Using Behavioral Measures to Assess Change in HIV Sexual Risk-Taking Following Pre-Exposure Prophylaxis (PrEP) Uptake in Heavy Drinking Young Men Who Have Sex With Men

使用行为测量来评估与男性发生性行为的酗酒年轻男性在接触前预防 (PrEP) 后艾滋病毒性风险行为的变化

• 批准号: 10081091
• 负责人: Nioud Mulugeta Gebru
• 金额: $ 4.26万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-16 至 2022-08-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081091
• 关键词: AIDS prevention; Address; Adherence; Age; Alcohol consumption; Alcohols; Area; Attention; Attitude; Behavior; Behavior Therapy; Clinical; Control Groups; Cross-Sectional Studies; Data; Data Analyses; Financial compensation; Funding; Future; HIV; HIV Infections; Heavy Drinking; Incidence; Individual; Intervention; Intervention Studies; Literature; Measures; Methodology; Methods; National Institute on Alcohol Abuse and Alcoholism; Outcome; Outcome Measure; Patient Self-Report; Pharmaceutical Preparations; Physicians; Prospective Studies; Psychological reinforcement; Randomized; Randomized Controlled Trials; Reporting; Research; Research Personnel; Rewards; Risk; Risk Factors; Role; Sexual Partners; Sexually Transmitted Diseases; Standardization; Study Subject; Substance administration; Targeted Research; Testing; Time; TimeLine; Training; Unsafe Sex; Work; alcohol demand; alcohol misuse; base; behavior change; behavior measurement; behavioral economics; career; clinically relevant; comparison group; condoms; control trial; design; discounting; experience; follow-up; heavy drinking young adult; innovation; medication compliance; men who have sex with men; movie; novel; open label; pill; pre-exposure prophylaxis; prevent; prospective; randomized trial; reduced alcohol use; reinforcer; response; sexual risk behavior; sexual risk taking; treatment adherence; treatment comparison; uptake; young adult; young men who have sex with men

Project Summary/Abstract HIV incidence rates are disproportionately high among young adult (ages 18-30) men who have sex with men (MSM), in part due to overlapping risk-factors, such as high rates of alcohol use. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention drug, but has little utility without strong adherence. The potential for risk compensation – an increase in sexual risk-taking (e.g., more condomless sex) as PrEP users believe their risk for HIV is reduced – is another considerable concern with PrEP, because PrEP does not protect against other sexually transmitted infections (STIs). Substantial evidence indicates that alcohol facilities the spread of HIV by increasing sexual risk-taking and reducing medication adherence, exacerbating both critical concerns with PrEP – increased sexual risk-taking and reduced PrEP adherence. However, alcohol has received little attention in the PrEP and risk compensation literature, with only two studies reporting on alcohol use. Further, research on PrEP and risk compensation is replete with methodological limitations, including an exclu- sive reliance on retrospective self-reports and largely consists of cross-sectional studies. Research examining PrEP and risk compensation is inconclusive, in part due to these limitations. There is an urgent need to address this as a quarter of physicians report unwillingness to prescribe PrEP due to risk compensation concerns. Thus, the proposed study will address these gaps and limitations by determining the effects of PrEP and alcohol use on sexual risk-taking by using novel behavioral measures before and after PrEP uptake. The proposed project will use the Sexual Delay Discounting Task (SDDT) pre- and post-PrEP uptake to examine changes in HIV sexual risk-taking and determine associations with alcohol use, demand and reinforcement. The SDDT is a novel measure of sexual risk-taking that minimizes retrospective self-report, is reliable and valid, yet underutilized. The SDDT assesses impact of partner STI/HIV status and condom availability on likelihood of condom use, and has shown stronger relations to clinical outcomes, compared to self-report and other discount- ing measures. Despite this promising supporting evidence, the SDDT has not been used as an outcome measure in intervention studies. This study will establish validity of the SDDT as an outcome measure for future studies, providing a novel target for research testing interventions to reduce alcohol use and sexual risk-taking. The proposed F31 will enhance a NIAAA-funded randomized control trial (UH2/UH3AA026214, Leeman) testing a mobile intervention to reduce alcohol misuse and enhance PrEP adherence. Heavy drinking young adult MSM (N = 80) will receive open-label PrEP for 30 days, with a follow-up at 6-months. A no treatment control group (no PrEP; no intervention; N = 40) will be added for the F31 to complete study measures following the same timeline. This F31 will enable the applicant to work with a highly-skilled, experienced training team to develop proficiencies in: (1) randomized controlled trial and experimental methods; (2) application of behavioral economics; and (3) longitudinal data analysis to prepare for a career as independent investigator in alcohol/HIV research.

项目概要/摘要 与男性发生性关系的年轻成年男性（18-30 岁）的艾滋病毒发病率异常高 （MSM），部分原因是重叠的风险因素，例如高饮酒率。暴露前预防 PrEP（PrEP）是一种有效的艾滋病毒预防药物，但如果没有很强的依从性，其效用不大。潜在风险 补偿——由于 PrEP 用户认为自己面临风险，性行为风险增加（例如，更多的无套性行为） HIV 感染率降低——这是 PrEP 的另一个重要问题，因为 PrEP 不能预防其他疾病 性传播感染（STI）。大量证据表明，酒精通过以下方式促进了艾滋病毒的传播： 增加性冒险行为和减少药物依从性，加剧了 PrEP 的两个关键问题 – 性行为风险增加，PrEP 依从性降低。然而，酒精却很少受到人们的关注。 PrEP 和风险补偿文献中，只有两项研究报告了饮酒情况。 此外，PrEP 和风险补偿的研究充满了方法学上的局限性，包括排除 严重依赖回顾性自我报告，主要由横断面研究组成。研究检验 PrEP 和风险补偿尚无定论，部分原因是这些限制。亟待解决 四分之一的医生表示，出于风险补偿的考虑，不愿意开 PrEP 处方。因此， 拟议的研究将通过确定 PrEP 和饮酒的影响来解决这些差距和局限性 通过在 PrEP 摄入前后使用新颖的行为措施来评估性风险。 拟议的项目将使用性延迟贴现任务 (SDDT) 在 PrEP 之前和之后进行检查 艾滋病毒性行为风险的变化，并确定与饮酒、需求和强化的关系。这 SDDT 是一种新颖的性冒险衡量标准，可最大程度地减少回顾性自我报告，可靠且有效，但 未得到充分利用。 SDDT 评估伴侣 STI/HIV 状况和安全套可用性对性传播感染可能性的影响 与自我报告和其他折扣相比，安全套的使用与临床结果显示出更强的关系。 措施。尽管有这些有希望的支持证据，但 SDDT 尚未被用作结果衡量标准 在干预研究中。这项研究将确立 SDDT 作为未来研究结果衡量标准的有效性， 为研究测试干预措施提供新的目标，以减少饮酒和性冒险。 拟议的 F31 将增强 NIAAA 资助的随机对照试验（UH2/UH3AA026214，Leeman）测试 旨在减少酒精滥用并提高 PrEP 依从性的移动干预措施。酗酒的年轻成年男男性接触者 (N = 80) 将接受为期 30 天的开放标签 PrEP，并进行 6 个月的随访。无治疗对照组（无 暴露前预防；不干预； N = 40）将为 F31 添加，以按照相同的时间表完成研究措施。 该 F31 将使申请人能够与技术精湛、经验丰富的培训团队合作，以提高能力 表现在：（1）随机对照试验和实验方法； (2)行为经济学的应用；和（3） 纵向数据分析，为酒精/艾滋病毒研究独立调查员的职业生涯做好准备。