Clinical Trials Directory

Trials / Completed

CompletedNCT04758299

Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits

At Home Self-testing Kits for SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) : A Randomized Trial Assessing How Consumers Interpret and Act on Test Results

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
360 (actual)
Sponsor
Barry Dewitt · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).

Detailed description

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC \[Centers for Disease Control\]-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention). Participants will be randomized to receive either information from the FDA authorized Ellume home test kit for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention). They will be given time to read the documents and the opportunity to download a full "instructions for use" document (the FDA authorized for the ELLUME test kit). They will then be randomized to one of four conditions, asking them to imagine a clinical context: a person with no symptoms and no close COVID-19 contact, no symptoms and close contact,

Conditions

Interventions

TypeNameDescription
OTHERdecision science-based designdecision science-based design explaining actions to take for a negative or positive COVID-19 test

Timeline

Start date
2021-03-13
Primary completion
2021-04-15
Completion
2021-04-30
First posted
2021-02-17
Last updated
2021-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04758299. Inclusion in this directory is not an endorsement.