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

NCT06373965 | Recruiting

• 1 other identifier: B2024-000
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Prevention Program

Keywords

HIV; transgender women

Outcome Measures

Primary Outcomes (3)

• 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.

  Time Frame: 3 and 6 months post-randomization

• 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.

  Time Frame: 3 and 6 months post-randomization

• 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.

  Time Frame: 3 and 6 months post-randomization

Study Arms (2)

CINTAI

EXPERIMENTAL

Participants 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.

Behavioral: Online to offline counseling

Control

ACTIVE COMPARATOR

The 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).

Behavioral: Online to offline counseling

Interventions

Online to offline counseling BEHAVIORAL

* 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.

CINTAI; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Connecticut: lead
• University of Malaya: collaborator

Study Sites (2)

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

Kuala Lumpur, Kuala Lumpur, 59990, Malaysia

RECRUITING

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

Kuala Lumpur, Kuala Lumpur, 59990, Malaysia

RECRUITING

Central Study Contacts

Roman Shrestha

CONTACT

8604862446; roman.shrestha@uconn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: August 13, 2024
• Primary Completion: December 6, 2025
• Study Completion (Estimated): December 18, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)