McGill University Health Centre/Research Institute of the McGill University Health Centre
Nitika Pie
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.
COVID-19
Abbott Panbio rapid antigen self-tests
COVIDSmart CARE! app
PHASE1
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 600 participants |
| Masking : | SINGLE |
| Masking Description : | The outcome evaluator (statistician) will be unaware of the intervention allocation (single-blind). |
| Primary Purpose : | SCREENING |
| 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. |
| Actual Study Start Date : | 2023-02-02 |
| Estimated Primary Completion Date : | 2023-12 |
| Estimated Study Completion Date : | 2024-03 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Cape Town Lung Institute
Cape Town, Western Cape, South Africa, 7700