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NCT Number: NCT07509827

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

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.

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Key information

Conditions

HIV Prevention HIV Related Stigma PrEP Adherence

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rainbow Sky Association of Thailand (RSAT), Bangkok, Bangkapi, Thailand

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Healthy Choices (mHC)+SPC

Behavioral

Intervention:

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

FRESH + SPC

Behavioral

Intervention:

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

mHC + FRESH + SPC

Behavioral

Intervention:

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. HIV testing uptake

    Time frame: Baseline, Month 3, Month 6

    Proportion of participants who complete HIV testing at each follow-up visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Nittaya Phanuphak, MD,PhD.

CONTACT

[email protected]

6681 825 3544

Rena Janamnuaysook, MBA

CONTACT

[email protected]

6698 516 4562

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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