Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men

基于夫妇的艾滋病毒预防对弱势年轻男性的功效

基本信息

批准号：
9204168
负责人：
Michael E Newcomb
金额：
$ 62.72万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-20 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9204168
关键词：
AIDS prevention AIDS/HIV problem Accounting Achievement Address Adherence Adolescent and Young Adult Adult Advertising Affect Age Agreement Anus Attention Behavioral Biological Caring Centers for Disease Control and Prevention (U.S.)Chlamydia Clinic Clinical Trials Continuity of Patient Care Coupled Couples Data Dose Education Enrollment Fatigue Future Goals Gonorrhea HIV HIV Infections HIV risk Heterosexuals Human immunodeficiency virus test Incidence Individual Infection Intervention Intervention Studies Lead Learning Life Measures Mediator of activation protein Mental health promotion Modality National Institute of Mental Health Outcome Outcome Measure Outcome Study Prevention Prevention approach Prevention strategy Preventive Intervention Primary Health Care Primary Prevention Prophylactic treatment Proxy Randomized Randomized Controlled Trials Relative Risks Reporting Research Risk Risk Behaviors Risk Reduction Secondary Prevention Sex Behavior Sexual Partners Surveys Testing Time Trust United States United States National Institutes of Health Urethra Viral Load result base behavior change behavioral health behavioral outcome community center condoms design efficacy testing efficacy trial ethnic diversity ethnic minority population improved innovation intervention effect intimate behavior male medication compliance meetings men men who have sex with men physical conditioning pilot trial post intervention prevent programs racial and ethnic racial diversity rectal sex sexual relationship skills social media transmission process uptake young man young men who have sex with men

项目摘要

Project Summary Adolescent and young adult men who have sex with men (YMSM) are the only group in the U.S. in which rates of new HIV infections are increasing, which reflects a large disparity relative to heterosexuals. Steady or main partner relationships account for a substantial proportion of new HIV infections in YMSM. Among YMSM a serious relationship status is perhaps the strongest predictor of condomless anal intercourse (CAI), and pre- exposure prophylaxis (PrEP) may be discontinued in a relationship. Romantic relationships also provide myriad benefits, including promotion of mental, behavioral, and physical health. Despite the critical importance of romantic relationship factors for HIV prevention, the vast majority of studies and interventions focus on individuals. We conducted formative research on coupled YMSM through an NIH R21 from which we developed an innovative couples-based intervention that addresses the continuum of HIV prevention and care for YMSM couples. The 2GETHER program integrates couples- and group-based modalities and is innovative in its design to address HIV transmission risk in couples regardless of serostatus; couples learn to utilize behavioral and biomedical approaches to prevent both HIV acquisition and transmission, with an overarching emphasis on improving relationship functioning. 2GETHER further encourages uptake of couples-based HIV testing for HIV-/unknown YMSM and medication adherence and engagement in care for HIV+ YMSM. We established feasibility, acceptability and preliminary efficacy of 2GETHER in a pilot trial of coupled YMSM (N=60 couples; 120 individuals), including significant decreases in HIV transmission risk behavior. Based on our highly successful pilot, we propose to test the efficacy of 2GETHER in large-scale randomized controlled trial (RCT). We will: (a) enroll racially diverse coupled YMSM; (b) randomize couples to either the 2GETHER intervention or attention-matched positive affect skills program for couples; (c) measure intervention outcomes through 12 months post-intervention. Analysis of study outcomes will utilize both individual- and dyadic-level data. Primary HIV risk behavioral outcome: an individual-level dichotomous variable indicating presence of CAI with a serodiscordant or unknown status partner. Exploratory analysis will calculate an innovative variable that accounts for the relative risk of sexual behaviors with partners of different serostatus, accounting for biomedical prevention. Primary biomedical outcome: Chlamydia/Gonnorhea incidence in individuals. Secondary dyadic-level HIV risk outcomes: concordance/discordance in relationship sexual agreement type and presence of agreement breaks. Secondary individual-level engagement in care outcomes: HIV testing uptake (HIV- men) and medication adherence (HIV+ men). In the context of increasing fatigue for HIV prevention, a healthy relationships program for coupled YMSM presents an opportunity to reinvigorate HIV prevention. Further, in the era of treatment as prevention, we must develop transmission prevention strategies for MSM regardless of serostatus that address the full continuum of prevention and care.

项目概要与男性发生性关系的青少年和年轻成年男性 (YMSM) 是美国唯一一个发生性行为的群体新发艾滋病毒感染者数量正在增加，这反映了相对于异性恋者的巨大差异。稳定或主要 YMSM 中新发艾滋病毒感染者中，伴侣关系占很大比例。 YMSM中a 认真的关系状态可能是无套肛交（CAI）的最强预测因素，并且预在恋爱关系中可能会停止暴露预防 (PrEP)。浪漫的关系也提供了无数好处，包括促进心理、行为和身体健康。尽管至关重要预防艾滋病毒的浪漫关系因素，绝大多数研究和干预措施都集中在个人。我们通过 NIH R21 对耦合 YMSM 进行了形成性研究，从中我们开发了一种基于夫妇的创新干预措施，解决艾滋病毒预防和护理的连续性问题适合 YMSM 夫妇。 2GETHER 计划整合了情侣和团体模式，具有创新性其设计旨在解决夫妻之间的艾滋病毒传播风险，无论血清状况如何；夫妻要学会利用预防艾滋病毒感染和传播的行为和生物医学方法，具有总体性强调改善关系功能。 2GETHER 进一步鼓励基于夫妻的艾滋病毒感染测试 HIV-/未知 YMSM 以及药物依从性和参与护理 HIV+ YMSM。我们在耦合 YMSM 的试点试验中确定了 2GETHER 的可行性、可接受性和初步功效（N = 60 对夫妇；120 个人），包括显着减少 HIV 传播风险行为。基于我们的试点非常成功，我们建议在大规模随机对照中测试 2GETHER 的功效试验（RCT）。我们将： (a) 招收不同种族的 YMSM； (b) 将情侣随机分配到 2GETHER 针对夫妻的干预或注意力匹配的积极情感技能计划； (c) 衡量干预结果干预后 12 个月内。研究结果分析将利用个人和二元层面数据。主要 HIV 风险行为结果：表明存在 CAI 的个体水平二分变量与血清不一致或身份未知的伴侣。探索性分析将计算一个创新变量解释了与不同血清状态的伴侣发生性行为的相对风险，解释了生物医学预防。主要生物医学结果：衣原体/淋病的发病率个人。次要二元水平 HIV 风险结果：性关系的一致性/不一致协议类型和协议中断的存在。个人层面对护理结果的次要参与： HIV 检测率（HIV- 男性）和药物依从性（HIV+ 男性）。在疲劳加剧的背景下 HIV 预防，一项针对 YMSM 的健康关系计划，为重振 HIV 提供了机会预防。此外，在治疗即预防的时代，我们必须制定传播预防策略对于 MSM，无论血清状态如何，都可以解决预防和护理的整个连续过程。