Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI)

Not Applicable

Recruiting

• Conditions: HIV Prevention Program

• Registration Number: NCT06373965
• Lead Sponsor: University of Connecticut

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.

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-08-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-12-06
• Study Completion: 2026-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIVST uptake	Time Frame: 3 and 6 months post-randomization	Uptake of HIV self-testing (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.
Linkage to PrEP	Time Frame: 3 and 6 months post-randomization	Linked to PrEP (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.
Linkage to HIV treatment services	Time Frame: 3 and 6 months post-randomization	Linked to ART services (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

Trial Locations

Locations (1)

Centre of Excellence for Research in Infectious Diseases and AIDS (CERiA), University Malaya; 🇲🇾 Kuala Lumpur, Malaysia