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.

与男性发生性关系的男性（MSM），特别是年轻的黑人/非洲裔美国人（“黑人”）和西班牙裔/拉丁裔 （“拉丁裔”）男男性接触者，在美国艾滋病毒诊断率最高，说明需要及时， 为这些人群提供有效和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），这是在结束艾滋病毒流行中预防新的艾滋病毒感染的支柱之一：A 美国的Plan for America计划。增加优先人群的PrEP使用是一项紧迫的艾滋病毒预防措施 需要的目前或即将推出的PrEP有三种选择：1）每日口服PrEP，由替诺福韦组成 富马酸二异山梨酯和恩曲他滨（TDF/FTC）或替诺福韦艾拉酚胺和恩曲他滨（TAF/FTC），2）2-1- 1次TDF/FTC给药，和3）每两个月注射一次长效卡博特拉韦（CAB-LA），预期 几个月后就可以上市了然而，PrEP的摄取与黑人中的艾滋病毒感染风险相反 和拉丁美洲年轻的男男性接触者谁是不太可能获得和坚持PrEP比白色和老年男男性接触者，尽管 与其他种族/族裔和年龄组相比，他们是感染艾滋病毒的最高风险群体。既有 在优先人群中增加PrEP筛查、咨询和启动的提供者层面的障碍， 患者层面的障碍，以遵守和坚持准备。因此，我们提出的研究将目标：1） 提供者层面的障碍，以最佳的PrEP筛查，咨询，并通过实践促进和启动 提供者在文化上一致的PrEP选项方面的培训，以及2）患者层面的PrEP依从性障碍， 通过移动的健康（mHealth）工具（mChoice App）实现持久性。基于CDC唯一的循证医学 PrEP药物依从性/持续性的干预、PrEPmate以及我们自己与CDC的形成性工作 （U 01 PS 003715; PI：Schnall）设计和构建移动健康应用程序，并将其与智能药盒（CleverCap）集成， 患者层面的干预，mChoice应用程序，将使口服PrEP用户能够自我监测他们的药物 实时依从性;提供有关PrEP选择的关键信息，有关预约的提醒消息， 视频，和同行的推荐服用PrEP;并促进参与者之间的双向沟通， 研究期间的研究人员。实践促进干预将包括三个阶段： 实施规划，其中将包括围绕文化上一致的PrEP选项的提供者培训， 实施形成性评价和实施后总结性评价。评估 有效性，我们将进行混合II型试验，同时测试文化的有效性， 一致的临床干预（mChoice App）和实施干预（实践促进）指导 执行和评价框架-综合执行框架 研究（CFIR）和达到，有效性，采用，实施和维护（RE-AIM）。结果 将有可能改善年轻黑人和拉丁裔男男性接触者的PrEP交付，并最终减少 美国纽约市和亚拉巴马州伯明翰市两个高度优先环境中新发艾滋病毒感染的发病率。