NCT07509853

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
May 2025May 2028

Study Start

First participant enrolled

May 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 22, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

PrEP, Harm reduction, Chemsex, Transgender, Sexual pleasure

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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

    Baseline, Month 3, and Month 6

Study Arms (2)

Pre-implementation Phase (Qualitative)

OTHER

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

Implementation Phase (Single-arm Intervention Study)

OTHER

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

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

Pre-implementation Phase (Qualitative)

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.

Implementation Phase (Single-arm Intervention Study)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMSM and transgender / gender diverse populations
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to communicate in Thai sufficiently to complete study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangerine Clinic, Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-BeingSexually Transmitted DiseasesChemsexHarm Reduction

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexual Behavior

Study Officials

  • Akarin Hiransuthikul, MD,MSc

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nittaya Phanuphak, MD,PhD.

CONTACT

Akarin Hiransuthikul, MD,MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2026

First Posted

April 3, 2026

Study Start

May 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

April 8, 2026

Record last verified: 2026-03

Locations