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

优化 PrEP 的吸收

基本信息

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
项目类别：
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

项目摘要

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（由申请人提供）：背景：男性性工作者 (MSW) 或与其他男性以性换取金钱、毒品或其他有价物品的男性，感染 HIV 的风险极高。罗德岛州普罗维登斯 (RI) 已做好准备是测试 MSW 的 PrEP 启动和坚持干预的地点，因为它拥有相当大的 MSW 市场（> 1,000 个基于街道和互联网的 MSW）此外，普罗维登斯是全国第一个 MSW 临时中心的所在地。称为“韦伯计划”，是该国第一个临床 PrEP 项目的所在地，由我们在米里亚姆医院/布朗大学的团队领导。在美国的 MSW，我们的跨学科研究团队设计了“PrEPare for Work”一揽子计划，其中包括两个部分：1) 用于启动 PrEP 的同行主导的基于优势的病例管理 (SBCM)，2) 咨询和解决问题的 PrEP 依从性干预我们建议分两个阶段对“PrEPare for Work”包进行试点测试，为未来的 R01 功效试验奠定基础。我们将：（第一阶段）进行开放阶段评估。 “PrEPare for Work”将通过最多 10 名 MSW 进行试点，参与者退出访谈的可接受性和可行性数据将用于最终确定下一阶段（第 2 阶段）使用的所有研究程序、调查问卷和干预手册；使用两阶段随机化设计的“PrEPare for Work”试点随机对照试验 (RCT) 第一阶段：106 名 MSW 将同样随机接受同行主导的 SBCM 或标准护理。（即仅转介）参与我们现有的 PrEP 诊所：第 1 阶段开始 PrEP 的人员 (n~44)，无论第 1 阶段的随机化条件如何，都将被同等地随机分配到“PrEPare for Work”。依从性干预或护理标准比较条件在第 1 阶段，主要结果是 PrEP 启动（初始处方配药、PrEP 启动时间）在第 2 阶段，主要结果是 PrEP 依从性（占 PrEP 的百分比）。特鲁瓦达-血液水平、头发样本、自我报告）和 6 个月时 PrEP 护理的保留情况主要研究评估访问包括：第 1 阶段、基线和 1 个月随访；第 2 阶段、基线、第 3 阶段和第 6 阶段。创新：必须制定和测试基于证据的干预措施，以提高具有复杂生活经历的高危人群对 PrEP 的接受度并优化其依从性，这将确保最需要 PrEP 的个人（例如 MSW）能够获得 PrEP。受益于其目前的研究将是针对 MSW“包装”PrEP 的首次研究，通过将 MSW 与我们团队现有的 PrEP 计划联系起来，进行持续的 PrEP 临床护理，我们将利用现有的基础设施，增强“PrEPare”的可持续性。 “for Work”包，如果在最终的 R01 功效随机对照试验中被证明有效。