HIV PreventionNCT07512856
The Implementation of a Trans-tailored Harm Reduction Service for Transgender Persons in Relation to chemsEX and Substance Use (iT-REX)
A study testing Transgender-tailored Harm Reduction Service in people with HIV Prevention and Substance Use, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention, Substance Use, Mental Health Disorders
- What is being tested?
- Transgender-tailored Harm Reduction Service
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to communicate in Thai sufficiently to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Tangerine Clinic, Institute of HIV Research and Innovation
Pathum Wan, Bangkok, 10330
Nittaya Phanuphak, MD.,Ph.D., +66 2 1605371, nittaya.p@ihri.org
Rena Janamnuaysook, MBA, +66 2 1605371, rena.j@ihri.org
About this study
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.
Read the 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.
- Conditions
- HIV Prevention, Substance Use, Mental Health Disorders, Sexually Transmitted Infections (STIs), Chemsex
- Being tested
- Transgender-tailored Harm Reduction Service
- Keywords
- PrEP, Harm reduction, Chemsex, Transgender
- Medical subject headings
- Substance-Related Disorders, Sexually Transmitted Diseases, Chemsex, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgender-tailored Harm Reduction ServiceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Transgender-tailored Harm Reduction Service | Other | 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. Receives: Behavioral: Transgender-tailored Harm Reduction Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 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)
Measured: Months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD,PhD., Principal investigator, Institute of HIV Research and Innovation (IHRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512856
- Sponsor's protocol ID
- IHRI035
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Trans-tailored Harm Reduction Service for Transgender Persons in Relation to chemsEX and Substance Use (iT-REX)
- ClinicalTrials.gov ID
- NCT07512856
- Acronym / sponsor ID
- IHRI035
- Conditions
- HIV Prevention, Substance Use, Mental Health Disorders, Sexually Transmitted Infections (STIs), Chemsex
- Keywords
- PrEP, Harm reduction, Chemsex, Transgender
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender-tailored Harm Reduction Service | Other | Behavioral: Transgender-tailored Harm Reduction ServiceParticipants (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to communicate in Thai sufficiently to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transgender-tailored Harm Reduction ServiceA 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 | Behavioural | Transgender-tailored Harm Reduction Service |
Primary outcome
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 (%)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nittaya Phanuphak, MD,PhD. principal investigator
Institute of HIV Research and Innovation (IHRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transgender-tailored Harm Reduction Service in people with HIV Prevention and Substance Use, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nittaya Phanuphak, MD,PhD. (6681 825 3544, nittaya.p@ihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake among eligible participants (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.