COVID-19 Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.). |
Country | Name | City | State |
---|---|---|---|
South Africa | University of Cape Town Lung Institute | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | University of Cape Town Lung Institute |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Diagnostic accuracy of COVIDSmart CARE! versus conventional reference standard. | We will compare the diagnostic performance of our interventional (digital self-testing strategy) versus conventional RT-PCR tested (a composite reference standard algorithm containing NAATs from a different manufacturer); with performance metrics (i.e., sensitivity, specificity, and positive and negative predictive values with 95% CI). | 1 year | |
Primary | Estimating the impact on turnaround time (TAT) from the point of taking a test to initiating a clinical action plan. | TAT is estimated to be <2 hours compared to 24 hours taken with a conventional RT-PCR test. | Less than 24-48 hours | |
Secondary | 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. | Proportional estimates of participants who action the guidance given via the App compared to those who undergo standard of care testing will measure the efficacy of the App on changing behaviour and/or linkage to care. | Less than 24-48 hours | |
Secondary | Impact on detection of new COVID-19 infections in each arm. | We will document the impact of digital self-testing versus conventional testing on the number of new COVID-19 infections detected in each arm. We will compare and document the proportion of newly identified participants as test positives in both arms. Test positives and test negatives will be confirmed by lab confirmed results and test protocols. | 1 year |
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