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: 9926687
• 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/9926687
• 关键词: AIDS prevention; Achievement; Address; Adherence; Age; Anti-Retroviral Agents; Bedside Testings; 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; 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; pre-exposure prophylaxis; prevent; programs; psychosocial; recruit; reduced substance use; skills; stressor; 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.

项目总结/摘要 在美国，与男性发生性关系的年轻男性（YMSM;年龄18-29岁）的艾滋病毒感染率不断上升。 暴露前预防（PrEP）是一种非常有效的预防艾滋病毒感染的药物，无论是在个人 人口水平。然而，在YMSM的一些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疗效。 不幸的是，药丸计数和自我报告的依从性在该人群中具有局限性，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 不能在护理点（POC）实施。我们开发了一种新的POC测试来测量尿液 首次达到PrEP的药物水平，提供针对性和加强依从性咨询的机会 在一次常规的临床访问中。在正确的咨询方法和框架方面存在巨大的知识差距， 必须解决药物水平反馈信息，以使用此策略来提高YMSM之间的依从性。 拟议的培训和研究计划，这K23应用程序将允许马修斯皮内利，医学博士获得 必要的技能，以实现他的职业目标，成为一个NIH资助的独立临床研究者， 在设计干预措施以提高男男性行为者坚持抗逆转录病毒治疗方面的专门知识 （男男性行为者）。在一个专门的指导团队的指导下，Spinelli博士将使用混合方法， 检验中心假设，即利用POC尿液生物测定检测PrEP依从性的干预措施可以 两者都有针对性，并加强坚持辅导。简短的干预措施是一种动机性访谈（MI） 初级保健提供者广泛采用的预防物质使用和医疗保健的咨询方法 治疗依从性Spinelli博士建议将简短的干预作为POC药物水平的框架。 在旧金山弗朗西斯科市诊所（SFCC）使用PrEP的YMSM之间的反馈。SFCC是市政性- 旧金山弗朗西斯科的传染病诊所，并有一个高容量的PrEP计划，促进招聘。 基于候选人先前在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）确定行为目标的PrEP坚持服从辅导 具体到YMSM;（2）开发POC生物测定增强坚持简短的干预，通过深入 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 通过头发替诺福韦水平测量的长期坚持，在一个试点随机 在YMSM中进行对照试验。这项拟议的研究计划的目标是通过一个 新的坚持支持，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，行为试验设计和评价。这一发现 该提案将导致R 01应用，以测试POC生物测定增强的依从性， YMSM在多个城市进行试验，目的是减轻MSM中的艾滋病毒负担。