A Randomized Controlled Trial of a Digital, Self-testing Strategy for COVID-19 Infection 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.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Abbott Panbio rapid antigen self-tests; Other: COVIDSmart CARE! app

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Keertan Dheda, MBBCh, PhD; Phone Number: 021 442 1816; Email: keertan.dheda@uct.ac.za
• Study Contact Backup: Name: Ali Esmail, MD; Phone Number: 021 442 1816; Email: ali.esmail@uct.ac.za

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7700
      • Recruiting
      • University of Cape Town Lung Institute
      • Contact: Ali Esmail, MD; Email: ali.esmail@uct.ac.za
      • Contact: Keertan Dheda, MBBCh, PhD; Phone Number: 021 442 1816; Email: keertan.dheda@uct.ac.za
      • Principal Investigator: Keertan Dheda, MBBCh, PhD
      • Sub-Investigator: Ali Esmail, MD
      • Sub-Investigator: Apoorva Anand, BDS, MScPH
      • Sub-Investigator: Jeremi Swanepoel, MBChB, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Arm; In the interventional arm, we will offer a self-administered supervised COVID-19 testing strategy with an investigational device - Abbott's Panbio COVID-19 Antigen Self-test. The self-test process will be facilitated by the COVIDSmart CARE! digital App and platform. Suspected COVID-19 patients will be triaged into one of three action plans: a) clinical care pathways, b) prevention (home quarantine, isolation) pathways, or c) social distancing.	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.
No Intervention: Conventional Arm; Participants presenting to test for SARS-CoV-2 will be staged on their self-reported severity of symptoms (mild, moderate, severe) and tested with rapid antigen tests, followed by RT-PCR testing. Suspected COVID-19 patients will be triaged into one of three action plans: a) clinical care pathways, b) prevention (home quarantine, isolation) pathways, or c) social distancing. Conventional arm is the standard of care arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: University of Cape Town Lung Institute
• Investigators: Principal Investigator: Nitika Pant Pai, MD, MPH, PhD, McGill University Health Centre Research Institute, Montreal, Canada

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; randomized controlled trial; COVID-19; rapid test; digital; self-test; point-of-care; self-sample; app-based
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 174921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No