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遵守的可行性、可接受性和初步功效 社区知情的替诺福韦/恩替西他滨接触前预防参与 对马里兰州巴尔的摩街头女性性工作者（FSW）的干预。PrEP是一种潜在的 授权的艾滋病毒保护方法是安全和有效的，但是，很少有研究告知PrEP 性工作者的目标和使用。疾病预防控制中心临床指南指出，从事性工作的妇女应采取PrEP措施。 通过社区参与过程，我们建议发展一个小组，mHealth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 提高FSW的认识，并加强PrEP的吸收和遵守。该研究的信息来自 心理授权和根本原因理论。本研究旨在：1）。就业社区 从事研究活动（例如，社区论坛、焦点小组、组件测试、深入访谈）， 确定FSW参与PrEP的特定障碍，并开发一个小组和mHealth增强SW- PrEP干预措施，以促进街头艾滋病毒阴性FSW（N=40）的PrEP吸收和坚持， 巴尔的摩马里兰州; 2）评估STAR-PrEP的可接受性（例如，拒绝率，干预参与） 和可行性（例如，招募，保留）的干预参与者（n=40），和初步疗效 在街头的干预与比较参与者（n=40）中， 马里兰州巴尔的摩的FSW 6个月随访; 2a）探索赋权的作用（例如， 耻辱，社会支持）和结构性脆弱性（例如，获得护理）因素作为相关或可能的 干预组（n=40）与对照组受试者相比，干预对研究结局影响的介质 （n=40）6个月随访时;和3）探索预测因子（即，无家可归、抑郁症、吸毒）， 在马里兰州的巴尔的摩，街头FSW（N=40）中每月药物依从性的PrEP参与者 6-月跟进。药物依从性将通过6个月的血浆和外周血单核细胞计数检测。 细胞测试该提案直接响应RFA-MH-17-361，并涉及3项NIH HIV/AIDS研究 优先事项：1）降低高风险但研究不足的人群中的“艾滋病毒/艾滋病发病率”; 2）减少 在社会和经济上处于边缘地位的妇女群体（主要是非洲人）之间的健康差距 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”。" 这项拟议中的干预措施是美国首批关注这一高风险但研究不足的人群的干预措施之一， 并通过与长期社区医疗服务提供者的合作关系来加强PrEP。 数据将为未来R 01的设计、招募和效应量提供信息，该R 01侧重于更大的试验目标 街头FSW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.