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: 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
• 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

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 与男性发生性关系的青少年和年轻人是美国唯一的群体 新的HIV感染正在增加，这反映了相对于异性恋者的巨大差异。稳定或主要 伴侣关系占YMSM中新的HIV感染的很大比例。在YMSM中 严重的关系状况也许是无避孕套肛门性交（CAI）的最强预测指标，并且 可能在关系中停止预防暴露（PREP）。浪漫关系也提供了无数 好处，包括促进精神，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着重于 个人。我们通过NIH R21进行了对YMSM耦合YMSM的形成性研究 开发了一种基于创新的夫妻干预措施，该干预措施解决了艾滋病毒预防和护理的连续性 对于YMSM夫妇。 2Gether计划整合了夫妻和基于团体的方式，并且具有创新性 在其设计中，无论血统如何，夫妇的艾滋病毒传播风险；夫妻学会利用 行为和生物医学方法可以防止艾滋病毒的获取和传播，并具有总体 强调改善关系功能。 2进一步鼓励以夫妻为基础的艾滋病毒 对HIV/未知YMSM的测试以及对HIV+ YMSM护理的药物依从性和参与度的测试。我们 在耦合YMSM的试点试验中，2Gether确定的可接受性，可接受性和初步疗效 （n = 60对夫妇； 120个人），包括艾滋病毒传播风险行为的显着降低。基于 我们非常成功的飞行员，我们建议测试2Gether在大规模随机控制中的功效 试验（RCT）。我们将：（a）参加种族多样的耦合YMSM； （b）随机将夫妻随机与2 gether 夫妻的干预或注意力匹配积极影响技能计划； （c）测量干预结果 干预后12个月。研究结果的分析将同时利用个体和二元级别 数据。原发性艾滋病毒风险行为结果：一个个体水平的二分法变量，表明存在CAI 与血清或未知状态合作伙伴。探索性分析将计算一个创新变量 与不同血清的伴侣有关性行为的相对风险，考虑到 生物医学预防。主要的生物医学结果：衣原体/Gonnorhea发病率 个人。次要二元级艾滋病毒风险结果：关系中的一致性/不一致 协议类型和存在协议中断。次要个人参与护理结果： HIV测试摄取（HIV-MEN）和药物依从性（HIV+男性）。在增加疲劳的背景下 艾滋病毒预防，耦合YMSM的健康关系计划为振兴艾滋病毒提供了机会 预防。此外，在预防治疗时代，我们必须制定预防传输策略 对于MSM，无论血清抗素如何解决预防和护理的完整连续性。