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Clinical Trials/NCT06373965
NCT06373965
Recruiting
Not Applicable

An Online HIV Self-testing Intervention with Online-to-offline Linkage to Care for Transgender Women

University of Connecticut1 site in 1 country50 target enrollmentAugust 13, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Prevention Program
Sponsor
University of Connecticut
Enrollment
50
Locations
1
Primary Endpoint
HIVST uptake
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 13, 2024
End Date
December 18, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roman Shrestha

Assistant Professor

University of Connecticut

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

Outcomes

Primary Outcomes

HIVST uptake

Time Frame: 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: 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: 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.

Study Sites (1)

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