Trial Outcomes & Findings for Harm Reduction Strategies for Gay, Bisexual and Other Men Who Have Sex With Men Engaging in Chemsex (NCT NCT06187415)
NCT ID: NCT06187415
Last Updated: 2026-06-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
1 month
Results posted on
2026-06-01
Participant Flow
Participants were recruited from an integrated care clinic specializing in sexual health and chemsex, from current UPrEPU users, and through online channels and word of mouth.
No significant events occurred between enrollment and participation. Eligible participants were directly onboarded to the UPrEPU app and completed baseline assessments. No washout, run-in period, or pre-assignment exclusions were reported.
Participant milestones
| Measure |
The Harm Reduction Mobile App
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.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
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20
|
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
The Harm Reduction Mobile App
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.
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|---|---|
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Overall Study
Lost to Follow-up
|
5
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
The Harm Reduction Mobile App
n=20 Participants
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.
Mobile app to reduce harm of chemsex: 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.
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|---|---|
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Age, Customized
Age · < 35 years
|
7 Participants
n=20 Participants
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Age, Customized
Age · ≥ 35
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13 Participants
n=20 Participants
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Sex: Female, Male
Female
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0 Participants
n=20 Participants
|
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Sex: Female, Male
Male
|
20 Participants
n=20 Participants
|
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Education
Bachelor's degree or higher
|
16 Participants
n=20 Participants
|
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Education
lower educational attainment
|
4 Participants
n=20 Participants
|
|
Employment Status
Employed
|
18 Participants
n=20 Participants
|
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Employment Status
Not employed
|
2 Participants
n=20 Participants
|
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Type of substance used for chemsex
Methamphetamine
|
19 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Type of substance used for chemsex
GHB/GBL
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11 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
|
|
Type of substance used for chemsex
MDMA
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4 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Type of substance used for chemsex
Viagra
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14 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
|
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Type of substance used for chemsex
Alkyl nitrites (Rush, poppers)
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11 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Type of substance used for chemsex
Sedative
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4 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Sexual behaviors
Having a sexual partner living with HIV in past 3 months
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9 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
|
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Sexual behaviors
Numbers of male sexual partners in the past 3 months ≥ 6
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6 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Sexual behaviors
CLAI in past 3 months
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19 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Sexual behaviors
Self-reported STI in the lifetime (any kind)
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7 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Preventive behaviors
HIV negative not on PrEP
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3 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Preventive behaviors
HIV negative on PrEP
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6 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
|
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Preventive behaviors
Living with HIV
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11 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Preventive behaviors
Mpox vaccination uptake
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14 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Preventive behaviors
HPV vaccination uptake
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13 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Preventive behaviors
Doxy-PEP use experience
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2 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Chemsex services utilization in the past three months
Chemsex recovery therapy groups or counseling
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9 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Chemsex services utilization in the past three months
Mental health clinic/hospital or rehab center
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9 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Chemsex services utilization in the past three months
Chemsex care programs affiliated with NGO
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4 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Chemsex services utilization in the past three months
Needle Syringe Program
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2 Participants
n=20 Participants • Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item.
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Self-efficacy for sexual safety
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21.30 Scale scores
STANDARD_DEVIATION 7.73 • n=20 Participants
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Sexual satisfaction
|
4.48 Scale scores
STANDARD_DEVIATION 1.81 • n=20 Participants
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PRIMARY outcome
Timeframe: 1 monthScores 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.
Outcome measures
| Measure |
Intervention Arm
n=20 Participants
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.
|
|---|---|
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Usability of the App
|
2.14 Scores on the MAUQ
Standard Deviation 1.15
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Adverse Events
The Harm Reduction Mobile App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Carol Strong
National Cheng Kung University
Phone: +886-6-2353535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place