Harnessing Social Network Support to Improve Retention in Care and Viral Suppression among Young Black Men in Chicago and Alabama: A Hybrid Type I Effectiveness-Implementation Trial of Project nGage

摘要 我们将对nGage项目进行一项混合I型有效性-实施随机对照试验 (“nGage”)干预，这是一种基于证据的、灵活的、量身定制的干预措施，它利用社会支持来 促进18岁HIV阳性年轻黑人MSM(YBMSM)的护理和病毒抑制(VS) 35.这项研究将在伊利诺伊州的芝加哥和阿拉巴马州(AL)进行，这两个地区是全国优先考虑的高负担地区 结束艾滋病毒流行计划。改善青壮年男男性接触者连续护理结果的现有努力往往依赖于 关于新创建的网络成员，例如同行导航员、支持小组、案例经理。经常遗漏于 这些方法是利用有机社交网络支持的重点尝试，即那些 已经提供了情感、信息和工具支持的关键形式。相比之下，nGage 开发了干预措施，以识别、激活和利用对YBMSM生活的有机社会网络支持 艾滋病毒携带者。该干预使用(1)社会网络可视化和理论来帮助男性确定支持 知己(SC)从事关怀；(2)针对SC的信息-动机-行为技能模型 激活和维持二元性社会支持；(3)建立关联的社会支持模型，针对留存的驱动因素 关爱和VS。内容通过单一的面对面会议和季度迷你助推器提供。NGage的 灵活性确保根据支持功能而不是其角色来选择SC。在试点RCT中 在芝加哥，我们证明了可行性、可接受性和有效性。现在要测试有效性，N=600 YBMSM 芝加哥和AL的艾滋病毒携带者将随机接受nGage(n=300)或照常治疗(TAU) 300例。我们还将招收300名SC。在干预后12个月，我们将重新随机化nGage二元组以 继续接受季度微型助推器(持续nGage：n=150)或返回TAU(n=150)。数据收集 在基线上，12个月和24个月将包括调查和电子病历(EMR)数据。学习 实施，我们将使用实施研究综合框架(CFIR)作为 决定因素框架和RE-AIM作为评价框架。具体目标是：(目标1)评估 (A)在N=600名18-35岁的YBMSM中，NGage与TAU在12个月内的有效性和(B)继续的价值 NGage超过12个月(持续nGage)。主要结果是保留在护理和VS，因为 通过EMR数据衡量；(目标2)检查干预效果(A)在芝加哥和AL之间是否不同，(B) 由指数的激励准备、污名期望和自我效能的变化调节，和(C)是 (目标3)评价nGage的实施情况 使用CFIR和RE-AIM框架。在该中心的指导下，我们将与 关键利益相关者评估内部和外部环境、实施者和干预特征，以及多个 影响实施的水平流程因素。我们将使用RE-AIM来评估REACH、采用率、 实施和维护，包括在每个临床环境和地理环境下的实施费用

Abstract We will conduct a Hybrid Type I effectiveness-implementation randomized controlled trial of the Project nGage (“nGage”) intervention, an evidence-based, flexible, and tailored intervention that harnesses social support to promote retention in care and viral suppression (VS) among HIV-positive young Black MSM (YBMSM) aged 18- 35. The study will take place in Chicago, IL, and Alabama (AL), two high-burden areas prioritized in the national Ending the HIV Epidemic Plan. Existing efforts to improve Continuum of Care outcomes for YBMSM often rely on newly created network members, e.g., peer navigators, support groups, case managers. Often missing from these approaches is a focused attempt to harness organic social network supports, i.e., those people who already offer critical forms of emotional, informational, and instrumental support. In contrast, the nGage intervention was developed to identify, activate, and harness organic social network support for YBMSM living with HIV. The intervention uses (1) social network visualization and theory to help men identify a Support Confidant (SC) to engage in care; (2) the Information-Motivation-Behavioral Skills Model targeted at the SC to activate and maintain dyadic social support; (3) a linked social support model to target the drivers of retention in care and VS. Content is delivered via a single face-to-face session and quarterly mini-boosters. nGage's flexibility ensures that SCs are selected based on their supportive function rather than their role. In a pilot RCT in Chicago, we demonstrated feasibility, acceptability, and efficacy. To now test effectiveness, N=600 YBMSM living with HIV in Chicago and AL will be randomized to receive nGage (n=300) or treatment as usual (TAU) (n=300). We also will enroll 300 SCs. At 12-months post-intervention, we will re-randomize nGage dyads to continue receiving quarterly mini-boosters (Sustained nGage: n=150) or return to TAU (n=150). Data collection at baseline, 12, and 24 months will include surveys and electronic medical record (EMR) data. To study implementation, we will use the Consolidated Framework for Implementation Research (CFIR) as the determinants framework and RE-AIM as the evaluation framework. The specific aims are to: (Aim 1) Evaluate the (a) effectiveness of nGage vs. TAU over 12 months in N=600 YBMSM aged 18-35 and (b) value of continuing nGage over another 12 months (Sustained nGage). The primary outcomes are retention in care and VS, as measured by EMR data; (Aim 2) Examine if intervention effects (a) vary between Chicago and AL, (b) are mediated by changes in the Index's motivational readiness, stigma expectancies, and self-efficacy, and (c) are moderated by Index's mental health and substance use; and (Aim 3) Evaluate the implementation of nGage using the CFIR and the RE-AIM framework. Guided by the CFIR, we will conduct surveys and focus groups with key stakeholders to assess the inner and outer settings, implementer and intervention characteristics, and multi- level process factors that influence implementation. We will use RE-AIM to assess Reach, Adoption, Implementation, and Maintenance, including implementation costs in each clinical setting and geographic context