Harm ReductionNCT06187415
Harm Reduction Strategies for Gay, Bisexual and Other Men Who Have Sex With Men Engaging in Chemsex
A study testing Mobile app to reduce harm of chemsex in people with Harm Reduction, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
This study is examining the usability and effectiveness of an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Harm Reduction
- What is being tested?
- Mobile app to reduce harm of chemsex
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals need to have a history of drug use (ecstasy, ketamine, crystal methamphetamine, mephedrone, and/or GHB/GBL)in a sexualized context in the previous year
- can read and understand chinese,
- willing to communicate with the research team through the mobile messenger app Line.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study is examining the usability and effectiveness of an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for individuals and communities.
Read the detailed description
The practice of sexualized drug use is historical and has been noted across a diversity of genders and people of various sexual orientations. The term "chemsex" has been used to specifically describe the use of psychoactive substances in sexualized settings among gay, bisexual, and other men who have sex with men (GBMSM), particularly stimulants like methamphetamine and mephedrone, or other drugs like γ-hydroxybutyrate (GHB), γ-butyrolactone (GBL). Chemsex among GBMSM has coincided with the emergence of sexual-networking mobile apps, creating new opportunities for finding new partners with the intention to engage in chemsex.
Harm reduction strategies for GBMSM engaging in chemsex are needed because the use of these drugs can have negative consequences for the physical and mental health of the people who use them. One of the main risks associated with chemsex is the possibility of overdose. In addition to the risk of overdose, chemsex may also increase the risk of sexually transmitted infections (STIs) and HIV transmission due to the higher possibility to engage in risky sexual behaviors.
Seeking help can be difficult for GBMSM who engage in chemsex due to stigma, making the harm reduction approach equally important as clinical treatment or intervention that emphasized an abstinence approach. Harm reduction strategies recognize that drug use is a complex issue and that it is not always possible or desirable for people to stop using drugs completely. Instead, harm reduction approaches aim to reduce the harm that can result from drug use and to support people in making healthier choices.
Considering also that mobile applications are another way to provide help to hard to reach population, this study aims to develop an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app. PrEP is a medication that can be taken daily to reduce the risk of HIV transmission. The aim of including PrEP adherence in the self-help harm reduction strategy is to ensure that participants have access to and are using an effective HIV prevention method. Behavior regulation strategies such as providing education about the risks of drug use, overdose prevention and management, and HIV prevention through correct PrEP intake, can be integrated into a mobile app that aims to minimize the negative consequences of drug use and reduce the risks associated with it, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for individuals and communities.
- Conditions
- Harm Reduction
- Being tested
- Mobile app to reduce harm of chemsex
- Medical subject headings
- Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app to reduce harm of chemsexBehavioural
Access to the mobile app which includes PrEP diary, demistification of chemsex urban legends, information on the location of needle and syringe services program, and alert sending to emergency contact.
| Study group | Role | What they receive |
|---|---|---|
| The harm reduction mobile app | Experimental | Participants in the intervention arm will receive access to all the app functions. The primary features of the app include PrEP taking diary, setting harm reduction goals, providing location of needle and syringe services program, providing accurate information on chemsex urban legends, and sending alerts to emergency contact in case of intoxication. Receives: Behavioral: Mobile app to reduce harm of chemsex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the App
Scores on the translated version of the mHealth App Usability questionnaire (MAUQ) was used to assess usability. Responses to the statements on the questionnaire ranged from 1(strongly agree) to 7 (strongly disagree). The questionnaire is the total score of each item divided by the number of items. The closer the mean value is to 1, the higher the app's usability will be.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2024
- Primary completion8 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Harm ReductionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Healing, Empowerment, Recovery of Chemsex (HERO) integrated care clinic
- Responsible party
- Principal investigator, Carol Strong, National Cheng Kung University
- Investigators
- Carol Strong, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187415
- Sponsor's protocol ID
- HarmReductionAPPService
- Status last verified
- May 2026
- First submitted
- 30 Nov 2023
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harm Reduction Strategies for Gay, Bisexual and Other Men Who Have Sex With Men Engaging in Chemsex
- ClinicalTrials.gov ID
- NCT06187415
- Acronym / sponsor ID
- HarmReductionAPPService
- Conditions
- Harm Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Healing, Empowerment, Recovery of Chemsex (HERO) integrated care clinic
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining the usability and effectiveness of an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for individuals and communities.
Detailed description
The practice of sexualized drug use is historical and has been noted across a diversity of genders and people of various sexual orientations. The term "chemsex" has been used to specifically describe the use of psychoactive substances in sexualized settings among gay, bisexual, and other men who have sex with men (GBMSM), particularly stimulants like methamphetamine and mephedrone, or other drugs like γ-hydroxybutyrate (GHB), γ-butyrolactone (GBL). Chemsex among GBMSM has coincided with the emergence of sexual-networking mobile apps, creating new opportunities for finding new partners with the intention to engage in chemsex.
Harm reduction strategies for GBMSM engaging in chemsex are needed because the use of these drugs can have negative consequences for the physical and mental health of the people who use them. One of the main risks associated with chemsex is the possibility of overdose. In addition to the risk of overdose, chemsex may also increase the risk of sexually transmitted infections (STIs) and HIV transmission due to the higher possibility to engage in risky sexual behaviors.
Seeking help can be difficult for GBMSM who engage in chemsex due to stigma, making the harm reduction approach equally important as clinical treatment or intervention that emphasized an abstinence approach. Harm reduction strategies recognize that drug use is a complex issue and that it is not always possible or desirable for people to stop using drugs completely. Instead, harm reduction approaches aim to reduce the harm that can result from drug use and to support people in making healthier choices.
Considering also that mobile applications are another way to provide help to hard to reach population, this study aims to develop an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app. PrEP is a medication that can be taken daily to reduce the risk of HIV transmission. The aim of including PrEP adherence in the self-help harm reduction strategy is to ensure that participants have access to and are using an effective HIV prevention method. Behavior regulation strategies such as providing education about the risks of drug use, overdose prevention and management, and HIV prevention through correct PrEP intake, can be integrated into a mobile app that aims to minimize the negative consequences of drug use and reduce the risks associated with it, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for individuals and communities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The harm reduction mobile app | Experimental | Behavioral: Mobile app to reduce harm of chemsexParticipants in the intervention arm will receive access to all the app functions. The primary features of the app include PrEP taking diary, setting harm reduction goals, providing location of needle and syringe services program, providing accurate information on chemsex urban legends, and sending alerts to emergency contact in case of intoxication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals need to have a history of drug use (ecstasy, ketamine, crystal methamphetamine, mephedrone, and/or GHB/GBL)in a sexualized context in the previous year
- can read and understand chinese,
- willing to communicate with the research team through the mobile messenger app Line.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mobile app to reduce harm of chemsexAccess to the mobile app which includes PrEP diary, demistification of chemsex urban legends, information on the location of needle and syringe services program, and alert sending to emergency contact. | Behavioural | The harm reduction mobile app |
Primary outcome
Usability of the App
Time frame: 1 month
Scores on the translated version of the mHealth App Usability questionnaire (MAUQ) was used to assess usability. Responses to the statements on the questionnaire ranged from 1(strongly agree) to 7 (strongly disagree). The questionnaire is the total score of each item divided by the number of items. The closer the mean value is to 1, the higher the app's usability will be.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Harm Reduction
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
Not yet recruiting
Connecting Online Military Personnel to Alcohol Harm-reducing Smartphone Support Study
Alcohol Use Disorder (AUD)
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
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. This study is not recruiting at the moment.
Carol Strong, PhD principal investigator
National Cheng Kung 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 Mobile app to reduce harm of chemsex in people with Harm Reduction, run by National Cheng Kung University at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 1 Jun 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the App (time frame: 1 month). 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 1 Jun 2026.