Mobile Combined Alcohol and HIV Prevention Including PrEP Uptake/Adherence for High-Risk Young Men

移动酒精和艾滋病毒联合预防，包括高危年轻男性的 PrEP 摄取/坚持

• 批准号: 10020295
• 负责人: ROBERT F LEEMAN
• 金额: $ 38.13万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020295
• 关键词: AIDS prevention; Address; Adherence; Aftercare; Age; Alcohol consumption; Alcohol or Other Drugs use; Alcohols; Area; Benchmarking; Blood; Data; Education; Elements; Ensure; Feedback; Florida; Focus Groups; Goals; HIV; HIV Infections; HIV Seronegativity; HIV risk; Heavy Drinking; Hispanics; Individual; Internet; Intervention; Intervention Studies; Latino; Mediator of activation protein; Monitor; Motivation; National Institute on Alcohol Abuse and Alcoholism; Online Systems; Outcome; Participant; Phase; Prevention; Preventive; Preventive Intervention; Radial; Randomized; Reporting; Risk; Risk Behaviors; Rural; Sex Behavior; Standardization; Surveys; Testing; Therapeutic; Unsafe Sex; Voice; alcohol content; alcohol prevention; avoidance of risky sexual behavior; base; brief motivational intervention; cost effective; design; drinking; follow-up; group intervention; high risk; high risk men; high risk population; infection risk; innovation; low socioeconomic status; medication compliance; men who have sex with men; open label; pre-exposure prophylaxis; prevent; recruit; reduced alcohol use; response; risk perception; sex; sexual risk behavior; success; theories; treatment adherence; uptake; usability; young adult; young man; young men who have sex with men

PROJECT SUMMARY The rate of new HIV infections remains unacceptable, particularly in Florida and among men who have sex with men (MSM). Black and Hispanic/Latino, as well as young adult MSM are at particularly high risk, due in part to overlapping risk behaviors like heavy drinking. Alcohol use increases unprotected sex and reduces treatment adherence, making combined alcohol and risky sex prevention optimal. New preventive efforts for HIV and alcohol are a high priority area for NIAAA and must be targeted to these highest-risk groups. The goal of this UH2/UH3 project is to develop and test initially a synergistic, mobile intervention that will reduce alcohol use and risky sex and prevent HIV infection among the highest-risk individuals. The proposed intervention combines brief motivational intervention; daily monitoring via interactive voice response (IVR) with personalized feedback; and pre-exposure prophylaxis (PrEP). Combining them offers the strengths of all 3 while compensating for limitations of each, yielding a combined intervention with great potential impact. Based on theory and prior evidence, we hypothesize that this combined preventive intervention will be associated with greater alcohol use reduction and medication adherence than a standardized educational control condition. This project is innovative in that this combination of 3 efficacious interventions has not been tested to reduce alcohol use and HIV risk. Further, there are no established interventions to enhance PrEP uptake/adherence and no studies have provided intervention targeting both alcohol and PrEP uptake/adherence. In the UH2 phase, we will recruit MSM ages 18-30 who report HIV-negative status for a web survey (N=683) to yield normative data for the personalized feedback intervention component and focus groups (N=30) to provide input on the initial version of the intervention. Based on the web survey and focus groups, the intervention will be modified and tested in a preliminary usability study (N=10) to prepare for the UH3 phase. Completing each benchmark of the UH2 phase indicates feasibility of the UH3 intervention study. For the UH3 phase, we will recruit higher-risk MSM (N=80) for a 30-day study to test the combined mobile alcohol and HIV preventive intervention. All participants will receive open-label PrEP and complete a 5-minute daily IVR assessment of alcohol/substance use, sexual behavior and PrEP taking. Participants randomized to intervention will get brief web-based alcohol and HIV prevention followed by IVR monitoring including personalized feedback. The web- based component is designed to increase risk perception and motivation to change while the IVR component will enhance PrEP adherence and bolster risk perception and motivation further. Participants randomized to control will get standardized education, not personalized intervention, and give IVR responses for assessment purposes only with no feedback. Follow-up will occur at the end of the 30-day intervention and 6-months post- treatment. This project represents an early step in developing and testing a cost-effective, scalable preventive intervention that will be readily accessible, even to rural and lower socioeconomic status individuals.

项目总结 新的艾滋病毒感染率仍然是不可接受的，特别是在佛罗里达州和有性行为的男性中 与男性(男男性接触者)。黑人和西班牙裔/拉丁裔以及年轻成年MSM的风险特别高，因为 部分原因是重叠的危险行为，如酗酒。饮酒会增加无保护措施的性行为，并减少 坚持治疗，使酒精和危险的性行为预防相结合成为最佳选择。新的预防措施 艾滋病毒和酒精是NIAAA的高度优先领域，必须针对这些高危群体。目标是 UH2/UH3项目的一部分是开发和初步测试一种协同的、移动的干预措施，它将减少酒精 使用和危险的性行为，并在高危人群中预防艾滋病毒感染。拟议的干预措施 结合简短的激励干预；通过交互式语音应答(IVR)进行日常监控 个性化反馈；暴露前预防(PrEP)。将它们结合在一起提供了所有三个组件的优势 同时弥补各自的局限性，产生具有巨大潜在影响的联合干预。基座 根据理论和先前的证据，我们假设这种联合的预防性干预将与 与标准化的教育控制条件相比，酒精使用量的减少和服药依从性更大。 这个项目是创新的，因为这种3种有效干预措施的组合还没有经过测试来减少 酒精使用和艾滋病毒风险。此外，还没有既定的干预措施来提高PrEP的摄取/依从性 也没有研究提供针对酒精和PrEP摄取/依从性的干预。在UH2中 阶段，我们将招募18-30岁报告艾滋病毒阴性状态的MSM进行网络调查(N=683)，以产生 为个性化反馈干预部分和重点人群(N=30)提供标准化数据 关于干预的初始版本的输入。基于网络调查和焦点小组，干预将 在初步可用性研究(N=10)中进行修改和测试，为UH3阶段做准备。完成每一项 UH2阶段的基准表明了UH3干预研究的可行性。对于UH3阶段，我们将 招募高危男男性接触者(N=80)进行为期30天的研究，以测试移动酒精和艾滋病毒联合预防 干预。所有参与者都将收到开放标签PrEP，并完成每天5分钟的IVR评估 酒精/药物使用、性行为和服用PrEP。随机接受干预的参与者将得到简要介绍 以网络为基础的酒精和艾滋病毒预防，然后进行IVR监测，包括个性化反馈。网络-- 基于组件的设计旨在提高风险感知和更改的动力，而IVR组件 将加强对PrEP的遵守，并进一步增强风险认知和动机。参与者被随机分配到 控制组将接受标准化的教育，而不是个性化的干预，并提供IVR响应以进行评估 目的只有一个，没有反馈。随访将在30天干预结束时和6个月后进行。 治疗。该项目是开发和测试具有成本效益、可扩展的预防措施的早期步骤 即使是农村和社会经济地位较低的个人也可以很容易地获得干预。