HIV Prevention, HIV Related Stigma, PrEP Adherence
Conditions
Keywords
mHealth, PrEP, HIV stigma
Brief summary
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
BEHAVIORALMobile Healthy Choices (mHC)+SPC
Intervention: * Behavioral: Mobile Healthy Choices (mHC) * Behavioral: Standard PrEP Counseling (SPC)
BEHAVIORALFRESH + SPC
Intervention: * Behavioral: FRESH (Finding Respect and Ending Stigma around HIV) * Behavioral: Standard PrEP Counseling (SPC)
BEHAVIORALmHC + FRESH + SPC
Intervention: * Behavioral: Mobile Healthy Choices (mHC) * Behavioral: FRESH * Behavioral: Standard PrEP Counseling (SPC)
Sponsors
Institute of HIV Research and Innovation Foundation, Thailand
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV-related stigma score | 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. |
| PrEP uptake | Baseline through Month 6 | Proportion of participants who initiate PrEP during the study period among those not on PrEP at baseline. |
| PrEP adherence | 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. |
| HIV testing uptake | Baseline, Month 3, Month 6 | Proportion of participants who complete HIV testing at each follow-up visit. |
Countries
Thailand
Contacts
CONTACTNittaya Phanuphak, MD,PhD.
CONTACTRena Janamnuaysook, MBA
PRINCIPAL_INVESTIGATORNittaya Phanuphak, MD,PhD.
INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
Outcome results
None listed