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

项目摘要/摘要 概述和背景。这是一项混合2实施方案--有效性随机化 完成HIV的受控试验(RCT)，社交网络支持的实施战略捆绑 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可以将艾滋病毒传播减少高达99%，1然而，PrEP服务并没有 迈阿密的拉美裔人充分接触到了这一点，迈阿密是美国艾滋病毒流行的中心。 没有自我认同为同性恋的LMSM比自我认同为同性恋的LMSM对PrEP的认识更低。 研究中，我们开发了一种创新的方法，基于性别自我认同来定制LMSM参与 利用基于社区的社交活动和药房。前期工作。这项试验是直接的下一步 我们的“结束艾滋病毒流行”(EHE)计划补充，在那里我们进行了所需的初步准备 研究启动这一混合试验，并在ISCI3的支持下，团队联合评估了可行性，改进了战略 并构建了一个以当地背景需求和偏好为信息的逻辑模型。在过去的两年里，PI已经 与拉丁裔Salud(LMSM当地的艾滋病毒机构)和CVS Health建立了合作伙伴关系。设计。我们将使用 创新的基于网络的方法，由PI的K99/R00资助的研究和社会传染所启发 理论4，该理论指出，健康行为偏好，包括PrEP的启动，受到观点和 在社交环境中盛行的态度，并通过友谊网络传播。 药房和社交活动将导致参与者随机分配完成HIV (社交网络支持组件+一站式PrEP组件；N=24个种子和288个LMSM好友)或 到标准健康促进组(N=312)。参与者将在基线上接受评估，并接受后续和 在6个月和12个月时采集干血斑点以量化替诺福韦二磷酸浓度。为 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 人员开始参与方案)和执行(执行的程度 战略是按计划交付的)结束艾滋病毒。我们还将使用整合框架 实施科学研究7，以检查与REACH和实施相关的背景因素 (例如，促进者、挑战或达成和实施的障碍；参与者对这些反应 战略)。我们将比较这些策略在PrEP启动中的有效性(目标2)(主要结果)，如 以及PrEP知识、保留和遵守(次要结果)。我们将确定基于理论的 主持人(例如，社交活动招聘与药店招聘)和干预的社交网络调解人 效果。我们还将评估友谊网络结构的演变如何有助于提高PrEP 入会仪式。这意味着什么。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很有前途的模式，可以在全国其他EHE优先领域复制。

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.