HIV risk reduction intervention for transwomen with intimate partner victimization

项目总结 在本R34应用中(PAR-18-276，预防和治疗的形成性和先导性干预研究 )，我们建议开发和试点一种初级艾滋病毒预防干预措施，以解决这两个问题 变性人妇女中艾滋病毒和亲密伴侣受害(IPV)的相互关联的风险。TW是 在美国受艾滋病毒影响最严重的人群中， 亲密伴侣受害。尽管TW之间存在艾滋病毒和IPV的双重和相互关联的风险，但 针对TW的基于经验的艾滋病毒预防干预措施很少，也没有针对与以下疾病相关的艾滋病毒风险的干预措施 这一人群中的IPV。这项治疗开发研究的目的是开发和评估 同时针对HIV和IPV的短暂干预的可行性、可接受性、安全性和初步效果 此外，还应针对TW的艾滋病毒和IPV相互关联的风险(例如，药物使用和创伤后应激障碍)。这个 拟议的干预措施将基于性别肯定框架，该框架强调人际关系 积极肯定跨性别者的身份和独特需求的进程，并将纳入 创伤-知情赋权方法，这是与IPV幸存者合作时的首选模式。 该干预被假设为在IPV和相关风险因素的背景下降低HIV风险(例如， 物质使用和创伤后应激障碍)，并改善一系列初级预防行为，如使用避孕套，事前 暴露预防(PrEP)，并重复艾滋病毒检测。重要的是，干预将为TW提供 应对IPV和最大化个人安全的行为技能和资源。我们将使用三个阶段 研究方法，以解决我们的具体目标。首先，我们将进行形成性质的研究，以发展 艾滋病毒-IPV预防干预培训手册和监测执行情况的保真度标尺。 第二，我们将进行开放式试点，细化和最终确定干预手册和研究方案。 第三，我们将进行一项随机试点试验，以测试HIV-IPV干预的时间和关注度 对照组。试验性试验的参与者将被跟踪6个月以上。我们将评估干预效果 关于主要结果，包括生物医学和行为艾滋病毒风险以及IPV的综合指标 安全性；次要结果，包括性传播感染诊断(包括艾滋病毒)，以及预防行为： 无公寓性行为，PrEP摄取，与病毒抑制的伴侣的相互一夫一妻制，以及IPV频率。我们 还将审查与干预的理论基础相关的变化机制，包括 性别肯定、赋权和自我效能。这项研究的结果将提供必要的 为在未来的大规模临床试验中检查这种艾滋病毒-IPV联合干预的有效性奠定了基础。

PROJECT SUMMARY In this R34 application (PAR-18-276, Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS), we propose to develop and pilot test a primary HIV prevention intervention to address the dual and interconnected risks of HIV and intimate partner victimization (IPV) in transgender women (TW). TW are among the populations most heavily affected by HIV in the United States (US) and are at elevated risk for intimate partner victimization. Despite the dual and interconnected risks of HIV and IPV among TW, there are few empirically based HIV prevention interventions that target TW, and none that target HIV risks related to IPV in this population. The purpose of this treatment development research is to develop and evaluate the feasibility, acceptability, safety, and initial effects of a brief intervention that concurrently targets HIV and IPV risk, as well as that addresses inter-related risks of HIV and IPV (e.g., substance use and PTSD) for TW. The proposed intervention will be based on the Gender Affirmation Framework, which emphasizes interpersonal processes to positively affirm the identities and unique needs of transgender people, and will also integrate a trauma-informed empowerment approach, which is the model of choice when working with survivors of IPV. The intervention is hypothesized to reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD), and to improve a range of primary prevention behaviors such as condom use, pre- exposure prophylaxis (PrEP), and repeat HIV testing. Importantly, the intervention will provide TW with behavioral skills and resources for addressing IPV and maximizing personal safety. We will use a three-phase research approach to address our specific aims. First, we will conduct formative qualitative research to develop an intervention training manual for HIV-IPV prevention and fidelity scales for monitoring implementation. Second, we will conduct an open pilot to refine and finalize the intervention manual and research protocol. Third, we will conduct a randomized pilot trial to test the HIV-IPV intervention compared to a time and attention matched control. Participants in the pilot trial will be followed over 6 months. We will assess intervention effects on primary outcomes including a composite indicator of biomedical and behavioral HIV risk as well as IPV safety; secondary outcomes including STI diagnoses (including HIV), as well as prevention behaviors: condomless sex, PrEP uptake, mutual monogamy with a virally suppressed partner, and IPV frequency. We will also examine mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial.