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: 10543868
• 负责人: Matthew A. Spinelli
• 金额: $ 19.7万
• 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/10543868
• 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; Dedications; Development Plans; Diagnostic; Diphosphates; Drug Monitoring; Electronics; Epidemic; Equipment; Evaluation; Feedback; Funding; Future; Goals; HIV; HIV Infections; HIV Seropositivity; HIV antiretroviral; HIV risk; Hair; Health system; Immunoassay; Incidence; Individual; Intervention; Interview; Knowledge; Maps; Measurement; Measures; Mediator; Medical; Mentors; Methods; Modeling; Monitor; Motivation; Municipalities; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Population; Populations at Risk; 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; brief intervention; care outcomes; 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; primary care provider; programs; psychosocial stressors; recruit; reduced substance use; screening, brief intervention, referral, and treatment; 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.

项目摘要/摘要 在美国，与男性发生性行为的年轻男性(18-29岁)的艾滋病毒发病率不断上升。 暴露前预防(PrEP)是一种高效的药物预防艾滋病毒感染，无论是在个人 和人口水平。然而，在基督教青年会的几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，以至于在整个研究过程中影响了疗效。 不幸的是，服药次数和自我报告的依从性在这一人群中有局限性，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门的工作人员，这意味着 不能在护理点(POC)实施。我们开发了一种新的POC检测方法来测量尿液 首次将药物水平提高到PrEP，提供了有针对性并加强依从性咨询的机会 在一次例行的临床访问中。在正确的咨询方法和框架上存在实质性的知识差距 必须解决药物层面的反馈信息，以使用这一战略来提高基督教青年会的依从性。 针对这一K23应用程序提出的培训和研究计划将允许马修·斯皮内利医学博士获得 实现他的职业目标--成为一名由NIH资助的独立临床研究员--所需的技能 在设计干预措施以提高男男性行为者抗逆转录病毒依从性方面的专业知识 (MSM)。在专门的指导团队的指导下，斯皮内利博士将使用混合方法来 测试中心假设，利用POC尿液生物测定来检测PrEP依从性的干预可以 两者都针对并加强了依从性咨询。简短的干预是一种激励性访谈(MI) 初级保健提供者广泛采用的预防药物使用和医疗的咨询方法 治疗依从性。Spinelli博士建议使用一个简短的干预作为POC药物水平的框架 在旧金山市诊所(SFCC)使用PrEP的YMSM的反馈。SFCC是市政性- 旧金山的传染病诊所，并有一个高容量的PrEP计划，促进招募。 基于候选人在PrEP护理结果和依从性诊断方面的先前研究，该提案将 解决以下具体目标：(1)确定可接受咨询的遵守PrEP的行为目标 针对YMSM；(2)通过深入开展POC生物测定增强型依从性简短干预 采访PrEP用户和提供商的反馈；(3)测试可接受性、可行性和初步影响 关于长期依从性，通过头发替诺福韦水平衡量，短期干预的试点随机进行 青年男性接触者对照试验。这项拟议的研究计划的目标是通过 新的坚持支持，并与斯皮内利博士的职业发展计划保持一致，以获得 干预设计、定性研究、行为试验设计和评估。这项研究的发现 提案将导致R01应用程序，以测试POC生物测定增强的遵从性简短干预 YMSM在多个城市进行试验，目的是减轻MSM中艾滋病毒的负担。