Optimizing PrEP uptake & Adherence among MSWs using a 2-stage randomization design

优化 PrEP 的吸收

• 批准号: 9145451
• 负责人: Katie Brooks Biello
• 金额: $ 26.43万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-23 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145451
• 关键词: AIDS prevention; Address; Adherence; Alcohol or Other Drugs use; Anal Sex; Behavior Therapy; Behavioral; Blood; Caring; Case Management; Client; Clinic; Clinical Trials; Cognitive; Cohort Studies; Complex; Counseling; Country; Data; Decision Making; Dose; Drops; Ensure; Epidemiology; Evaluation; Evidence based intervention; Face; Focus Groups; Future; Gays; Grant; HIV; HIV Infections; HIV risk; Hair; Homelessness; Hospitals; Individual; Injection of therapeutic agent; Internet; Intervention; Interview; Life; Life Experience; Link; Manuals; Marketing; Measures; Mental Depression; Meta-Analysis; Methods; Modality; Oral; Participant; Patient Self-Report; Pharmaceutical Preparations; Phase; Population; Populations at Risk; Prevalence; Preventive Intervention; Problem Solving; Procedures; Process; Professional counselor; Prophylactic treatment; Publishing; Questionnaires; Randomized; Randomized Controlled Trials; Research; Research Infrastructure; Research Personnel; Rhode Island; Risk; Sampling; Site; Staging; Subgroup; Surveys; Tenofovir; Testing; Time; Training; Unemployment; United States; United States National Institutes of Health; Universities; Victimization; Visit; Work; antiretroviral therapy; base; cisgender; clinical care; design; efficacy trial; emtricitabine; follow-up; high risk; innovation; male; male sex worker; men; men who have sex with men; peer; pill; pilot trial; pre-clinical; primary outcome; programs; psychosocial; public health relevance; secondary outcome; sex; skills training; standard of care; theories; transgender women; transmission process; treatment adherence; truvada; uptake; working men

 DESCRIPTION (provided by applicant): Background: Male sex workers (MSW), or men who exchange sex for money, drugs, or other items of value with other men, are at exceptionally high risk for HIV infection. Pre-exposure prophylaxis (PrEP, truvada) is effective for reducing HIV acquisition among HIV uninfected individuals, but its efficacy is highly dependent on uptake and excellent adherence, which can pose problems among certain groups. Providence, Rhode Island (RI) is primed to be a site for testing of a PrEP initiation and adherence intervention for MSW, as it has a sizeable market for MSW (>1,000 street and internet based MSW). Additionally, Providence is the site of the nation's first drop-in center for MSW, called Project Weber, and is the site of one of the first clinical PrEP programs in the country, led by our team at Miriam Hospital/Brown University. Overview: Informed by our abundance of formative research and programmatic work with MSWs in the US, our interdisciplinary investigator team designed the "PrEPare for Work" package that includes two components: 1) peer-led strengths-based case management (SBCM) for PrEP initiation and 2) a counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use. We propose to pilot test the "PrEPare for Work" package in two phases, laying the groundwork for a future R01 efficacy trial. We will: (Phase 1) conduct an open phase evaluation of "PrEPare for Work". The intervention will be piloted with up to 10 MSW. Acceptability and feasibility data and participant exit interviews will be used to finalize all study procedures, questionnaire and intervention manual for use in the next phase; (Phase 2) conduct a pilot randomized controlled trial (RCT) of "PrEPare for Work" using a two-stage randomization design. Stage 1: 106 MSW will be equally randomized to receive either the peer-led SBCM or standard of care (i.e., referrals only) for engagement with our existing PrEP clinic. Stage 2: Those from stage 1 who initiate PrEP (n~44), regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition. In stage 1, the primary outcome is PrEP initiation (initial prescription filled, time-to-PrEP initiation). In stage 2, the primary outcomes are PrEP adherence (% of truvada-blood levels, hair samples, self-report) and retention in PrEP care at 6 months. Major study assessment visits are: for stage 1, baseline and 1-month follow up; for stage 2, baseline, 3-, and 6- months. Innovation: Evidence-based interventions to enhance uptake and optimize adherence of PrEP among at risk populations with complex life experiences must be developed and tested. This will ensure that individuals, such as MSW, who are most in need of PrEP, can benefit from its application. The current study would be the first of its kind with respect to "packaging" PrEP for MSW. By linking MSW to our team's existing PrEP program for ongoing PrEP clinical care, we will leverage existing infrastructure-enhancing the sustainability of the "PrEPare for Work" package, if shown to be effective in an eventual R01 efficacy RCT.

 描述（由适用提供）：背景：男性性工作者（MSW），或与其他男性交换性别，毒品或其他有价值物品的男性，艾滋病毒感染的风险异常高。暴露前预防（PREP，TRUVADA）有效地减少了未感染的艾滋病毒的艾滋病毒，但其有效性高度依赖于摄取和出色的依从性，这可能会在某些群体中造成问题。罗德岛州普罗维登斯（Providence）（RI）被准备为测试MSW的准备启动和依从性干预措施的地点，因为它具有MSW（> 1,000个街道和基于Internet的MSW）的巨大市场。此外，普罗维登斯（Providence）是美国第一个名为Weber Project Project Weber的第一个临时中心的地点，也是该国首批临床预备计划之一的所在地，由我们在Miriam Hospital/Brown University团队领导。概述：通过我们与美国MSW的大量形成性研究和程序合作，我们的跨学科研究人员团队设计了“准备工作的准备”计划，其中包括两个组成部分：1）基于同伴领导的基于优势的案例管理（SBCM）进行准备计划和2个组成部分，以及2个用于辅导和解决问题的预科疗法干预措施，以解决辅导和解决问题的辅助干预措施，以探讨最佳携带者的个人化范围。我们建议通过两个阶段进行“准备工作准备”计划，为未来的R01效率试验奠定了基础。我们将：（第1阶段）对“准备工作准备”进行开放阶段评估。干预措施将驾驶最多10 MSW。可接受性和可行性数据和参与退出访谈将用于最终确定下一阶段使用的所有研究程序，问卷和干预手册； （第2阶段）使用两阶段的随机化设计进行“准备工作”的飞行员随机对照试验（RCT）。第1阶段：106 MSW将同样随机地接收同伴领导的SBCM或护理标准（即仅转介），以与我们现有的Prep诊所交战。第2阶段：从阶段1发起准备的人（n〜44），无论阶段1随机条件如何，都将同样随机分配到“准备工作”依从性干预或护理标准比较条件。在第1阶段，主要结果是准备计划（填充初始处方，prep prep倡议）。在第2阶段中，主要结果是预科（Truvada-blood水平的百分比，头发样本，自我报告）和6个月的预科护理保留。主要的研究评估访问是：对于第1阶段，基线和1个月的随访；对于第2阶段，基线，3个月和6个月。创新：必须开发和测试具有复杂生活经验的风险种群中的良好摄取和优化PREP的循证干预措施。这将确保最需要PREP的个人（例如MSW）可以从其应用中受益。当前的研究将是关于MSW的“包装”准备的第一个此类研究。通过将MSW链接到我们团队现有的持续准备临床护理的预备计划，我们将利用现有的基础设施增强“准备工作”计划的可持续性，如果在事件R01有效性RCT中有效，则可以利用“准备工作”计划的可持续性。