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. .

项目概要 在美国，针对男性夫妇的艾滋病毒检测和咨询 (CHTC) 已成为一项有前景的项目 二元艾滋病毒预防策略。 CHTC 等干预措施可解决初级卫生保健中的艾滋病毒风险 关系，是全面的国家预防战略的重要组成部分。高达三分之二 MSM 中的艾滋病毒感染发生在主要伙伴关系的背景下。利率特别明显 适合新兴成年 MSM（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 并未关注吸毒问题 – 特别是 YMSM 中 HIV 感染风险的明确相关性。二、恒天提供有限 在合作伙伴进行大量沟通的情况下提供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点了“We Test”干预措施，该干预措施 包括两个辅助 CHTC 组件。第一个是物质使用模块 (SUM)，它引发形成 药物使用协议以及关于合作伙伴如何在观察药物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)。我们最近的试点随机对照试验的结果 （DA036419，PI-Starks）表明这些成分可以降低吸毒和吸毒相关问题的几率。 我们现在提议进行多站点试验，以测试 We Test 组件的功效并评估 假定的调节者和调解者。拟议的 RCT 直接建立在 DA036419。参与者包括 240 对男性夫妇，其中至少一名伴侣年龄在 18 至 29 岁之间；艾滋病毒阴性； 并报告最近（过去 30 天）的药物使用情况；以及最近（过去 3 个月）的 HIV/STI 性传播风险 行为。该研究利用药物使用（指甲检测）、艾滋病毒检测和淋病的生物标记， 衣原体和梅毒。对 HIV 阳性参与者进行病毒载量测试。增加 招募的普遍性和可行性，夫妇可以在纽约市的两个地点平等地报名 和底特律。参与者将通过析因设计随机分配，以照常接受 CHTC；恒天+SUM； 恒天+ACTV；或恒天+SUM+ACTV。随访将在干预后 3、6、9 和 12 个月进行。 博士。 Starks、Stephenson（Co-​​I）、Kahle（Co-I；生物统计学家）和 Sullivan（顾问）有大量研究成果 对男性夫妻的研究经验。该小组完成了试点随机对照试验，产生了形成性的结果 该提案的数据。该研究得到了埃默里大学 CFAR 预防科学核心和临床中心的支持 病毒学研究实验室。测试的干预措施是一种创新且高度可扩展的改编 现有的恒天干预。此外，将物质使用干预措施纳入 CHTC 可能会 通过提供额外的资金来源和扩大看到的提供者群体来促进吸收 相关服务。结果将为未来实施/有效性试验的发展提供信息。 。