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: 10686097
• 负责人: Rachel K Scott
• 金额: $ 27.12万
• 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/10686097
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Affect; Age; Award; Barrier Contraception; Behavior Therapy; Black race; Collection; Country; District of Columbia; Dwarfism; Education; 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; Reduce health disparities; 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; emtricitabine; evidence base; falls; feasibility testing; 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; women of color

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.

项目总结 在美国和美国，顺性女性(CGW)占新增艾滋病毒诊断病例的近20% 在这一人群中，预防艾滋病毒的研究和公共卫生努力一直不足。大多数CGW收购 通过异性传播的艾滋病毒和黑色CGW受到的影响不成比例。华盛顿特区(DC)是 美国南部HIV流行的震中；CGW的HIV流行率比 全国平均水平，在黑人CGW中高出十倍。鉴于病毒的严重性和普遍性， 流行病，DC是有效开发和试行针对CGW的HIV预防干预的示范地点 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，艾滋病毒是高度可预防的 预防(PrEP)，然而，在CGW中使用PrEP存在重大的社会结构障碍， 包括医疗不信任、成本、耻辱和缺乏机会。我们在生育年龄方面的初步研究 处于艾滋病毒高危状态的CGW呼应了医疗提供者和同行支持在 文献中报道了PrEP级联中的参与和保持。有越来越多的证据表明 支持社会结构干预措施的重要性，以解决已查明的成功实施初级保健方案的障碍 交付和利用。目前没有基于证据的干预措施来改善PrEP启动， 坚持，坚持，坚持不懈，在美国CGW。 这项规划建议建立在Shikamana项目成功的多管齐下的基础上，这是一项社会- 在坦桑尼亚的CGW中采取结构性干预措施预防艾滋病毒(NIMH R01奖，由CDC认可 作为由Kerrigan博士(co-I)领导的循证干预(EBI)，以及PI与 育龄妇女是DC感染艾滋病毒的高危人群。在本提案中，我们计划对项目进行调整和调整 采取Shikamana办法，解决艾滋病毒预防方面的特定文化、社会结构障碍。我们的 具体目标是：1)干预发展：我们将适应现有的多管齐下的Shikamana项目 干预与美国南部育龄黑人CGW一起使用。此干预将整合A)提供商 减少隐性偏见的培训，并积极地将艾滋病毒预防作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、坚持和坚持的社会结构性障碍。 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和 收集相关的结果衡量标准，为未来的试验提供信息。我们将利用PRISM框架来 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 为我们计划的多点试验做准备，以提高在PrEP级联中的参与度和保留率。