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

mChoice：通过在两个高度优先的环境中提供定制的提供者培训和依从性援助，提高少数族群 MSM 的 PrEP 接受度和依从性

• 批准号: 10324998
• 负责人: Rebecca Schnall
• 金额: $ 103.92万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10324998
• 关键词: mChoice; Improving; PrEP; Uptake; Adherence

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.

与男人发生性关系（MSM）的男人，尤其是年轻的黑人/非裔美国人（“黑人”）和西班牙裔/拉丁裔 （“拉丁裔”）MSM，在美国（美国）的HIV诊断率最高，说明了及时的需求 这些人群容易且文化上一致的HIV预防工具。一种这样的工具是预曝光 预防（PREP），这是预防新艾滋病毒感染的支柱之一： 美国计划在美国。优先人群增加的预备使用是紧急的艾滋病毒预防 需要。目前有三个准备选项或即将提供的准备：1）每日口服预备完成Tenofovir 毒fumarate和emtricitabine（TDF/FTC）或Tenofovir Alafenamide和Emtricitabine（TAF/FTC），2）2-1-- 1剂量TDF/FTC和3）双月注射的长效Cabotegravir（Cab-la），预计将 在几个月内就可以使用。但是，PREP的吸收与黑色的HIV获取风险相反 和拉丁裔年轻的MSM，他们不太可能与白色和年龄较大的MSM目的地访问和遵守准备 是相对于其他种族/种族和年龄段获得艾滋病毒的最高风险群体。都有 提供者级别的障碍，以增加优先人群中的预备筛查，咨询和主动性 患者级别遵守和持久性的障碍。因此，我们提出的研究将针对：1） 提供者级别级别的障碍，通过实践设施和A 提供者在文化上一致的准备方案的培训，以及2）患者级依从性的障碍和 通过移动健康（MHealth）工具（MCHOICE应用程序）的持久性。建立在唯一基于CDC的证据的基础上 干预药物的依从性/持久性，预序和我们自己与CDC的形成性工作 （U01PS003715; PI：Schnall）设计和构建MHealth应用程序，并将其与智能药盒（CleverCap）集成 患者级干预MCHOICE应用程序将使口服准备用户能够自我监测其药物治疗 实时依从性；提供有关准备选择的关键信息，提醒有关约会的消息， 视频和同行的证明；并促进参与者之间的双向沟通 研究人员在研究期间。实践设施干预将完成三个阶段： 实施计划，其中包括围绕文化一致的准备选项的提供者培训， 实施形成性评估和实施后总结性评估。评估 有效性，我们将进行一项Hybrid II型试验，简单地测试文化的有效性 指导的一致临床干预（MCHOICE应用程序）和实施干预（实践设施） 通过互补的实施和评估框架 - 实施的合并框架 研究（CFIR）以及覆盖范围，有效性，采用，实施和维护（RE-AIM）。发现 有可能改善年轻黑人和拉丁裔MSM的准备递送，并最终减少 在美国，纽约市和阿拉巴马州伯明翰的两个高优先级环境中，新的艾滋病毒感染发生率。