Efficacy of a PrEP uptake & Adherence Intervention among male sex workers using a 2-stage randomization design

PrEP 摄取的功效

• 批准号: 10273650
• 负责人: Katie Brooks Biello
• 金额: $ 82.82万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-08 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10273650
• 关键词: AIDS prevention; Address; Adherence; Affect; Anal Sex; Appointment; Area; Bisexual; Caring; Case Management; Client; Clinic; Cognitive Therapy; Collaborations; Communities; Cost Analysis; Cost Savings; Counseling; County; Data; Decision Making; Development; Discrimination; Effectiveness of Interventions; Employment; Epidemiology; Ethnic Origin; Evaluation; Female; Funding; Gays; HIV; HIV Infections; HIV risk; Hair; Health behavior; Healthcare; Housing; Imprisonment; Incidence; Individual; Informal Social Control; Injections; Intervention; Interview; Life; Longitudinal cohort study; Los Angeles; Mathematical Model Simulation; Measures; Mediator of activation protein; Medical; Mental Depression; Meta-Analysis; Modeling; Motivation; National Institute of Drug Abuse; National Institute of Mental Health; Oral; Participant; Pharmaceutical Preparations; Population; Population Intervention; Positioning Attribute; Prevalence; Prevention program; Problem Solving; Provider; Publishing; Qualitative Research; Race; Randomized; Randomized Controlled Trials; Research; Research Design; Rhode Island; Risk; Risk Factors; Sampling; Secure; Self Efficacy; Self-Examination; Sexual Partners; Social Work; Specific qualifier value; Structure; Subgroup; Substance Addiction; Substance Use Disorder; Technology; Tenofovir; Testing; Text Messaging; Time; United States; United States National Institutes of Health; Urinalysis; Vagina; Victimization; Work; arm; base; behavioral economics; comorbidity; comparison intervention; condomless anal sex; cost effectiveness; cost estimate; data format; design; drug use behavior; efficacy testing; evidence base; experience; follow up assessment; high risk; high risk population; improved; interest; intervention cost; intervention effect; male; male sex worker; men; men who have sex with men; motivational enhancement therapy; peer; pill; pre-exposure prophylaxis; psychosocial; satisfaction; sex; skills; skills training; social; standard of care; substance use; theories; transmission process; treatment arm; uptake

PROJECT SUMMARY/ABSTRACT Background: Male sex workers (MSWs), or men who exchange sex for money, goods, drugs, or other items of value with other men, are at exceptionally high risk for HIV infection. Pre-exposure prophylaxis (PrEP) is effective at reducing HIV acquisition among HIV uninfected individuals, but its efficacy is highly dependent on uptake and excellent adherence. However, uptake of and adherence to PrEP among those who might benefit the most from using PrEP, such as MSWs, remains suboptimal. A successful PrEP uptake and adherence package must be responsive and tailored to MSWs’ distinct psychosocial and contextual circumstances. Overview of Proposal: The current proposal is a culmination of over 10 years of research with this population, including qualitative research, epidemiological assessments and programmatic work. These formative data led to an NIMH-funded R34 (MPIs: Biello, Mimiaga, Chan), which allowed our interdisciplinary team and community partners to collaborate on the development and pilot testing of a theory-based intervention— “PrEPare for Work”—to address 1) access to and uptake of PrEP at local PrEP clinics/providers via strength- based case management using principles of motivational interviewing (e.g., focusing on values, strengths and change efforts, making reflective and empathetic statements), and 2) provide cognitive-behavioral therapy- informed PrEP adherence counseling (e.g., problem-solving skill-building) with personalized, daily text message reminders to optimize PrEP adherence among MSWs. The pilot RCT demonstrated the feasibility, acceptability and preliminary efficacy of “PrEPare for Work”. Conceptual Model: The “PrEPare for Work” intervention is based on Social Cognitive Therapy (SCT), which specifies a core set of mechanisms that influence health behavior with a primary emphasis on self-regulation and self-reflection, including self-efficacy. Overview of Study Design: We now propose to test the efficacy of the “PrEPare for Work” package in the Greater Providence area and in Los Angeles County using a two-stage randomization design. Stage 1: 500 MSW will be equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or standard of care to evaluate successful PrEP uptake (verified by real-time tenofovir urinalysis; prescription data) within 2 months. Stage 2: those who initiate PrEP (n~156; ~55% from Stage 1 intervention arm and ~20% from Stage 1 SOC arm) will be equally re-randomized to the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem solving, and motivational interviewing adherence counseling and personalized, daily text messaging reminders) or SOC to assess PrEP adherence (tenofovir concentration in hair sample) and retention in PrEP care (appointments attended) over 12 months. We will also examine the degree to which improvements in PrEP uptake and adherence occur in the context of the conceptual mediators (e.g., PrEP motivation, self-efficacy) and moderators (e.g., race/ethnicity, substance use, perceived HIV risk) of the intervention. Intervention cost-effectiveness will be assessed.

项目摘要/摘要 背景：男性性工作者（MSWS）或将性交换性换成金钱，商品，毒品或其他物品的男性 与其他男人的价值，艾滋病毒感染的艺术极高的风险。 有效地减少未感染艾滋病毒的艾滋病毒的艾滋病毒收购，但高度依赖 但是，吸收和依从性。 使用PREP（例如MSWS）的最多仍然是最佳的。 包装必须是响应，并根据MSWS独特的社会心理和背景情况进行量身定制。 提案概述：当前的提案是对这一人群进行10年研究的高潮， 包括定性研究，流行病学评估和程序化工作。 到Ann Nimh资助的R34（MPI：Bielo，Mimiaga，Chan），这允许我们的跨学科团队和 社区合作伙伴在基于理论的干预措施的开发和试点测试上合作 - “准备工作” - 解决1）通过强度在当地的Prep诊所/提供者中访问和吸收PREP- 使用动机访谈原则的基于案例管理（例如，专注于价值观，强度和优势， 变化敌方，做出反思性和善解人意的陈述），以及2）提供认知行为疗法 - 知情的准备依从性咨询（例如，解决问题的技能构建）具有个性化的每日文本 消息提醒您优化MSW中的Pro Prep依从性。 可接受性和初步功效“准备工作”。 干预基于社会认知疗法（SCT），该疗法指定了一组核心机制 影响健康行为，主要重点是自我调节和自我反省，涵盖自我效能。 研究设计的概述：我们现在建议测试您中“准备工作”包的功效 更大的普罗维登斯地区和洛杉矶县使用两阶段的随机设计 MSW将同样随机接收“准备工作阶段1干预措施” 案例管理和促进的准备链接）或评估标准成功吸收准备 （通过实时替诺福韦尿液分析验证；处方数据）2个月内。 （n〜156; 〜55％的1阶段干预臂，从第1阶段的SOC臂分为20％）将同样重新融合 进行“准备工作阶段2干预” 采访依从性咨询和个性化的每日文本消息传递提醒）或SOC评估PREP 依从性（头发样本中的替诺福韦的contration）和预备护理保留（参加的预约）超过12 几个月。 概念调解人的背景（例如，准备动机，自我效能感）和主持人（例如种族/种族， 将评估毒品使用，感知的HIB风险）。