Menu
Recruiting NCT07512856

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

No phase Interventional HIV Prevention Substance Use Mental Health Disorders Sexually Transmitted Infections (STIs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transgender-tailored Harm Reduction Service.
Who it may be relevant to
Registry conditions: HIV Prevention, Substance Use, Mental Health Disorders, Sexually Transmitted Infections (STIs). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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

Primary outcome measures

  • PrEP uptake among eligible participants [Time frame: Baseline to Month 12]
  • PrEP adherence based on self-reported adherence [Time frame: Months 3, 6, 9, and 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Tangerine Clinic, Institute of HIV Research and Innovation — Pathum Wan

Identifiers

NCT: NCT07512856 · IHRI035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗