mHealth HIV Prevention for Transgender Women

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05271097
• Other study ID #: 2000030146
• Secondary ID: 1R21AI157857-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2022
• Source: Yale University
• Contact: Jeffrey Wickersham, PhD
• Phone: 203-737-4158
• Email: jeffrey.wickersham[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• MyLink2Care app full functionality
Participants will be shown how to download the app and use the assessment tool.
• MyLink2Care app major intervention features inactivated
Participants will be shown how to download the app and use the assessment tool.

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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	6 months
Primary	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	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	Acceptability of the MyLink2Care app based on perceived usefulness of participants assessed in qualitative interviews	Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.	6 months
Primary	Acceptability of the MyLink2Care app based on barriers and facilitators identifies by participants in qualitative interviews	Acceptability will be based on analysis of qualitative data which includes barriers and facilitators	6 months
Primary	Acceptability of the MyLink2Care app based on usability concerns identified by participants in qualitative interviews	Acceptability will be based on analysis of qualitative data which includes usability concerns.	6 months
Primary	Acceptability of the MyLink2Care app based on refinement feedback identified by participants in qualitative data interviews	Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.	6 months
Secondary	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).	3 months
Secondary	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	6 months
Secondary	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	3 months
Secondary	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.	6 months
Secondary	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.	6 months