HIV PreventionPLEASURENCT07509853
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
A study testing Pleasuremeter-guided qualitative interview and Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services in people with HIV Prevention and Substance Use, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention, Substance Use, Mental Health
- What is being tested?
- Pleasuremeter-guided qualitative interview and Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to communicate in Thai sufficiently to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Tangerine Clinic, Institute of HIV Research and Innovation
Pathum Wan, Bangkok, 10330
Nittaya Phanuphak, MD.,Ph.D., +66 2 1605371, nittaya.p@ihri.org
Jakkrapatara Boonruang, MD, +66 2 1605371, jakkrapatara.b@ihri.org
About this study
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.
- Conditions
- HIV Prevention, Substance Use, Mental Health, Sexually Transmitted Infections (STIs), Chemsex
- Being tested
- Pleasuremeter-guided qualitative interview, Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services
- Keywords
- PrEP, Harm reduction, Chemsex, Transgender, Sexual pleasure
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being, Sexually Transmitted Diseases, Chemsex, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleasuremeter-guided qualitative interviewBehavioural
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
Pleasuremeter-based sexual pleasure discussion integrated with harm reduction servicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akarin Hiransuthikul, MD,MSc, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509853
- Sponsor's protocol ID
- IHRI040
- Acronym
- PLEASURE
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07509853
- Acronym / sponsor ID
- PLEASURE / IHRI040
- Conditions
- HIV Prevention, Substance Use, Mental Health, Sexually Transmitted Infections (STIs), Chemsex
- Keywords
- PrEP, Harm reduction, Chemsex, Transgender, Sexual pleasure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation Phase (Qualitative) | Other | Behavioral: Pleasuremeter-guided qualitative interviewParticipants (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. |
| Implementation Phase (Single-arm Intervention Study) | Other | Behavioral: Pleasuremeter-based sexual pleasure discussion integrated with harm reduction servicesParticipants (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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to communicate in Thai sufficiently to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleasuremeter-guided qualitative interviewSemi-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 | Behavioural | Pre-implementation Phase (Qualitative) |
| Pleasuremeter-based sexual pleasure discussion integrated with harm reduction servicesParticipants 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. | Behavioural | Implementation Phase (Single-arm Intervention Study) |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akarin Hiransuthikul, MD,MSc principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleasuremeter-guided qualitative interview and Pleasuremeter-based sexual pleasure discussion integrated with harm reduction services in people with HIV Prevention and Substance Use, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nittaya Phanuphak, MD,PhD. (6681 825 3544, nittaya.p@ihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.