Integrated online-to-offline (O2O) model of care for HIV prevention and treatment among men who have sex with men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial (Preprint)

HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale-up HIV testing rates. However, it faces shortcomings due to concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment. This study aims to describe the protocol used in developing and testing a web-based platform (i.e., CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia. The methods are reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines. The CINTAI project will be conducted in two phases. In phase I (development phase), we will adapt existing HIVST web-based platforms (Jom-Test and Adam's Love) to create a new online-to-offline HIVST and counseling platform called “CINTAI” for Malaysian MSM. In phase II (testing phase), we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of “CINTAI” compared to treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected using the Consolidated Framework for Implementation Research (CFIR) to guide future adoption and scale-up. As of April 2024, 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, web-based platform, called CINTAI, which provides a virtual platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV-negative) or HIV treatment services (if HIV-positive). Based on participant feedback during Phase I, we are currently optimizing CINTAI and the research protocols for a pilot trial (phase II), which will commence in May 2024. Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI 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.