A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples

项目摘要 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 新的艾滋病毒感染正在增加，这反映了相对于异性恋者的巨大差距。稳定还是主要 在青年男男性接触者中，伴侣关系在新的艾滋病毒感染中占很大比例。在YMSM中a 严重的关系状态可能是无安全套肛交（CAI）的最强预测因子， 暴露预防（PrEP）也可以在关系中中断。酒精和药物使用很重要 影响YMSM中的艾滋病毒风险，特别是在严重的关系中。浪漫的关系也提供了 无数的好处，包括促进心理，行为和身体健康。尽管至关重要 浪漫的关系因素预防艾滋病毒，绝大多数研究和干预措施的重点是 个体我和我的研究团队通过NIH R21对耦合YMSM进行了形成性研究， 我开发了一种创新的夫妇为基础的干预，解决艾滋病毒预防的连续性， 照顾YMSM夫妇。2GETHER计划整合了基于夫妇和团体的模式， 其设计具有创新性，以解决夫妇之间的艾滋病毒传播风险，而不论血清状况如何;夫妇学会 利用行为和生物医学方法预防艾滋病毒的获得和传播， 重点是改善关系运作。2GETHER进一步鼓励夫妇- 基于HIV-/未知YMSM的HIV检测，并解决药物依从性和HIV+护理障碍 YMSM。我建立了可行性，可接受性和初步疗效2GETHER在一个试点试验的耦合 YMSM（N=52对夫妇; 104人），包括艾滋病毒传播风险行为的显着减少。我 试点主要集中在预防风险行为，鉴于其非常有希望的效果，我现在采取一个 重要的科学风险，也评估其对参与护理的影响。我想测试一下 2GETHER在相对于现有公共卫生实践（PHP）的比较有效性RCT中。我将：（a）注册 种族多元化的情侣YMSM;（B）将情侣随机分配到2GETHER干预或PHP（情侣 艾滋病毒自愿咨询和艾滋病毒检测- YMSM;艾滋病毒+ YMSM的生命步骤艾滋病毒药物依从性）; (c)衡量干预后12个月的干预结果。主要行为结果： 根据性行为的相对风险计算的艾滋病毒阳性/阴性男性的个人水平传播风险变量（a 传统的CAI结果也将被检查）。主要生物医学结局：衣原体/淋病发病率。 次要结局：HIV发病率和HIV检测率（HIV-男性）、病毒载量（HIV+男性）和物质 使用问题和关系功能，因为这些都是艾滋病毒风险的媒介。在日益增长的背景下， 疲劳的艾滋病毒预防，我相信一个健康的关系计划，耦合YMSM提供了一个机会 重振艾滋病毒预防工作。此外，在治疗即预防的时代， 针对男男性行为者的预防战略，无论其血清状况如何，都要解决预防和护理的全面连续性问题。

Project Summary Adolescent and young adult men who have sex with men (YMSM) are the only group in the U.S. where 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 also be discontinued in a relationship. Alcohol and drug use are important influences on HIV risk in YMSM, particularly in serious relationships. 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. My research team and I conducted formative research on coupled YMSM through an NIH R21 from which I 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 addresses medication adherence and barriers to care for HIV+ YMSM. I established feasibility, acceptability and preliminary efficacy 2GETHER in a pilot trial of coupled YMSM (N=52 couples; 104 individuals), including significant decreases in HIV transmission risk behavior. My pilot focused primarily on prevention of risk behavior, and given its highly promising effects, I now take an important scientific risk to also evaluate its effects on engagement in care. I propose to test the efficacy of 2GETHER in a comparative effectiveness RCT relative to existing public health practice (PHP). I will: (a) enroll racially diverse coupled YMSM; (b) randomize couples to either the 2GETHER intervention or PHP (couples voluntary HIV counseling and testing for HIV- YMSM; Life-Steps HIV medication adherence for HIV+ YMSM); (c) measure intervention outcomes through 12 months post-intervention. Primary behavioral outcome: an individual-level transmission risk variable for both HIV+/- men calculated based on relative risk of sex acts (a traditional CAI outcome will also be examined). Primary biomedical outcome: Chlamydia/Gonnorhea incidence. Secondary outcomes: HIV incidence and HIV testing uptake (HIV- men), viral load (HIV+ men), and substance use problems and relationship functioning as these are mediators of HIV risk. In the context of increasing fatigue for HIV prevention, I believe 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.