mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings

与男性(MSM)发生性关系的男性，特别是年轻的黑人/非裔美国人(“黑人”)和西班牙裔/拉丁裔 (“拉丁裔”)MSM，是美国艾滋病毒诊断率最高的，说明需要及时、 为这些人群提供有效的、文化上一致的艾滋病毒预防工具。其中一个工具就是预曝光。 预防(PrEP)，这是防止新的艾滋病毒感染的支柱之一，以结束艾滋病毒流行：a 美国的“为美国计划”倡议。优先人群更多地使用PrEP是预防艾滋病毒的当务之急 需要。目前或即将推出三种PrEP方案：1)每日口服替诺福韦PrEP 富马酸异丙酚和恩曲他滨(TDF/FTC)或替诺福韦丙氨酰胺和恩曲他滨(TAF/FTC)，2)2-1- 1剂量TDF/FTC，3)两个月注射长效卡波替格雷(CAB-LA)，预计将 最快将在几个月内推出。然而，在黑人中，PrEP的摄取率与HIV感染风险相反 和拉丁裔年轻MSM，他们比白人和年长的MSM更不可能获得和遵守PrEP，尽管 相对于其他种族/民族和年龄组，是感染艾滋病毒的最高风险群体。两者都有 在优先人群中增加PrEP筛查、咨询和启动的提供者级别的障碍 患者层面对PrEP的坚持和坚持的障碍。因此，我们建议的研究目标如下：1) 提供者级别的障碍，通过实践促进和 提供有关文化一致性PrEP选项的培训，以及2)患者层面的PrEP遵守障碍和 通过移动健康(MHealth)工具(MChoice App)实现持久性。建立在疾控中心唯一的循证基础上 干预PrEP用药依从性/持久性、PrEPmate，以及我们与疾病预防控制中心的合作 (U01PS003715；PI：Schnall)设计和构建一个mHealth应用程序，并将其与智能药盒(CleverCap)集成， 患者级别的干预，mChoice App，将使口服PrEP用户能够自我监控他们的药物 实时遵守；提供有关PrEP选择的关键信息、有关约会的提醒消息、 参加PrEP的同行的视频和推荐信；并促进参与者和 研究人员在研究过程中。实践促进干预将包括三个阶段：前 实施规划，其中将包括围绕文化契合的PrEP选项的提供商培训， 实施与形成性评价、实施后总结性评价。要评估 有效性，我们将同时进行一项混合类型II试验，以测试文化上的 一致性临床干预(MChoice App)和实施干预(实践促进)指导 按相辅相成的执行和评价框架--执行综合框架 研究(CFIR)和REACH、有效性、采用、实施和维护(RE-AIM)。发现 将有可能改善年轻黑人和拉丁裔MSM的PrEP交付，并最终减少 在美国纽约市和阿拉巴马州伯明翰这两个高度优先的环境中新感染艾滋病毒的发生率。

Men who have sex with men (MSM), especially young Black/African American (“Black”) and Hispanic/Latino (“Latino”) MSM, have the highest rates of HIV diagnoses in the United States (US), illustrating the need for timely, efficacious, and culturally congruent HIV prevention tools for these populations. One such tool is pre-exposure prophylaxis (PrEP), which is one of the pillars to prevent new HIV infections in the Ending the HIV Epidemic: A Plan for America initiative in the US. Increasing PrEP use by priority populations is an urgent HIV prevention need. There are three PrEP options currently or soon to be available: 1) daily oral PrEP comprised of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) or tenofovir alafenamide and emtricitabine (TAF/FTC), 2) 2-1- 1 dosing of TDF/FTC, and 3) bi-monthly injectable long-acting cabotegravir (CAB-LA), which is expected to become available in as soon as a few months. Yet, uptake of PrEP is inverse to HIV acquisition risk among Black and Latino young MSM who are less likely to access and adhere to PrEP than White and older MSM despite being the highest risk group for acquiring HIV relative to other racial/ethnic and age groups. There are both provider-level barriers to increasing PrEP screening, counseling, and initiation among priority populations and patient-level barriers to adherence and persistence to PrEP. Therefore, our proposed study will target: 1) provider-level barriers to optimal PrEP screening, counseling, and initiation through practice facilitation and a provider training on culturally congruent PrEP options, and 2) patient-level barriers to PrEP adherence and persistence through a mobile health (mHealth) tool (mChoice App). Building on the only CDC evidence-based intervention for PrEP medication adherence/persistence, PrEPmate, and our own formative work with the CDC (U01PS003715; PI: Schnall) to design and build a mHealth app and integrate it with a smart pill box (CleverCap), the patient-level intervention, mChoice App, will enable oral PrEP users to self-monitor their medication adherence in real-time; provide key information about PrEP choices, reminder messages about appointments, videos, and testimonials of peers taking PrEP; and promote two-way communication between participants and the study staff during the study. The practice facilitation intervention will comprise three phases: pre- implementation planning, which will include provider training around culturally congruent PrEP options, implementation with formative evaluation, and post-implementation summative evaluation. To assess the effectiveness, we will conduct a Hybrid Type II trial simultaneously testing the effectiveness of a culturally congruent clinical intervention (mChoice App) and an implementation intervention (practice facilitation) guided by complementary implementation and evaluation frameworks–the Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Findings will have the potential to improve PrEP delivery for young Black and Latino MSM and, ultimately, decrease the incidence of new HIV infections in two high-priority settings in the US, New York City and Birmingham, Alabama.