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NCT Number: NCT07505875

Pre-implementation Study to Develop Trans-tailored Services for Transgender Persons in Relation to chemsEX

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.

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Key information

Conditions

Substance Use Behavior Chemically-Induced Disorders Chemsex Communicable Diseases Disease Attributes Genital Diseases HIV Prevention Harm Reduction Infections Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Infections (STIs) Substance-Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Able to communicate in Thai
  • Provide informed consent

Exclusion criteria

  • Unable to participate in in-depth interview (IDI) (online or onsite)

Treatment and study plan

Understanding of chemsex patterns, impacts, and service needs among transgender persons

Behavioral

: During study period (single visit within ~12 months study duration)

Primary outcomes

  1. Key themes on chemsex behaviors and service needs

    Time frame: 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.

  2. Barriers and facilitators to implementation of transgender-tailored chemsex services

    Time frame: 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.

  3. Chemsex-related behavioral and demographic characteristics

    Time frame: At interview (single time point)

    Descriptive characteristics of participants, including demographic data, substance use patterns, and behavioral risk factors collected via questionnaire.

  4. HIV-related stigma score

    Time frame: 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)

  5. Transgender-related stigma score

    Time frame: 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)

  6. PrEP adherence (self-reported adherence score)

    Time frame: 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)

  7. Intervention acceptability score

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nittaya Phanuphak, MD,PhD.

CONTACT

[email protected]

6681 825 3544

Rena Janamnuaysook, MBA

CONTACT

[email protected]

662 160 5371

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Collaborators

  • amfAR, The Foundation for AIDS Research

Registry information

Acronym: T-REX

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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