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The goal of this clinical trial is to understand how the introduction of an app-based intervention changes knowledge, attitudes, and practices on COVID-19 self-testing.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (App) Group | Experimental | 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. |
|
| Control (No App) Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMARTest mobile app for COVID-19 self-testing | Behavioral | The mobile app has self-testing features and information with regard to self-testing and COVID-19. |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire Score - study initiation | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yael Hirsch-Moverman, PhD | Columbia University | Principal Investigator |
| Samuel K. Sia, PhD | Columbia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICAP Harlem Prevention Center | New York | New York | 10027 | United States |
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.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Participants will either be given access to the self-testing mobile app or not.
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |