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

Harm Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06187415
• Other study ID #: HarmReductionAPPService
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 individuals and communities.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Harm Reduction

Intervention

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.

Locations

Country	Name	City	State
Taiwan	NationalCKU	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng Kung University	Healing, Empowerment, Recovery of Chemsex (HERO) integrated care clinic

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harm reduction behavior	a questionnaire will assess the change in chemsex harm reduction behavior every three months	3 months
Primary	Self-efficacy for sexual safety	scores on the self-efficacy for the sexual safety scale will be measured every 3 months. The total score ranges from 7 to 35. A higher score will indicate a higher level of self-efficacy for safe sex	3 months
Primary	Self-reported negative chemsex experiences	a questionnaire will be used to assess the change in the magnitude of negative chemsex experiences	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Sexual satisfaction	Scores on the satisfaction on sex life scale-revised measured every three months. Higher score means better sexual satisfaction	3 months
Secondary	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
Secondary	Feasibility of the app	measured by collecting data from app analytics one month after administering the baseline questionnaire	1 month
Secondary	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
Secondary	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