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)

The study evaluates the integration of a sexual pleasure-based approach into harm reduction services for MSM and transgender persons engaging in chemsex or substance use in Thailand, using the "Pleasuremeter" tool to improve sexual health and related outcomes.

Study Overview

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

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Recruiting
        • Tangerine Clinic, Institute of HIV Research and Innovation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • Physical and psychological satisfaction
  • Self-determination
  • Consent
  • Safety
  • Privacy
  • Confidence
  • Communication/negotiation
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:

  • Sexual pleasure assessment using Pleasuremeter (0-10 scale, 3-month recall)
  • Behavioral risk and substance use assessment
  • HIV/STI testing
  • Mental health screening using Electronic Mental Wellness Tool (e-mwTool)
  • Social and stigma assessment
  • Harm reduction services (drug literacy, counseling, referral, harm reduction kits)

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:

  • Physical and psychological satisfaction
  • Self-determination
  • Consent
  • Safety
  • Privacy
  • Confidence
  • Communication/negotiation

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.

  • Scale range: 0 to 10
  • Minimum value: 0 (lowest level of sexual pleasure)
  • Maximum value: 10 (highest level of sexual pleasure)
  • Interpretation: Higher scores indicate better sexual pleasure and satisfaction

Scores may be analyzed as:

  • Overall composite score
  • Domain-specific scores
Baseline, Month 3, and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Akarin Hiransuthikul, MD,MSc, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

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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