COVID-19 Self-testing Study

NCT ID: NCT05701878

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2023-09-06

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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMARTest mobile app for COVID-19 self-testing

Intervention Type BEHAVIORAL

The mobile app has self-testing features and information with regard to self-testing and COVID-19.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Yael Hirsch-Moverman

Assistant Professor of Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yael Hirsch-Moverman, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Samuel K. Sia, PhD

Role: STUDY_CHAIR

Columbia University

Locations

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ICAP Harlem Prevention Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAU0815

Identifier Type: -

Identifier Source: org_study_id

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