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

April 2, 2026 updated by: Institute of HIV Research and Innovation Foundation, Thailand
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rena Janamnuaysook, MBA
  • Phone Number: 6698 516 4562
  • Email: rena.j@ihri.org

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Recruiting
        • Tangerine Clinic, Institute of HIV Research and Innovation
        • Contact:
        • Contact:
          • Rena Janamnuaysook, MBA
          • Phone Number: +66 2 1605371
          • Email: rena.j@ihri.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transgender-tailored Harm Reduction Service
Participants (transgender women, transgender men, and non-binary persons engaging in chemsex or substance use) will receive a comprehensive, transgender-tailored harm reduction service over a 12-month follow-up period. The intervention includes substance use harm reduction, sexual health services including HIV pre-exposure prophylaxis (PrEP), mental health screening and support, and socio-legal assistance. Participants will attend study visits at baseline and months 3, 6, 9, and 12, with assessments of behavioral risks, substance use, mental health, HIV/STI testing, and social outcomes.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)
Baseline to Month 12
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)
Months 3, 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Investigators

  • Principal Investigator: Nittaya Phanuphak, MD,PhD., Institute of HIV Research and Innovation (IHRI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHRI035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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