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

在美国，男男性行为者(MSM)感染艾滋病毒的比例更高。年轻的男男性接触者 基督教青年会，特别是有色人种的基督教青年会，是所有人群中艾滋病毒发病率最高的。尽管人们意识到 恋爱关系安全，主要伴侣关系占男男性接触者新感染艾滋病毒的很大比例 (35-68%)，这一比例在基督教青年会中要高得多。男男性接触者大幅减少避孕套和PrEP 在开始一段关系时使用，尽管对许多夫妇来说风险仍然很高。然而，健康的浪漫 人际关系为个人的健康和幸福提供了无数的好处。因此，我们创建了2gether，它 将循证关系教育(例如，沟通、解决冲突)与艾滋病毒预防相结合 (例如，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 并降低男性夫妇感染艾滋病毒的风险。2展示了可行性和可行性的证据 可接受性，以及在试点试验中对艾滋病毒危险行为和关系功能的初步影响。 我们还将2gether用于在线管理，包括3个在线教学技能模块和2个 基于视频会议的技能培训课程，并正在随机试验中评估其疗效。尽管 它的承诺，我们已经确定了几个关键差距，以夫妇为基础的艾滋病毒预防：1)现场技能培训是 繁重且不划算，2)许多结伴的男男性接触者无法登记结伴，因此 被排除在外，以及3)较新的、高风险的关系很少参加试验，所以我们需要传授关系技能来 恋爱开始前的单身男男性接触者。我们的目标是将2gether升级为可扩展和定制的 针对单身和结伴MSM的干预方案，包括：1)独立的关系教育 以及针对单身和结伴MSM的HIV预防电子健康计划(“ERE”)，以及2)两项额外的二元技能 辅导课程(仅限MSM以二人组身份参加)。目标1：评估定制的2gether的影响 男男性接触者HIV感染干预包。我们将招募5000名HIV阴性的男男性接触者来测试 关于干预后24个月HIV发病率的2gether量身定制干预方案的整体 相对于控制。我们还将探索特定定制元素的影响：(A)检查差异 单一MSM与配对MSM的有效性；(B)在配对MSM中，分析 超越自动ERE计划的二元技能辅导课程。目标2：探索不同领域的差异影响 男男性接触者亚群之间的治疗武器。我们将探索不同年龄组治疗的不同效果， 种族/民族、乡村和变性人的经历。目标3：研究2gether的实施 在全国范围内向扩展提供信息并确定成本。采用混合类型1的有效性-实施 在试验设计中，我们将使用混合方法来确定促进者和实施障碍。我们将衡量 通过与国家利益攸关方的深入访谈，确定关键的实施决定因素和成果，以 告知未来的实施策略，并进行成本分析，以估算计划实施的成本。

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.