Status:
UNKNOWN
A Randomized Controlled Trial of a Digital, Self-testing Strategy for COVID-19 Infection in South Africa.
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
University of Cape Town Lung Institute
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
As the world opens up to rapidly increasing vaccination coverage and newer variants, there is an even greater need for timely access to at-home COVID-19 testing, or self-testing based out of kiosks, o...
Detailed Description
The investigators hypothesize that a rapid digital self-testing strategy that evaluates the risk of severe COVID-19 infection and guides participants on the methods of self-test interpretation and ens...
Eligibility Criteria
Inclusion
- Aged 18 years and above
- All sexes and genders
- Suspecting COVID-19 exposure
- Symptomatic or asymptomatic for COVID-19
- Mental capacity to provide informed consent
- Access to internet connectivity and digitally literate
- Access to a smart device that can download and run the COVIDSmart CARE! App (e.g., Android tablet version 6 or higher).
Exclusion
- Participants with serious mental health or clinical condition which limits their capacity to provide informed consent.
- Those with apparent severe COVID-19 symptoms requiring urgent hospitalization (e.g., severe shortness of breath, impaired level of consciousness, etc.).
Key Trial Info
Start Date :
February 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05436795
Start Date
February 2 2023
End Date
March 1 2024
Last Update
October 23 2023
Active Locations (1)
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1
University of Cape Town Lung Institute
Cape Town, Western Cape, South Africa, 7700