COVID-19 Self-testing Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Field Test of COVID-19 Self-testing With Rapid Antigen Tests

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: SMARTest mobile app for COVID-19 self-testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: comfortable with communication in English 18 years old or older owns a smartphone running either Android or iOS operating systems willing to download a COVID-19 self testing app is willing to receive and send text messages for the study (and fill out surveys linked from text messages) is willing to self-test themselves with COVID-19 rapid tests

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will either be given access to the self-testing mobile app or not.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (App) Group<br>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. | Behavioral: SMARTest mobile app for COVID-19 self-testing<br>* The mobile app has self-testing features and information with regard to self-testing and COVID-19.<br>|
| No Intervention: Control (No App) Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire | 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 | 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 (  1 month after enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, COVID-19, self-testing, mobile-app, SMARTest, randomized control trial, antigen test, mobile health, digital health