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.

项目概要/摘要 背景：男性性工作者（MSW），或以性行为换取金钱、物品、毒品或其他物品的男性 对其他男性有价值的人，感染艾滋病毒的风险异常高。暴露前预防 (PrEP) 是 可以有效减少未感染艾滋病毒的个体中艾滋病毒的感染，但其功效高度依赖于 吸收和良好的依从性。然而，那些可能受益的人对 PrEP 的接受和坚持 使用 PrEP（例如 MSW）的效果仍然不够理想。 PrEP 的成功采用和坚持 一揽子计划必须针对城市固体工人独特的社会心理和背景情况做出反应并量身定制。 提案概述：当前提案是针对该人群 10 多年研究的结晶， 包括定性研究、流行病学评估和规划工作。这些形成性数据导致 NIMH 资助的 R34（MPI：Biello、Mimiaga、Chan），这使得我们的跨学科团队和 社区合作伙伴合作开发和试点测试基于理论的干预措施—— “PrEPare for Work”——通过以下方式解决 1) 在当地 PrEP 诊所/提供者获得和采用 PrEP 的问题： 基于动机访谈原则的案例管理（例如，关注价值观、优势和 改变努力，做出反思和同理心的陈述），以及2）提供认知行为治疗- 通过个性化的每日文本提供知情的 PrEP 依从性咨询（例如，解决问题的技能培养） 消息提醒，以优化 MSW 的 PrEP 依从性。试点 RCT 证明了可行性， “PrEPare for Work”的可接受性和初步功效。概念模型：“工作准备” 干预以社会认知疗法 (SCT) 为基础，它指定了一套核心机制， 影响健康行为，主要强调自我调节和自我反思，包括自我效能。 研究设计概述：我们现在建议测试“PrEPare for Work”包的功效 大普罗维登斯地区和洛杉矶县采用两阶段随机化设计。第一阶段：500 MSW 将同样随机接受“PrEPare for Work 第一阶段干预”（基于力量的干预） 病例管理和促进 PrEP 连接）或护理标准，以评估成功的 PrEP 吸收情况 （通过实时替诺福韦尿液分析验证；处方数据）2 个月内。第 2 阶段：启动 PrEP 的人 （n~156；~55% 来自第一阶段干预组，~20% 来自第一阶段 SOC 组）将同样重新随机化 到“工作准备第二阶段干预”（一对一技能培训、解决问题和激励 采访依从性咨询和个性化的每日短信提醒）或 SOC 来评估 PrEP 坚持（头发样本中的替诺福韦浓度）和保留 PrEP 护理（参加预约）超过 12 几个月。我们还将检查 PrEP 吸收和依从性的改善程度 概念中介因素（例如 PrEP 动机、自我效能）和调节因素（例如种族/民族、 物质使用、感知艾滋病毒风险）的干预措施。将评估干预措施的成本效益。