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

变性人(‘跨性别者’)女性(即具有女性和/或女性性别认同的个人 出生时男性)是美国和全世界感染艾滋病毒风险最高的人群之一。其中一个 大多数一致报告的变性妇女中艾滋病毒传播的背景是在主要伙伴关系内 和一个非变性人的男性。尽管初级伙伴关系对预防艾滋病毒至关重要，但 绝大多数针对变性妇女的艾滋病毒预防研究和干预措施都是以个人为重点的。为 在过去的10年里，我们进行了研究，以确定减少艾滋病毒传播的干预目标 在变性女性及其男性伴侣中使用定性、调查和干预适应 方法学(R01DA018621；R34MH093232)。基于我们对以下方面的概念和经验理解 艾滋病毒在这些夫妇中的传播风险，我们最近开发并试点测试了第一对已知的夫妇- 对变性妇女及其男性主要伴侣二人组(称为“夫妻艾滋病毒”)的艾滋病毒预防干预 干预计划“；CHIP)，这是可行的、可接受的，并显著减少了性行为 危险行为与对照组比较。基于我们非常成功的R34发现，我们建议测试 芯片计划在大规模随机对照试验(RCT)中降低HIV风险的有效性 血清一致性阴性和血清不一致性夫妇。我们将招收不同种族的跨性女性和他们的 男性伴侣和随机夫妇接受芯片干预或增强护理标准(SOC) 控制条件。新人将在12个月内每季度接受一次跟踪调查。对研究结果的分析将利用 包括个人级别和二元级别的数据。我们的主要结果是艾滋病毒风险的综合衡量 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。芯片干预建立在多年的形成工作基础上，目标是 人际和社会因素对变性女性及其男性HIV危险行为的影响 合伙人。如果芯片干预与增强的SOC控制条件相比显示出有效性， 将支持在艾滋病毒预防和护理环境中实施这一办法，以减少 一些最优先的艾滋病毒预防人群在艾滋病毒传播和获取方面的差异。

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.