Evaluation of mHealth Intervention to Promote HIV Prevention and Overcome Stigma Among Transgender Women (EMPOW.HER)

March 29, 2026 updated by: Institute of HIV Research and Innovation Foundation, Thailand
This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study uses a Multiphase Optimization Strategy (MOST) design to adapt, refine, and evaluate two mobile-based interventions: Mobile Healthy Choices (mHC) and Finding Respect and Ending Stigma around HIV (FRESH). The interventions are designed to address stigma, improve empowerment, and enhance uptake and adherence to HIV pre-exposure prophylaxis (PrEP). The study includes formative research, intervention adaptation, beta testing, and a pilot factorial randomized trial among TGW aged 18-29 in Bangkok, Thailand, with follow-up over 6 months

Study Type

Interventional

Enrollment (Estimated)

108

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

  • Name: Rena Janamnuaysook, MBA
  • Phone Number: 6698 516 4562
  • Email: rena.j@ihri.org

Study Contact Backup

Study Locations

  • Thailand
    • Bangkapi
      • Bangkok, Bangkapi, Thailand, 10240
        • Recruiting
        • Rainbow Sky Association of Thailand (RSAT)
        • Contact:
        • Contact:
    • Building 3, Patpong, Surawong Road
      • Bangkok, Building 3, Patpong, Surawong Road, Thailand, 10500
        • Recruiting
        • The Service Workers In Group Foundation (SWING)
        • Contact:
    • Pathumwan
      • Bangkok, Pathumwan, Thailand, 10330
        • Recruiting
        • Institute of HIV Research and Innovation (IHRI)
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-29 years
  • Male sex at birth
  • Self-identify as transgender woman/female spectrum
  • HIV-negative (laboratory confirmed)
  • Recent condomless sex
  • Able to understand Thai
  • Not on PrEP or poorly adherent (≤3 pills/week)

Exclusion Criteria:

  • Serious cognitive or psychiatric condition affecting consent
  • Active suicidal ideation or major mental illness
  • Medical contraindications to PrEP
  • Enrolled in another HIV intervention study

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard PrEP Counseling (SPC) only
Participants receive standard HIV prevention services including standard PrEP counseling (SPC), HIV testing, and routine care
Experimental: mHC + SPC

Description:

Participants receive SPC plus the mobile Healthy Choices (mHC) intervention, a 4-session (20 minutes each) motivational interviewing-based program delivered via smartphone using CIAS over 3 months to promote PrEP uptake and adherence.
Behavioral: Mobile Healthy Choices (mHC)+SPC

Intervention:

  • Behavioral: Mobile Healthy Choices (mHC)
  • Behavioral: Standard PrEP Counseling (SPC)
Experimental: FRESH + SPC

Description:

Participants receive SPC plus FRESH, a 6-session (10-15 minutes each) multimedia intervention delivered via smartphone over 3 months to reduce HIV-related and intersectional stigma and improve empowerment.
Behavioral: FRESH + SPC

Intervention:

  • Behavioral: FRESH (Finding Respect and Ending Stigma around HIV)
  • Behavioral: Standard PrEP Counseling (SPC)
Experimental: mHC + FRESH + SPC

Description:

Participants receive SPC plus both mHC and FRESH interventions delivered via smartphone over 3 months.
Behavioral: mHC + FRESH + SPC

Intervention:

  • Behavioral: Mobile Healthy Choices (mHC)
  • Behavioral: FRESH
  • Behavioral: Standard PrEP Counseling (SPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-related stigma score
Time Frame: Baseline, Month 3, Month 6
HIV-related stigma (including internalized, perceived, anticipated, and enacted stigma) will be assessed using validated stigma scales. Higher scores indicate greater stigma.
Baseline, Month 3, Month 6
PrEP uptake
Time Frame: Baseline through Month 6
Proportion of participants who initiate PrEP during the study period among those not on PrEP at baseline.
Baseline through Month 6
PrEP adherence
Time Frame: Baseline, Month 3, Month 6

PrEP adherence will be assessed using:

  • Self-reported adherence (e.g., number of doses taken in past 7 or 30 days)
  • Tenofovir diphosphate (TFV-DP) levels from dried blood spots Higher levels indicate better adherence.
Baseline, Month 3, Month 6
HIV testing uptake
Time Frame: Baseline, Month 3, Month 6
Proportion of participants who complete HIV testing at each follow-up visit.
Baseline, Month 3, Month 6

Collaborators and Investigators

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

Sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Nittaya Phanuphak, MD,PhD., INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION

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 (Actual)

August 1, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHRI034

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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