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

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

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.

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.

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