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

NCT05436795 | Unknown Phase 1

• 1 other identifier: 174921
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; self-test; self-sample; point-of-care; randomized controlled trial; rapid test; digital; app-based; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  Less than 24-48 hours

• Impact on detection of new COVID-19 infections in each arm.

  1 year

Other Outcomes (1)

• Diagnostic accuracy of COVIDSmart CARE! versus conventional reference standard.

  1 year

Study Arms (2)

Interventional Arm

EXPERIMENTAL

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; Other: COVIDSmart CARE! app

Conventional Arm

NO INTERVENTION

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.

Interventions

Abbott Panbio rapid antigen self-tests DEVICE

COVID-19 self-testing will be performed using investigational Abbott Panbio rapid antigen self-test kits that require self-sampled nasal swabs.

Interventional Arm

COVIDSmart CARE! app OTHER

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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.).

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• University of Cape Town Lung Institute: collaborator

Study Sites (1)

University of Cape Town Lung Institute

Cape Town, Western Cape, 7700, South Africa

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nitika Pant Pai, MD, MPH, PhD

  McGill University Health Centre Research Institute, Montreal, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keertan Dheda, MBBCh, PhD

CONTACT

021 442 1816; keertan.dheda@uct.ac.za

Ali Esmail, MD

CONTACT

021 442 1816; ali.esmail@uct.ac.za

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator (statistician) will be unaware of the intervention allocation (single-blind).
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 29, 2022
• Study Start: February 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)