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.