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NCT Number: NCT07512856

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

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.

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Key information

Conditions

HIV Prevention Behavior Chemically-Induced Disorders Chemsex Communicable Diseases Disease Attributes Genital Diseases Harm Reduction Infections Mental Disorders Mental Health Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Infections (STIs) Substance Use Substance-Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transgender-tailored Harm Reduction Service

Behavioral

A comprehensive, multi-component harm reduction service tailored for transgender individuals engaging in chemsex, substance use, implemented at Tangerine Clinic.

The intervention includes:

  • Substance Use Harm Reduction
  • Drug-specific literacy, safer use education
  • Counseling on overdose prevention and safer consumption
  • Provision of harm reduction kits
  • Sexual Health Services
  • HIV testing
  • STI screening and treatment (CT/NG, syphilis, HBV, HCV)
  • Provision of PrEP including:
  • Daily oral PrEP
  • Event-driven PrEP
  • Mental Health Services
  • Screening using:
  • Electronic Mental Wellness Tool
  • Community Mental Wellness Tool
  • Referral to psychiatric care when indicated
  • Socio-legal Support
  • Counseling on stigma, discrimination, and legal issues
  • Support for gender-affirming care access

Primary outcomes

  1. PrEP uptake among eligible participants

    Time frame: 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 (%)

  2. PrEP adherence based on self-reported adherence

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nittaya Phanuphak, MD,PhD.

CONTACT

[email protected]

6681 825 3544

Rena Janamnuaysook, MBA

CONTACT

[email protected]

6698 516 4562

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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