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 我们将对项目nGage进行一项混合I型有效性-实施随机对照试验 （“nGage”）干预，一种基于证据的，灵活的，量身定制的干预措施，利用社会支持， 促进18岁以下艾滋病毒阳性的年轻黑人男男性行为者（YBMSM）的护理和病毒抑制（VS）保留 35.这项研究将在伊利诺伊州的芝加哥和亚拉巴马（AL）进行，这两个高负担地区是国家优先考虑的地区。 终止艾滋病毒流行病计划。现有的改善YBMSM连续护理结果的努力通常依赖于 在新创建的网络成员上，例如，同行领航员，支持小组，个案经理经常失踪， 这些方法是集中尝试利用有机的社会网络支持，即，的那些人 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YBMSM生活的有机社会网络支持 感染了艾滋病毒干预使用（1）社会网络可视化和理论来帮助男性识别支持 （2）信息-动机-行为技能模式，针对的是SC， 激活和维持二元社会支持;（3）一个链接的社会支持模型，以针对保留的驱动因素， 内容通过一次面对面会议和每季度一次的小型宣传活动提供。nGage的 灵活性确保了根据其支助职能而不是其作用来选择供应链委员会。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。到目前为止，测试有效性，N=600 YBMSM 芝加哥和AL的HIV感染者将随机接受nGage（n=300）或常规治疗（TAU） （n=300）。我们还将招募300名SC。在干预后12个月，我们将重新随机化nGage二联体， 继续接受每季度一次的小型加强治疗（持续nGage：n=150）或返回TAU（n=150）。数据收集 在基线、12个月和24个月时，将包括调查和电子病历（EMR）数据。研究 实施研究的综合框架（CFIR）， 决定因素框架和RE-AIM作为评价框架。具体目标是：（目标1）评价 （a）在N=600名18-35岁的YBMSM中，nGage与TAU在12个月内的有效性，以及（B）继续使用的价值 nGage超过12个月（持续nGage）。主要结果是保持护理和VS，因为 通过EMR数据测量;（目标2）检查干预效果（a）是否在芝加哥和AL之间变化，（B）是否 通过指数的动机准备、耻辱预期和自我效能的变化来介导，以及（c）是 由指数的心理健康和物质使用调节;以及（目标3）评估nGage的实施情况 使用CFIR和RE-AIM框架。在CFIR的指导下，我们将进行调查和焦点小组， 关键利益攸关方评估内部和外部环境，实施者和干预措施的特点，以及多方面的 影响实施的过程因素。我们将使用RE-AIM来评估覆盖率、采用率， 实施和维护，包括每个临床环境和地理环境中的实施成本

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