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

• 批准号: 9766168
• 负责人: Michael E Newcomb
• 金额: $ 50.85万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 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/9766168
• 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; Development; Dose; Education; Enrollment; Fatigue; Future; Goals; Gonorrhea; HIV; HIV Infections; HIV risk; Heterosexuals; Human immunodeficiency virus test; Incidence; Individual; Infection; Intervention; Learning; Life; Measures; Mediator of activation protein; Mental health promotion; Modality; Motivation; National Institute of Mental Health; Outcome; Outcome Measure; Outcome Study; Prevention; Prevention approach; Prevention strategy; Preventive Intervention; Primary Health Care; Primary Prevention; Proxy; Randomized; Randomized Controlled Trials; Relative Risks; Reporting; Research; Risk; Risk Behaviors; Risk Reduction; Secondary Prevention; Sexual Partners; Surveys; Testing; Time; Trust; United States; United States National Institutes of Health; Urethra; Viral Load result; barrier to care; base; behavior change; behavioral health; behavioral outcome; care outcomes; community center; condoms; design; efficacy testing; efficacy trial; ethnic diversity; ethnic minority population; improved; infection risk; innovation; intervention effect; intimate behavior; male; medication compliance; men; men who have sex with men; men' s group; methamphetamine use; physical conditioning; pilot trial; post intervention; pre-exposure prophylaxis; prevent; programs; racial and ethnic; racial diversity; rectal; sexual relationship; sexual risk behavior; skills; social media; transmission process; uptake; young adult; young man; young men who have sex with men

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.

项目摘要 青春期和青壮年男男性行为者(YMSM)是美国唯一一个 新感染艾滋病毒的人数正在增加，这反映了相对于异性恋者的巨大差距。稳定或主要 在基督教青年会新感染艾滋病毒的患者中，伴侣关系占很大比例。在基督教青年会中， 严重的关系状况可能是无套肛交(CAI)的最强预测因子，而Pre-Pre 在一段关系中，暴露预防(PrEP)可能会停止。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。尽管关键的重要性在于 恋爱关系因素对HIV的预防作用，绝大多数研究和干预都集中在 个人。我们通过NIH R21对耦合YMSM进行了形成性研究，在此基础上我们进行了 开发了一种创新的以夫妇为基础的干预措施，解决了艾滋病毒预防和护理的连续性问题 为基督教青年会夫妇准备的。2gether计划整合了基于夫妻和团体的模式，具有创新性 在其设计中，无论血清状态如何，都要解决夫妇中艾滋病毒传播的风险；夫妇学会利用 预防艾滋病毒感染和传播的行为和生物医学方法，主要是 强调改善人际关系的运作。2gether进一步鼓励夫妻感染艾滋病毒 HIV-/未知YMSM的检测以及对HIV+YMSM的用药依从性和护理参与度。我们 2gether在耦合YMSM中试中的可行性、可接受性和初步疗效 (n=60对夫妇；120人)，包括艾滋病毒传播危险行为的显著减少。基于 我们的试验非常成功，我们建议在大规模随机对照试验中测试2gether的疗效 试验(RCT)。我们将：(A)招募不同种族的结对基督教青年会；(B)将夫妇随机分配到第二个家庭 针对夫妇的干预或注意匹配的积极情感技能计划；(C)衡量干预结果 经过干预后12个月。对研究结果的分析将同时利用个人层面和二元层面 数据。原发HIV风险行为结局：一个个体水平的二分变量，表明存在脑血管意外 与一名血清不一致或身份不明的伴侣。探索性分析将计算出一个创新变量 解释了与不同血清状态的伴侣发生性行为的相对风险， 生物医学预防。主要生物医学结果：#年衣原体/淋球菌发病率 个人。二元水平的次级HIV风险结果：性关系中的和谐/不和谐 协议类型和是否存在协议中断。次要的个人层面对护理结果的参与： 艾滋病毒检测、吸食(艾滋病毒-男子)和服药依从性(艾滋病毒+男子)。在疲惫加剧的情况下 HIV预防，一项针对夫妻青年男性接触者的健康关系计划提供了重振HIV的机会 预防。此外，在治疗即预防的时代，我们必须制定传播预防战略。 对于MSM，无论血清状态如何，都应解决预防和护理的全过程。