If you find anything in error, please contact Stephanie Rodgers (firstname.lastname@example.org).
Application Name: Karen Dominguez
Application Owner: Karen Dominguez
Application Technical Contact: Karen Dominguez
Application Support Model: Consultants who developed the app or other consultant (Softura)
Application Administration Model: Consultants who developed the app or other consultant (Softura)
This application is part of a research study. This app will help determine the efficacy of telemedicine health initiatives. The app will provide participants with a way to track their progress through the study and will be the way participants can interact with our study staff. Only participants eligible for the study will be able to use the app. The app is to assist participants in tracking their progress in the study as well as to conduct telemedicine visits through an API to Zoom.
The purpose of the mobile app is to provide a way to communicate with participants and collect information relevant to Pre-exposure prophylaxis (PrEP) as a method for HIV prevention. The app includes tracking for kits that will be shipped to participant's homes for self-specimen collection for laboratory testing, an API to Zoom for telemedicine consultations with clinicians, and an API with SurveyGizmo for data collection. Participants will be able to message with study staff and track their progress on the study through the app. The study will assess if the app can promote persistence in PrEP care through mobile app communication and monitoring more than requiring participants to attend in-person clinic visits. PrEP@Home project has three components. There is an admin site which is used to manage all study data such as participant information, messaging and lab results. There is a mobile app which is downloaded by participants to stay engaged with the study and perform necessary activities. Lastly, there is a web service which acts as a liaison between the mobile app and the study database.
Application Marketplace ID/Link:
|ServiceNow Request||Distribution Status & Date||Internal Review Status & Date||ePHI Indicator||Target User Base|
|Ready to be submitted to public app marketplaces|
Internal Review Status: Complete
|Review Request Date||Office of Technology Transfer Review||Legal Counsel Review (if applicable)||Marketing & Communications Review||Compliance & Regulatory Review||IT Security Review|
Architecture Review (if applicable)
Pre-approval request (to run concurrently with development)
|Justin Burns is contact||n/a||pre-approved (per Peta Westmaas 2018.06.19)||deferring to IRB for approval||pre-approved (per Elliot Kendall 2018.05.07)||n/a|
Sent to reviewers
Per Peta Westmass
Conditional approval: Must comply with HIPAA and FDA
Upload collateral as it is collected.
Relevant approval artifacts and documentation may be found here: https://emory.app.box.com/folder/49053526117
- Completed IP Disclosure.
- Commercial Evaluation Report.
- Legal Counsel Review.
- Marketing and Communications Review.
- Compliance and Regulatory Review.
- IT Security Review.
- Architecture Review.
- App Store Submission Templates (Apple App Store & Google Play).
- Distribution Review Checklist.