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 我们将对 nGage 项目进行混合 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 HIV 阳性年轻黑人 MSM (YBMSM) 的护理保留和病毒抑制 (VS) 35. 该研究将在伊利诺伊州芝加哥和阿拉巴马州 (AL) 进行，这两个地区是国家优先考虑的高负担地区。 结束艾滋病毒流行计划。改善 YBMSM 连续护理结果的现有努力通常依赖于 新创建的网络成员，例如同行导航员、支持小组、案例经理。经常失踪于 这些方法是集中尝试利用有机社交网络支持，即那些 已经提供了关键形式的情感、信息和工具支持。相比之下，nGage 制定干预措施是为了识别、激活和利用对 YBMSM 生活的有机社交网络支持 患有艾滋病毒。该干预措施使用 (1) 社交网络可视化和理论来帮助男性识别支持者 密友（SC）从事护理工作； (2) 针对SC的信息-动机-行为技能模型 激活并维持二元社会支持； (3) 一个链接的社会支持模型，针对保留的驱动因素 护理和VS。内容通过一次面对面会议和每季度的迷你助推器提供。 nGage的 灵活性确保了 SC 的选择是基于其支持功能而不是角色。在试点随机对照试验中 在芝加哥，我们展示了可行性、可接受性和有效性。现在测试有效性，N=600 YBMSM 芝加哥和阿拉巴马州的 HIV 感染者将被随机分配接受 nGage (n=300) 或照常治疗 (TAU) （n=300）。我们还将招收 300 名 SC。干预后 12 个月，我们将重新随机化 nGage 二元组 继续接受季度迷你助推器（持续 nGage：n=150）或返回 TAU（n=150）。数据收集 基线、12 个月和 24 个月将包括调查和电子病历 (EMR) 数据。学习 实施时，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作为评估框架。具体目标是：（目标 1）评估 (a) nGage 与 TAU 在 12 个月内对 N=600 名 18-35 岁的 YBMSM 的有效性以及 (b) 持续治疗的价值 nGage 再持续 12 个月（持续 nGage）。主要结果是保留护理和 VS，因为 通过 EMR 数据测量； （目标 2）检查芝加哥和阿拉巴马州之间的干预效果 (a) 是否不同，(b) 是否不同 由指数的动机准备度、耻辱期望和自我效能的变化来调节，并且（c）是 由 Index 的心理健康和物质使用情况调节； （目标 3）评估 nGage 的实施 使用 CFIR 和 RE-AIM 框架。在 CFIR 的指导下，我们将开展调查和焦点小组 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方面 影响实施的水平过程因素。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的实施成本