PrEP Point-of-Care Brief-Intervention for Adherence among Young Men Who Have Sex with Men (PrEP2-BAY Study)

PrEP 护理点简短干预对男男性行为的年轻男性的依从性（PrEP2-BAY 研究）

• 批准号: 10333259
• 负责人: Matthew A. Spinelli
• 金额: $ 21.06万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-24 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10333259
• 关键词: AIDS prevention; Achievement; Address; Adherence; Age; Anti-Retroviral Agents; Behavior Therapy; Behavioral; Behavioral trial; Biological Assay; Cities; Client; Clinic; Clinical; Clinical Investigator; Clinical Trials; Counseling; Data; Development Plans; Diagnostic; Diphosphates; Drug Monitoring; Epidemic; Equipment; Evaluation; Feedback; Funding; Future; Goals; Gold; HIV; HIV Infections; HIV Seropositivity; HIV antiretroviral; HIV risk; Hair; Health system; Immunoassay; Incidence; Individual; Intervention; Interview; Knowledge; Maps; Measurement; Measures; Mediator of activation protein; Medical; Mentors; Methods; Monitor; Motivation; Municipalities; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Population; Preventive; Productivity; Provider; Public Health; Qualitative Research; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Research Personnel; Risk; Risk Behaviors; Role; Sampling; San Francisco; Sexually Transmitted Diseases; Spectrometry; Surveys; Tenofovir; Testing; Therapeutic; Therapeutic Uses; Time; Training; United States; United States National Institutes of Health; Urine; Visit; Work; acceptability and feasibility; base; brief intervention; care outcomes; care providers; career; career development; cohort; contextual factors; cost; critical period; design; improved; interest; medication compliance; men who have sex with men; motivational enhancement therapy; novel; pill; point of care; point of care testing; pre-exposure prophylaxis; prevent; programs; psychosocial stressors; recruit; reduced substance use; skills; substance use prevention; theories; therapy adherence; therapy design; therapy development; time use; tool; trial design; uptake; young men who have sex with men

PROJECT SUMMARY/ABSTRACT Young men who have sex with men (YMSM; ages 18-29 years) have rising HIV incidence in the United States. Pre-exposure prophylaxis (PrEP) is a highly effective medication prevent HIV infection, both at the individual and population level. However, in several clinical trials and demonstration projects among YMSM, a majority of participants had adherence to PrEP sufficiently low to compromise efficacy throughout the study. Unfortunately, pill-counts and self-reported adherence have limitations in this population, and therapeutic drug monitoring using previously available methods requires expensive equipment and specialized staff, meaning it cannot be implemented at the point-of-care (POC). We have developed a novel POC test to measure urine drug-levels to PrEP for the first time, providing the opportunity to target and enhance adherence counseling during a routine clinical visit. Substantial knowledge gaps on the correct counseling approach and framing of the drug-level feedback message must be addressed to use this strategy to improve adherence among YMSM. The proposed training and research plan for this K23 application will allow Matthew Spinelli, MD to acquire the necessary skills to achieve his career goal of becoming an NIH-funded independent clinical investigator with expertise in designing interventions to improve antiretroviral adherence among men who have sex with men (MSM). Under the guidance of a dedicated mentoring team, Dr. Spinelli will use a mixed methods approach to test the central hypothesis that an intervention leveraging a POC urine bioassay to detect PrEP adherence can both target and enhance adherence counseling. Brief interventions are a motivational interviewing (MI) counseling approach with wide uptake by primary care providers for substance use prevention and medical therapy adherence. Dr. Spinelli proposes a brief intervention be used as the framework for POC drug-level feedback among YMSM using PrEP at the San Francisco City Clinic (SFCC). SFCC is the municipal sexually- transmitted disease clinic for San Francisco and has a high-volume PrEP program, facilitating recruitment. Building on the candidate's prior research in PrEP care outcomes and adherence diagnostics, this proposal will address the following specific aims: (1) identify behavioral targets for PrEP adherence amenable to counseling specific to YMSM; (2) develop the POC bioassay-enhanced adherence brief intervention through in-depth interview feedback from PrEP users and providers; (3) test the acceptability, feasibility, and preliminary impact on long-term adherence, measured through hair tenofovir levels, of the brief intervention in a pilot randomized controlled trial among YMSM. This proposed research plan has the goal of optimizing PrEP's impact through a novel adherence support and is aligned with Dr. Spinelli's career development plan to gain expertise in intervention design, qualitative research, and behavioral trial design and evaluation. The findings of this proposal will lead to a R01 application to test a POC bioassay-enhanced adherence brief intervention among YMSM in a multi-city trial, with the goal of reducing the burden of HIV among MSM.

项目概要/摘要 在美国，男男性行为者（YMSM；年龄 18-29 岁）的艾滋病毒发病率不断上升。 暴露前预防 (PrEP) 是一种非常有效的药物，可预防 HIV 感染，无论是在个人还是在 和人口水平。然而，在YMSM的多个临床试验和示范项目中，大多数 参与者对 PrEP 的依从性足够低，以致于在整个研究过程中影响疗效。 不幸的是，药物计数和自我报告的依从性在这一人群中存在局限性，并且治疗药物 使用以前可用的方法进行监测需要昂贵的设备和专业人员，这意味着 无法在护理点 (POC) 实施。我们开发了一种新颖的 POC 测试来测量尿液 首次将药物水平纳入 PrEP，提供了有针对性和加强依从性咨询的机会 在例行临床就诊期间。在正确的咨询方法和框架方面存在巨大的知识差距 必须解决药物层面的反馈信息，才能使用此策略来提高 YMSM 的依从性。 针对该 K23 应用程序提出的培训和研究计划将使 Matthew Spinelli 医学博士能够获得 实现成为 NIH 资助的独立临床研究者的职业目标所需的技能 设计干预措施以提高男男性行为者抗逆转录病毒依从性的专业知识 （男男性行为者）。在专门的指导团队的指导下，Spinelli 博士将使用混合方法来 检验中心假设，即利用 POC 尿液生物测定来检测 PrEP 依从性的干预措施可以 既针对并加强依从性咨询。简短的干预是动机访谈（MI） 初级保健提供者广泛采用的预防药物滥用和医疗咨询方法 治疗依从性。 Spinelli 博士提出了一个简短的干预措施作为 POC 药物水平的框架 YMSM 在旧金山城市诊所 (SFCC) 使用 PrEP 的反馈。 SFCC 是市政性 旧金山传播疾病诊所，并拥有大量 PrEP 计划，促进了招募。 基于候选人之前在 PrEP 护理结果和依从性诊断方面的研究，该提案将 解决以下具体目标：(1) 确定适合咨询的 PrEP 依从性行为目标 特定于 YMSM； (2)通过深入开展POC生物测定强化依从性简短干预 采访 PrEP 用户和提供者的反馈； （3）测试可接受性、可行性和初步影响 在一项随机试验中，通过头发替诺福韦水平测量短期干预的长期依从性 YMSM 之间的对照试验。该拟议研究计划的目标是通过以下方式优化 PrEP 的影响： 新颖的坚持支持，并与 Spinelli 博士的职业发展计划保持一致，以获得以下方面的专业知识 干预设计、定性研究以及行为试验设计和评估。本次调查结果 该提案将导致 R01 申请，以测试 POC 生物测定增强依从性的简短干预 YMSM 正在进行多城市试验，目标是减轻 MSM 中的艾滋病毒负担。