Digital self-testing for COVID-19 in South Africa
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.
This study is testing a new app that lets people in South Africa self-test for COVID-19 to see if it works better and faster than regular lab tests.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Cape Town, Western Cape) |
| Trial ID | NCT05436795 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a digital self-testing strategy for COVID-19, comparing it to conventional lab-based testing. Participants will use the COVIDSmart CARE! app to perform self-tests at kiosks or private spaces, aiming to improve turnaround time for results and facilitate timely action plans for those testing positive. The study will assess the effectiveness of this approach in detecting infections and guiding participants on necessary actions, such as clinical care or quarantine. The trial will include both symptomatic and asymptomatic individuals aged 18 and above who suspect COVID-19 exposure.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older who suspect COVID-19 exposure and have access to the internet and a smart device.
Not a fit: Patients with severe COVID-19 symptoms requiring hospitalization or those unable to provide informed consent due to mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide faster and more accessible COVID-19 testing, leading to timely interventions and improved health outcomes.
How similar studies have performed: While digital self-testing strategies are emerging, this specific approach is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Cape Town, Western Cape
- University of Cape Town Lung Institute — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Nitika Pant Pai, MD, MPH, PhD — McGill University Health Centre Research Institute, Montreal, Canada
- Study coordinator: Keertan Dheda, MBBCh, PhD
- Email: keertan.dheda@uct.ac.za
- Phone: 021 442 1816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.