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

NCT05436795 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Cape Town Lung Institute

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Nitika Pant Pai, MD, MPH, PhD · McGill University Health Centre Research Institute, Montreal, Canada

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436795 on ClinicalTrials.gov