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HIV Prevention ProgramNCT06373965

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

A study testing Online to offline counseling in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention Program
What is being tested?
Online to offline counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteMalaysia
Study dates
13 Aug 2024to 18 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years;
  • Cisgender male;
  • HIV-negative or HIV status unknown;
  • Own or have access to a computer, tablet, or internet-enabled smartphone

Who cannot join

  • Currently on PrEP
  • Unable to provide informed consent
  • Unable to read and understand English or Bahasa Malaysia

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Centre of Excellence for Research in Infectious Diseases and AIDS (CERiA), University Malaya

    Kuala Lumpur, Kuala Lumpur, 59990

Other trials in Malaysia

About this study

Official title: An Online HIV Self-testing Intervention With Online-to-offline Linkage to Care for Transgender Women

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.

Read the 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.

Being tested
Online to offline counseling
Keywords
HIV, transgender women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online to offline counselingBehavioural

    • Online registration and risk assessment: Users complete an onboarding process comprised of creating an account, entering demographic data, customizing settings, and completing the baseline risk assessment.
    • HIVST kit order, management, and monitoring: The platform will allow users to request HIVST kits via standard mail or self-pickup at user-preferred sites (e.g., LGBT-friendly clinics). After completing the mandatory section of the questionnaire and selecting a delivery option, a random personal identification number will be assigned by the system, which will be used to track future HIVST requests, collect HIVST results, and monitor subsequent linkage to further testing and HIV care.
    • eHIVST and O2O linkage to HIV clinical services: After unsealing the test kit, participants will find a reminder card to schedule their O2O pre- and post-test e-counseling appointment.
Study groups in NCT06373965
Study groupRoleWhat they receive
CINTAIExperimentalParticipants randomized to the Jom-TestPlus group will have access to all Jom-TestPlus features, including: assessment center; online registration; risk calculator; HIVST kit order, management, and monitoring; automated reminders; real-time e-counseling (eHIVST, active referral services); chemsex-related harm reduction services (screening, chemsex e-counseling, PartyPack ordering), chat function (ability to chat with counselors and research staff); and knowledge center (multimedia library on information and resources on HIV testing, PrEP, treatment, risks, and chemsex). Participants will follow a defined pathway to accessing HIVST kit ordering, e-counseling, and subsequent O2O linkage to clinical services.
Receives: Behavioral: Online to offline counseling
ControlActive comparatorThe TAU group will have access to the assessment center (risk assessment, follow-up surveys), knowledge center (multimedia library on information and resources on HIV testing, PrEP, treatment, risks, and chemsex), and a voucher for no-cost community-based HIV testing (sent via secure, encrypted email or can be downloaded on the Jom-TestPlus).
Receives: Behavioral: Online to offline counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIVST uptake

    Uptake of HIV self-testing (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

    Measured: Time Frame: 3 and 6 months post-randomization

  2. Linkage to PrEP

    Linked to PrEP (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

    Measured: Time Frame: 3 and 6 months post-randomization

  3. Linkage to HIV treatment services

    Linked to ART services (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

    Measured: Time Frame: 3 and 6 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start13 Aug 2024
  3. Primary completion20 May 2026
  4. Study completion18 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373965
Sponsor's protocol ID
B2024-000
Status last verified
Oct 2026
First submitted
15 Apr 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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