Clinical trial NCT05271097: MHealth HIV Prevention for Transgender Women
Official title: Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: transgender
HIV prevention
HIV intervention
transgender woman
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-03-08
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the MyLink2Care app using percentages of individuals screened
timeFrame: 6 months
measure: Feasibility of the MyLink2Care app using percentages of individuals eligible
timeFrame: 6 months
measure: Feasibility of the MyLink2Care app using percentages of individuals enrolled
timeFrame: 6 months
measure: Feasibility of the MyLink2Care app using percentages of individuals retained
timeFrame: 6 months
measure: Feasibility of the MyLink2Care app using the percentage of participants that accessed the app
timeFrame: 6 months
measure: Acceptability of the MyLink2Care app based on the subjective usability measure
timeFrame: 6 months
measure: Acceptability of the MyLink2Care app based on perceived usefulness of participants assessed in qualitative interviews
timeFrame: 6 months
measure: Acceptability of the MyLink2Care app based on barriers and facilitators identifies by participants in qualitative interviews
timeFrame: 6 months
measure: Acceptability of the MyLink2Care app based on usability concerns identified by participants in qualitative interviews
timeFrame: 6 months
measure: Acceptability of the MyLink2Care app based on refinement feedback identified by participants in qualitative data interviews
timeFrame: 6 months
Secondary outcomes:
measure: Preliminary Efficacy of the MyLink2Care app through dried blood spot (DBS) testing as PrEP adherence measure
timeFrame: 3 months
measure: Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure
timeFrame: 6 months
measure: Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence
timeFrame: 3 months
measure: Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence
timeFrame: 6 months
measure: Preliminary Efficacy of the MyLink2Care app using proportion of participants who persist on PrEP
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
affiliation: Yale University
name: Jeffrey Wickersham, PhD
role: PRINCIPAL_INVESTIGATOR
References: