Abstract Malaysia’s HIV epidemic is rapidly expanding with recent evidence suggesting accelerated sexual transmission, especially in MSM: 10% in 2008 to 54% in 2016. Evidence suggests high HIV prevalence in MSM being nationally (21.6%) and in Kuala Lumpur (43%). Central to this expanding HIV epidemic in MSM is condomless sex, STIs, and co-occurring psychiatric and substance use disorders (P/SUD), especially depression and amphetamine-type stimulant (ATS) use. Insights into Malaysia’s HIV prevention gap are multi-factorial. Both homosexuality and substance use is criminalized in Malaysia, making MSM bear the dual burden of stigma and discrimination, including in healthcare, which promotes P/SUD disparities in MSM. MSM are often hesitant to disclose their sexuality, risk behaviors or depressive symptoms, mostly due to fear of stigma, discrimination, or criminalization. Stigma and discrimination are also enacted on MSM by healthcare providers resulting in extraordinary health disparities and low prevention uptake. Strategies that facilitate screening and prevention practices in a non-judgmental fashion are likely to increase access to evidence-based prevention like HIV testing and pre-exposure prophylaxis (PrEP), especially if screening and counseling addresses P/SUD. Introducing an innovative app-based platform to deliver holistic HIV prevention services represents a paradigm shift in HIV prevention since it can deliver effective prevention in a confidential, less-stigmatizing and convenient manner. Building on the advantages for scalability and dissemination afforded using app platform, we propose to develop and test the efficacy of a clinic-affiliated app (myCareLink) to deliver an integrated HIV prevention intervention that will promote HIV testing and linkage to PrEP and incorporates screening and support for underlying P/SUD in Malaysian MSM. The design of this study will take place in 2 phases. The R21 phase will consist of 2 stages: 1) We will adapt, expand and refine an existing app, which will be integrated within the existing clinical care system. First, we will conduct focus groups with MSM (n=25) and stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the myCareLink app (alpha version). Then, the prototype will undergo usability testing (n=20), followed by the full development of the app (beta version); 2) Expanded Beta testing (n=50) of the myCareLink app will assess its usability and acceptability. The R33 phase will involve conducting a Type 1 Hybrid Implementation Science Trial to evaluate the efficacy of myCareLink app vs. treatment as usual (TAU) in 268 Malaysian MSM for primary (HIV testing and PrEP uptake) and secondary (PrEP adherence and persistence) efficacy outcomes. Multi-level implementation outcomes will involve stakeholders’ perspective of the relative advantage of myCareLink app over TAU, adaptability, perceived design quality and packaging, compatibility in the Malaysian context, interest in sharing the app with others and readiness for implementation. Research capacity strengthening between Yale and the University of Malaya will occur through collaborative learning between researchers at both institutions to promote expansion of mHealth research.

Narrative The proposed research focuses on developing and prospectively testing the efficacy of a clinic-affiliated app (myCareLink) to deliver an integrated HIV prevention intervention in Malaysian MSM. We expect that this project will lead to the development of an innovative and culturally tailored app that will promote HIV testing and linkage to PrEP by addressing co-morbid psychiatric and substance use disorder (P/SUD) in Malaysian MSM.