COVID-19 Self-testing Study
Field Test of COVID-19 Self-testing With Rapid Antigen Tests
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2023
CompletedFebruary 16, 2024
February 1, 2024
5 months
January 24, 2023
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
Intervention (App) Group
EXPERIMENTALParticipants 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 INTERVENTIONParticipants 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.
Interventions
The mobile app has self-testing features and information with regard to self-testing and COVID-19.
Eligibility Criteria
You may qualify if:
- English-speaking
- 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)
You may not qualify if:
- Not willing to self-test themselves with COVID-19 rapid tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICAP Harlem Prevention Center
New York, New York, 10027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yael Hirsch-Moverman, PhD
Columbia University
- STUDY CHAIR
Samuel K. Sia, PhD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Epidemiology
Study Record Dates
First Submitted
January 24, 2023
First Posted
January 27, 2023
Study Start
April 3, 2023
Primary Completion
September 6, 2023
Study Completion
September 6, 2023
Last Updated
February 16, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
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.