An interventional study of Transgender-tailored Harm Reduction Service in HIV Prevention, Substance Use and Mental Health Disorders, sponsored by Institute of HIV Research and Innovation Foundation, Thailand. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Institute of HIV Research and Innovation Foundation, Thailand · Not applicable, Interventional, and Prevention
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 140 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Institute of HIV Research and Innovation Foundation, Thailand is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
PrEP uptake among eligible participants
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 (%)
Time frame: Baseline to Month 12
PrEP adherence based on self-reported adherence
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)
Time frame: Months 3, 6, 9, and 12
Started Feb 2024 (actual). Primary completion is estimated for Feb 2027, 36 months after the start.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 36 months is close to that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Institute of HIV Research and Innovation Foundation, Thailand