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Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis (PrEP) compared to treatment as usual. A new clinic-affiliated app (to be called MyLink2Care) will be developed (by adapting an existing app) and tested to deliver an integrated HIV prevention intervention that incorporates tailored HIV prevention and gender affirming care (GAC) services to TGW in Malaysia. The specific aims of the study include: * Aim 1: Guided by the modified IM Adapt model, an existing mobile app will be adapted, expanded, and refined. Focus groups will be conducted with TGW (n=20) and clinical stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the MyLink2Care app (alpha version), which will undergo usability testing (N=10), followed by full development of the app (beta version). * Aim 2 Conduct beta testing of the fully developed version of the MyLink2Care app (N=15) to assess its usability and acceptability. * Aim 3: Assess preliminary feasibility and acceptability of the MyLink2Care app within a pilot, randomized controlled trial, compared with treatment as usual for engagement in the HIV prevention cascade (N=50). Together, these aims will address multilevel barriers to HIV testing and PrEP uptake in Malaysian TGW. Feasibility is high based on the investigators extensive experience with HIV prevention in TGW, theory-guided behavioral interventions, mHealth expertise, and longstanding work in Malaysia.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
Yes
University of Malaya
Kuala Lumpur, Malaysia
Start Date
July 12, 2023
Primary Completion Date
March 1, 2025
Completion Date
March 1, 2025
Last Updated
March 18, 2025
50
ACTUAL participants
MyLink2Care app full functionality
OTHER
MyLink2Care app major intervention features inactivated
OTHER
Lead Sponsor
Yale University
Collaborators
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07071623