Overview
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.
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:
- 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.
Eligibility
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
