Strategies to Prevent HIV Acquisition Among Transgender MSM in the US

项目总结 在美国，与男性发生性行为的变性人(跨性MSM)面临感染艾滋病毒的风险，并要求 性别肯定、响应文化的生物行为艾滋病毒预防战略。拟议研究的目标是 是评估以数字方式提供的基于同伴的策略改善PrEP指示的PrEP摄取的能力 HIV阴性的成年跨性男男性接触者(行为定义为与有阴茎的人发生性关系)。本研究 提出了一项数字开放标签随机2x2析因试验(1：1：1：1随机化)的同伴传递的HIV 旨在增加HIV高发区跨性男男性接触者PrEP摄取率的预防策略 美国东部和南部的地理热点。具体目的是：(1)比较两种药物的疗效 个人(PrEP4T：一对一同行导航)和基于组(男性生活技能：基于小组 行为干预)在6个月内实施同伴提供的艾滋病毒预防策略，以增加PrEP 300例PrEP阴性的成年跨性男男性接触者的摄取(主要结果)；(2)通过 哪些同行提供的干预措施会影响关注医疗保健赋权的PrEP的接受，TRANS 社区支持，以及信息、动机和行为技能；以及(3)探索PrEP决策 和定性的干预体验。每隔3个月进行一次生物行为评估，共21个月 通过自我管理的调查；远程艾滋病毒自我检测(第四代检测)和PrEP的生物测量通过 恩曲他滨三磷酸(FTC-TP)和替诺福韦二磷酸(TFV-DP)使用干血斑(DBS) 评估批准的基于TFV的PrEP方案在该人群中的吸收情况；以及性传播感染(淋病、衣原体、 梅毒)通过电子病历(EMR)发布。该小组将使用参与性人口视角 与非变性MSM合作，确保跨性MSM有意义的参与。建议的研究是 通过解决服务不足的NIH健康差距人群中的艾滋病毒预防问题具有重要意义，并将填补关键的 在生物行为艾滋病毒预防和同伴参与方法方面存在差距。这项研究与美国国家 优先在艾滋病毒高发的高危人群中实施艾滋病毒预防综合战略 并将推进《2021-2025年国家战略计划》，以结束艾滋病毒流行。

PROJECT SUMMARY Transgender men who have sex with men (trans MSM) are at-risk of HIV acquisition in the US and require gender-affirming culturally responsive biobehavioral HIV prevention strategies. The goal of the proposed study is to assess the ability of digitally delivered peer-based strategies to improve PrEP uptake in PrEP-indicated HIV-negative adult trans MSM (defined behaviorally as sex with a person who has a penis). This study proposes a digital open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP uptake in trans MSM residing in high HIV incidence geographic hotspots in the Eastern and Southern US. The specific aims are to: (1) Compare the efficacy of individual (PrEP4T: one-on-one peer navigation) and group-based (LifeSkills for Men: small group-based behavioral intervention) peer-delivered HIV prevention strategies implemented over 6 mo to increase PrEP uptake (primary outcome) in 300 PrEP-indicated HIV-negative adult trans MSM; (2) Examine mechanisms by which peer-delivered interventions impact PrEP uptake focusing on healthcare empowerment, trans community support, and information, motivation, and behavioral skills; and (3) Explore PrEP decision-making and intervention experiences qualitatively. Biobehavioral assessments will be conducted every 3 mo for 21 mo with self-administered surveys; remote HIV self-testing (4th gen tests) and biologic measures of PrEP via emtricitabine triphosphate (FTC-TP) and tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) to evaluate uptake of approved TFV-based PrEP regimens in this population; and STIs (gonorrhea, chlamydia, syphilis) via electronic medical record (EMR) releases. The team will use a participatory population perspective to work “with” not “on” trans MSM ensuring meaningful participation of trans MSM. The proposed study is significant by addressing HIV prevention in an underserved NIH health disparities population and will fill critical gaps in biobehavioral HIV prevention and peer-engaged approaches. The study is aligned with US national priorities to implement integrated strategies for HIV prevention in at-risk populations in high HIV incidence geographic hotspots and will advance the 2021-2025 National Strategic Plan to End the HIV epidemic.