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

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:

• Surveys of peers and healthcare workers to determine the feasibility, acceptability, and appropriateness of the peer-navigation strategy,
• Direct observations, document review, interviews with peers, and healthcare worker focus groups to characterize fidelity and adaptation of the peer navigation strategy,
• Measures of implementation costs,
• In-depth interviews with peer navigators to characterize their experiences,
• Focus-group discussions (FGDs) with healthcare workers, and
• 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