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Recruiting NCT07509827

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

No phase Interventional HIV Prevention HIV Related Stigma PrEP Adherence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile Healthy Choices (mHC)+SPC, FRESH + SPC, mHC + FRESH + SPC.
Who it may be relevant to
Registry conditions: HIV Prevention, HIV Related Stigma, PrEP Adherence. Basic parameters: 18 years — 29 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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

Interventions

  • Behavioral Mobile Healthy Choices (mHC)+SPC
    Intervention: * Behavioral: Mobile Healthy Choices (mHC) * Behavioral: Standard PrEP Counseling (SPC)
  • Behavioral FRESH + SPC
    Intervention: * Behavioral: FRESH (Finding Respect and Ending Stigma around HIV) * Behavioral: Standard PrEP Counseling (SPC)
  • Behavioral mHC + FRESH + SPC
    Intervention: * Behavioral: Mobile Healthy Choices (mHC) * Behavioral: FRESH * Behavioral: Standard PrEP Counseling (SPC)

Primary outcome measures

  • HIV-related stigma score [Time frame: Baseline, Month 3, Month 6]
  • PrEP uptake [Time frame: Baseline through Month 6]
  • PrEP adherence [Time frame: Baseline, Month 3, Month 6]
  • HIV testing uptake [Time frame: Baseline, Month 3, Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

Thailand · 3 centers
  • Rainbow Sky Association of Thailand (RSAT) — Bangkok
  • The Service Workers In Group Foundation (SWING) — Bangkok
  • Institute of HIV Research and Innovation (IHRI) — Bangkok

Identifiers

NCT: NCT07509827 · IHRI034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗