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: 10488047
• 负责人: Rebecca Schnall
• 金额: $ 103.99万
• 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: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10488047
• 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.

男男性行为者 (MSM)，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 (US) 的 HIV 诊断率最高，这说明需要及时、 为这些人群提供有效且文化上一致的艾滋病毒预防工具。其中一种工具就是预曝光 预防 (PrEP)，是结束艾滋病毒流行过程中预防新发艾滋病毒感染的支柱之一：A 美国的“美国计划”倡议。优先人群增加 PrEP 的使用是一项紧急的艾滋病毒预防措施 需要。目前或即将推出三种 PrEP 方案： 1) 每日口服 PrEP（含替诺福韦） 富马酸二吡呋酯和恩曲他滨 (TDF/FTC) 或替诺福韦艾拉酚胺和恩曲他滨 (TAF/FTC)，2) 2-1- 1 剂 TDF/FTC，以及 3) 每两个月注射一次的长效卡博特韦 (CAB-LA)，预计会 最快几个月内即可上市。然而，黑人中 PrEP 的采用与 HIV 感染风险成反比 和拉丁裔年轻 MSM 相比白人和年长 MSM，他们获得和坚持 PrEP 的可能性较小，尽管 相对于其他种族/族裔和年龄组，他们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层面的障碍 患者层面的 PrEP 依从性和持久性障碍。因此，我们提出的研究目标是：1） 通过实践促进和 提供者关于文化上一致的 PrEP 选项的培训，以及 2) 患者层面的 PrEP 依从性障碍和 通过移动健康 (mHealth) 工具（mChoice 应用程序）进行持久化。建立在 CDC 唯一基于证据的基础上 PrEP 药物依从性/持久性的干预、PrEPmate 以及我们自己与 CDC 的形成性工作 （U01PS003715；PI：Schnall）设计和构建移动医疗应用程序并将其与智能药盒（CleverCap）集成， 患者层面的干预措施 mChoice 应用程序将使口服 PrEP 用户能够自我监控他们的药物治疗 实时遵守；提供有关 PrEP 选择的关键信息、有关预约的提醒消息、 视频以及接受 PrEP 的同伴的感言；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，其中包括围绕文化上一致的 PrEP 选项进行提供者培训， 实施形成性评价和实施后总结性评价。评估 有效性，我们将进行混合型 II 试验，同时测试文化上的有效性 一致的临床干预（mChoice App）和实施干预（实践促进）指导 通过补充实施和评估框架——综合实施框架 研究 (CFIR) 和范围、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 实施，并最终减少 美国纽约市和阿拉巴马州伯明翰两个高度优先地区的新艾滋病毒感染发生率。