Expanding the potential of couples HIV testing: Adjunct modules to reduce drug use among vulnerable male couples

扩大夫妇艾滋病毒检测的潜力：减少弱势男性夫妇吸毒的辅助模块

• 批准号: 10217086
• 负责人: Tyrel J Starks
• 金额: $ 68.24万
• 依托单位: HUNTER COLLEGE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10217086
• 关键词: 4-hydroxybutyric acid; AIDS prevention; Address; Age; Agreement; Amphetamines; Assertiveness; Behavioral; Biological Assay; Biological Markers; Chlamydia; Chlamydia Infections; Clinical Virology; Cocaine; Communication; Counseling; Couples; Crack Cocaine; Data; Data Analytics; Development; Drug usage; Enrollment; Feedback; Funding; Funding Agency; Future; Goals; Gonorrhea; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; HIV risk; HIV/STD; Human immunodeficiency virus test; Individual; Infection; Intervention; Interview; Investments; Joints; Ketamine; Laboratory Research; Link; Marijuana; Measures; Mediating; Mediator of activation protein; Methodology; New York City; Nitrates; Participant; Patient Self-Report; Pharmaceutical Preparations; Play; Prevention; Prevention strategy; Process; Protocols documentation; Provider; Public Health; Randomized; Recording of previous events; Reporting; Research; Resources; Risk; Risk Behaviors; Role; Sampling; Science; Services; Sexual Partners; Site; Structure of nail of finger; Syphilis; Testing; Training; Treatment Efficacy; United States National Institutes of Health; Viral Load result; Work; aged; binge drinking; club drug; condomless anal sex; condoms; data format; design; ecstasy; effectiveness implementation trial; efficacy evaluation; efficacy testing; emerging adult; ethnic diversity; experience; follow-up; implementation research; infection risk; innovation; intervention effect; male couples; men; men who have sex with men; multi-site trial; post intervention; pre-exposure prophylaxis; racial and ethnic; recruit; secondary outcome; sex; sexual HIV transmission; skills; skills training; substance use; theories; transmission process; uptake; young men who have sex with men

Project Summary Couples HIV testing and counseling (CHTC) for male couples in the US has emerged as a promising dyadic HIV prevention strategy. Interventions such as CHTC, which address HIV-risk within primary relationships, are an essential component to a comprehensive national prevention strategy. Up to two-thirds of HIV infections among MSM occur within the context of primary partnerships. Rates are particularly pronounced for emerging adult MSM (aged 18-29). Estimates suggest 79% to 84% of HIV infections are transmitted by primary partners5. The current CHTC protocol is limited in two ways. First, CHTC does not incorporate a focus on drug use – a well-established correlate of HIV infection risk among YMSM specifically. Second, CHTC provides limited guidance for formal communication skills training in instances where partners have substantial communication deficits. To address these limitations, our group has developed and pilot-tested the We Test intervention, which includes two adjunct CHTC components. The first is a substance use module (SUM) that elicits the formation of a substance use agreement and a discussion about how partners can support one another in observing drug use limits. The second is an assertive communication training video (ACTV). Results from our recent pilot RCT (DA036419, PI-Starks) suggest these components decrease the odds of drug use and drug-related problems. We now propose a multi-site trial powered to test the efficacy of We Test’s components and evaluate putative moderators and mediators. The proposed RCT builds directly upon the pilot data generated by DA036419. Participants include 240 male couples in which at least one partner is age 18 – 29; HIV negative; and reports recent (past 30 days) drug use; and recent (past 3 months) sexual HIV/STI transmission risk behavior. The study utilizes biological markers for drug use (fingernail assay), HIV testing, and gonorrhea, chlamydia, and syphilis. Viral load testing is conducted with HIV positive participants. To increase generalizability and the feasibility of recruitment, couples be enrolled equally across 2-sites in New York City and Detroit. Participants will be randomized in a factorial design to receive CHTC as usual; CHTC + SUM; CHTC + ACTV; or CHTC+SUM+ACTV. Follow-ups will occur at 3-, 6-, 9-, and 12-months post intervention. Drs. Starks, Stephenson (Co-I), Kahle (Co-I; biostatistician) and Sullivan (Consultant) have substantial experience in the study of male couples. This group completed the pilot RCT which produced the formative data for this proposal. The study is supported by the Emory CFAR Prevention Sciences Core and the Clinical Virology Research Laboratory. The intervention tested is an innovative and highly scalable adaptation of the existing CHTC intervention. In addition, the integration of a substance use intervention into CHTC might facilitate uptake by affording access to additional funding sources and expanding the pool of providers who see the service as relevant. Results would inform the development of a future implementation/effectiveness trial. .

项目摘要 美国针对男性夫妇的艾滋病毒检测和咨询(CHTC)已成为一项前景看好的 二元艾滋病毒预防战略。CHTC等干预措施，解决初级卫生保健中的艾滋病毒风险问题 关系，是全面的国家预防战略的一个重要组成部分。高达三分之二的 男男性接触者中的艾滋病毒感染是在初级伙伴关系范围内发生的。利率特别明显 适用于新兴成年男男性接触者(18-29岁)。据估计，79%至84%的艾滋病毒感染是通过 主要合作伙伴5. 当前的CHTC协议在两个方面受到限制。首先，CHTC没有将重点放在药物使用上- 特别是在基督教男同性恋者中，艾滋病毒感染风险的一个公认的相关性。其次，CHTC提供的服务有限 在合作伙伴有大量沟通的情况下，对正式沟通技能培训的指导 赤字。为了解决这些限制，我们的团队开发并试行了We测试干预，它 包括两个附属的CHTC组件。第一个是物质使用模块(SUM)，它引出了 一份药物使用协议和一场关于合作伙伴如何在观察毒品方面相互支持的讨论 使用限制。第二个是自信沟通培训视频(ACTV)。我们最近的试验性随机对照试验结果 (DA036419，Pi-Starks)建议这些成分降低吸毒和与毒品相关的问题的几率。 我们现在建议进行一项多点试验，以测试我们测试的组件的有效性并评估 假定的主持人和调解人。建议的RCT直接建立在由 DA036419。参与者包括240对男性夫妇，其中至少有一人的年龄在18-29岁之间； 并报告最近(过去30天)吸毒；最近(过去3个月)性传播艾滋病毒/性传播疾病的风险 行为。这项研究利用生物标记物来吸毒(指甲化验)、艾滋病毒检测和淋病， 衣原体和梅毒。病毒负荷测试是在艾滋病毒阳性参与者中进行的。增加 普适性和招募的可行性，夫妇可以在纽约市的两个网站平等地注册 还有底特律。参与者将按析因设计随机接受CHTC，照常接受CHTC+SUM； CHTC+ACTV；或CHTC+SUM+ACTV。在干预后3个月、6个月、9个月和12个月进行随访。 斯塔克斯、斯蒂芬森(Co-I)、Kahle(Co-I；生物统计学家)和Sullivan(顾问)博士拥有大量 研究男性夫妇的经验。这组人完成了试验性RCT，它产生了形成性 这项提案的数据。这项研究得到了埃默里CFAR预防科学核心和临床 病毒学研究实验室。测试的干预是一种创新的、高度可扩展的适应 现有的CHTC干预措施。此外，将药物使用干预纳入CHTC可能会 通过提供更多资金来源和扩大提供商池来促进吸收，这些提供商看到 相关的服务。结果将为今后执行/有效性试验的发展提供信息。 。