Health TrialsbyHealthPanel

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

ConditionsHIV PreventionHIV Related StigmaPrEP Adherence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-29
SponsorInstitute of HIV Research and Innovation Foundation, Thailand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-29 years

Male sex at birth

Self-identify as transgender woman/female spectrum

HIV-negative (laboratory confirmed)

Disqualifiers

Serious cognitive or psychiatric condition affecting consent

Active suicidal ideation or major mental illness

Medical contraindications to PrEP

Enrolled in another HIV intervention study

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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)

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: Standard PrEP Counseling (SPC) onlyNo intervention 0 interventions
Group B: mHC + SPCExperimental treatment 1 intervention
Group C: FRESH + SPCExperimental treatment 1 intervention
Group D: mHC + FRESH + SPCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HIV-related stigma score

HIV-related stigma (including internalized, perceived, anticipated, and enacted stigma) will be assessed using validated stigma scales. Higher scores indicate greater stigma.

Time frame
Baseline, Month 3, Month 6
2

PrEP uptake

Proportion of participants who initiate PrEP during the study period among those not on PrEP at baseline.

Time frame
Baseline through Month 6
3

PrEP adherence

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.

Time frame
Baseline, Month 3, Month 6
4

HIV testing uptake

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

Time frame
Baseline, Month 3, Month 6

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of HIV Research and Innovation Foundation, Thailand

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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