Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial (NCT04494516) | Clinical Trial Compass
CompletedNot Applicable
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
Ethiopia, South Africa183 participantsStarted 2021-06-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Interview 1:
* Adult caregiver (18 years of age or older) of a child (\<15 years of age) who was exposed to TB in the last two years where at least one child was evaluated for and offered either TB preventive therapy or TB treatment.
or
* Community health team members from one of the Ethiopian or South African clinics in which the CHIP-TB trial will be conducted.
or
* TB nurse from one of the 16 Ethiopian or South African clinics in which the study will be conducted
or
* Pediatrician or medical officer working in pediatrics at the relevant Ethiopian or South African District Hospital who sees outpatient pediatric consultations including TB-exposed children
or
* Program manager or policy maker in the relevant Ethiopian or South African district or provincial office who manages TB, PMTCT, and/or other pediatric programming
Exclusion Criteria for Interview 1:
* Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who are unable or unwilling to provide informed consent for both the interview and audio-recording
Inclusion Criteria for Interview 2:
* Any community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who participated in the program for at least 3 months
* Any adult caregiver whose child participated in the community-based TB prevention program
Exclusion Criteria for Interview 2:
* Any adult caregivers, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perception of intervention adaptations as assessed by an in-depth interview
Timeframe: Within six months prior to CHIP-TB trial initiation
2
Perception of implementation strategies as assessed by an in-depth interview
Timeframe: Within six months prior to CHIP-TB trial initiation
3
Perception of the social context of the community-based health teams as assessed by an in-depth interview
Timeframe: Within six months prior to CHIP-TB trial initiation
4
Perception of the lessons learned as assessed by an in-depth interview
Timeframe: Within four months after CHIP-TB Trial completion