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，与男性发生性关系（MSM）的男性受艾滋病毒的影响不成比例。年轻的MSM （YMSM），尤其是YMSM的颜色，在任何组中都有最高的HIV事件。尽管感知到了 浪漫关系的安全，主要合作伙伴关系是MSM中新的HIV感染的很大比例 （35-68％），在YMSM中，这一比例要高得多。 MSM大大减少避孕套和准备 使用一段关系后，许多夫妻的持续高风险。但是，健康的浪漫 关系为个人健康和福祉带来了无数的好处。那我们创建了2gether， 整合基于证据的关系教育（例如，沟通，解决冲突）和预防HIV （例如，一夫一妻制/非婚姻协议，行为/生物医学预防），以优化关系 雄性夫妇的功能和降低艾滋病毒风险。 2结示了可行性的证据和 在试点试验中，可接受性以及对艾滋病毒风险行为和关系功能的初步影响。 我们还为在线管理改编了2个，由3个在线教学技能模块和2个组成 基于视频会议的技能教练会议，并在随机试验中评估其有效性。尽管 它的承诺是，我们已经确定了基于夫妻的艾滋病毒预防的几个关键差距：1）现场技能教练是 燃烧而不是成本效益，2）许多合作的MSM无法招募伙伴，因此 排除，3）更新的高风险关系很少参加试验，因此我们需要将关系技能交付给 关系倡议之前的单个MSM。我们的目标是升级2GETHETHE到可扩展的量身定制的 单身和合作MSM的干预套餐，包括：1）独立关系教育 单身和合作MSM的HIV预防eHealth计划（​​“ ERE”），以及2）另外两种额外的二元技能 教练课程（仅适用于MSM作为二元组）。 AIM 1：评估量身定制的2Gether的影响 MSM中HIV发病率的干预包。我们将注册5,000名HIV阴性MSM，以测试 两次干预后24个月的艾滋病毒事件的2Gether量身定制干预套件 相对于控制。我们还将探索特定量身定制元素的影响：（a）检查差异 单一MSM和合作的MSM之间的有效性； （b）在合作的MSM中，分析 自动化计划以外的二元技能教练会议。目标2：探索跨越差异的影响 MSM亚组之间的治疗臂。我们将按年龄探索跨治疗部门的差异效应， 种族/种族，粗糙和跨性别经验。目标3：研究2Gether的实施 在全国范围内，以告知规模并确定成本。采用混合1型有效性 - 实践 试验设计，我们将使用混合方法来识别促进者和实施障碍。我们将衡量 主要实施通过与国家利益相关者进行深入的访谈来确定和结果 为未来的实施策略提供信息，并进行成本分析以估计计划实施成本。