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OpenTrials
Active, Not Recruiting

NCT Number: NCT05271097

MHealth HIV Prevention for Transgender Women

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyLink2Care app full functionality

Other

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

MyLink2Care app major intervention features inactivated

Other

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

Primary outcomes

  1. Feasibility of the MyLink2Care app using percentages of individuals screened

    Time frame: 6 months

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

  2. Feasibility of the MyLink2Care app using percentages of individuals eligible

    Time frame: 6 months

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

  3. Feasibility of the MyLink2Care app using percentages of individuals enrolled

    Time frame: 6 months

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

  4. Feasibility of the MyLink2Care app using percentages of individuals retained

    Time frame: 6 months

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

  5. Feasibility of the MyLink2Care app using the percentage of participants that accessed the app

    Time frame: 6 months

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 3 months

    The investigators will measure PrEP adherence DBS at 3 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in red blood cells (RBC).

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

    Time frame: 6 months

    The investigators will measure PrEP adherence DBS at 6 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC

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

    Time frame: 3 months

    The investigators will measure PrEP adherence using the visual analogue scale at 3 months

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

    Time frame: 6 months

    The investigators will measure PrEP adherence using the visual analogue scale at 6 months.

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

    Time frame: 6 months

    Preliminary Efficacy of the app will be calculated using the proportion of participants who persist on PrEP. Persistence on PrEP is measured on the app when completing PrEP care.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2022
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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