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: 9564824
• 负责人: ROBERT F LEEMAN
• 金额: $ 18.48万
• 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 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9564824
• 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 risk; Heavy Drinking; Hispanics; Individual; Infection; Internet; Intervention; Intervention Studies; Latino; Mediator of activation protein; Monitor; Motivation; National Institute on Alcohol Abuse and Alcoholism; Online Systems; Outcome; Participant; Pharmaceutical Preparations; 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; 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; sex risk; 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.

项目概要 新发艾滋病毒感染率仍然令人无法接受，特别是在佛罗里达州和有性行为的男性中 与男性（MSM）。黑人和西班牙裔/拉丁裔以及年轻的男男性接触者面临特别高的风险，因为 部分原因是酗酒等重叠的危险行为。饮酒会增加无保护性行为并减少 坚持治疗，使酒精和危险性行为的联合预防达到最佳效果。新的预防措施 艾滋病毒和酒精是 NIAAA 的高度优先领域，必须针对这些最高风险群体。目标 该 UH2/UH3 项目的目的是开发并初步测试一种协同的移动干预措施，以减少酒精摄入量 性行为和危险性行为，并预防高危人群感染艾滋病毒。拟议的干预措施 结合简短的动机干预；通过交互式语音应答 (IVR) 进行日常监控 个性化反馈；和暴露前预防（PrEP）。将它们结合起来可发挥全部 3 种优势 同时弥补各自的局限性，产生具有巨大潜在影响的综合干预措施。基于 根据理论和先前的证据，我们假设这种联合预防干预措施将与 比标准化教育控制条件更好地减少饮酒和服药依从性。 该项目的创新之处在于，这 3 种有效干预措施的组合尚未经过测试可以减少 饮酒和艾滋病毒风险。此外，没有既定的干预措施来增强 PrEP 的吸收/依从性 并且没有研究提供针对酒精和 PrEP 摄取/依从性的干预措施。在UH2 阶段，我们将招募 18-30 岁报告 HIV 阴性状况的 MSM 进行网络调查 (N=683)，以得出结果 为个性化反馈干预组件和焦点小组（N = 30）提供规范数据 关于干预的初始版本的输入。根据网络调查和焦点小组，干预措施将 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。完成每一个 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 招募高风险 MSM (N=80) 进行为期 30 天的研究，以测试流动酒精和 HIV 预防措施的结合 干涉。所有参与者都将接受开放标签的 PrEP 并完成每日 5 分钟的 IVR 评估 酒精/药物使用、性行为和 PrEP 服用。随机接受干预的参与者将得到简短的介绍 基于网络的酒精和艾滋病毒预防，然后是 IVR 监控，包括个性化反馈。网络- 基于组件的目的是增加风险感知和变革的动力，而 IVR 组件 将提高 PrEP 依从性并进一步增强风险认知和动机。参与者随机分配到 控制将得到标准化教育，而不是个性化干预，并给出IVR响应进行评估 仅用于目的，不提供任何反馈。随访将在 30 天干预结束时和干预后 6 个月进行。 治疗。该项目代表了开发和测试具有成本效益、可扩展的预防措施的早期步骤 即使对于农村和社会经济地位较低的个人来说，干预措施也很容易获得。