FINISHING HIV: An EHE model for Latinos Integrating One-Stop-Shop PrEP Services, a Social Network Support Program and a National Pharmacy Chain

完成艾滋病毒：针对拉丁裔的 EHE 模式，整合一站式 PrEP 服务、社交网络支持计划和全国药房连锁店

• 批准号: 10652529
• 负责人: Mariano Juan Kanamori Nishimura
• 金额: $ 71.01万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-23 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10652529
• 关键词: Address; Adherence; Affect; Area; Attitude; Awareness; Blood; Caring; Charge; Client; Collaborations; Collection; Communities; Consolidated Framework for Implementation Research; Consultations; Counseling; County; Diffusion; Diphosphates; Dryness; Effectiveness; Emotional; Enrollment; Environment; Epidemic; Event; Evolution; Florida; Fostering; Frequencies; Friends; Friendships; Funding; Gays; HIV; HIV diagnosis; Health; Health Promotion; Health behavior; Hearing; Hybrids; Information Services; Infrastructure; Insurance; Intervention; Knowledge; Latino; Latino Population; Logic; Mediator; Methods; Modeling; Network-based; Newly Diagnosed; Participant; Penetration; Pharmacy facility; Population; Prevention; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reaction; Research; Respondent; Risk Reduction; Running; Sampling; Science; Services; Social Environment; Social Network; Social support; Spottings; Tenofovir; Visit; Visualization; Work; bilingualism; community engagement; compare effectiveness; contagion; contextual factors; design; effectiveness evaluation; effectiveness-implementation RCT; empowerment; epidemic preparedness; evidence base; high risk population; implementation science; implementation strategy; improved; innovation; intervention effect; male; men who have sex with men; patient assistance; peer; personalized approach; pre-exposure prophylaxis; preference; primary outcome; programs; rapid testing; recruit; secondary outcome; sex; social; social cohesion; social culture; support network; telehealth; theories; transmission process

Project Summary/Abstract Overview and Background. This is a proposal for a hybrid 2 implementation-effectiveness randomized controlled trial (RCT) of FINISHING HIV, an implementation strategy bundle of a social network support component and a one-stop-shop PrEP component to improve PrEP initiation of Latino men who have sex with men (LMSM). PrEP can reduce HIV transmission by up to 99%,1 however, PrEP services are not being sufficiently accessed by Latinos in Miami, the epicenter of the HIV epidemic in the US.2 Further, LMSM who do not self-identify as gay have lower PrEP awareness than LMSM who self-identify as gay.3 To prepare for this study, we have developed an innovative approach that tailors LMSM engagement based on sexual self-identity using community-based social events and pharmacies. Preliminary work. The trial is a direct next step from our “Ending the HIV Epidemic” (EHE) planning supplements, where we conducted the needed preliminary study to launch this hybrid trial, and with ISCI3 support, the team jointly assessed feasibility, refined strategies and built a logic model informed by local context needs and preferences. Over the past two years, the PI has built partnerships with Latinos Salud (a local HIV agency for LMSM) and CVS Health. Design. We will use an innovative network-based approach informed by the PI’s K99/R00 funded research and Social Contagion Theory,4 which states that health behavior preferences, including PrEP initiation, are affected by opinions and attitudes prevailing in one’s social environment, and spread through friendship networks.5 Penetration at pharmacies and social events will lead to random assignment of the participants to either FINISHING HIV (social network support component + one-stop-shop PrEP component; N=24 seeds and 288 LMSM friends) or to standard health promotion (N=312). Participants will be assessed at baseline, and receive follow ups and dried blood spots collection at 6 and 12 months to quantify tenofovir diphosphate concentrations. For implementation (Aim 1), we will use RE-AIM framework6 to evaluate Reach (the extent to which high risk persons initiate participation in the program), and Implementation (the extent to which implementation strategies are delivered as designed) of FINISHING HIV. We will also use Consolidated Framework for Implementation Science Research7 to examine contextual factors associated with Reach and Implementation (e.g., facilitators and challenges or barriers to reach and implementation; participants reaction to these strategies). We will compare effectiveness (Aim 2) of the strategies in PrEP initiation (primary outcome), as well as PrEP knowledge, retention, and adherence (secondary outcomes). We will identify theory-based moderators (e.g., recruitment at social events vs. pharmacies) and social network mediators of intervention effects. We will also assess how friendship network structural evolutions contribute to increasing PrEP initiation. Implications. Our use of a social network support, one-stop-shop PrEP, and community and national pharmacy chain partners is a promising model that can be replicated in other EHE priority areas nationwide.

项目概要/摘要 概述和背景 这是关于混合 2 实施效果随机化的提案。 FINISHING HIV 的对照试验 (RCT)，社交网络支持的实施策略包 组件和一站式 PrEP 组件，以改善与性行为的拉丁裔男性的 PrEP 启动 男性 (LMSM)，PrEP 可以减少高达 99% 的 HIV 传播，1 然而，PrEP 服务尚未得到落实。 迈阿密是美国艾滋病毒流行的中心，拉丁裔可以充分利用这些信息。2 此外，LMSM 确实做到了这一点 不自我认同为同性恋者的 PrEP 意识低于自我认同为同性恋者的 LMSM。3 为此做好准备 研究中，我们开发了一种创新方法，根据性别自我认同定制 LMSM 参与度 利用基于社区的社交活动和药房进行试验是下一步的直接工作。 我们的“结束艾滋病毒流行”（EHE）规划补充，我们在其中进行了必要的初步 研究启动这项混合试验，并在 ISCI3 的支持下，团队共同评估了可行性，完善了策略 并根据当地环境需求和偏好建立了一个逻辑模型。在过去的两年里，PI 已经做到了这一点。 与 Latinos Salud（当地的 LMSM 艾滋病毒机构）和 CVS Health 建立了合作伙伴关系。 基于 PI 的 K99/R00 资助的研究和社会传染的基于网络的创新方法 理论 4 指出，健康行为偏好（包括 PrEP 启动）受到观点和观点的影响。 社会环境中盛行的态度，并通过友谊网络传播。5 渗透 药房和社交活动将导致参与者随机分配到“完成艾滋病毒” （社交网络支持组件 + 一站式 PrEP 组件；N=24 个种子和 288 个 LMSM 朋友）或 参与者将接受基线评估，并接受随访和评估。 在 6 个月和 12 个月时收集干血点以量化二磷酸替诺福韦浓度。 实施（目标1），我们将使用RE-AIM框架6来评估Reach（高风险的程度） 发起参与该计划的人）和实施（实施的程度） 我们还将使用《消除艾滋病毒综合框架》。 实施科学研究7 检查与影响力和实施相关的背景因素 （例如，达成和实施的促进因素和挑战或障碍；对这些因素的反应 我们将比较 PrEP 启动策略的有效性（目标 2）（主要结果），如 以及 PrEP 知识、保留率和依从性（次要结果）。 调解者（例如，社交活动与药房的招募）和社交网络干预调解者 我们还将评估友谊网络结构演变如何有助于增加 PrEP。 我们使用社交网络支持、一站式 PrEP 以及社区和国家。 药房连锁合作伙伴是一种有前景的模式，可以在全国其他 EHE 优先领域复制。