Clinical trial NCT06373965: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI)
Official title: An Online HIV Self-testing Intervention with Online-to-offline Linkage to Care for Transgender Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention Program
Keywords: HIV
transgender women
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2024-04-18
Enrollment: 50
Sex: FEMALE
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 transgender women (TGW) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like TGW, and allows immediate engagement in the post-test linkage process to prevention or treatment services.

Detailed description: Globally, transgender women (TGW) are disproportionately impacted by the HIV epidemic, with an estimated HIV prevalence of 19.1%. Malaysia, one of SE Asia's fastest-growing economies, is witnessing a rapid transition to its HIV epidemic. Malaysia has an estimated 80,000 TGW in-country, of which 12.4% are living with HIV. TGW experience numerous unique vulnerabilities to HIV, including discrimination in employment and economic opportunities, steering many TGW into high-risk occupations, such as sex work. High levels of stigma and discrimination against TGW by healthcare providers can foster a hostile environment toward TGW, complicating efforts to scale-up of HIV testing and prevention services among trans women, including preexposure prophylaxis (PrEP). Modeling studies suggest that increased HIV testing and uptake of PrEP is the most impactful and cost-effective strategy for reducing new infections. Despite this, only 37% of TGW in Malaysia have ever been HIV tested. HIV self-testing (HIVST) may be particularly impactful among TGW in Malaysia, where anti-trans stigma persists. Although willingness to use HIVST is high (48%) among Malaysian TGW, its use is still minimal due to a 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., HIVST and linkage to care). Leveraging eHealth technology for HIV services delivery is ideal given that nearly all (\>93.6%) TGW use online technology (e.g., smartphone, tablet, computer) and indicate a strong preference for a web-based platform for HIVST. As such, HIVST with real-time e-counseling (eHIVST), integrated with online-to-offline (O2O) linkage to prevention and treatment, offers an innovative and empowering approach that could transform TGW's uptake of HIV testing and engagement in the broader HIV care continuum. This proposal - submitted in response to the Notice of Special Interest (Administrative Supplements for Research on Sexual and Gender Minority Populations; NOT-OD-22-032) - requests an SGM administrative supplement to add a sample of TGW to parent award (R34MH130233), a project that focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate an O2O service delivery model with eHIVST that facilitates rapid linkage to the HIV prevention and treatment continuum for men who have sex with men (MSM) in Malaysia. Expanding Jom-TestPlus to include TGW represents a significant opportunity to leverage existing resources from the parent award to address HIV and other health inequities among broader SGM populations. If successful, Jom-TestPlus will serve as a model that can easily be adapted for various health outcomes and healthcare services delivery in these populations and other LMICs.

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:

* Currently on PrEP
* 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 Infectious Diseases and AIDS (CERiA), University Malaya
city: Kuala Lumpur
country: Malaysia
facility: Centre of Excellence for Research in Infectious Diseases and AIDS (CERiA), University Malaya
Study officials:
References: