mHealth HIV Prevention for Transgender Women

Not Applicable

• Conditions: HIV
• Interventions: Other: MyLink2Care app major intervention features inactivated; Other: MyLink2Care app full functionality

• Registration Number: NCT05271097
• Lead Sponsor: Yale University

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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-02-24
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-08
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-24
• Study Start: 2022-07-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment-as-usual (TAU)	MyLink2Care app major intervention features inactivated	Participants in the TAU group will receive the MyLink2Care app with major intervention features inactivated.
MyLink2Care app	MyLink2Care app full functionality	Participants in the MyLink2Care group will be provided with full app access and will be encouraged to use all features of the app.

Primary Outcome Measures

Name	Time	Method
Feasibility of the MyLink2Care app using percentages of individuals enrolled	6 months	The investigators will use the percentage of individuals enrolled to determine the feasibility of the MyLink2Care app
Feasibility of the MyLink2Care app using percentages of individuals retained	6 months	The investigators will use the percentage of individuals retained to determine the feasibility of the MyLink2Care app
Acceptability of the MyLink2Care app based on barriers and facilitators identifies by participants in qualitative interviews	6 months	Acceptability will be based on analysis of qualitative data which includes barriers and facilitators
Feasibility of the MyLink2Care app using percentages of individuals screened	6 months	The investigators will use the percentage of individuals screened to determine the feasibility of the MyLink2Care app
Feasibility of the MyLink2Care app using percentages of individuals eligible	6 months	The investigators will use the percentage of individuals eligible to determine the feasibility of the MyLink2Care app
Acceptability of the MyLink2Care app based on usability concerns identified by participants in qualitative interviews	6 months	Acceptability will be based on analysis of qualitative data which includes usability concerns.
Acceptability of the MyLink2Care app based on refinement feedback identified by participants in qualitative data interviews	6 months	Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.
Feasibility of the MyLink2Care app using the percentage of participants that accessed the app	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.
Acceptability of the MyLink2Care app based on perceived usefulness of participants assessed in qualitative interviews	6 months	Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.
Acceptability of the MyLink2Care app based on the subjective usability measure	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.

Secondary Outcome Measures

Name	Time	Method
Preliminary Efficacy of the MyLink2Care app using proportion of participants who persist on PrEP	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.
Preliminary Efficacy of the MyLink2Care app through dried blood spot (DBS) testing as PrEP adherence measure	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).
Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure	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
Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence	6 months	The investigators will measure PrEP adherence using the visual analogue scale at 6 months.

Trial Locations

Locations (1)

University of Malaya; 🇲🇾 Kuala Lumpur, Malaysia