- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05701878
COVID-19 Self-testing Study
Field Test of COVID-19 Self-testing With Rapid Antigen Tests
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rapid diagnostic testing has been shown to be an important tool in controlling the spread of the COVID-19 pandemic by identifying people when they are likely to be most contagious and reducing crowding at testing sites. In addition to employer-mandated testing, rapid antigen tests are becoming increasingly used by individuals. A method to promote frequent self-testing would help break the chain of viral transmission, slow the spread of disease, slow the spread of vaccine-resistant variants, and improve pandemic management.
The ubiquity of smartphones along with their data connectivity capabilities and onboard sensors make them an attractive tool to complement rapid diagnostic tests and an important component of decentralized testing. Smartphone-based tools have shown high acceptability among healthcare workers for the real-time tracking of rapid test results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Terry Chern, MS
- Phone Number: 909-569-9511
- Email: tlc2156@cumc.columbia.edu
Study Locations
-
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New York
-
New York, New York, United States, 10027
- ICAP Harlem Prevention Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking
- 18 years old or older
- Owns a smartphone running either Android or iOS operating systems
- Willing to download a COVID-19 self-testing app
- Willing to receive and send text messages for the study (and fill out surveys linked from text messages)
Exclusion Criteria:
- Not willing to self-test themselves with COVID-19 rapid tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention (App) Group
Participants in this group will be given access to a COVID-19 self-testing app (SMARTest).
Access to the app, given exclusively to this group, will be in addition to the 12 COVID-19 self-test kits participants receive.
|
The mobile app has self-testing features and information with regard to self-testing and COVID-19.
|
No Intervention: Control (No App) Group
Participants in this group will not be given access to the COVID-19 self-testing app (SMARTest).
Participants will only receive the 12 COVID-19 self-test kits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire Score - study initiation
Time Frame: Baseline
|
COVID-19 Rapid Tests Knowledge, Attitudes, and Practices Questionnaire is a self-assessment measuring participant attitudes, knowledge, and practices toward COVID-19 rapid tests and self-testing.
|
Baseline
|
COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire Score - study completion
Time Frame: At study completion (About 1 month after enrollment)
|
COVID-19 Rapid Tests Knowledge, Attitudes, and Practices Questionnaire is a self-assessment measuring participant attitudes, knowledge, and practices toward COVID-19 rapid tests and self-testing.
|
At study completion (About 1 month after enrollment)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Samuel K. Sia, PhD, Columbia University
- Principal Investigator: Yael Hirsch-Moverman, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAU0815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers. However if plans change and IPD is made available to other researchers, the data will be de-identified unless disclosure of the information is required by law or the participant has authorized the disclosure.
Data that may be shared (not individual participant data) would consist of responses to the baseline and follow-up questionnaires, and recorded self-testing frequency. If the participant is in the intervention (App) group of the study, this may also include scans of the self-tests taken through the app, user engagement metrics tracked by the app, and responses to app feedback questionnaire(s). To reiterate, this data would be de-identified and would not be able to be traced back to the participant.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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