Chemsex, HIV Prevention, Mental Health Disorders, Sexually Transmitted Infections (STIs), Substance Use
Conditions
Keywords
PrEP, Harm reduction, Chemsex, Transgender
Brief summary
This study evaluates a comprehensive transgender-tailored harm reduction service for transgender women, transgender men, and non-binary individuals engaging in chemsex or substance use in Thailand, focusing on PrEP uptake, HIV/STI outcomes, mental health, and socio-legal impacts.
Detailed description
The iT-REX study is a prospective mixed-methods implementation study conducted at Tangerine Clinic in Bangkok, Thailand. It is part of a two-phase project using the EPIS framework to develop and implement a comprehensive harm reduction service tailored for transgender populations engaging in chemsex or substance use. Approximately 140 HIV-negative participants aged ≥18 years will be enrolled and followed for 12 months with visits at baseline, 3, 6, 9, and 12 months. The study evaluates behavioral risks, substance use, HIV/STIs, mental health, and socio-legal outcomes. A subset of participants will undergo qualitative interviews to assess implementation outcomes such as acceptability, feasibility, and satisfaction.
Interventions
BEHAVIORALTransgender-tailored Harm Reduction Service
A comprehensive, multi-component harm reduction service tailored for transgender individuals engaging in chemsex, substance use, implemented at Tangerine Clinic. The intervention includes: 1. Substance Use Harm Reduction * Drug-specific literacy, safer use education * Counseling on overdose prevention and safer consumption * Provision of harm reduction kits 2. Sexual Health Services * HIV testing * STI screening and treatment (CT/NG, syphilis, HBV, HCV) * Provision of PrEP including: * Daily oral PrEP * Event-driven PrEP 3. Mental Health Services * Screening using: * Electronic Mental Wellness Tool * Community Mental Wellness Tool * Referral to psychiatric care when indicated 4. Socio-legal Support * Counseling on stigma, discrimination, and legal issues * Support for gender-affirming care access
Sponsors
Institute of HIV Research and Innovation Foundation, Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identified transgender women, transgender men, or non-binary persons * Age ≥18 years * HIV-negative * Engaged in chemsex or substance use within past 12 months * Able to provide informed consent
Exclusion criteria
• Inability to communicate in Thai sufficiently to complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake among eligible participants | Baseline to Month 12 | Proportion of participants who initiate any form of HIV pre-exposure prophylaxis (daily oral PrEP or event-driven PrEP) during the 12-month follow-up period among those not on PrEP at baseline. Metric: Percentage (%) |
| PrEP adherence based on self-reported adherence | Months 3, 6, 9, and 12 | Proportion of participants reporting consistent use of PrEP according to the prescribed regimen (daily or event-driven), assessed using self-report during follow-up visits. Metric:Percentage (%) A. PrEP adherence (self-report) * Metric: % B. PrEP adherence (visit-based adherence score) * Metric: score (scale range 0-100) |
Countries
Thailand
Contacts
CONTACTNittaya Phanuphak, MD,PhD.
CONTACTRena Janamnuaysook, MBA
PRINCIPAL_INVESTIGATORNittaya Phanuphak, MD,PhD.
Institute of HIV Research and Innovation (IHRI)
Outcome results
None listed