Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men
NCT ID: NCT04248790
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2020-05-25
2020-10-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Currently on medication that might interact with PrEP, such as drugs contain lamivudine in the pre-PrEP assessment.
20 Years
100 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cheng-Kung University Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
National Tsing Hua University
OTHER
National Cheng Kung University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carol Strong
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol Strong, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cheng Kung University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cheng Kung University Hospital
Tainan City, Tainan, Taiwan
Taipei city hospital (Renai Branch)
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MOST 108-2636-B-006-004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TaiwanUPrEPU
Identifier Type: -
Identifier Source: org_study_id