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NCT05701878 Clinical Trial

COVID-19 Self-testing Study

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05701878
Other study ID # AAAU0815
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2023
Est. completion date September 6, 2023

Study information
Verified date February 2024
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 6, 2023
Est. primary completion date September 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• SMARTest mobile app for COVID-19 self-testing
The mobile app has self-testing features and information with regard to self-testing and COVID-19.

Locations
Country Name City State
United States ICAP Harlem Prevention Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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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