Thursday, November 21, 2024
11/21/2024
PROJECT SUMMARY Among the ~2.5 million persons who develop incident tuberculosis (TB) in sub-Saharan Africa annually, about one in five does not complete treatment, even though highly effective treatments for TB and concurrent HIV are now widely available. This contributes significantly to the high TB mortality worldwide, especially among persons living with HIV. Clinical and public health guidelines universally recommend TB education and counseling (TB- EC) to improve adherence to and outcomes of TB treatment and antiretroviral therapy (ART), but many barriers to delivery exist. There is growing community interest in adapting peer-led strategies from the HIV field to improve provision of TB-EC and outcomes of TB and HIV. We recently developed and implemented a multi-component peer-navigation strategy for delivery of TB-EC among persons with TB with and without HIV in Uganda, including (1) task-shifting of TB-EC to peers with TB; (2) restructuring of clinic workflows; (3) a TB-EC checklist; (4) individualized adherence planning; and (5) behavior-change messaging. In a preliminary evaluation, we found that the adapted TB-EC strategy was feasible and acceptable, and improved both TB literacy and treatment outcomes. We now propose a 16-site, cluster-randomized, hybrid Type 2 effectiveness-implementation trial to evaluate the impact of peer-navigation on TB/TB-HIV treatment adherence and clinical outcomes among new PWTB with and without HIV in Uganda. We will conduct these studies through the Uganda TB Implementation Research Consortium (U-TIRC), an academic-public health partnership hosted at the Walimu non-governmental organization and involving Makerere University, the Uganda National TB Program (NTP), New York University, and Yale University. Our primary effectiveness outcomes include TB treatment completion and ART retention at one year. Our primary implementation outcomes include TB treatment and ART initiation, adherence, and persistence. We will conduct rigorous mediation analyses to test our hypotheses about the social and behavioral mechanisms through which peer navigation strategy was designed to influence client outcomes. We will nest convergent mixed-methods studies of implementation fidelity and context to understand provider and health system influences. Our overall hypothesis is that peer navigation will improve TB/TB-HIV treatment adherence and clinical outcomes compared to standard TB-EC by addressing individual and health-system barriers to TB treatment and ART. These studies address several NIH research priorities, including overcoming barriers to implementing evidence-based interventions for TB-HIV and improving medication adherence. We expect that our rigorous design and implementation plans will provide high-quality data on the effectiveness and implementation of a novel peer-navigation strategy to promote TB treatment and ART adherence. We will disseminate our findings to participants, the Uganda National TB Program, and the global TB and HIV communities to inform how TB-EC is offered to persons with TB/TB-HIV. If successful, our study will lead to future work evaluating the impact, sustainability, and cost-effectiveness of the peer-navigation strategy at scale.
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