Clinical trial NCT06576648: Thailand Transgender Women Stigma Study
Official title: Optimizing Mobile Interventions to Overcome Stigma and Promote HIV Prevention Among Thai Young Transgender Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-Exposure Prophylaxis
HIV Prevention
mHealth
Stigma
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Institute of HIV Research and Innovation Foundation, Thailand
First posted: 2024-08-29
Enrollment: 154
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This project will develop a multi-component, technology-delivered intervention designed to reduce HIV and intersectional stigma and improve the use of HIV pre-exposure prophylaxis (PrEP) among HIV-negative Thai, young transgender women (18-29 years).


Eligibility criteria: Aim 1 (Formative Research and Beta-Testing) Transgender women

Inclusion Criteria:

* Ages between 18 and 29 years
* Male sex at birth
* Self-identifies as women, transgender women or culturally identifies with the female spectrum
* Laboratory-confirmed HIV-negative status
* Self-reported recent history of condomless sex
* Able to understand, read and speak Thai
* Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion Criteria:

* Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
* Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
* Currently enrolled in another HIV intervention study.

Healthcare providers Inclusion criteria

* Age 18 or above
* Has provided HIV prevention or treatment services for TGW for at least one year Exclusion criteria
* None

Aim 2 (Pilot RCT) Transgender women Inclusion criteria

* Ages between 18 and 29 years
* Male sex at birth
* Self-identifies as women, transgender women or culturally identifies with the female spectrum
* Laboratory-confirmed HIV-negative status
* Self-reported recent history of condomless sex
* Able to understand, read and speak Thai
* Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion criteria

* Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
* Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
* Currently enrolled in another HIV intervention study.

Primary outcomes:
measure: Intervention Acceptability: System Usability Score (SUS)
timeFrame: Month 3, Month 6
measure: Intervention Acceptability: Exit Interview
timeFrame: Month 3
measure: Intervention Feasibility: Participant retention
timeFrame: Baseline through Month 6
measure: Intervention Feasibility: Number of FRESH sessions viewed
timeFrame: Baseline through Month 6
measure: Intervention Feasibility: Number of mHC sessions completed
timeFrame: Baseline through Month 6
measure: PrEP Uptake: Self-report
timeFrame: Month 3, Month 6
measure: PrEP Adherence: Visual analog scale
timeFrame: Baseline, Month 3, and Month 6
measure: PrEP Adherence: Self-Reported Adherence
timeFrame: Baseline, Month 3, and Month 6
measure: PrEP Adherence: DBS testing
timeFrame: Baseline, Month 3, and Month 6
measure: HIV testing uptake: Self-report
timeFrame: Baseline, Month 3, and Month 6
measure: Intersectional stigma
timeFrame: Baseline, Month 3, and Month 6
measure: Internalized stigma
timeFrame: Baseline, Month 3, and Month 6
measure: Perceived stigma
timeFrame: Baseline, Month 3, and Month 6
measure: Anticipated stigma
timeFrame: Baseline, Month 3, and Month 6
measure: Enacted stigma
timeFrame: Baseline, Month 3, and Month 6
measure: PrEP stigma
timeFrame: Baseline, Month 3, and Month 6
Secondary outcomes:
measure: Empowerment
timeFrame: Baseline, Month 3, and Month 6
measure: Information: HIV Knowledge
timeFrame: Baseline, Month 3, and Month 6
measure: Information: PrEP Knowledge
timeFrame: Baseline, Month 3, and Month 6
measure: Motivation: Rollnick's Readiness Ruler
timeFrame: Baseline, Month 3, and Month 6
measure: Motivation: Decisional Balance for Problem Behavior
timeFrame: Baseline, Month 3, and Month 6
measure: Behavioral Skills
timeFrame: Baseline, Month 3, and Month 6
measure: HIV
timeFrame: Baseline, Month 3, and Month 6
measure: STI
timeFrame: Baseline and Month 6
measure: Sexual Risk
timeFrame: Baseline, Month 3, and Month 6
measure: Adaptive coping
timeFrame: Baseline, Month 3, and Month 6
measure: Resilience
timeFrame: Baseline, Month 3, and Month 6
measure: Substance use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: Baseline, Month 3, and Month 6
measure: Substance use: Alcohol Use Disorder Identification Text (AUDIT-C)
timeFrame: Baseline, Month 3, and Month 6
measure: Mental health
timeFrame: Baseline, Month 3, and Month 6
measure: Perceived HIV risk
timeFrame: Baseline, Month 3, and Month 6
measure: Social support
timeFrame: Baseline, Month 3, and Month 6
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Institute of HIV Research and Innovation
city: Bangkok
country: Thailand
facility: Rainbow Sky Association of Thailand
city: Bangkok
country: Thailand
facility: SWING Foundation
Study officials:
affiliation: University of Massachusetts, Worcester
name: Bo Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: