NCT06187415

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

November 30, 2023

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Usability of the app

    Scores on the translated version of the mHealth App Usability questionnaire will be 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

  • Feasibility of the app

    Feasibility of the app will be measured by assessing the user's frequency of app log-ins, use of app components, and duration of app use.

    1 month

Study Arms (1)

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.

Behavioral: Mobile app to reduce harm of chemsex

Interventions

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.

The harm reduction mobile app

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailschemsex engaging individuals aged 18 years or older that are cisgender men or transgender female who have sex with men are eligible for the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NationalCKU

Tainan, Taiwan

Location

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Carol Strong, PhD

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2023

First Posted

January 2, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations