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

改善顺性别女性暴露前预防 (PrEP) 服务的社会结构干预 (CGW) (PrEP-CGW)

• 批准号: 10327920
• 负责人: Rachel K Scott
• 金额: $ 24.56万
• 依托单位: MEDSTAR HEALTH RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10327920
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Affect; Age; Award; Barrier Contraception; Centers for Disease Control and Prevention (U.S.); Collection; Color; Country; Dwarfism; Epidemic; Evidence based intervention; FDA approved; Family Planning; Fumarates; Funding; Future; Gender; Grant; HIV; HIV diagnosis; Heterosexuals; High Risk Woman; Intervention; Literature; Location; Male Condoms; Medical; Modeling; Multi-Institutional Clinical Trial; Multicenter Trials; National Institute of Mental Health; Oral; Outcome Measure; Patient-Centered Care; Patients; Population; Practical, Robust Implementation and Sustainability Model; Preparation; Prevalence; Provider; Public Health; Reporting; Research; Research Priority; Risk; Services; Severities; Social Behavior; Tanzania; Tenofovir; Testing; Training; United States; United States Food and Drug Administration; Washington; Woman; acceptability and feasibility; cis-female; cost; design; education access; emtricitabine; evidence base; feasibility testing; health disparity; implicit bias; improved; multi-site trial; peer; peer support; pre-exposure prophylaxis; prevent; preventive intervention; reproductive; social stigma; social structure; therapy development; transmission process; uptake

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.

项目概要 在美国 (US) 的新艾滋病毒诊断中，顺性别女性 (CGW) 占近 20% 大多数 CGW 的艾滋病毒预防研究和公共卫生工作都不够。 HIV 通过异性性传播，而黑人 CGW 受到的影响尤为严重。 美国南部艾滋病毒流行中心；CGW 的艾滋病毒感染率是美国南部的七倍 考虑到这一问题的严重性和普遍性，黑人 CGW 的平均水平高出十倍。 流行病流行期间，华盛顿特区是有效开发和试点艾滋病毒预防干预措施的示范地点，以便 CGW 能够 在美国南部进行了测试。 通过持续使用屏障避孕和艾滋病毒预暴露，艾滋病毒是可以高度预防的 预防 (PrEP)，然而，CGW 中使用 PrEP 存在重大社会结构障碍， 包括医疗不信任、成本、耻辱和缺乏机会。我们对生育年龄的初步研究。 艾滋病毒高危人群中的 CGW 呼应了医疗服务提供者和同伴支持的至关重要性 文献中报道的 PrEP 级联的参与度和保留度 越来越多的证据表明。 支持社会结构干预措施的重要性，以解决已发现的成功 PrEP 障碍 目前没有基于证据的干预措施来改善 PrEP 的启动， 美国 CGW 的遵守和坚持。 该规划提案以“Shikamana 项目”成功的多管齐下方法为基础，该项目是一个社会 坦桑尼亚 CGW 中预防艾滋病毒的结构干预（NIMH R01 奖，得到 CDC 认可） 作为由 Kerrigan 博士（co-I）领导的循证干预措施 (EBI)，并以 PI 的形成性研究为基础 在本提案中，我们计划调整和调整该项目。 Shikamana 方法旨在解决艾滋病毒预防中的特定文化、社会结构障碍。 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 与美国南部育龄黑人 CGW 一起使用的干预措施 该干预措施将整合 A) 提供者。 进行培训，以隐式地减少偏见并积极地将艾滋病毒预防重新定义为以患者为中心的护理的一部分，以及 B) 同行导航，以解决 PrEP 启动、坚持和持久的社会结构障碍。 2) 可行性和可接受性测试：我们将评估这种艾滋病预防的可行性和可接受性 此外，我们将评估使用回归不连续性设计和干预的可行性。 收集相关的结果指标，为未来的试验提供信息。我们将利用 PRISM 框架来进行评估。 评估患者和组织的观点、影响范围、采用和干预措施的可接受性和可行性 为我们计划的多站点试验做好准备，以提高 PrEP 级联的参与度和保留率。