NCT05917210

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,920 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.

Detailed description

Study Design Aim 1. The investigators will conduct a parallel, cluster-randomized, hybrid Type 2, effectiveness-implementation trial at 16 sites in Uganda. This clinical trials registration focuses on Aim 1. In addition, we will pursue two additional non-interventional aims to better understand the implementation and outcomes of Aim 1: Aim 2. Within the Aim 1 study, the investigators will also perform a mediation analysis of social and behavioral factors (i.e., TB knowledge, perceived social support, general self-efficacy, HIV/TB stigma) to identify causal mechanisms of impact. Aim 3. The investigators will conduct nested quantitaive, qualitative, and mixed methods studies to assess the implementation fidelity and context of the peer-navigation strategy for TB-EC, including the following sub-aims: 1. Surveys of peers and healthcare workers to determine the feasibility, acceptability, and appropriateness of the peer-navigation strategy, 2. Direct observations, document review, interviews with peers, and healthcare worker focus groups to characterize fidelity and adaptation of the peer navigation strategy, 3. Measures of implementation costs, 4. In-depth interviews with peer navigators to characterize their experiences, 5. Focus-group discussions (FGDs) with healthcare workers, and 6. In-depth interviews with people with tuberculosis (PWTB) to characterize their experiences.

Conditions

• Tuberculosis
• HIV

Interventions

Type	Name	Description
BEHAVIORAL	Peer-Navigaton TB-EC Strategy	Participants receive a peer-navigation strategy for TB education and counseling, including individual-level components such as peer navigator support, an illustrated TB-EC booklet with checklist, individualized adherence planning, and behavior-change messaging; and clinic-level components such as task-sharing with peer navigators, workflow restructuring, community of practice meetings, and implementation champions to support delivery.
BEHAVIORAL	Usual TB-EC Strategy	Participants receive usual TB education and counseling delivered by healthcare workers, including individual-level components such as TB-HIV education using a flipchart and use of treatment supporters; and clinic-level components such as routine TB-EC delivery by healthcare workers.

Timeline

• Start date: 2026-03-16
• Primary completion: 2028-04-16
• Completion: 2028-10-16
• First posted: 2023-06-23
• Last updated: 2026-03-20

Locations

1 site across 1 country: Uganda