Developing and Implementing Provider-Training and Evidence-Based Tools to Support Pre-exposure Prophylaxis (PrEP) Decision-Making and Increase PrEP Adherence Among Young Men Who Have Sex With Men: Protocol for the PrEP Choice Longitudinal Cohort Study.

IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2025-03-20 DOI:10.2196/64186
Crissi Rainer, Rebecca Schnall, Mary R Tanner, Carla A Galindo, Karen W Hoover, Sylvie Naar, Maeve Brin, Andres Martinez, Haomiao Jia, Maria Mendoza, Lisa Hightow-Weidman
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Abstract

Background: Despite the availability of highly effective HIV pre-exposure prophylaxis (PrEP), uptake and adherence to PrEP among young men who have sex with men (YMSM) remains low, limiting its impact on the prevention of HIV infection. Strategies that incorporate an array of prevention options and provide YMSM and their providers with tailored education and support tools, including tools to support shared decision-making, are needed.

Objective: The goals of the Centers for Disease Control and Prevention (CDC)-funded PrEP Choice study include the development and deployment of CDC guideline-consistent PrEP provider training and the implementation of evidence-based provider- and client-facing PrEP education and support tools. Under this initiative, the CDC funded 2 research projects, Florida State University (the Expanding PrEP in Communities of Color [EPICC] project), and Columbia University (the mChoice project).

Methods: Providers from both projects will complete the PrEP Choice online training, which was developed to educate providers on PrEP options and how to engage clients in open discussions around sexual health and PrEP options. EPICC project providers will also attend online tailored motivational interviewing (TMI) training sessions, and mChoice project providers will view a training video on cultural competency and humility in PrEP care. Following training, each project will enroll a cohort of 400 participants receiving care from study providers and follow them for 12-18 months. Participants will complete online surveys every 3 months and provide biomarkers to assess PrEP adherence. Electronic health record (EHR) data will be collected every 6 months to provide additional information on clinic attendance, PrEP prescriptions, and HIV/sexually transmitted infection (STI) testing. Each project will provide cohort participants with a unique digital health tool to support the PrEP choice and ongoing adherence. The study will assess the effectiveness of training and educational and support tools in practice and the critical factors associated with the successful uptake of and adherence to PrEP by participants. The study will also monitor patterns of PrEP use among YMSM, including types of PrEP and switching between types.

Results: Formative work to develop and prepare the tools for implementation was completed in 2023. The EPICC project began provider training in early 2024, and the mChoice project began in spring 2024. Cohort enrollment for both projects began after provider training began.

Conclusions: Given the changing PrEP landscape, implementation of provider education and tools to maximize uptake and adherence is needed. By delivering culturally competent and interactive provider training on PrEP options, the study will help providers counsel and guide participants on the effective and safe use of PrEP. The digital health tools created will support participant adherence to help them optimize PrEP benefits. Through the cohort design, the PrEP Choice study will provide real-world data about PrEP use that will be critical for informing future guidelines and tools.

International registered report identifier (irrid): DERR1-10.2196/64186.

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开发和实施提供者培训和基于证据的工具,以支持暴露前预防(PrEP)决策,并增加年轻男男性行为者的PrEP依从性:PrEP选择纵向队列研究方案。
背景:尽管有高效的艾滋病毒暴露前预防(PrEP),但年轻男男性行为者(YMSM)对PrEP的吸收和依从性仍然很低,限制了其对预防艾滋病毒感染的影响。需要制定包含一系列预防方案的战略,并为YMSM及其提供者提供量身定制的教育和支持工具,包括支持共同决策的工具。目的:美国疾病控制与预防中心(CDC)资助的PrEP选择研究的目标包括开发和部署符合CDC指南的PrEP提供者培训,以及实施基于证据的提供者和面向客户的PrEP教育和支持工具。在这一倡议下,疾病预防控制中心资助了两个研究项目,佛罗里达州立大学(扩展有色人种社区PrEP项目)和哥伦比亚大学(mChoice项目)。方法:两个项目的提供者将完成PrEP选择在线培训,该培训旨在教育提供者关于PrEP选择以及如何让客户参与有关性健康和PrEP选择的公开讨论。EPICC项目提供者还将参加在线量身定制的动机访谈(TMI)培训课程,mChoice项目提供者将观看关于PrEP护理中的文化能力和谦逊的培训视频。培训结束后,每个项目将招募400名接受研究提供者护理的参与者,并对他们进行12-18个月的随访。参与者将每3个月完成一次在线调查,并提供生物标志物来评估PrEP的依从性。电子健康记录(EHR)数据将每6个月收集一次,以提供有关诊所就诊情况、预防措施处方和艾滋病毒/性传播感染(STI)检测的额外信息。每个项目将为队列参与者提供一个独特的数字健康工具,以支持PrEP的选择和持续坚持。该研究将评估培训、教育和支持工具在实践中的有效性,以及与参与者成功接受和坚持PrEP相关的关键因素。该研究还将监测男性男性使用PrEP的模式,包括PrEP的类型和类型之间的转换。结果:开发和准备实施工具的形成性工作于2023年完成。EPICC项目于2024年初开始对供应商进行培训,mChoice项目于2024年春季开始。两个项目的队列登记在提供者培训开始后开始。结论:鉴于PrEP环境的变化,需要实施提供者教育和工具,以最大限度地吸收和坚持。通过提供具有文化竞争力和互动式的PrEP提供者培训,该研究将帮助提供者就PrEP的有效和安全使用向参与者提供咨询和指导。创建的数字健康工具将支持参与者坚持使用PrEP,帮助他们优化PrEP的益处。通过队列设计,PrEP选择研究将提供有关PrEP使用的真实数据,这将对指导未来的指南和工具至关重要。国际注册报告标识符(irrid): DERR1-10.2196/64186。
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