Clinical trial NCT05436795: A Randomized Controlled Trial of a Digital, Self-testing Strategy for COVID-19 Infection in South Africa.
Official title: Evaluation of the Impact of a Digital Self-testing Strategy in Individuals With Suspected COVID-19 Infection in South Africa on Time to Action Plans, Linkage to Care, Detection of New Infections: A Randomized Controlled Superiority Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: COVID-19
self-test
self-sample
point-of-care
randomized controlled trial
rapid test
digital
app-based
SARS-CoV-2
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: University of Cape Town Lung Institute
First posted: 2022-06-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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, offices, or private spaces.

Data on digital strategies that complement self-testing are sparse. Using a superiority randomized controlled trial design (open-label, single-blinded), the investigators will aim to evaluate the impact of a digital self-testing strategy offered out of kiosks/private spaces on the turnaround time to test results, the proportion of participants initiated on action plans, and new infection detected with the strategy. The investigators will compare these outcomes to a conventional lab-based strategy.

Significance:

A digital, portable, self-testing strategy will facilitate rapid self-knowledge of COVID-19 status and rapid classification into clinical/quarantine/prevention plans.

The study will document the impact of a digitally connected self-testing strategy for COVID-19 infection. Upon completion of the strategy, the digital program will be available for global dissemination.

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 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Estimating the impact on turnaround time (TAT) from the point of taking a test to initiating a clinical action plan.
timeFrame: Less than 24-48 hours
Secondary outcomes:
measure: The impact of the COVIDSmart CARE! self-testing strategy on the proportion of participants taking an appropriate COVID-19 related action compared to conventional COVID-19 testing strategies at 24 hours post randomization.
timeFrame: Less than 24-48 hours
measure: Impact on detection of new COVID-19 infections in each arm.
timeFrame: 1 year
Other outcomes:
measure: Diagnostic accuracy of COVIDSmart CARE! versus conventional reference standard.
timeFrame: 1 year
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
state: Western Cape
Study officials:
affiliation: McGill University Health Centre Research Institute, Montreal, Canada
name: Nitika Pant Pai, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: