Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2023-07-12
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MyLink2Care app
Participants in the MyLink2Care group will be provided with full app access and will be encouraged to use all features of the app.
MyLink2Care app full functionality
Participants will be shown how to download the app and use the assessment tool.
treatment-as-usual (TAU)
Participants in the TAU group will receive the MyLink2Care app with major intervention features inactivated.
MyLink2Care app major intervention features inactivated
Participants will be shown how to download the app and use the assessment tool.
Interventions
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MyLink2Care app full functionality
Participants will be shown how to download the app and use the assessment tool.
MyLink2Care app major intervention features inactivated
Participants will be shown how to download the app and use the assessment tool.
Eligibility Criteria
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Inclusion Criteria
* Identify as a transgender woman
* Condomless sex in the last 30 days
* Own a smartphone
Exclusion Criteria
* Unable to read and understand English or Bahasa Malaysia
18 Years
MALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Wickersham, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Malaya
Kuala Lumpur, , Malaysia
Countries
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Other Identifiers
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2000030146
Identifier Type: -
Identifier Source: org_study_id
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