessing this
intervention and one after the cluster randomized trial. Trained interviewers will conduct
1-hour semi-structured in-depth interviews that will be audio-recorded, translated and
transcribed for thematic analysis using a priori and emergent domains of interest.
Free-listing, ranking exercises and cultural consensus will be used to identify
context-specific intervention adaptations and implementation strategies.
Description:
Tuberculosis (TB) remains a top 10 cause of child mortality in sub-Saharan Africa.
Short-course combination TB preventive therapy (TPT) regimens are highly effective with high
completion rates and therefore hold promise to reduce the 1 million pediatric TB patients and
233,000 child TB deaths annually. TPT effectiveness requires improvement in access to
pediatric TB preventive care. The World Health Organization (WHO) estimates only 23% of the
1.3 million TB-exposed children under 5 years old initiated TPT in 2017. The investigators'
previous data suggest 50-75% of TB-exposed children under 5 years old fail to be either
identified or linked to TB preventive care. Children under 5 years are at exceptionally high
risk of TB disease due to not only immature immune systems, but also HIV infection and HIV
exposure. Guidelines have long recommended TPT for children under 5 years, but have recently
been expanded to children under 15 years. Developing and testing innovative health care
delivery models to accompany new WHO-endorsed short-course combination TPT regimens is
essential to reduce TB-associated global child morbidity and mortality.
Integrated community case management (iCCM) is a cost-effective intervention that increases
child survival by bringing curative therapies to at risk children in the community. Recently,
algorithms for screening pediatric patients with household exposure to TB have been
simplified to include symptom screening only, eliminating costly laboratory and radiographic
evaluations that are barriers to treatment and do not improve sensitivity and specificity of
the assessment. The CHIP-TB Trial plans to assess whether integrated community-based
pediatric TB/HIV prevention services is feasible, acceptable and effective in increasing TPT
uptake among child TB contacts under 15 years in a cluster-randomized trial in South Africa
and Ethiopia, two high-burden, resource-limited settings.
Nested within this larger trial, the investigators will use qualitative research to (1)
describe the social context in which the community health teams perform the team's duties,
(2) make context-specific adaptations to the intervention to maximize its effectiveness, (3)
define a context-specific implementation strategy and evaluation plan, and (4) learn
important lessons for the future scale up and dissemination of the community-based
intervention.
The investigators will conduct 10-15 paired semi-structured individual in-depth interviews
(IDI) for each of the four key stakeholder groups: (1) caregivers of TB-exposed children, (2)
community health team members, (3) clinic-based nurse and clinic or hospital-based physician
providers, and (4) health system managers and policy makers, for a total of ~120 IDIs (~60 in
South Africa and ~60 in Ethiopia) both pre and post trial. Before the intervention the
investigators will conduct a one-hour interview that will explore the inner setting of the
community health team's environment from each stakeholder perspective and will develop and
decide upon key intervention adaptations and implementation strategies for the
community-based TB/HIV prevention program that will be assessed with a one-year
cluster-randomized trial. Upon trial completion, the investigators will conduct another 10-15
semi-structured IDIs with each stakeholder group in each country (total ~120 IDIs) to
identify key facilitators and barriers to the implementation. Thematic content analysis with
an inductive approach will be used to analyze transcripts for both a priori and emergent
domains of interest. A coding scheme will be adapted from Consolidated Framework for
Implementation Research (CFIR) constructs. Free listing, ranking, and cultural consensus will
be used to identify intervention adaptations and implementation strategies that are context
specific. The investigators will use Smith's Saliency Index to analyze the free listed data,
mean rank order to assess ranking exercises, and the Eigenvalue to evaluate consensus across
groups all using the ANTHROPAC ® 4.0 software.