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Completed

NCT Number: NCT04758299

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

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).

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Key information

Conditions

COVID-19 Testing Decision Making

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

decision science-based design

Other

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

Primary outcomes

  1. choice of action to take with negative test

    Time frame: day 1

    choice of actions consistent with CDC-recommendations (eg, isolate or not) for various clinical scenarios (eg, with/without known exposure, with/without symptoms)

    Which of the following are safe for Jamie to do over the next week about being around others? [safe, not safe]

    • Take no additional precautions.
    • Stay at home except to visit close family or friends. Take no additional precautions at home
    • Stay at home except when going to the grocery store. Take no additional precautions at home
    • Stay at home all the time, without exceptions. Take no additional precautions at home.
    • Stay at home all the time, without exceptions and avoid contact with others, including others in the household

Secondary outcomes

  1. Likelihood of COVID-19 infection (qualitative)

    Time frame: day 1

    Judgments about the likelihood of COVID-19 infection with a negative or positive test result

    How likely is it that Jamie is infected with COVID-19? (choose one)

    • Definitely yes
    • Very likely
    • Likely
    • Unlikely
    • Very Unlikely
    • Definitely not

  2. Likelihood of COVID-19 infection (quantitative)

    Time frame: day 1

    Judgments about the likelihood of COVID-19 infection with a negative ot positive test result

    Response using a "slider" to capture numeric estimate

  3. safe practices

    Time frame: day 1

    Change in intent to practice standard public health practices to reduce COVID-19 transmission (hand washing, social distancing, masks) - question asked before and after seeing test result

    What else do you think Jamie should do to protect himself and others from COVID-19? [choose: all of the time, most of the time, some of the time, a little of the time, none of the time] In general

    • Wash hands often
    • Avoid close contact with people who seem sick (e.g., cough, sneeze, fever)
    • Stay home

    Outside your home

    • Try to avoid crowds
    • Wear a mask when around others
    • Keep 6 feet from others
    • Avoid contact with anyone

  4. ease of use of information rating

    Time frame: day 1

    how easy/hard is it to use information about interpreting test results

    How easy or difficult was it to read the information about interpreting the test result?" (check one)

    • Very difficult
    • Difficult
    • Neutral
    • Easy
    • Very easy

  5. usefulness of information rating

    Time frame: day 1

    how useful is the information about interpreting test results

    The information about interpreting the home test kit results was (check one)

    • Extremely useful
    • Useful
    • Neutral
    • Useless
    • Completely useless

  6. helpfulness of information for what to do given positive test result

    Time frame: day 1

    How helpful was the information for what to if test was positive

    The information helped me know what to do if test result is positive

    a. Strongly agree

    • Agree
    • Neutral
    • Disagree
    • Strongly disagree

  7. helpfulness of information for what to do given negative test result

    Time frame: day 1

    How helpful was the information for what to if test was negative

    The information helped me know what to do if test result is negative

    a. Strongly agree

    • Agree
    • Neutral
    • Disagree
    • Strongly disagree

  8. Assess effect of the FDA authorized description of test accuracy

    Time frame: day 1

    According to the test's FDA-authorized label, a clinical study conducted in the USA in 2020 showed that the test "correctly identified 96% of positive samples and 100% of negative samples in patients with symptoms. In people without symptoms the test correctly identified 91% of positive samples and 96% of negative samples."

    Based on this information, if Jamie has COVID now, what is the chance that the test will be wrong and say that he does not?

    RESPONSE (probability estimate) using slider

Other outcomes

  1. ordering postest probability of infection

    Time frame: day 1

    correct ordering of posttest probability of infection risk (derived from qualitative and quantitative ratings)

Sponsors and collaborators

Lead sponsor

Barry Dewitt

Other

Collaborators

  • Dartmouth College
  • University of Pittsburgh

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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