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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of HIV Research and Innovation Foundation, Thailand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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: 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

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Transgender-tailored Harm Reduction ServiceOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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