Peer-led TB and HIV education and adherence counseling in Uganda

Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda

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

• Phase: NA
• Study type: Interventional
• Enrollment: 1920 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 1 site (Kampala)
• Trial ID: NCT05917210 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Kampala

• Walimu — Kampala, Uganda (RECRUITING)

Study contacts

• Principal investigator: J. Lucian Davis, MD, MAS — Yale University
• Study coordinator: J. Lucian Davis, MD, MAS

Conditions: Tuberculosis, HIV, tuberculosis, hiv, implementation science, Uganda, Yale, Makerere