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

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

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections; Pre-Exposure Prophylaxis
• Intervention / Treatment: Behavioral: mobile app to improve adherence to PrEP self-management

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10629
    • Taipei city hospital (Renai Branch)
  • Tainan
    • Tainan City, Tainan, Taiwan, 701
      • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

• Male.
• Aged 20 or above.
• Resides in Taiwan and able to understand, read, and speak Mandarin Chinese.
• Remains HIV negative prior to and during the study period.
• The results of the laboratory tests are eligible to initiate PrEP.
• Currently taking PrEP or willing to initiate PrEP.
• Reports having 4 times or above anal sex with men in the past month.
• Owns an Android or Apple operating system (iOS) smartphone and willing to download the study app.
• Willing to wear the device we provided during the study period.

Exclusion criteria:

• With abnormal kidney function (creatinine clearance rate ≦ 60 mL/minute).
• Currently on medication that might interact with PrEP, such as drugs contain lamivudine in the pre-PrEP assessment.

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: Experimental: the mobile App; 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.	Behavioral: mobile app to improve adherence to PrEP self-management; Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Scores on system usability scale (SUS) for this app at the first month and the fourth month.	4 months
Feasibility: data based on the app analytics	Frequency of app log-in;; Use of app components such as PrEP-taking and sex behavior reports;; Duration of app use	4 months
Efficacy of adherence monitoring	Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: data from qualitative interviews	any technical challenges participants may have encountered;; recommendations for the app improvement;; users' satisfaction and comfort in using this app	4 months

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Taipei Veterans General Hospital, Taiwan; National Cheng-Kung University Hospital; National Tsing Hua University
• Investigators: Principal Investigator: Carol Strong, PhD, National Cheng Kung University

Publications and helpful links

General Publications

• Strong C, Wu HJ, Tseng YC, Yuan CW, Yu YF, Liao JC, Chen YW, Hung YC, Li CW, Huang PH, Ko NY, Ku SW. Mobile App (UPrEPU) to Monitor Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: Protocol for a User-Centered Approach to Mobile App Design and Development. JMIR Res Protoc. 2020 Dec 1;9(12):e20360. doi: 10.2196/20360.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: TaiwanUPrEPU; MOST 108-2636-B-006-004 (Other Grant/Funding Number: Taiwan Ministry of Science and Technology)

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