Peer-led TB and HIV education and adherence counseling in Uganda
Official title: Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
Run by Yale University · NCT05917210 · Data updated 2026-11-12
This trial will test whether peer-led TB education and counseling helps adults with tuberculosis (with or without HIV) stick to treatment and have better health outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1920 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (Kampala) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | April 16, 2028 |
| Study ends | October 16, 2028 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT05917210 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who are registered as new, relapse, treatment failure, or previously lost-to-follow-up TB cases and who are screened and invited within 30 days of starting TB treatment, provided they do not have drug-resistant TB, are not transferring care, live within 40 km of the clinic, and can consent.
✕Probably not a fit
People with possible or confirmed drug-resistant TB, those transferring care from another facility, those living more than 40 km from the clinic, or those lacking capacity to consent are excluded and therefore unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a parallel, cluster-randomized, hybrid Type 2 trial at 16 clinics in Uganda comparing a peer-navigation TB education and counseling (TB-EC) strategy to the usual TB-EC approach. Adult patients newly starting TB treatment are enrolled within 30 days and clusters (clinics) are randomized to deliver either peer-led or usual care. The study measures clinical outcomes alongside implementation outcomes and will perform mediation analyses of social and behavioral factors. Nested quantitative and qualitative components (surveys, observations, interviews, focus groups, and cost measures) will assess fidelity, acceptability, and context of the peer-navigation strategy.
Why it matters
Potential benefit: If successful, the peer-led approach could improve treatment adherence, increase cure rates, and provide a scalable model to strengthen TB and TB/HIV care in Uganda.
How similar studies have gone: Peer support and peer-navigation interventions have shown mixed but generally promising results for improving adherence in TB and HIV programs in low-resource settings, though the specific peer-led TB-EC package tested in a cluster-randomized hybrid trial is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Registered as a new, relapse, treatment failure, or previously lost-to-follow-up * TB case according to the on-site NTP TB Treatment Register * Screened and invited to participate within 30 days of TB treatment initiation Exclusion Criteria: * Diagnosed with possible or confirmed drug-resistant TB * Transferring TB care into the clinic from an off-site facility * Residing \>40 km from the enrolling clinic * Lacking mental capacity to provide informed consent
Where it's running
-
Walimu
Kampala, Uganda Recruiting
Study contacts
- Principal investigator: J. Lucian Davis, MD, MAS — Yale University
- Study coordinator: J. Lucian Davis, MD, MAS
- Email: Lucian.Davis@yale.edu
- Phone: 203-785-2912
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.