Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

项目摘要 我们的目标是开发和评估依从性的可行性、可接受性和初步疗效。 社区知晓的替诺福韦/埃米替拉宾暴露前预防(PrEP)参与 马里兰州巴尔的摩街头女性性工作者的干预。预科是一种潜在的 安全有效的艾滋病毒保护方法，然而，很少有研究向PrEP提供信息 在暗娼中进行目标定位和使用。CDC临床指南指出，PrEP适用于从事性工作的妇女。 通过社区参与的过程，我们建议发展一个小团体，由移动健康增强的同行- 导航员干预，STAR-PrEP(性工作者采取行动和责任)，旨在提高PrEP 在暗娼和妇女中提高认识，以提高PrEP的接受率和依从性。这项研究的信息来源是 心理赋权和根本原因理论。本研究的目的是：1)。雇佣社区 参与研究活动(例如，社区论坛、焦点小组、组件测试、深入访谈)以 确定特定于FSW的PrEP参与障碍，并开发一个小团队和mHealth增强型软件- PREP干预促进街道HIV阴性暗娼(N=40)对PrEP的吸收和依从性 马里兰州巴尔的摩；2)评估STAR-PrEP的可接受性(例如，拒绝率、干预参与度) 干预参与者(n=40)的可行性(例如，招募、保留)以及初步效果 街道人群与对照人群(n=40)PrEP摄取和依从性的比较 马里兰州巴尔的摩的FSWs进行了6个月的随访；2a)探索赋权的作用(例如，感知到的 耻辱、社会支持)和结构性脆弱性(例如，获得护理的机会)是相关或可能的因素 干预(n=40)与对照参与者中干预效果对研究结果的中介作用 (n=40)在6个月的随访中；3)探索STAR的预测因素(即无家可归、抑郁、吸毒)。 马里兰州巴尔的摩街头暗娼(N=40)每月药物依从性的准备参与者 6个月随访。药物依从性将通过6个月的血浆和外周血单核细胞来检测 细胞测试。该提案直接响应RFA-MH-17-361，并涉及3个NIH艾滋病毒/艾滋病研究 优先事项：1)减少高危但研究不足的人群中的“艾滋病毒/艾滋病发病率”；2)减少 主要是非洲人的社会和经济边缘化妇女群体的健康差距 美国；以及3)培训同行导航员，以增加“进行高度优先的艾滋病毒/艾滋病研究的劳动力”。 拟议中的干预措施是首批关注美国这一高风险但未得到充分研究的人群之一， 并通过与长期的社区医疗保健提供者合作开出PrEP处方而得到加强。 数据将为未来R01的设计、招募和效果大小提供信息，该R01专注于更大规模的试验目标 街边的FSWs和PrEP提供者。

Project Summary We aim to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed tenofovir/emticitrabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement intervention among street-based female sex workers (FSWs) in Baltimore, Maryland. PrEP is a potentially empowering method of HIV protection that is safe and effective, however, there is little research to inform PrEP targeting and use among FSWs. The CDC Clinical Guidelines indicate PrEP for women engaged in sex work. Through a community participatory process, we propose developing a small group, mHealth-enhanced peer- navigator intervention, STAR-PrEP (Sex workers Take Action and Responsibility), aimed raise PrEP awareness among FSWs and to to enhance PrEP uptake and adherence. The study is informed by psychological empowerment and fundamental cause theories. The study aims to: 1). employ community engaged research activities (e.g., community forums, focus groups, component testing, in-depth interviews) to identify FSW-specific barriers to PrEP engagement and to develop a small group and mHealth enhanced SW- PrEP intervention to promote PrEP uptake and adherence among street-based HIV-negative FSWs (N=40) in Baltimore Maryland; 2) assess the STAR-PrEP’s acceptability (e.g., refusal rates, intervention engagement) and feasibility (e.g., recruitment, retention) among intervention participants (n=40), and preliminary efficacy on PrEP uptake and adherence in intervention versus comparison participants (n=40) among street-based FSWs in Baltimore, Maryland at 6-month follow-up; 2a) to explore the role of empowerment (e.g. perceived stigma, social support) and structural vulnerability (e.g., access to care) factors as correlates or possible mediators of the intervention effect on study outcomes in intervention (n=40) versus comparison participants (n=40) at 6-month follow-up; and 3) to explore predictors (i.e., homelessness, depression, drug use) of STAR- PrEP participants on monthly drug adherence among street-based FSWs (N=40) in Baltimore, Maryland at the 6-month follow up. Drug adherence will be detected by 6-monthly plasma and peripheral blood mononuclear cells tests. The proposal is directly responsive to RFA-MH-17-361 and addresses 3 NIH HIV/AIDS Research Priorities: 1) reducing “incidence in HIV/AIDS” among a high risk yet understudied population; 2) reducing health disparities among socially and economically marginalized group of women who are largely African American; and 3) training peer navigators to increase a “workforce to conduct high priority HIV/AIDS research." The proposed intervention is one of the first to focus on this high-risk yet understudied population in the U.S., and is strengthened by its partnership with longstanding community healthcare providers to prescribe PrEP. Data will inform the design, recruitment, and effect size of a future R01 focused on a larger trial targeting street-based FSWs and PrEP providers.