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

PrEP 摄取的功效

基本信息

批准号：
10598594
负责人：
Katie Brooks Biello
金额：
$ 72.55万
依托单位：
BROWN UNIVERSITY
依托单位国家：
美国
项目类别：
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/10598594
关键词：
AIDS prevention Address Adherence Affect Anal Sex Appointment Area Behavioral Bisexual Caring Case Management Client Clinic Cognitive Therapy Collaborations Communities Cost Analysis Cost Savings Counseling County Data Decision Making Development Discrimination Economics Effectiveness of Interventions Empathy Employment Epidemiology Ethnic Origin Evaluation Female Focus Groups Funding Gays HIV HIV Infections HIV risk Hair Health behavior Healthcare Heterosexuals Housing Imprisonment Incidence Individual Informal Social Control Injecting drug user Intervention Interview Life Longitudinal cohort study Los Angeles Manuals Mathematical Model Simulation Measures Mediator Medical Mental Depression Meta-Analysis Modeling Motivation National Institute of Drug Abuse National Institute of Mental Health Needs Assessment 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 Subgroup Substance Addiction Substance Use Disorder Technology Tenofovir Testing Text Messaging Time Transact United States United States National Institutes of Health Urinalysis Vagina Victimization Work arm comorbidity comparison intervention condomless anal sex cost effectiveness cost estimate design drug use behavior efficacy evaluation 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 pilot test pre-exposure prophylaxis psychosocial satisfaction sex skills skills training social standard of care substance use theories transmission process treatment arm uptake

项目摘要

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于其他男性来说，暴露前预防 (PrEP) 的风险特别高。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然而，那些可能受益的人对 PrEP 的采用和坚持情况良好。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：当前的提案是针对该人群 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，这些形成性数据为主导。 NIMH 资助的 R34（MPIs：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，做出反思和同理心的努力），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”概念模型的可接受性和初步功效：“PrEPare for Work”。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 PrEP 的成功采用（通过实时替诺福韦尿液分析验证；处方数据）第 2 阶段：开始 PrEP 的患者。（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 “PrEPare for Work 第 2 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 我们还将检查 PrEP 的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、将评估干预措施的成本效益。