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

年轻男性夫妇艾滋病毒一级和二级预防一体化的新方法

基本信息

批准号：
9179853
负责人：
Michael E Newcomb
金额：
$ 231.75万
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：
2016-06-01 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9179853
关键词：
AIDS prevention Accounting Address Adolescent and Young Adult Alcohol consumption Alcohol or Other Drugs use Anus Behavioral Caring Chlamydia Counseling Coupled Couples Drug usage Enrollment Fatigue Goals HIV HIV Infections HIV risk Heterosexuals Human immunodeficiency virus test Incidence Individual Infection Intervention Intervention Studies Learning Life Measures Mediator of activation protein Mental health promotion Modality Outcome Prevention Prevention approach Prevention strategy Primary Prevention Prophylactic treatment Public Health Practice Randomized Relative Risks Reporting Research Risk Risk Behaviors Risk Reduction Secondary Prevention United States National Institutes of Health Viral Load result base behavioral health behavioral outcome comparative effectiveness design efficacy testing improved innovation male medication compliance men men who have sex with men novel strategies physical conditioning pilot trial post intervention prevent programs racial diversity secondary outcome sex transmission process uptake 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. 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.

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，并且在关系中也可以停止预防暴露（PREP）。酒精和吸毒很重要对YMSM的艾滋病毒风险的影响，尤其是在认真的关系中。浪漫关系也提供无数的好处，包括促进精神，行为和身体健康。尽管很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。我和我的研究团队通过NIH R21从我开发了一种创新的夫妻干预措施，该干预涉及预防艾滋病毒的连续性并照顾YMSM夫妇。 2Gether程序整合了夫妻和基于群体的模式，并且是无论血清素如何，夫妇的艾滋病毒传播风险都可以解决艾滋病毒的传播风险；夫妻学会利用行为和生物医学方法来防止艾滋病毒的获取和传播，总体上强调改善关系功能。 2进一步鼓励夫妻吸收 - 基于HIV/未知YMSM的HIV测试，并解决了药物的依从性和护理HIV+的障碍 YMSM。我在耦合的试点试验中建立了可行性，可接受性和初步疗效2 YMSM（n = 52对夫妇； 104个人），包括HIV传播风险行为的显着降低。我的飞行员主要集中于预防风险行为，并鉴于其高度有希望的影响，我现在接受重要的科学风险也可以评估其对护理参与的影响。我建议测试 2与现有公共卫生实践（PHP）相对的比较有效性RCT。我将：（a）注册种族多样化的YMSM；（b）随机将夫妻随机与2Gether干预或PHP（夫妻自愿艾滋病毒咨询和测试HIV-YMSM；艾滋病毒+ ymsm的生命步骤HIV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：基于性行为的相对风险计算的HIV +/-男性的个人级传播风险变量（a）传统的CAI结果也将进行检查）。原发性生物医学结果：衣原体/Gonnorhea发病率。次要结果：HIV发病率和HIV测试摄取（HIV-MEN），病毒载荷（HIV+男性）和物质使用问题和关系功能，因为这些是艾滋病毒风险的介体。在增加的背景下我认为预防艾滋病毒的疲劳，我相信耦合YMSM的健康关系计划提供了机会振兴预防艾滋病毒。此外，在预防治疗时代，我们必须发展传播 MSM的预防策略不管血清固醇如何解决预防和护理的完整连续性。