Actively Recruiting

Phase Not Applicable
Age: 18Years - 29Years
MALE
ID07509827

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

Led by Institute of HIV Research and Innovation Foundation, Thailand · Updated on 2026-04-03

108

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

Institute of HIV Research and Innovation Foundation, Thailand

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a mobile health (mHealth) intervention designed to reduce HIV-related and overlapping stigma while improving the use and adherence to HIV pre-exposure prophylaxis (PrEP) among HIV-negative young transgender women aged 18 to 29 in Thailand. This study uses a Multiphase Optimization Strategy to adapt and test two mobile-based programs, Mobile Healthy Choices (mHC) and Finding Respect and Ending Stigma around HIV (FRESH), aiming to empower participants and support better HIV prevention behaviors. Participants are randomly assigned to one of four groups: standard HIV prevention services including counseling and testing; standard counseling plus the mHC intervention consisting of four motivational interviewing sessions delivered via smartphone over three months; standard counseling plus the FRESH intervention, a six-session multimedia program also delivered via smartphone over three months; or a combination of both mHC and FRESH interventions with standard counseling. These mobile programs focus on reducing stigma and encouraging PrEP use and adherence. During the six-month follow-up, participants undergo assessments at baseline, three months, and six months to measure HIV-related stigma, PrEP uptake and adherence, and HIV testing uptake. The study involves questionnaires, interviews, and monitoring of PrEP use to evaluate the interventions' impact. This research is sponsored by the Institute of HIV Research and Innovation Foundation in Thailand and aims to improve HIV prevention strategies for transgender women.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 29Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-29 years
  • Assigned male sex at birth
  • Self-identify as transgender woman or female spectrum
  • Laboratory confirmed HIV-negative
  • Recent condomless sex
  • Able to understand Thai language
  • Not currently on PrEP or taking 3 or fewer PrEP pills per week
Not Eligible

You will not qualify if you...

  • Serious cognitive or psychiatric condition affecting ability to consent
  • Active suicidal thoughts or major mental illness
  • Medical reasons preventing use of PrEP
  • Currently enrolled in another HIV intervention study

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 3 months

Participants receive behavioral interventions delivered via smartphone over 3 months to promote HIV prevention, reduce stigma, and improve empowerment. Interventions include Mobile Healthy Choices (mHC), Finding Respect and Ending Stigma around HIV (FRESH), and Standard PrEP Counseling (SPC).

Multiple sessions delivered remotely via smartphone over 3 months

Follow-up

Duration - 3 months

Participants are followed for an additional 3 months after intervention completion to monitor PrEP uptake, adherence, HIV testing, and stigma levels.

Scheduled follow-up visits at Month 3 and Month 6

Trial Site Locations

Total: 3 locations

1

Rainbow Sky Association of Thailand (RSAT)

Bangkok, Bangkapi, Thailand, 10240

Actively Recruiting

2

The Service Workers In Group Foundation (SWING)

Bangkok, Building 3, Patpong, Surawong Road, Thailand, 10500

Actively Recruiting

3

Institute of HIV Research and Innovation (IHRI)

Bangkok, Pathumwan, Thailand, 10330

Actively Recruiting

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Research Team

N

Nittaya Phanuphak, MD,PhD.

R

Rena Janamnuaysook, MBA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

4

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