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

Primary Purpose

HIV Infections, Pre-Exposure Prophylaxis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
mobile app to improve adherence to PrEP self-management
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • National Cheng Kung University Hospital
  • Taipei city hospital (Renai Branch)
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: the mobile App

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 28, 2020
Last Updated
December 28, 2020
Sponsor
National Cheng Kung University
Collaborators
National Cheng-Kung University Hospital, Taipei Veterans General Hospital, Taiwan, National Tsing Hua University
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1. Study Identification

Unique Protocol Identification Number
NCT04248790
Brief Title
Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men
Official Title
Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
Collaborators
National Cheng-Kung University Hospital, Taipei Veterans General Hospital, Taiwan, National Tsing Hua University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pre-Exposure Prophylaxis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: the mobile App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mobile app to improve adherence to PrEP self-management
Intervention Description
Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.
Primary Outcome Measure Information:
Title
Usability
Description
Scores on system usability scale (SUS) for this app at the first month and the fourth month.
Time Frame
4 months
Title
Feasibility: data based on the app analytics
Description
Frequency of app log-in; Use of app components such as PrEP-taking and sex behavior reports; Duration of app use
Time Frame
4 months
Title
Efficacy of adherence monitoring
Description
Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Feasibility: data from qualitative interviews
Description
any technical challenges participants may have encountered; recommendations for the app improvement; users' satisfaction and comfort in using this app
Time Frame
4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Strong, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
701
Country
Taiwan
Facility Name
Taipei city hospital (Renai Branch)
City
Taipei
ZIP/Postal Code
10629
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33258793
Citation
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.
Results Reference
derived

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

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