ClinicalTrials.gg
RecruitingNCT07509853PLEASUREUpdated Apr 8, 2026

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

An interventional study of Pleasuremeter-guided qualitative interview and Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services in HIV Prevention, Substance Use and Mental Health, sponsored by Institute of HIV Research and Innovation Foundation, Thailand. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Institute of HIV Research and Innovation Foundation, Thailand · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2025, registered Mar 2026).
  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • HIV Prevention
  • Substance Use
  • Mental Health
  • Sexually Transmitted Infections (STIs)
  • Chemsex

Keywords

  • PrEP, Harm reduction, Chemsex, Transgender, Sexual pleasure
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 300 is above the median of 108 across 1,840 interventional 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
No

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable to communicate in Thai sufficiently to complete study procedures
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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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.

    Behavioral: Pleasuremeter-guided qualitative interview

  • 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).

    Behavioral: Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services

Interventions

  • BehavioralPleasuremeter-guided qualitative interview

    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

  • BehavioralPleasuremeter-based sexual pleasure discussion integrated with harm reduction services

    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.

06

What researchers measure

Primary outcomes

  1. Willingness to engage in sexual pleasure discussions assessed using the Pleasuremeter tool

    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.

    Time frame: Baseline, Month 3, and Month 6 (over 6 months follow-up)

  2. Sexual pleasure score assessed by the Pleasuremeter (0-10 scale)

    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

    Time frame: Baseline, Month 3, and Month 6

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 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07509853
Lead sponsor
Institute of HIV Research and Innovation Foundation, Thailand
Responsible party
Sponsor
First posted
Apr 3, 2026
Start date
May 1, 2025
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Apr 8, 2026

Study contacts

Nittaya Phanuphak, MD,PhD.
Contact
nittaya.p@ihri.org
6681 825 3544
Akarin Hiransuthikul, MD,MSc
Contact
akarin.h@chula.ac.th
662 252 7864 ext. 3719
Akarin Hiransuthikul, MD,MSc
principal investigator · Chulalongkorn University

Oversight

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

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