Strategies to Prevent HIV Acquisition Among Transgender MSM in the US

项目摘要 在美国，与男性发生性关系的跨性别男性（transMSM）有感染艾滋病毒的风险， 在文化上对性别问题有敏感认识的生物行为艾滋病毒预防战略。拟议研究的目标 评估数字化提供的基于同行的策略改善PrEP适应症患者PrEP吸收的能力 HIV阴性的成年trans-MSM（定义为与有阴茎的人发生性行为）。本研究 提出了一项数字化开放标签随机2x2析因试验（1：1：1：1随机化）， 预防策略旨在增加居住在艾滋病毒高发病率地区的trans-MSM的PrEP摄取 美国东部和南部的地理热点。具体目的是：（1）比较 个人（PrEP 4 T：一对一同伴导航）和基于小组的（男性生活技能：基于小组的 行为干预）同伴提供的艾滋病毒预防策略实施超过6个月，以增加PrEP 在300例PrEP指示的HIV阴性成人transMSM中的摄取（主要结局）;（2）通过以下方式检查机制： 哪些同行提供的干预措施会影响PrEP的吸收，重点是医疗保健授权， 社区支持，信息，动机和行为技能;（3）探索PrEP决策 和干预经验定性。生物行为评估将每3个月进行一次，持续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的生物措施， 恩曲他滨三磷酸盐（FTC-TP）和替诺福韦二磷酸盐（TFV-DP），使用干血斑（DBS）， 评估该人群对批准的基于TFV的PrEP方案的接受情况;和性传播感染（淋病、衣原体， 梅毒）通过电子病历（EMR）发布。该小组将采用参与性人口观点 与变性男男性接触者合作，而不是与变性男男性接触者合作，确保变性男男性接触者有意义的参与。拟定研究 重要的是通过解决艾滋病毒预防在一个服务不足的国家卫生研究院健康差距的人口，并将填补关键 生物行为艾滋病毒预防和同伴参与方法的差距。该研究与美国国家 在艾滋病毒高发病率的高危人群中实施艾滋病毒预防综合战略的优先事项 该计划将推动2021-2025年结束艾滋病毒流行的国家战略计划。

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.