The Implementation of a Trans-tailored Harm Reduction Service for Transgender Persons in Relation to chemsEX and Substance Use (iT-REX)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- PrEP uptake among eligible participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to communicate in Thai sufficiently to complete study procedures
研究组 & 干预措施
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.
干预措施: Transgender-tailored Harm Reduction Service (Behavioral)
结局指标
主要结局
PrEP uptake among eligible participants
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点