mHealth HIV Prevention for Transgender Women

March 8, 2022 updated by: Yale University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: MyLink2Care app full functionality
Participants will be shown how to download the app and use the assessment tool.
Active Comparator: treatment-as-usual (TAU)
Participants in the TAU group will receive the MyLink2Care app with major intervention features inactivated.
Other: MyLink2Care app major intervention features inactivated
Participants will be shown how to download the app and use the assessment tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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
6 months
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
6 months
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 months
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.
6 months
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.
6 months
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
6 months
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months
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
6 months
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
3 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Jeffrey Wickersham, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2000030146
  • 1R21AI157857-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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