Budhwani Henna, Paulino-Ramírez Robert, Waters John, Bond Christyenne L, Ruiz Ingrid, Long Dustin M, Varas-Díaz Nelson, Naar Sylvie, Nyblade Laura, Turan Janet M
Florida State University, College of Nursing, Center of Population Sciences for Health Equity, Tallahassee, FL, United States.
Universidad Iberoamericana (UNIBE), Santo Domingo, Dominican Republic.
Contemp Clin Trials Commun. 2022 Aug 19;29:100980. doi: 10.1016/j.conctc.2022.100980. eCollection 2022 Oct.
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.
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.
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.
本方案详细介绍了在多米尼加共和国对“消除艾滋病毒相关耻辱与歧视”（FRESH）干预措施的调整及试点测试。FRESH是一项在医疗机构中减少耻辱感的干预措施，旨在减少影响艾滋病毒感染者（PLHIV）的耻辱感，重点关注感染艾滋病毒的性少数群体（SGM）所经历的与艾滋病毒相关的交叉耻辱感。在成功调整FRESH干预措施后，将通过开展一项试点阶梯式楔形整群随机对照试验进行试点测试。
本研究包含三个目标；目标1包括探索性定性评估，具体为与感染艾滋病毒的男男性行为者（MSM）（n = 24 - 32）进行四次焦点小组讨论，并对感染艾滋病毒的跨性别女性进行深入访谈，以探讨他们在诊所的耻辱经历（n = 9 - 12）。还将对艾滋病毒医护人员进行深入访谈，以阐明他们对SGM客户的看法和行为（n = 9 - 12）。在目标2中，根据目标1的数据，我们将使用ADAPT - ITT框架的连续阶段，为多米尼加共和国迭代调整FRESH干预措施。在目标3中，将通过整群阶梯式楔形随机对照试验对调整后的干预措施进行试点测试，以评估干预措施和研究方案的可行性和可接受性。
如果该试点试验成功，下一步将包括在多米尼加共和国或类似的讲西班牙语的加勒比国家进行更大规模的试验，测试调整后的干预措施，以评估其在临床环境中减少对艾滋病毒感染者耻辱感的有效性。
