Rainer Crissi, Schnall Rebecca, Tanner Mary R, Galindo Carla A, Hoover Karen W, Naar Sylvie, Brin Maeve, Martinez Andres, Jia Haomiao, Mendoza Maria, Hightow-Weidman Lisa
Institute on Digital Health and Innovation, College of Nursing, Florida State University, Tallahassee, FL, United States.
School of Nursing, Columbia University, New York, NY, United States.
JMIR Res Protoc. 2025 Mar 20;14:e64186. doi: 10.2196/64186.
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.
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).
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.
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.
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.
尽管有高效的艾滋病病毒暴露前预防(PrEP)措施,但男男性行为者(YMSM)中PrEP的接受率和依从性仍然很低,限制了其对预防艾滋病病毒感染的影响。需要采取一系列预防措施,并为YMSM及其医疗服务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。
由美国疾病控制与预防中心(CDC)资助的PrEP Choice研究的目标包括开发和部署符合CDC指南的PrEP医疗服务提供者培训,以及实施基于证据的面向医疗服务提供者和患者的PrEP教育与支持工具。在此倡议下,CDC资助了2个研究项目,佛罗里达州立大学(有色人种社区扩大PrEP项目[EPICC])和哥伦比亚大学(mChoice项目)。
两个项目的医疗服务提供者都将完成PrEP Choice在线培训,该培训旨在教育医疗服务提供者有关PrEP选项以及如何让患者参与围绕性健康和PrEP选项的公开讨论。EPICC项目的医疗服务提供者还将参加在线定制动机性访谈(TMI)培训课程,mChoice项目的医疗服务提供者将观看关于PrEP护理中文化能力和谦逊态度的培训视频。培训结束后,每个项目将招募400名接受研究医疗服务提供者护理的参与者,并对他们进行12至18个月的随访。参与者每3个月完成一次在线调查,并提供生物标志物以评估PrEP依从性。每6个月收集一次电子健康记录(EHR)数据,以提供有关就诊情况、PrEP处方以及艾滋病毒/性传播感染(STI)检测的更多信息。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选择和持续依从性。该研究将评估培训、教育和支持工具在实际应用中的有效性,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YMSM中PrEP的使用模式,包括PrEP类型以及不同类型之间的转换。
2023年完成了开发和准备实施工具的形成性工作。EPICC项目于2024年初开始医疗服务提供者培训,mChoice项目于2024年春季开始。两个项目的队列招募在医疗服务提供者培训开始后启动。
鉴于PrEP情况不断变化,需要实施医疗服务提供者教育和工具以最大限度地提高接受率和依从性。通过提供关于PrEP选项的具有文化胜任力和互动性的医疗服务提供者培训,该研究将帮助医疗服务提供者为参与者提供关于有效和安全使用PrEP的咨询和指导。创建的数字健康工具将支持参与者的依从性,帮助他们优化PrEP的益处。通过队列设计,PrEP Choice研究将提供关于PrEP使用的真实世界数据,这对于为未来的指南和工具提供信息至关重要。
国际注册报告识别码(IRRID):DERR1-10.2196/64186