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

• ClinicalTrials.gov Identifier: NCT04758299
• Recruitment Status: Completed
• First Posted: February 17, 2021
• Last Update Posted: May 25, 2021
• Sponsor: Barry Dewitt
• Collaborators: Dartmouth College; University of Pittsburgh
• Information provided by (Responsible Party): Barry Dewitt, Carnegie Mellon University

Tracking Information

• First Submitted Date: February 12, 2021
• First Posted Date: February 17, 2021
• Last Update Posted Date: May 25, 2021
• Actual Study Start Date: March 13, 2021
• Actual Primary Completion Date: April 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2021)

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]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 16, 2021)

• 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)

  1. Definitely yes
  2. Very likely
  3. Likely
  4. Unlikely
  5. Very Unlikely
  6. Definitely not
• 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
• 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

  1. Wash hands often
  2. Avoid close contact with people who seem sick (e.g., cough, sneeze, fever)
  3. Stay home Outside your home
  4. Try to avoid crowds
  5. Wear a mask when around others
  6. Keep 6 feet from others
  7. Avoid contact with anyone
• 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)

  1. Very difficult
  2. Difficult
  3. Neutral
  4. Easy
  5. Very easy
• 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)

  1. Extremely useful
  2. Useful
  3. Neutral
  4. Useless
  5. Completely useless
• 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

  1. Agree
  2. Neutral
  3. Disagree
  4. Strongly disagree
• 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

  1. Agree
  2. Neutral
  3. Disagree
  4. Strongly disagree
• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 16, 2021)

ordering postest probability of infection [ Time Frame: day 1 ]

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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,

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Investigator)
Primary Purpose: Other

Condition

• COVID-19 Testing
• Decision Making

Intervention

Other: decision science-based design

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

Study Arms

• No Intervention: Standard care
  information from an FDA authorized home test kit for what actions to take for a negative or positive COVID-19 test
• Experimental: Decision science-based design
  Information from a decision science-based design (of similar length to the FDA authorized home test kit information) for what actions to take for a negative or positive COVID-19 test
  Intervention: Other: decision science-based design

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2021): 360
• Original Estimated Enrollment (submitted: February 16, 2021): 1000
• Actual Study Completion Date: April 30, 2021
• Actual Primary Completion Date: April 15, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04758299
• Other Study ID Numbers: STUDY2020_501
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Barry Dewitt, Carnegie Mellon University
• Original Responsible Party: Same as current
• Current Study Sponsor: Barry Dewitt
• Original Study Sponsor: Same as current

Collaborators

• Dartmouth College
• University of Pittsburgh

Investigators

• Principal Investigator: Barry Dewitt; Carnegie Mellon University
• Principal Investigator: Steven Woloshin, MD; Dartmouth College
• Principal Investigator: Tamar Krishnamurti, PhD; University of Pittsburgh
• Principal Investigator: Baruch Fischhoff, PhD; Carnegie Mellon University

• PRS Account: Carnegie Mellon University
• Verification Date: May 2021