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Clinical Trials/NCT04248790
NCT04248790
Completed
N/A

Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: A Pilot Study

National Cheng Kung University3 sites in 1 country35 target enrollmentMay 25, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Infections
Sponsor
National Cheng Kung University
Enrollment
35
Locations
3
Primary Endpoint
Efficacy of adherence monitoring
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study is testing feasibility and acceptability of a theoretically based mobile application (app), UPrEPU, to increase adherence to pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) to prevent human immunodeficiency virus (HIV).

Detailed Description

This study aims to develop an effective mobile application (app), UPrEPU to recognize the factors and decisions that affect PrEP adherence in high-risk populations to improve PrEP adherence. Key components of the app include a sex/PrEP diary using ecological momentary assessment to facilitate accurate data collection; PrEP taking reminder; HIV and sexually transmitted infections (STI) testing information and reminders; HIV and PrEP information and videos; geo-location. After eligible PrEP candidates agree to participate in the study, we will ask participants to install the app. Then, we will begin to collect their sexual diary and PrEP taking log via ecological momentary assessment. Participants will also complete monthly assessments. The monthly follow-up will test HIV/STI and drug concentration. The participants will be interviewed for difficulties when they use our app and giving feedback on it.

Registry
clinicaltrials.gov
Start Date
May 25, 2020
End Date
October 23, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carol Strong

Associate Professor

National Cheng Kung University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Efficacy of adherence monitoring

Time Frame: 4 months

Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data

Usability

Time Frame: 4 months

Scores on system usability scale (SUS) for this app at the first month and the fourth month.

Feasibility: data based on the app analytics

Time Frame: 4 months

1. Frequency of app log-in; 2. Use of app components such as PrEP-taking and sex behavior reports; 3. Duration of app use

Secondary Outcomes

  • Feasibility: data from qualitative interviews(4 months)

Study Sites (3)

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