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.

项目摘要 艾滋病毒新感染率仍然是不可接受的，特别是在佛罗里达和有性行为的男性中 男同性恋（MSM）黑人和西班牙裔/拉丁裔，以及年轻的成年男男性接触者的风险特别高，由于在 部分原因是重叠的危险行为，如酗酒。饮酒会增加无保护的性行为， 坚持治疗，使酒精和危险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的一个高度优先领域，必须针对这些风险最高的群体。目标 UH 2/UH 3项目的一个主要目标是开发和初步测试一种协同的、移动的干预措施， 使用和危险性行为，并预防高危人群感染艾滋病毒。拟议的干预 结合简短的动机干预;通过交互式语音应答（IVR）进行日常监测， 个性化反馈;和暴露前预防（PrEP）。结合它们提供了所有3个优点 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性干预与以下因素有关： 更大的酒精使用减少和药物依从性比标准化的教育控制条件。 该项目是创新的，因为这3种有效干预措施的组合尚未经过测试，以减少 饮酒与艾滋病风险此外，没有既定的干预措施来提高PrEP的吸收/坚持 没有研究提供针对酒精和PrEP摄取/依从性的干预措施。在UH 2 在第一阶段，我们将招募年龄在18-30岁之间的MSM，他们报告HIV阴性状态进行网络调查（N=683）， 个性化反馈干预组件和焦点小组（N=30）的规范性数据， 对干预措施初始版本的输入。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UH 3阶段做准备。完成每个 UH 2阶段的基准表明UH 3干预研究的可行性。对于UH 3阶段，我们将 招募高风险MSM（N=80）进行为期30天的研究，以测试移动的酒精和艾滋病毒预防剂的组合 干预所有参与者将接受开放标签PrEP，并完成5分钟的每日IVR评估， 酒精/物质使用，性行为和PrEP服用。随机分配到干预组的参与者将得到简短的 基于网络的酒精和艾滋病毒预防，随后进行IVR监测，包括个性化反馈。网络- 的组件旨在提高风险感知和改变的动机，而IVR组件 将提高PrEP的依从性，并进一步增强风险认知和动机。受试者随机分配至 对照组将接受标准化教育，而不是个性化干预，并给予IVR应答进行评估 只有目的，没有反馈。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一种具有成本效益的、可扩展的预防性 这些干预措施将是容易获得的，即使是农村和社会经济地位较低的个人。