Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | 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)
| Months 3, 6, 9, and 12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Inability to communicate in Thai sufficiently to complete study procedures
Transgender & non-binary population
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nittaya Phanuphak, MD,PhD. | Contact | 6681 825 3544 | nittaya.p@ihri.org | |
| Rena Janamnuaysook, MBA | Contact | 6698 516 4562 | rena.j@ihri.org |
| Name | Affiliation | Role |
|---|---|---|
| Nittaya Phanuphak, MD,PhD. | Institute of HIV Research and Innovation (IHRI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangerine Clinic, Institute of HIV Research and Innovation | Recruiting | Pathum Wan | Bangkok | 10330 | Thailand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D012749 | Sexually Transmitted Diseases |
| D000099004 | Chemsex |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
Not provided
Not provided