Shrestha Roman, Wickersham Jeffrey A, Khati Antoine, Azwa Iskandar, Ni Zhao, Kamarulzaman Adeeba, Sullivan Patrick Sean, Jadkarim Luzan, Eger William H, Gautam Kamal, Altice Frederick L
Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.
AIDS Program, Yale School of Medicine, New Haven, CT, United States.
JMIR Res Protoc. 2022 Dec 21;11(12):e43318. doi: 10.2196/43318.
BACKGROUND: Men who have sex with men (MSM) are disproportionately affected by the HIV epidemic in Malaysia and globally. Cross-cutting prevention strategies such as mobile health (mHealth), particularly smartphone apps, hold great promise for HIV prevention efforts among Malaysian MSM, especially when linked to HIV testing and pre-exposure prophylaxis (PrEP). OBJECTIVE: This study aims to adapt an existing app to create and test a clinic-integrated app (JomPrEP), a virtual platform to deliver HIV testing and PrEP services for MSM in Malaysia. METHODS: The JomPrEP project involves developing and testing an app-based platform for HIV prevention among Malaysian MSM and will be conducted in 2 phases. In phase I (development phase), we will adapt an existing mHealth app (HealthMindr) to create a new clinic-integrated app called "JomPrEP" to deliver holistic HIV prevention services (eg, HIV testing, PrEP, support services for mental health and substance use) among MSM in Malaysia. During phase II (testing phase), we will use a type I hybrid implementation science trial design to test the efficacy of JomPrEP while gathering information on implementation factors to guide future scale-up in real-world settings. RESULTS: As of September 2022, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, clinic-integrated JomPrEP app, which provides a virtual platform for MSM in Malaysia to facilitate their engagement in HIV prevention in a fast and convenient manner. Based on participant feedback provided during phase I, we are currently optimizing JomPrEP and the research protocols for a large-scale efficacy trial (phase II), which will commence in January 2023. CONCLUSIONS: Scant HIV prevention resources coupled with entrenched stigma, discrimination, and criminalization of same-sex sexual behavior and substance use hamper access to HIV prevention services in Malaysia. If found efficacious, JomPrEP can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT05325476; https://clinicaltrials.gov/ct2/show/NCT05325476. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43318.
背景：男男性行为者（MSM）在马来西亚及全球的艾滋病毒疫情中受到的影响尤为严重。跨领域预防策略，如移动健康（mHealth），特别是智能手机应用程序，在马来西亚男男性行为者的艾滋病毒预防工作中具有巨大潜力，尤其是与艾滋病毒检测和暴露前预防（PrEP）相结合时。 目的：本研究旨在改编一款现有应用程序，创建并测试一款诊所集成应用程序（JomPrEP），这是一个为马来西亚男男性行为者提供艾滋病毒检测和PrEP服务的虚拟平台。 方法：JomPrEP项目包括为马来西亚男男性行为者开发和测试一个基于应用程序的艾滋病毒预防平台，将分两个阶段进行。在第一阶段（开发阶段），我们将改编一款现有的移动健康应用程序（HealthMindr），创建一个名为“JomPrEP”的新诊所集成应用程序，为马来西亚男男性行为者提供全面的艾滋病毒预防服务（如艾滋病毒检测、PrEP、心理健康和物质使用支持服务）。在第二阶段（测试阶段），我们将使用I型混合实施科学试验设计来测试JomPrEP的疗效，同时收集有关实施因素的信息，以指导未来在实际环境中的扩大规模。 结果：截至2022年9月，我们已完成拟议研究的第一阶段。基于第一阶段完成的一系列形成性工作，我们开发了一个功能齐全的诊所集成JomPrEP应用程序，为马来西亚男男性行为者提供了一个虚拟平台，以快速便捷的方式促进他们参与艾滋病毒预防。根据第一阶段参与者提供的反馈，我们目前正在优化JomPrEP和大规模疗效试验（第二阶段）的研究方案，该试验将于2023年1月开始。 结论：在马来西亚，艾滋病毒预防资源匮乏，加上对同性性行为和物质使用的污名化、歧视以及刑事定罪，阻碍了男男性行为者获得艾滋病毒预防服务。如果被证明有效，JomPrEP可以轻松适用于一系列针对男男性行为者的健康结果和医疗服务，包括适用于其他低收入和中等收入国家。 试验注册：ClinicalTrials.gov NCT05325476；https://clinicaltrials.gov/ct2/show/NCT05325476。 国际注册报告识别码（IRRID）：DERR1-10.2196/43318。
Int J Environ Res Public Health. 2022-12-24
Lancet. 2019-10-23
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