Clinical trial NCT04758299: Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Testing
Decision Making
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: University of Pittsburgh
First posted: 2021-02-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either information from the FDA authorized 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).

There are 4 groups (clinical scenarios) within each randomized arm (the scenarios are patient with no symptoms and no exposure; no symptoms and exposure; symptoms and no exposure; symptoms and exposure.
Primary purpose: OTHER

Brief 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,

Eligibility criteria: Inclusion Criteria:

* Participants must be \>18 years old, communicate in English, reside in the United States.

Exclusion Criteria:

* Respondents who complete the survey in under a minute.

Primary outcomes:
measure: choice of action to take with negative test
timeFrame: day 1
Secondary outcomes:
measure: Likelihood of COVID-19 infection (qualitative)
timeFrame: day 1
measure: Likelihood of COVID-19 infection (quantitative)
timeFrame: day 1
measure: safe practices
timeFrame: day 1
measure: ease of use of information rating
timeFrame: day 1
measure: usefulness of information rating
timeFrame: day 1
measure: helpfulness of information for what to do given positive test result
timeFrame: day 1
measure: helpfulness of information for what to do given negative test result
timeFrame: day 1
measure: Assess effect of the FDA authorized description of test accuracy
timeFrame: day 1
Other outcomes:
measure: ordering postest probability of infection
timeFrame: day 1
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Barry Dewitt
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Steven Woloshin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Tamar Krishnamurti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carnegie Mellon University
name: Baruch Fischhoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woloshin S, Dewitt B, Krishnamurti T, Fischhoff B. Assessing How Consumers Interpret and Act on Results From At-Home COVID-19 Self-test Kits: A Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):332-341. doi: 10.1001/jamainternmed.2021.8075.