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 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 新感染艾滋病毒的人数正在增加，这反映了与异性恋者相比的巨大差距。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）可以在关系中中断。浪漫的关系也提供了无数 福利，包括促进心理，行为和身体健康。尽管至关重要， 浪漫的关系因素对艾滋病预防，绝大多数的研究和干预措施的重点是 个体我们通过NIH R21对耦合YMSM进行了形成性研究， 开发了一种创新的夫妇为基础的干预措施，解决艾滋病毒预防和护理的连续性 为YMSM夫妇。2GETHER计划整合了基于夫妇和团体的模式，具有创新性 在其设计中，无论血清状况如何，都要解决夫妇之间艾滋病毒传播风险;夫妇学会利用 行为和生物医学方法来预防艾滋病毒的获得和传播， 强调改善关系运作。2GETHER进一步鼓励夫妇之间的艾滋病毒感染 检测HIV-/未知YMSM和药物依从性和参与HIV+ YMSM的护理。我们 在配对YMSM的先导性试验中确定了2GETHER的可行性、可接受性和初步疗效 （N=60对夫妇; 120人），包括艾滋病毒传播风险行为的显着减少。基于 我们非常成功的试点，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）招募种族多样的YMSM夫妇;（B）将夫妇随机分配到2GETHER 为夫妇提供干预或注意力匹配积极情感技能方案;（c）衡量干预结果 干预后12个月。研究结局分析将采用个体和二元水平 数据主要HIV危险行为结果：一个指示CAI存在的个体水平二分变量 血清不一致或身份不明的伴侣。探索性分析将计算一个创新变量， 占与不同血清状态的伴侣发生性行为的相对风险，占 生物医学预防主要生物医学结局： 个体二级二分水平艾滋病毒风险结局：性关系中的一致性/不一致性 协议类型和协议中断的存在。护理结果中的次要个人参与： 接受艾滋病毒检测（艾滋病毒-男子）和坚持服药（艾滋病毒阳性男子）。在日益疲劳的背景下， 艾滋病毒预防，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 预防此外，在治疗即预防的时代，我们必须制定预防传播战略 针对男男性行为者，不论其血清状况如何，都应提供全面的预防和护理。