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, orself-testing based out of kiosks, offices, or private spaces.Data on digital strategies that complement self-testing are sparse. Using a superiorityrandomized controlled trial design (open-label, single-blinded), the investigators willaim to evaluate the impact of a digital self-testing strategy offered out ofkiosks/private spaces on the turnaround time to test results, the proportion ofparticipants initiated on action plans, and new infection detected with the strategy. Theinvestigators will compare these outcomes to a conventional lab-based strategy.Significance:A digital, portable, self-testing strategy will facilitate rapid self-knowledge ofCOVID-19 status and rapid classification into clinical/quarantine/prevention plans.The study will document the impact of a digitally connected self-testing strategy forCOVID-19 infection. Upon completion of the strategy, the digital program will beavailable for global dissemination.
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 ensuing action plans will be more impactful in detecting COVID-19
infection and will facilitate more participants to take an appropriate course of action
compared to the conventional strategy. Action plans initiated will be either: a) clinical
care, b) prevention (home quarantine, isolation), or c) social distancing. Taken
together, these actions will impact health outcomes during the current and ensuing
SARS-CoV-2 surges.
Using a superiority randomized controlled trial (RCT) design, the investigators will
randomize participants to either the App-based self-testing arm or the conventional
testing arm (screening and testing performed by a health care worker (HCW) at the
COVID-19 testing site). A confirmatory RT-PCR test will be performed in both arms. The
standard of care will be offered in the conventional arm.
The interventional strategy will be offered in kiosks/private spaces within COVID-19
testing sites or student health clinics. The COVIDSmart CARE! digital App-based program
will be downloaded onto the test kiosk based tablets or participants' smartphones. This
strategy will yield self-test results and guided action plans in a rapid turnaround time.
Device: Abbott Panbio rapid antigen self-tests
COVID-19 self-testing will be performed using investigational Abbott Panbio rapid antigen
self-test kits that require self-sampled nasal swabs.
Other: COVIDSmart CARE! app
Guided by the application that connects, educates, and communicates a digital,
contactless open access strategy, participants will have the opportunity to self-test and
assess their risk level of COVID-19 infection, as well as the option to refer their close
contacts to testing for those who are COVID-19 positive, through the study platform.
Inclusion Criteria:
- 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 Criteria:
- 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.).
University of Cape Town Lung Institute
Cape Town, Western Cape, South Africa
Investigator: Keertan Dheda, MBBCh, PhD
Contact: 021 442 1816
keertan.dheda@uct.ac.za
Keertan Dheda, MBBCh, PhD
021 442 1816
keertan.dheda@uct.ac.za
Ali Esmail, MD
021 442 1816
ali.esmail@uct.ac.za
Nitika Pant Pai, MD, MPH, PhD, Principal Investigator
McGill University Health Centre Research Institute, Montreal, Canada