Contemporary Clinical Trials Communications (Oct 2022)
Adapting and pilot testing an HIV and intersectional stigma reducing intervention for Dominican Republic healthcare contexts: Protocol for translational research
Abstract
Background: This protocol details the adaptation and pilot testing of the Finding Respect and Ending Stigma around HIV (FRESH) intervention in Dominican Republic. FRESH is a healthcare setting stigma-reduction intervention designed to reduce stigmas affecting people living with HIV (PLHIV), focusing on HIV and intersectional stigmas experienced by sexual and gender minority (SGM) people living with HIV. After the successful adaptation of the FRESH intervention, it will be pilot-tested through the conduct of a pilot stepped wedge cluster randomized controlled trial. Methods: Three aims are included in this study; Aim 1 includes exploratory qualitative assessment, specifically the conduct four focus groups with men who have sex with men (MSM) living with HIV (n = 24–32) and in-depth interviews with transgender women living with HIV to explore their experiences with stigma in clinics (n = 9–12). In-depth interviews will also be held with HIV healthcare workers to elucidate their perceptions and behaviors towards their SGM clients (n = 9–12). In Aim 2, informed by Aim 1 data, we will use the sequential phases of the ADAPT-ITT framework to iteratively adapt the FRESH intervention for the Dominican Republic. In Aim 3, the adapted intervention will be pilot-tested via a cluster stepped wedge randomized controlled trial to assess feasibility and acceptability of the intervention and study protocols. Conclusions: If this pilot trial is successful, next steps will include testing the adapted intervention across Dominican Republic or in similar Spanish-speaking Caribbean nations in a larger trial to assess effectiveness in reducing stigma in clinical settings towards PLHIV.