ClinicalTrials.gg
RecruitingNCT07505875T-REXUpdated Apr 6, 2026

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

An observational study in Substance Use, HIV Prevention and Sexually Transmitted Infections (STIs), sponsored by Institute of HIV Research and Innovation Foundation, Thailand. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Institute of HIV Research and Innovation Foundation, Thailand · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Substance Use
  • HIV Prevention
  • Sexually Transmitted Infections (STIs)

Keywords

  • Chemsex, Harm reduction
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 50 is below the median of 251 across 299 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

G1: Transgender chemsex users

  • Transgender women or transgender men
  • Current or former chemsex users

G2: Family / partners

  • Family members, friends, or partners of transgender persons
  • Never engaged in chemsex
  • Able to communicate in Thai

G3: Stakeholders

  • Healthcare providers, policymakers, law enforcement, counselors, community leaders
  • Involved in chemsex-related care/policy
  • Able to communicate in Thai

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable to participate in in-depth interview (IDI) (online or onsite)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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

  • 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.

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

  • 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.

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

Interventions

  • BehavioralUnderstanding of chemsex patterns, impacts, and service needs among transgender persons

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

06

What researchers measure

Primary outcomes

  1. Key themes on chemsex behaviors and service needs

    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.

    Time frame: At interview (single time point)

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

    Barriers and facilitators to implementation identified using the Consolidated Framework for Implementation Research (CFIR) domains based on stakeholder and participant interviews.

    Time frame: At interview (single time point)

  3. Chemsex-related behavioral and demographic characteristics

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

    Time frame: At interview (single time point)

  4. HIV-related stigma score

    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)

    Time frame: Baseline, Month 3, Month 6

  5. Transgender-related stigma score

    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)

    Time frame: Baseline, Month 3, Month 6

  6. PrEP adherence (self-reported adherence score)

    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)

    Time frame: Baseline, Month 3, Month 6

  7. Intervention acceptability score

    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)

    Time frame: Month 3

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07505875
Lead sponsor
Institute of HIV Research and Innovation Foundation, Thailand
Collaborators
amfAR, The Foundation for AIDS Research
Responsible party
Sponsor
First posted
Apr 1, 2026
Start date
May 1, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Nittaya Phanuphak, MD,PhD.
Contact
nittaya.p@ihri.org
6681 825 3544
Rena Janamnuaysook, MBA
Contact
rena.j@ihri.org
662 160 5371
Nittaya Phanuphak, MD,PhD.
principal investigator · Institute of HIV Research and Innovation (IHRI)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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