MHealth HIV Prevention for Transgender Women

Yale University

Status: Active, not recruiting

Conditions: HIV

Treatments: Other: MyLink2Care app major intervention features inactivated; Other: MyLink2Care app full functionality

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05271097

1R21AI157857-01A1 (U.S. NIH Grant/Contract)

2000030146

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HIV-negative
• Identify as a transgender woman
• Condomless sex in the last 30 days
• Own a smartphone

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MyLink2Care app

Experimental group

Description:

Participants in the MyLink2Care group will be provided with full app access and will be encouraged to use all features of the app.

Treatment:

Other: MyLink2Care app full functionality

treatment-as-usual (TAU)

Active Comparator group

Description:

Participants in the TAU group will receive the MyLink2Care app with major intervention features inactivated.

Treatment:

Other: MyLink2Care app major intervention features inactivated