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

Not Applicable

Completed

• Conditions: HIV Infections; Pre-Exposure Prophylaxis
• Interventions: Behavioral: mobile app to improve adherence to PrEP self-management

• Registration Number: NCT04248790
• Lead Sponsor: National Cheng Kung University

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.

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2020-05-25
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: the mobile App	mobile app to improve adherence to PrEP self-management	Participants in the intervention arm will receive access to all the app capabilities. The app features include information on HIV testing locations, sex and PrEP diary and reminder of taking PrEP.

Primary Outcome Measures

Name	Time	Method
Efficacy of adherence monitoring	4 months	Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data
Usability	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	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 Outcome Measures

Name	Time	Method
Feasibility: data from qualitative interviews	4 months	1. any technical challenges participants may have encountered; 2. recommendations for the app improvement; 3. users' satisfaction and comfort in using this app

Trial Locations

Locations (3)

Taipei city hospital (Renai Branch); 🇨🇳 Taipei, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan City, Tainan, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan