NCT07512856

The Implementation of a Trans-tailored Harm Reduction Service for Transgender Persons in Relation to chemsEX and Substance Use (iT-REX)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Institute of HIV Research and Innovation Foundation, Thailand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Prevention
• Substance Use
• Mental Health Disorders
• Sexually Transmitted Infections (STIs)
• Chemsex

Interventions

Type	Name	Description
BEHAVIORAL	Transgender-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

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Thailand