Ssimusango: Multi-level intervention for intersectional stigma reduction to improve HIV outcomes for transgender women

项目摘要/摘要 变性人妇女(TGW)感染艾滋病毒的风险很高，是一个重要的、研究不足的关键 撒哈拉以南非洲的人口。在全球范围内，TGW人群感染艾滋病毒的风险是其他成年人的14倍 年龄15-49岁。TGW在交叉口经历的交叉污名和歧视(ISD) 艾滋病毒、性取向、少数性别认同和性工作导致护理参与度低，效果不佳 坚持艾滋病毒暴露前预防(PrEP)和抗逆转录病毒治疗(ART)。还有很多工作要做 解决与艾滋病毒相关的性传播疾病，扩大TGW的治疗和预防覆盖面。两个以证据为基础 有减少ISD的干预措施可用--(1)卫生政策+(HP+)全面设施方法(TFA)治疗耻辱 减少(诊所一级的干预)和(2)艾滋病毒教育、同理心和赋权(HIVE3)(个人- 一级干预)--但这些措施还没有在撒哈拉以南非洲的TGW中得到调整和实施。惠普+ HIVE3和HIVE3是互补的干预措施，可以结合起来减少卫生设施和个人水平 耻辱。然而，还需要研究来证明适应的多水平HP+/HIVE3干预，Ssimusango (在卢甘达语中的意思是不自责或责备他人)，减少与艾滋病毒相关的耻辱，改善艾滋病毒 TGW的结果。为了解决这些问题，我们将进行一项随机等待名单对照试验，以测试 Ssimusango对PrEP依从性和病毒抑制的初步疗效 护理，使用地位中立的办法，即参与护理，而不管艾滋病毒状况如何。我们还将使用 用定性方法评估干预提供的机制和协同效应。利用多- 我们多国研究团队的学科专业知识，并在坎帕拉的四个卫生机构工作，排名 在PEPFAR乌干达耻辱记分卡上，我们提出了以下具体目标：(1)适应HP+ 和HIVE3减少耻辱干预措施，以解决乌干达TGW的ISD问题(干预适应)；(2) 使用120 TGW进行混合类型1有效性实施试验，以初步测试 Ssimusango在(A)PrEP依从性和(B)病毒抑制(干预实施)方面的有效性； (3)使用定性方法和交叉性增强的综合方法对Ssimusango进行评价 实施研究框架(干预评估)。临床层面的实施结果是 采用、保真度和可持续性评估使用主要信息提供人访谈、培训出席表、 观察清单和快速反馈调查。个人层面的结果：(1)在3岁和6岁时坚持PrEP 干预后几个月，通过尿替诺福韦水平(主要结果)和(2)病毒抑制(艾滋病毒)来衡量 RNA&lt；50拷贝/毫升)和(3)干预后6个月ISD减少(次级结果)。这个多层次的 实施ISD干预措施的方法将改善TGW- “弱势群体中最脆弱者”--在乌干达建立污名研究能力，并产生可操作的 乌干达和撒哈拉以南非洲地区扩大规模和实施方案的数据。

PROJECT SUMMARY/ABSTRACT Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched key population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 14 times higher than other adults aged 15-49 years. Intersectional stigma and discrimination (ISD) experienced by TGW at the intersections of HIV, sexual orientation, gender minority identity and sex work results in poor engagement in care and suboptimal adherence to HIV pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART). Much work remains in addressing HIV-related ISD and scaling up treatment and prevention coverage for TGW. Two evidence-based ISD-reduction interventions are available -- (1) Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction (a clinic-level intervention) and (2) HIV Education, Empathy and Empowerment (HIVE3) (an individual- level intervention) -- but these have not been adapted and implemented for TGW in sub-Saharan Africa. HP+ and HIVE3 are complementary interventions that could be combined to reduce health facility- and individual-level stigma. However, research is needed to show if the adapted multi-level HP+/HIVE3 intervention, Ssimusango (means “no self-blame or blaming others” in Luganda), decreases HIV-related stigma and improves HIV outcomes for TGW. To address these questions, we will conduct a randomized wait-list controlled trial to test the preliminary effectiveness of Ssimusango on PrEP adherence and viral suppression, compared with standard of care, using a status-neutral approach i.e., engagement in care regardless of HIV status. We will also use qualitative methods to assess mechanisms and synergies of intervention delivery. Leveraging the multi- disciplinary expertise of our multi-national research team, and working at four health facilities in Kampala ranked lowest on the PEPFAR Uganda stigma scorecard, we propose the following specific aims: (1) adapt the HP+ and HIVE3 stigma-reduction interventions to address ISD for TGW in Uganda (intervention adaptation); (2) conduct a hybrid type 1 effectiveness-implementation trial with 120 TGW to pilot test the preliminary effectiveness of Ssimusango on (a) PrEP adherence and (b) viral suppression (intervention implementation); and (3) evaluate Ssimusango using qualitative methods and the Intersectionality-Enhanced Consolidated Framework for Implementation Research (intervention evaluation). Clinic-level implementation outcomes are adoption, fidelity, and sustainability assessed using key informant interviews, training attendance sheets, observation checklists, and rapid feedback surveys. Individual-level outcomes: (1) PrEP adherence at 3 and 6 months post-intervention, measured by urine tenofovir levels (primary outcome) and (2) viral suppression (HIV RNA <50 copies/mL) and (3) ISD reduction 6 months post-intervention (secondary outcomes). This multi-level approach to implementing ISD interventions will improve PrEP and ART adherence outcomes among TGW - “the most vulnerable of the vulnerable” -, build stigma research capacity in Uganda, and generate actionable data for scale-up and program implementation in Uganda and sub-Saharan Africa.