Harm Reduction Strategies for Gay, Bisexual and Other Men Who Have Sex With Men Engaging in Chemsex

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.

Study Overview

• Status: Completed
• Conditions: Harm Reduction
• Intervention / Treatment: Behavioral: Mobile app to reduce harm of chemsex

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • NationalCKU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	scores on the Patient Health Questionnaire (PHQ-9) will be assessed every three months. The scores ranges from 0 to 27. A cutoff score of 10 indicates major depression	3 months
Sleep quality	Scores on the Single-Item Sleep Quality Scale will be measured every three months. The scores ranges from 0 to 10 where in 0 means terrible sleep quality, 1 to 3 means poor, 4 to 6 means fair, 7 to 9 means good and 10 means excellent.	3 months
Suicide	Scores on the Suicide Behavior Questionnaire-Revised (SBQ-R) item 1 will be measured every three months. The cut off score that will be used in identifying individuals with established suicide status is 2	1 month
Usability and acceptability of the app	Scores on the mHealth App Usability questionnaire measured at the first month of follow up. Scores range from 18 to 126. The questionnaire score is that 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.	1 month
Feasibility of the app	measured by collecting data from app analytics one month after administering the baseline questionnaire	1 month
Drug dependence	Scores on the severity of dependence scale measured every three months of follow up. Total score ranges from 0 to 15. A higher total score indicates a higher level of dependence.	3 months
Goal changes	A questionnaire will be used to provide a descriptive account of harm reduction goal changes. It will be assessed every three months	3 months
Sexual satisfaction	Scores on the satisfaction on sex life scale-revised measured every three months. Higher score means better sexual satisfaction	3 months

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Healing, Empowerment, Recovery of Chemsex (HERO) integrated care clinic
• Investigators: Principal Investigator: Carol Strong, PhD, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 8, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Harm Reduction
• Other Study ID Numbers: HarmReductionAPPService

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No