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COVID-19 Self-testing Study

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMARTest mobile app for COVID-19 self-testing
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring COVID-19, self-testing, mobile-app, SMARTest, randomized control trial, RCT, antigen test, mobile health, digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ICAP Harlem Prevention CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (App) Group

Control (No App) Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2023
Last Updated
January 25, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05701878
Brief Title
COVID-19 Self-testing Study
Official Title
Field Test of COVID-19 Self-testing With Rapid Antigen Tests
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, self-testing, mobile-app, SMARTest, randomized control trial, RCT, antigen test, mobile health, digital health

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will either be given access to the self-testing mobile app or not.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (App) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (No App) Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMARTest mobile app for COVID-19 self-testing
Intervention Description
The mobile app has self-testing features and information with regard to self-testing and COVID-19.
Primary Outcome Measure Information:
Title
COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire
Description
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.
Time Frame
Baseline
Title
COVID-19 Self-Testing Knowledge, Attitudes, and Practices Questionnaire
Description
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.
Time Frame
At study completion (~ 1 month after enrollment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terry Chern, MS
Phone
909-569-9511
Email
tlc2156@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Justman, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel K. Sia, PhD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
ICAP Harlem Prevention Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Justman, MD
First Name & Middle Initial & Last Name & Degree
Sharon Mannheimer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

COVID-19 Self-testing Study

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