Clinical trial NCT06373952: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex with Men
Official title: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex with Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention Program
Keywords: HIV
men who have sex with men
website
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2024-04-18
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services.

Detailed description: Malaysia's HIV epidemic is rapidly expanding, with recent evidence suggesting increasing sexual transmission, especially in MSM. HIV prevalence among MSM is now at an all-time high of 21.6% and is concentrated in the country's capital, Kuala Lumpur, where prevalence among MSM is 43% in 2020, up from 22% just four years before. Insights into Malaysia's expanding HIV epidemic are multi-factorial: Both homosexuality and substance use are criminalized in Malaysia. MSM are, therefore, often hesitant to disclose their sexuality or risk behaviors, primarily due to fear of stigma, discrimination, or criminalization. Further, evidence suggests the widespread use (24%) of psychoactive substances (e.g., amphetamine-type stimulants) before or during a sexual encounter, also known as sexualized drug use (chemsex) among Malaysian MSM, which leads to high-risk sexual practices (e.g., condomless sex). Stigma and discrimination are also enacted on MSM by healthcare providers, which foster a hostile environment toward MSM, complicating efforts to scale-up of HIV testing and subsequent linkage to HIV prevention (pre-exposure prophylaxis) and treatment (antiretroviral therapy) services. HIV testing jumpstarts entry into the HIV prevention and treatment cascades. New HIV testing guidelines recommend MSM test every 3 to 6 months, as early HIV testing is a cost-effective strategy for stemming the HIV epidemic. Yet, HIV testing rates remain low among Malaysian MSM: ever tested (70.3%) and last year tested (30.9%). HIV selftesting (HIVST) may be particularly impactful among MSM in Malaysia. Although willingness to use HIVST is high in this group, its use is still minimal due to lack of access to HIVST kits, concerns related to misinterpreting results, and missed opportunities for counseling and linkage to care. In this context, eHealth represents an innovative platform to transform the face of HIV service delivery (i.e., testing and linkage to care). Leveraging eHealth platforms for HIV services delivery in Malaysia is ideal given that nearly all (\>99%) MSM use some form of communication technology (e.g., smartphone, laptop) and has a strong preference for web-based platforms for HIVST. Therefore, a web-based HIVST platform, called Jom-Test®, was developed to promote HIV testing by providing free anonymous HIVST. The results demonstrated high feasibility and acceptability for the platform but low post-test linkage to treatment and prevention services. The findings further indicated the need for real-time (online) access to counselors for pre- and post-test counseling and support for linkage to HIV and chemsex-related harm reduction services (offline). To address this evidence gap, this application proposes to jump-start the broader HIV care continuum by adapting, expanding, and refining an existing Jom-Test® platform. The enhanced version, to be called Jom-TestPlus, will include real-time e-counseling (eHIVST) with integrated O2O linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for Malaysian MSM. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services.

Eligibility criteria: Inclusion Criteria:

* • Age ≥18 years;

  * Cisgender male;
  * HIV-negative or HIV status unknown;
  * Own or have access to a computer, tablet, or internet-enabled smartphone

Exclusion Criteria:

* • Unable to provide informed consent

  * Unable to read and understand English or Bahasa Malaysia

Primary outcomes:
measure: HIVST uptake
timeFrame: Time Frame: 3 and 6 months post-randomization
measure: Linkage to PrEP
timeFrame: Time Frame: 3 and 6 months post-randomization
measure: Linkage to HIV treatment services
timeFrame: Time Frame: 3 and 6 months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Centre of Excellence For Research in AIDS (CERiA)
Study officials:
References: