MHealth HIV Prevention for Transgender Women

NCT05271097 | Active Not Recruiting DMC

• 2 other identifiers: 20000301461R21AI157857-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

transgender; HIV prevention; HIV intervention; transgender woman

Outcome Measures

Primary Outcomes (10)

• Feasibility of the MyLink2Care app using percentages of individuals screened

  The investigators will use the percentage of individuals screened to determine the feasibility of the MyLink2Care app

  6 months

• Feasibility of the MyLink2Care app using percentages of individuals eligible

  The investigators will use the percentage of individuals eligible to determine the feasibility of the MyLink2Care app

  6 months

• Feasibility of the MyLink2Care app using percentages of individuals enrolled

  The investigators will use the percentage of individuals enrolled to determine the feasibility of the MyLink2Care app

  6 months

• Feasibility of the MyLink2Care app using percentages of individuals retained

  The investigators will use the percentage of individuals retained to determine the feasibility of the MyLink2Care app

  6 months

• Feasibility of the MyLink2Care app using the percentage of participants that accessed the app

  The investigators will determine the percentage of participants that accessed the app, with ≥60% of participants accessing app as lower threshold. The higher the percentage, the higher the feasibility.

  6 months

• Acceptability of the MyLink2Care app based on the subjective usability measure

  Acceptability will be based on descriptive statistics from the subjective usability measure, with a target mean score of ≥ 50. The higher the score, the higher the acceptability. Minimum score for the scale is 0, highest is 100.

  6 months

• Acceptability of the MyLink2Care app based on perceived usefulness of participants assessed in qualitative interviews

  Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.

  6 months

• Acceptability of the MyLink2Care app based on barriers and facilitators identifies by participants in qualitative interviews

  Acceptability will be based on analysis of qualitative data which includes barriers and facilitators

  6 months

• Acceptability of the MyLink2Care app based on usability concerns identified by participants in qualitative interviews

  Acceptability will be based on analysis of qualitative data which includes usability concerns.

  6 months

• Acceptability of the MyLink2Care app based on refinement feedback identified by participants in qualitative data interviews

  Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.

  6 months

Secondary Outcomes (5)

• Preliminary Efficacy of the MyLink2Care app through dried blood spot (DBS) testing as PrEP adherence measure

  3 months

• Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure

  6 months

• Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence

  3 months

• Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence

  6 months

• Preliminary Efficacy of the MyLink2Care app using proportion of participants who persist on PrEP

  6 months

Study Arms (2)

MyLink2Care app

EXPERIMENTAL

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

Other: MyLink2Care app full functionality

treatment-as-usual (TAU)

ACTIVE COMPARATOR

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

Other: MyLink2Care app major intervention features inactivated

Interventions

MyLink2Care app full functionality OTHER

Participants will be shown how to download the app and use the assessment tool.

MyLink2Care app

MyLink2Care app major intervention features inactivated OTHER

Participants will be shown how to download the app and use the assessment tool.

treatment-as-usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Study Officials

• Jeffrey Wickersham, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 8, 2022
• Study Start: July 12, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)