- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509853
Integrating Sexual Pleasure Into Harm Reduction Services for Men Who Have Sex With Men and Transgender Persons Who Engage in Chemsex or Substance Use in Thailand (PLEASURE)
Study Overview
Status
Conditions
Detailed Description
This is a sequential exploratory mixed-methods implementation study conducted at IHRI clinics in Bangkok. The study includes a pre-implementation phase (qualitative interviews) and an implementation phase where the adapted "Pleasuremeter" is integrated into harm reduction services.
Approximately 300 participants will be enrolled and followed at baseline, month 3, and month 6. Outcomes include sexual pleasure, behavioral risk, substance use, HIV/STI testing, mental health, and socio-legal factors. The study also evaluates acceptability, satisfaction, and feasibility of integrating a pleasure-based approach into existing services.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nittaya Phanuphak, MD,PhD.
- Phone Number: 6681 825 3544
- Email: nittaya.p@ihri.org
Study Contact Backup
- Name: Akarin Hiransuthikul, MD,MSc
- Phone Number: 3719 662 252 7864
- Email: akarin.h@chula.ac.th
Study Locations
-
-
Bangkok
-
Pathum Wan, Bangkok, Thailand, 10330
- Recruiting
- Tangerine Clinic, Institute of HIV Research and Innovation
-
Contact:
- Nittaya Phanuphak, MD.,Ph.D.
- Phone Number: +66 2 1605371
- Email: nittaya.p@ihri.org
-
Contact:
- Jakkrapatara Boonruang, MD
- Phone Number: +66 2 1605371
- Email: jakkrapatara.b@ihri.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- MSM, transgender women, transgender men, or non-binary persons
- Age ≥18 years
- Engaged in chemsex or substance use within past 12 months
- Able to provide informed consent
Exclusion Criteria:
• Unable to communicate in Thai sufficiently to complete study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pre-implementation Phase (Qualitative)
Participants (MSM, transgender/gender-diverse individuals, and healthcare providers) will participate in one-time in-depth interviews (IDIs) to explore understanding, cultural relevance, and appropriateness of the Pleasuremeter tool in the Thai context.
|
Semi-structured in-depth interviews guided by the Pleasuremeter framework, covering 7 domains of sexual pleasure:
|
|
Other: Implementation Phase (Single-arm Intervention Study)
Participants (MSM and transgender/gender-diverse individuals engaging in chemsex/substance use) will receive a multi-component intervention integrating the Pleasuremeter tool into routine study visits over 6 months (baseline, month 3, month 6).
|
Participants will undergo:
The intervention aims to facilitate structured discussions on sexual pleasure within harm reduction services. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to engage in sexual pleasure discussions assessed using the Pleasuremeter tool
Time Frame: Baseline, Month 3, and Month 6 (over 6 months follow-up)
|
The primary outcome is the proportion of participants who agree to engage in structured discussions on sexual pleasure using the Pleasuremeter, a structured assessment tool covering 7 domains:
Willingness will be assessed at each study visit (baseline, month 3, month 6) based on participant acceptance or refusal to complete the Pleasuremeter assessment. |
Baseline, Month 3, and Month 6 (over 6 months follow-up)
|
|
Sexual pleasure score assessed by the Pleasuremeter (0-10 scale)
Time Frame: Baseline, Month 3, and Month 6
|
Sexual pleasure will be measured using the Pleasuremeter, a composite self-reported scale assessing 7 domains of sexual experience.
Scores may be analyzed as:
|
Baseline, Month 3, and Month 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Akarin Hiransuthikul, MD,MSc, Chulalongkorn University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Pathologic Processes
- Disease Attributes
- Infections
- Communicable Diseases
- Chemically-Induced Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Personal Satisfaction
- Sexual Behavior
- Substance-Related Disorders
- Sexually Transmitted Diseases
- Psychological Well-Being
- Harm Reduction
- Chemsex
Other Study ID Numbers
- IHRI040
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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