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: 10626930
• 负责人: Tyrel J Starks
• 金额: $ 123.12万
• 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/10626930
• 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; Data; Data Analytics; Development; Drug usage; Enrollment; Feedback; Funding; Funding Agency; 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; Methodology; New York City; Nitrates; Participant; Patient Self-Report; Pharmaceutical Preparations; Play; Prevention; Prevention strategy; Process; Protocols documentation; Provider; Public Health; Race; Randomized; Recording of previous events; Reporting; Research; Resources; Risk; Risk Behaviors; Role; Sampling; Science; Services; 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; delivery vehicle; design; ecstasy; effectiveness/implementation trial; efficacy evaluation; efficacy testing; emerging adult; ethnic diversity; experience; follow-up; future implementation; implementation research; infection risk; innovation; intervention delivery; intervention effect; male couples; men; men who have sex with men; multi-site trial; pilot test; post intervention; pre-exposure prophylaxis; 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 夫妇艾滋病毒检测和咨询（CHTC）的男性夫妇在美国已成为一个有前途的 预防艾滋病毒的双重战略。干预措施，如CHTC，解决初级保健中的艾滋病毒风险 这种关系是全面的国家预防战略的一个重要组成部分。多达三分之二的 男男性行为者中的艾滋病毒感染发生在主要伙伴关系的背景下。利率尤其明显 新出现的成年MSM（18-29岁）。据估计，79%至84%的艾滋病毒感染是通过以下途径传播的： 主要合作伙伴5. 目前的CHTC协议在两个方面受到限制。第一，本中心并不关注吸毒问题- 一个明确的相关性艾滋病毒感染的风险之间的YMSM特别。第二，CHTC提供有限的 在合作伙伴有大量沟通的情况下，为正式沟通技能培训提供指导 赤字为了解决这些局限性，我们的团队开发并试点测试了We Test干预措施， 包括两个辅助的CHTC组件。第一个是物质使用模块（SUM）， 关于药物使用协议和讨论如何合作伙伴可以相互支持， 使用限制。第二个是自信沟通训练视频（ACTV）。我们最近试点RCT的结果 （DA 036419，PI-Starks）表明这些成分降低了药物使用和药物相关问题的几率。 我们现在提出了一个多站点试验，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。拟议的RCT直接建立在以下方面生成的试点数据基础上： DA036419.参与者包括240对男性夫妇，其中至少一方年龄在18 - 29岁之间;艾滋病毒阴性; 报告最近（过去30天）吸毒;和最近（过去3个月）性传播艾滋病毒/性传播疾病风险 行为这项研究利用了药物使用（指甲检测）、艾滋病毒检测和淋病的生物标志物， 衣原体和梅毒对艾滋病毒阳性参与者进行病毒载量检测。增加 招募的普遍性和可行性，夫妇在纽约市的2个研究中心平等入组 和底特律。受试者将按照析因设计随机接受CHTC常规治疗; CHTC + SUM; CHTC + ACTV;或CHTC+SUM+ACTV。将在干预后3、6、9和12个月进行随访。 Starks博士、斯蒂芬森（Co-I）、Kahle（Co-I;生物统计学家）和Sullivan（顾问） 研究男性伴侣的经验。该组完成了试点RCT，该RCT产生了形成性的 这份提案的数据。这项研究得到了埃默里CFAR预防科学核心和临床研究的支持。 病毒学研究实验室。测试的干预措施是一种创新的和高度可扩展的适应 现有的CHTC干预措施。此外，将物质使用干预纳入CHTC可能会 通过提供额外的资金来源和扩大提供者的范围， 服务是相关的。结果将为未来实施/有效性试验的制定提供信息。 .