COVID-19 Self-testing Study

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05701878

Collaborator

(none)

100

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

25.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Behavioral: SMARTest mobile app for COVID-19 self-testing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will either be given access to the self-testing mobile app or not.Participants will either be given access to the self-testing mobile app or not.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.	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.
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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire [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.
COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire [At study completion (~ 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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