Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07505875
Acronym
T-REX
Enrollment
50
Registered
2026-04-01
Start date
2024-05-01
Completion date
2027-05-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Chemsex, Harm reduction

Brief 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.

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.

Interventions

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

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

Sponsors

Institute of HIV Research and Innovation Foundation, Thailand
Lead SponsorOTHER
amfAR, The Foundation for AIDS Research
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Key themes on chemsex behaviors and service needsAt 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 servicesAt 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 characteristicsAt interview (single time point)Descriptive characteristics of participants, including demographic data, substance use patterns, and behavioral risk factors collected via questionnaire.
HIV-related stigma scoreBaseline, Month 3, Month 6HIV-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 scoreBaseline, Month 3, Month 6Transgender-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)Baseline, Month 3, Month 6Self-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 scoreMonth 3Description: 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)

Countries

Thailand

Contacts

CONTACTNittaya Phanuphak, MD,PhD.
nittaya.p@ihri.org6681 825 3544
CONTACTRena Janamnuaysook, MBA
rena.j@ihri.org662 160 5371
PRINCIPAL_INVESTIGATORNittaya Phanuphak, MD,PhD.

Institute of HIV Research and Innovation (IHRI)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026