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

利用社交网络支持改善芝加哥和阿拉巴马州年轻黑人的护理保留和病毒抑制：nGage 项目的 I 型混合有效性实施试验

• 批准号: 10569099
• 负责人: David S Batey
• 金额: $ 55.04万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-26 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10569099
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Age; Alabama; Anti-Retroviral Agents; Area; Behavioral; Behavioral Sciences; Caring; Case Management; Case Manager; Characteristics; Chicago; Clinic; Clinical; Communities; Computerized Medical Record; Consolidated Framework for Implementation Research; Continuity of Patient Care; County; Coupled; Data; Data Collection; Deep South; Effectiveness; Emotional; Enrollment; Ensure; Epidemic; Evaluation; Evidence based intervention; Expectancy; Focus Groups; Foundations; Geography; Goals; HIV; HIV Seropositivity; Health; Hybrids; Incidence; Intervention; Life; Link; Maintenance; Measures; Mediating; Mental Health; Modeling; Monitor; Motivation; Outcome; Persons; Positioning Attribute; Process; Public Health; Race; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Research; Risk; Role; Self Efficacy; Services; Site; Social Network; Social support; Substance abuse problem; Support Groups; Surveys; Testing; Theoretical model; Viral; Viral Load result; Visit; Visualization; aged; behavior change; black men; black men who have sex with men; care outcomes; cooking; effectiveness testing; effectiveness-implementation RCT; effectiveness/implementation trial; epidemic preparedness; evidence base; experience; flexibility; health disparity; implementation cost; implementation evaluation; implementation science; implementation strategy; improved; improved outcome; indexing; innovation; intervention effect; member; men; novel; peer; post intervention; primary outcome; programs; recruit; response; skills; social engagement; social stigma; stressor; substance use; substance use treatment; theories; therapy design; transmission process; treatment as prevention; treatment as usual

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

抽象的 我们将进行项目不良的I型混合I型实施随机对照试验 （“ NGAGE”）干预，一种基于证据，灵活和量身定制的干预措施，可利用社会支持 促进18岁年龄的HIV阳性黑人MSM（YBMSM）中的护理和病毒抑制（VS）保留率 35。这项研究将在芝加哥，伊利诺伊州和阿拉巴马州（AL）进行，两个高负地区在国家 结束HIV流行计划。现有的改善YBMSM的护理结果的努力通常依赖 在新创建的网络成员中，例如同行导航员，支持组，案例经理。经常缺少 这些方法是利用有机社交网络支持的重点尝试，即 已经提供了情感，信息和工具支持的关键形式。相比之下，不利者 开发了干预措施来识别，激活和利用YBMSM生活的有机社交网络支持 与艾滋病毒。干预使用（1）社交网络可视化和理论来帮助男性确定支持 知己（SC）从事护理； （2）针对SC的信息动机行为技能模型 激活和维持二元社会支持； （3）链接的社会支持模型，以针对保留驱动力的驱动力 护理和VS。内容是通过一次面对面的会话和季度迷你启动者提供的。不民不齐的 灵活性确保SC是根据其支持功能而不是其角色选择的。在飞行员RCT中 在芝加哥，我们证明了可行性，可接受性和有效性。现在测试有效性，n = 600 ybmsm 在芝加哥和艾尔（Al）患艾滋病毒（HIV （n = 300）。我们还将注册300 SC。干预后12个月，我们将重新将NGAGE DYAD重新融合到 继续接收季度迷你启动（持续的NGAGE：n = 150）或返回tau（n = 150）。数据收集 在基线时，12个月和24个月将包括调查和电子病历（EMR）数据。学习 实施，我们将使用合并框架进行实施研究（CFIR）作为 决定因素框架并将其作为评估框架。具体目的是：（目标1）评估 （a）在12个月内N = 600 YBMSM年龄在18-35岁和（b）继续的价值的（a）在12个月内的有效性 不民不理论在12个月内（持续的无力尽）。主要结果是保留在护理和VS中， 通过EMR数据衡量； （AIM 2）检查干预效果（a）在芝加哥和AL之间是否有所不同，（b）是 该指数的动机准备性，污名和自我效能感以及（c）的变化介导了 由指数的心理健康和药物使用来主持； （AIM 3）评估NGAGE的实施 使用CFIR和RE-AIM框架。在CFIR的指导下，我们将与 关键利益相关者评估内部和外部设置，实施者和干预特征，以及 影响实施的水平过程因素。我们将使用re-aim评估覆盖范围，采用， 实施和维护，包括在每个临床环境和地理环境中的实施成本