HIV risk reduction intervention for transwomen with intimate partner victimization

针对亲密伴侣受害的跨性别女性的艾滋病毒风险降低干预措施

• 批准号: 10361570
• 负责人: DAWN M JOHNSON
• 金额: $ 24.44万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-07 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10361570
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Affect; Attention; Behavior; Behavioral; Clinical Trials; Communities; Counseling; Development; Diagnosis; Educational Intervention; Epidemic; Feedback; Focus Groups; Foundations; Frequencies; Future; Gender; Gender Identity; HIV; HIV Infections; HIV Seropositivity; HIV risk; Human immunodeficiency virus test; Individual; Injury; Intervention; Intervention Studies; Interview; Manuals; Mediation; Modeling; Monitor; Multiple Partners; Participant; Persons; Pharmaceutical Preparations; Phase; Police; Population; Post-Traumatic Stress Disorders; Predisposition; Prevention; Prevention Research; Primary Prevention; Procedures; Process; Protocols documentation; Public Health; Qualitative Research; Randomized; Relaxation Therapy; Research; Research Project Grants; Resources; Risk; Risk Behaviors; Risk Factors; Risk Reduction; Safety; Self Efficacy; Services; Sex Manuals; Sexually Transmitted Diseases; Structure; Substance Use Disorder; Surveys; Survivors; Time; Training; Trauma; United States; Unsafe Sex; Victimization; Violence; Viral; base; behavior measurement; brief intervention; burden of illness; cisgender; comparative; comparison intervention; condoms; design; efficacy evaluation; empowered; empowerment; evidence base; experience; high risk; improved; intervention effect; male; medical attention; multi-component intervention; pilot test; pilot trial; post intervention; pre-exposure prophylaxis; preventive intervention; primary outcome; reduced substance use; research and development; secondary outcome; sex; skills; substance use; syndemic; theories; therapy development; transgender; transgender women; transmission process; uptake

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.

项目摘要 在这项R34申请中（PAR-18-276，预防和治疗的形成性和试点干预研究 我们建议发展和试验一项预防艾滋病病毒的初级干预措施，以解决艾滋病病毒/艾滋病的双重问题。 以及跨性别女性（TW）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中存在艾滋病毒和IPV的双重和相互关联的风险， 很少有基于经验的艾滋病毒预防干预措施针对TW，而没有针对艾滋病毒风险的干预措施涉及 IPV在这个人群中。本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 风险，以及解决艾滋病毒和IPV的相互关联的风险（例如，物质使用和PTSD）。的 拟议的干预措施将以性别肯定框架为基础，该框架强调人际关系， 积极肯定变性人的身份和独特需求的进程，并将纳入一个 创伤知情赋权方法，这是与IPV幸存者合作时选择的模式。 假设干预措施可以在IPV和相关风险因素（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，如避孕套的使用， 暴露预防（PrEP）和重复HIV检测。重要的是，干预将为TW提供 解决IPV和最大限度地提高人身安全的行为技能和资源。我们将使用三相 研究方法，以解决我们的具体目标。首先，我们将进行形成性定性研究， 艾滋病毒-IPV预防干预培训手册和用于监测实施情况的忠诚度量表。 二是开展开放试点，完善并最终确定干预手册和研究方案。 第三，我们将进行一个随机的试点试验，以测试HIV-IPV干预相比，一个时间和注意力 匹配对照。将对试点试验的参与者进行为期6个月的随访。我们将评估干预效果 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;次要结局，包括STI诊断（包括HIV），以及预防行为： 无安全套性行为、PrEP摄入、与病毒抑制伴侣的一夫一妻制和IPV频率。我们 还将研究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 这是一项基础工作，以在未来的大规模临床试验中检查这种联合HIV-IPV干预的有效性。