Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis (PrEP) Services for Cisgender Women (CGW) (PrEP-CGW)

项目摘要 在美国，顺性别女性（CGW）占艾滋病毒新诊断的近20%， 在这一人群中预防艾滋病毒的研究和公共卫生努力不足。大多数CGW收购 通过异性性传播的艾滋病毒和黑人CGW受到不成比例的影响。华盛顿，华盛顿特区（DC）是 美国南部艾滋病流行的中心; CGW中的艾滋病流行率是 全国平均水平，黑人CGW高出十倍。鉴于其严重性和普遍性， 艾滋病流行，DC是有效开发和试点CGW艾滋病毒预防干预措施的典范， 在美国南部进行测试。 通过坚持使用屏障避孕和艾滋病毒暴露前预防艾滋病毒是高度可预防的 预防（PrEP），然而，CGW中使用PrEP存在重大的社会结构障碍， 包括对医疗的不信任、费用、耻辱和缺乏机会。我们对生育年龄的初步研究 处于艾滋病毒高风险的CGW回应了医疗提供者和同伴支持的至关重要性， 在文献中报道的PrEP级联中的参与和保留。越来越多的证据表明 支持社会结构性干预措施的重要性，以解决已确定的成功PrEP的障碍 交付和使用。目前还没有基于证据的干预措施来改善PrEP的启动， 在美国的CGW中坚持和坚持。 该规划建议建立在Shikamana项目的成功多管齐下的方法基础上，该项目是一个社会性的， 坦桑尼亚CGW中预防艾滋病毒的结构性干预（NIMH R 01奖，CDC认可 作为由Kerrigan博士（co-I）领导的循证干预（EBI），以及PI的形成性研究， 生殖年龄CGW在高风险的艾滋病毒在华盛顿特区。在本提案中，我们计划调整和调整项目 Shikamana的方法，以解决特定的文化，社会结构的艾滋病毒预防障碍。我们 具体目标是：1）干预发展：我们将调整现有的多管齐下的Shikamana项目 用于美国南部育龄黑人CGW的干预措施。这一干预措施将整合A）供应商 提供培训，以减轻隐性偏见，并积极地将艾滋病毒预防作为以病人为中心的护理的一部分， B）同伴导航，以解决PrEP启动、依从性和持续性的社会结构障碍。 2)可行性和可接受性测试：我们将评估这种艾滋病毒预防的可行性和可接受性 干预此外，我们将评估使用回归不连续设计的可行性， 收集相关的结局指标，为未来的试验提供信息。我们将利用PRISM框架， 评估患者和组织的观点，覆盖范围，采用和干预的可接受性和可行性， 为我们计划的多中心试验做准备，以增加PrEP级联中的参与度和保留率。

PROJECT SUMMARY Cisgender Women (CGW) account for nearly 20% of new HIV diagnoses in the United States (US) and both research and public health efforts in HIV prevention in this population have fallen short. Most CGW acquire HIV via heterosexual transmission, and Black CGW are disproportionately affected. Washington, D.C. (DC) is an epicenter of the HIV epidemic in the Southern US; HIV prevalence among CGW is seven-fold higher than the national average, and ten-fold higher among Black CGW. Given the severity and pervasiveness of the epidemic, DC is the model location to efficiently develop and pilot a HIV prevention intervention for CGW to be tested across the Southern US. HIV is highly preventable through consistent use of barrier contraception and HIV pre-exposure prophylaxis (PrEP), however there are significant socio-structural barriers to PrEP use among CGW, including medical mistrust, cost, stigma, and lack of access. Our preliminary research in reproductive-age CGW at high risk for HIV echoed the critical importance of medical provider and peer support in engagement and retention in the PrEP cascade reported in the literature. There is mounting evidence to support the importance of socio-structural interventions to address identified barriers to successful PrEP delivery and utilization. There are currently no evidenced-based interventions to improve PrEP initiation, adherence, and persistence among CGW in the US. This planning proposal builds upon the successful multi-pronged approach of Project Shikamana, a socio- structural intervention to prevent HIV among CGW in Tanzania (a NIMH R01 award, recognized by CDC as an evidence-based intervention (EBI) led by Dr. Kerrigan (co-I) and upon the PI’s formative research with reproductive-age CGW at high-risk for HIV in DC. In this proposal, we plan to adapt and tailor the Project Shikamana approach to address the culturally-specific, socio-structural barriers to HIV prevention. Our specific aims are: 1) Intervention Development: We will adapt the existing multi-pronged Project Shikamana Intervention for use with Southern US reproductive-age Black CGW. This intervention will integrate A) provider training to mitigate implicit biases and positively reframe HIV prevention as part of patient-centered care, and B) peer navigation to address socio-structural barriers to PrEP initiation, adherence, and persistence. 2) Feasibility & Acceptability Testing: We will evaluate the feasibility and acceptability of this HIV prevention intervention. Additionally, we will evaluate the feasibility of using a regression discontinuity design and the collection of associated outcome measures to inform a future trial. We will utilize the PRISM framework to assess patient and organizational perspectives, reach, adoption, and intervention acceptability and feasibility in preparation for our planned, multi-site trial to increase engagement and retention in the PrEP cascade.