Pre-implementation Study to Develop Trans-tailored Services for Transgender Persons in Relation to chemsEX
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Key themes on chemsex behaviors and service needs
研究概览
简要总结
The study is a pre-implementation cross-sectional study exploring chemsex behaviors among transgender persons and gathering perspectives from multiple stakeholders to inform the development of transgender-tailored harm reduction services.
详细描述
This study is designed under the EPIS framework (Exploration and Preparation phases) to better understand chemsex use among transgender populations in Thailand.
The study aims to:
- Explore reasons and patterns of chemsex use
- Assess positive and negative impacts (physical, sexual, mental, and socio-legal)
- Identify key components, barriers, and facilitators for developing transgender-tailored chemsex services
Data will be collected using a mixed-methods approach, including:
- In-depth interviews (IDIs)
- Self-administered questionnaires Participants include transgender chemsex users, their family/partners, and stakeholders such as healthcare providers and policymakers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Able to communicate in Thai
- •Provide informed consent
排除标准
- •Unable to participate in in-depth interview (IDI) (online or onsite)
研究组 & 干预措施
Family Members, Friends, or Partners
Family members, friends, or partners of transgender persons who have not engaged in chemsex. Participants will provide perspectives on the social, behavioral, and relational impacts of chemsex and support needs.
干预措施: Understanding of chemsex patterns, impacts, and service needs among transgender persons (Behavioral)
Transgender Chemsex Users
Transgender women and transgender men who are current or former chemsex users. Participants will take part in semi-structured in-depth interviews (IDIs) exploring chemsex behaviors, patterns of use, perceived impacts, and needs for transgender-tailored harm reduction services.
干预措施: Understanding of chemsex patterns, impacts, and service needs among transgender persons (Behavioral)
Stakeholders
Stakeholders including healthcare providers, policy makers, law enforcement officers, counselors, public health professionals, and community leaders involved in care, policy, or regulation related to chemsex. Participants will be interviewed to identify system-level facilitators and barriers to implementation of services.
干预措施: Understanding of chemsex patterns, impacts, and service needs among transgender persons (Behavioral)
结局指标
主要结局
Key themes on chemsex behaviors and service needs
时间窗: At interview (single time point)
Qualitative themes identified from semi-structured in-depth interviews, including: * Reasons for engaging in chemsex * Patterns of substance use * Perceived positive and negative impacts * Harm reduction practices * Needs for transgender-tailored services Themes will be identified using thematic analysis.
Barriers and facilitators to implementation of transgender-tailored chemsex services
时间窗: At interview (single time point)
Barriers and facilitators to implementation identified using the Consolidated Framework for Implementation Research (CFIR) domains based on stakeholder and participant interviews.
Chemsex-related behavioral and demographic characteristics
时间窗: At interview (single time point)
Descriptive characteristics of participants, including demographic data, substance use patterns, and behavioral risk factors collected via questionnaire.
HIV-related stigma score
时间窗: Baseline, Month 3, Month 6
HIV-related stigma will be assessed using the HIV Stigma Scale (HSS). The HSS is a validated instrument measuring multiple domains of stigma, including personalized stigma, disclosure concerns, negative self-image, and concerns with public attitudes. The total score ranges from 40 to 160, with higher scores indicating greater levels of HIV-related stigma (worse outcome) Score (range: 40-160)
Transgender-related stigma score
时间窗: Baseline, Month 3, Month 6
Transgender-related stigma will be measured using the Transgender Identity Survey (TIS) (or instrument used in the protocol). This scale assesses experiences of stigma, discrimination, and internalized transphobia. Unit of Measure: Score (range: 20-100)
PrEP adherence (self-reported adherence score)
时间窗: Baseline, Month 3, Month 6
Self-reported adherence will be measured using a standardized adherence questionnaire assessing the number of doses taken over the past 30 days. Scores range from 0 to 100%, with higher percentages indicating better adherence (better outcome). In addition, adherence will be objectively assessed using tenofovir diphosphate (TFV-DP) concentrations in dried blood spots. Unit of Measure: Percentage (%) Drug concentration (fmol/punch)
Intervention acceptability score
时间窗: Month 3
Description: Acceptability will be assessed using the System Usability Scale (SUS). The SUS is a 10-item questionnaire with scores ranging from 0 to 100, with higher scores indicating better usability and acceptability (better outcome). Score (range: 0-100)
次要结局
未报告次要终点