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

基本信息

批准号：
10403968
负责人：
Tyrel J Starks
金额：
$ 68.93万
依托单位：
HUNTER COLLEGE
依托单位国家：
美国
项目类别：
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/10403968
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 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 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 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

项目摘要

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 CHTC 等二元艾滋病毒预防策略，可解决初级卫生保健中的艾滋病毒风险。关系是国家综合预防战略的重要组成部分（多达三分之二）。 MSM 中的艾滋病毒感染发生在主要伴侣关系中，发病率尤其明显。对于新兴成年 MSM（18-29 岁），估计 79% 至 84% 的 HIV 感染是通过以下途径传播的。主要合作伙伴5. 目前的 CHTC 协议有两个限制：首先，CHTC 没有关注药物使用—— 其次，CHTC 提供的艾滋病毒感染风险的相关性有限。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为了解决这些缺陷，我们的团队开发并试点了“我们测试”干预措施。包括两个辅助 CHTC 组件，第一个是引发形成的物质使用模块 (SUM)。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第二个是我们最近的试点 RCT 的果断沟通培训视频 (ACTV)。（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 组件的功效并评估拟议的 RCT 直接建立在由以下机构生成的试点数据之上。 DA036419。参与者包括 240 对男性夫妇，其中至少一名伴侣的艾滋病毒呈阴性；并报告近期（过去 30 天）吸毒情况；以及近期（过去 3 个月）性 HIV/STI 传播风险该研究利用生物标志物进行吸毒（指甲）、艾滋病毒检测和淋病检测，对艾滋病毒阳性参与者进行病毒载量检测。招募的普遍性和可行性，纽约市两个地点的夫妇可以平等地报名参与者将按照析因设计随机接受 CHTC + SUM； CHTC + ACTV；或 CHTC+SUM+ACTV 将在干预后 3、6、9 和 12 个月进行。 Starks、Stephenson 博士（Co-I）、Kahle（Co-I；生物统计学家）和 Sullivan（顾问）有大量研究成果该小组完成了试点随机对照试验，并产生了形成性结果。该研究的数据得到了埃默里大学 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对病毒学研究实验室的创新和高度可扩展的改造。此外，将物质使用干预措施纳入 CHTC 中可能是可行的。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的结果将为未来实施/有效性试验的发展提供信息。。