Effectiveness of Relationship Education for Reducing HIV Incidence in Men Who Have Sex with Men

关系教育对降低男男性行为者艾滋病毒发病率的有效性

• 批准号: 10379360
• 负责人: Michael E Newcomb
• 金额: $ 192.17万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10379360
• 关键词: AIDS prevention; Address; Affect; Agreement; Behavior; Behavioral; Black race; Characteristics; Color; Communication; Cost Analysis; Coupled; Couples; Education; Effectiveness; Effectiveness of Interventions; Elements; Enrollment; Ethnic Origin; Funding; Goals; HIV; HIV Infections; HIV Seronegativity; HIV risk; Health; Human immunodeficiency virus test; Hybrids; Incidence; Individual; Infection; Intervention; Interview; Latinx; Measures; Methods; Outcome; Participant; Personal Satisfaction; Prevention; Prevention program; Prevention strategy; Preventive; Preventive service; Public Health; Race; Randomized Controlled Trials; Research; Research Methodology; Risk; Risk Behaviors; Rural; Safety; Sampling; Sexual Partners; Subgroup; Sum; Testing; Underserved Population; United States; United States National Institutes of Health; acceptability and feasibility; base; cisgender; clinical decision-making; condomless anal sex; condoms; conflict resolution; cost; cost effective; cost estimate; eHealth; effectiveness evaluation; effectiveness implementation trial; effectiveness testing; evidence base; experience; follow-up; future implementation; high risk; implementation barriers; implementation determinants; implementation outcomes; implementation strategy; improved; innovation; interest; male couples; men of color; men who have sex with men; pilot trial; post intervention; pre-exposure prophylaxis; preference; program costs; programs; randomized trial; recruit; rectal; rurality; secondary outcome; skills; transgender; transgender men; treatment arm; treatment effect; trial design; uptake; young men who have sex with men

Men who have sex with men (MSM) are disproportionately impacted by HIV in the United States. Young MSM (YMSM), particularly YMSM of color, have the highest HIV incidence of any group. Despite the perceived safety of romantic relationships, main partnerships account for a large proportion of new HIV infections in MSM (35-68%), and this proportion is much higher amongst YMSM. MSM substantially reduce condom and PrEP use upon entry into a relationship, despite continued high risk for many couples. However, healthy romantic relationships provide myriad benefits to individual health and wellbeing. Thus, we created 2GETHER, which integrates evidence-based relationship education (e.g., communication, conflict resolution) and HIV prevention (e.g., monogamy/non-monogamy agreements, behavioral/biomedical prevention), to optimize relationship functioning and reduce HIV risk in male couples. 2GETHER demonstrated evidence of feasibility and acceptability, as well as preliminary effects on HIV risk behaviors and relationship functioning, in a pilot trial. We have also adapted 2GETHER for online administration, consisting of 3 online didactic skills modules and 2 videoconference-based skills coaching sessions, and are evaluating its efficacy in a randomized trial. Despite its promise, we have identified several critical gaps in couple-based HIV prevention: 1) live skills coaching is burdensome and not cost-effective, 2) many partnered MSM are unable to enroll partners and are thus excluded, and 3) newer, high risk relationships rarely enroll in trials, so we need to deliver relationship skills to single MSM before relationship initiation. Our goal is to upgrade 2GETHER into a scalable and tailored intervention package for both single and partnered MSM, consisting of: 1) a standalone relationship education and HIV prevention eHealth program (“eRE”) for single and partnered MSM, and 2) two additional dyadic skills coaching sessions (for MSM participating as dyads only). Aim 1: Evaluate the impact of the tailored 2GETHER intervention package on HIV incidence in MSM. We will enroll 5,000 HIV-negative MSM to test effectiveness of the entirety of the 2GETHER tailored intervention package on HIV incidence at 24-months post-intervention relative to control. We will also explore effects of particular tailored elements: (a) examine differential effectiveness between single and partnered MSM; (b) among partnered MSM, analyze the additive benefit of dyadic skills coaching sessions beyond the automated eRE program. Aim 2: Explore differential effects across treatment arms among subgroups of MSM. We will explore differential effects across treatment arm by age, race/ethnicity, rurality, and transgender experience. Aim 3: Research the implementation of 2GETHER nationally to inform scale out and determine cost. Employing a Hybrid Type 1 Effectiveness–Implementation Trial design, we will use mixed methods to identify facilitators and barriers to implementation. We will measure key implementation determinants and outcomes through in-depth interviews with national stakeholders to inform future implementation strategies, and conduct cost analysis to estimate cost of program implementation.

在美国，男男性行为者（MSM）受到艾滋病毒的影响不成比例。年轻的男男性接触者 （YMSM），特别是有色人种的YMSM，在任何群体中艾滋病发病率最高。尽管人们认为 安全的浪漫关系，主要的合作伙伴占很大比例的新感染艾滋病毒的男男性接触者 （35-68%），这一比例在YMSM中要高得多。MSM大幅减少避孕套和PrEP 尽管对许多夫妇来说仍然存在高风险，但在进入关系时使用。健康浪漫 人际关系为个人的健康和福祉带来了无数的好处。我们创造了两个世界， 整合基于证据的关系教育（例如，传播、解决冲突）和预防艾滋病毒 (e.g.,一夫一妻制/非一夫一妻制协议，行为/生物医学预防），以优化关系 降低男性夫妇感染艾滋病毒的风险。2GETHER证明了可行性证据， 可接受性，以及对艾滋病毒的危险行为和关系功能的初步影响，在试点试验。 我们还对2GETHER进行了在线管理调整，包括3个在线教学技能模块和2个 视频会议为基础的技能辅导课程，并正在评估其疗效的随机试验。尽管 我们已经确定了基于夫妇的艾滋病毒预防中的几个关键差距：1）生活技能指导是 负担和不符合成本效益，2）许多合作的男男性接触者无法登记的合作伙伴，因此， 排除，3）新的，高风险的关系很少参加试验，所以我们需要提供关系技能， 男男性接触者在开始交往之前我们的目标是将2GETHER升级为一个可扩展的、量身定制的 针对单身和有伴侣的男男性行为者的干预方案，包括：1）独立的关系教育 和艾滋病毒预防电子健康计划（“eRE”）的单身和合作伙伴的男男性接触者，和2）两个额外的二元技能 辅导课程（仅适用于作为二人组参加的MSM）。目标1：评估量身定制的2GETHER的影响 关于男男性行为者艾滋病毒感染率干预措施。我们将招募5,000名艾滋病毒阴性的男男性接触者， 在干预后24个月，针对艾滋病毒发病率的2GETHER整体干预措施 相对于对照。我们还将探讨特定定制元素的影响：（a）检查差异 （B）在有伴侣的男男性接触者中，分析 自动化eRE计划之外的二元技能辅导课程。目标2：探索不同的影响 MSM亚组中的治疗组。我们将按年龄探索治疗组间的差异效应， 种族/民族，农村，和跨性别的经验。目标3：研究2GETHER的实现 在全国范围内通报扩大规模的情况并确定费用。采用混合类型1容错性-实现 试验设计，我们将使用混合的方法来确定促进者和实施的障碍。我们将测量 通过与国家利益攸关方的深入访谈， 为未来的实施战略提供信息，并进行成本分析，以估计项目实施的成本。