MHealth HIV Prevention for Transgender Women

N/AActive Not RecruitingNCT05271097

Yale University50 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

HIV

Interventions

MyLink2Care app full functionalityOTHER

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

MyLink2Care app major intervention features inactivatedOTHER

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

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Malaya

Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 6 months

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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).

Time frame: 3 months

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

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

Time frame: 6 months

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

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

Time frame: 3 months

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

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

Time frame: 6 months

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

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.

Time frame: 6 months