Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 1:55 AM
Study NCT ID:
NCT05436795
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of a Digital, Self-testing Strategy for COVID-19 Infection in South Africa.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome evaluator (statistician) will be unaware of the intervention allocation (single-blind).'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diagnostic accuracy of COVIDSmart CARE! versus conventional reference standard.', 'timeFrame': '1 year', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Estimating the impact on turnaround time (TAT) from the point of taking a test to initiating a clinical action plan.', 'timeFrame': 'Less than 24-48 hours', 'description': 'TAT is estimated to be \\<2 hours compared to 24 hours taken with a conventional RT-PCR test.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Less than 24-48 hours', 'description': '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.'}, {'measure': 'Impact on detection of new COVID-19 infections in each arm.', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'self-test', 'self-sample', 'point-of-care', 'randomized controlled trial', 'rapid test', 'digital', 'app-based', 'SARS-CoV-2'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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.\n\nData 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.\n\nSignificance:\n\nA digital, portable, self-testing strategy will facilitate rapid self-knowledge of COVID-19 status and rapid classification into clinical/quarantine/prevention plans.\n\nThe 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.', 'detailedDescription': "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.\n\nUsing 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years and above\n* All sexes and genders\n* Suspecting COVID-19 exposure\n* Symptomatic or asymptomatic for COVID-19\n* Mental capacity to provide informed consent\n* Access to internet connectivity and digitally literate\n* Access to a smart device that can download and run the COVIDSmart CARE! App (e.g., Android tablet version 6 or higher).\n\nExclusion Criteria:\n\n* Participants with serious mental health or clinical condition which limits their capacity to provide informed consent.\n* Those with apparent severe COVID-19 symptoms requiring urgent hospitalization (e.g., severe shortness of breath, impaired level of consciousness, etc.).'}, 'identificationModule': {'nctId': 'NCT05436795', 'briefTitle': 'A Randomized Controlled Trial of a Digital, Self-testing Strategy for COVID-19 Infection in South Africa.', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '174921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Arm', 'description': "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.", 'interventionNames': ['Device: Abbott Panbio rapid antigen self-tests', 'Other: COVIDSmart CARE! app']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Arm', 'description': '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.\n\nConventional arm is the standard of care arm.'}], 'interventions': [{'name': 'Abbott Panbio rapid antigen self-tests', 'type': 'DEVICE', 'description': 'COVID-19 self-testing will be performed using investigational Abbott Panbio rapid antigen self-test kits that require self-sampled nasal swabs.', 'armGroupLabels': ['Interventional Arm']}, {'name': 'COVIDSmart CARE! app', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Interventional Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7700', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Keertan Dheda, MBBCh, PhD', 'role': 'CONTACT', 'email': 'keertan.dheda@uct.ac.za', 'phone': '021 442 1816'}, {'name': 'Ali Esmail, MD', 'role': 'CONTACT', 'email': 'ali.esmail@uct.ac.za'}, {'name': 'Keertan Dheda, MBBCh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ali Esmail, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Apoorva Anand, BDS, MScPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeremi Swanepoel, MBChB, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Cape Town Lung Institute', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'centralContacts': [{'name': 'Keertan Dheda, MBBCh, PhD', 'role': 'CONTACT', 'email': 'keertan.dheda@uct.ac.za', 'phone': '021 442 1816'}, {'name': 'Ali Esmail, MD', 'role': 'CONTACT', 'email': 'ali.esmail@uct.ac.za', 'phone': '021 442 1816'}], 'overallOfficials': [{'name': 'Nitika Pant Pai, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre Research Institute, Montreal, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cape Town Lung Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nitika Pai', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}