A couples-based approach to HIV prevention for transgender women and their male partners

变性妇女（即，具有女性和/或女性性别认同的个人， 出生时为男性）是美国和全世界艾滋病毒感染风险最高的人群。之一 最一致报告的跨性别妇女艾滋病毒传播情况是在主要伙伴关系中， 和一个非变性人在一起尽管初级伙伴关系对预防艾滋病毒至关重要， 绝大多数针对跨性别女性的艾滋病毒预防研究和干预措施都是以个人为重点的。为 过去10年，我们开展了研究，以确定减少艾滋病毒传播的干预目标 在跨性别女性及其男性伴侣中使用定性，调查和干预适应 方法学（R 01 DA 018621; R34 MH 093232）。基于我们对以下问题的概念性和经验性理解， 在这些夫妇中，艾滋病毒传播的风险，我们最近开发和试点测试了第一对已知的夫妇- 基于艾滋病毒预防干预的跨性别妇女和他们的男性主要合作伙伴二人组（称为“夫妇艾滋病毒 干预计划”; CHIP），这是可行的，可接受的，并产生了显着减少性行为， 与对照组相比，风险行为。基于我们非常成功的R34发现，我们建议测试 CHIP计划在大规模随机对照试验（RCT）中降低艾滋病毒风险的有效性， 血清一致阴性和血清不一致夫妇。我们将招收不同种族的跨性别女性和她们的 男性伴侣和随机夫妇接受CHIP干预或加强标准护理（SOC） 控制条件每季度将对夫妇进行为期12个月的随访。研究结局分析将利用 个人和二元数据。我们的主要成果是艾滋病毒风险的综合衡量标准 传播，包括艾滋病毒风险的有效行为指标以及生物医学确认 病毒抑制和PrEP依从性。CHIP干预建立在多年形成性工作的基础上， 人际和社会因素对跨性别男女艾滋病危险行为的影响 伙伴如果CHIP干预与增强的SOC控制条件相比显示出功效， 将支持在艾滋病毒预防和护理环境中实施这一方法， 艾滋病毒的传播和感染在一些最优先预防艾滋病毒的人群中存在差异。

Transgender (`trans') women (i.e., individuals with a feminine and/or female gender identity who were assigned male at birth) are among the populations at highest risk for HIV in the United States and worldwide. One of the most consistently reported contexts for HIV transmission among trans women is within a primary partnership with a non-transgender male. Despite the critical importance of primary partnerships for HIV prevention, the vast majority of HIV prevention studies and interventions for trans women have been individually-focused. For the past 10 years we have conducted research to identify intervention targets for reducing HIV transmission among trans women and their male partners using qualitative, survey, and intervention adaptation methodologies (R01DA018621; R34MH093232). Based on our conceptual and empirical understandings of HIV transmission risks among these couples, we recently developed and pilot tested the first known couples- based HIV prevention intervention for trans women and their male primary partner dyads (called “Couples HIV Intervention Program”; CHIP), which was feasible, acceptable, and produced significant reductions in sexual risk behavior compared to the control group. Based on our highly successful R34 findings, we propose to test the efficacy of the CHIP program in large-scale randomized controlled trial (RCT) to reduce HIV risk among seroconcordant negative and serodiscordant couples. We will enroll racially diverse trans women and their male partners and randomize couples to either the CHIP intervention or an enhanced standard of care (SOC) control condition. Couples will be followed quarterly over 12-months. Analysis of study outcomes will utilize both individual- and dyadic-level data. Our primary outcome is a composite measure of risk for HIV transmission which encompasses validated behavioral indicators of HIV risk as well as biomedical confirmation of viral suppression and PrEP adherence. The CHIP intervention builds on years of formative work that targets interpersonal and social factors as mechanisms of HIV risk behavior among trans women and their male partners. If the CHIP intervention demonstrates efficacy in comparison to an enhanced SOC control condition, there will be support for implementing this approach within HIV prevention and care settings in order to reduce disparities in HIV transmission and acquisition among some of the highest priority HIV prevention populations.