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

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).

Study Overview

• Status: Completed
• Conditions: Decision Making; COVID-19 Testing
• Intervention / Treatment: Other: decision science-based design

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
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carnegie Mellon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: decision science-based design; decision science-based design explaining actions to take for a negative or positive COVID-19 test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
choice of action to take with negative test	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	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likelihood of COVID-19 infection (qualitative)	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	day 1
Likelihood of COVID-19 infection (quantitative)	Judgments about the likelihood of COVID-19 infection with a negative ot positive test result Response using a "slider" to capture numeric estimate	day 1
safe practices	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 homeOutside your home; Try to avoid crowds; Wear a mask when around others; Keep 6 feet from others; Avoid contact with anyone	day 1
ease of use of information rating	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	day 1
usefulness of information rating	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	day 1
helpfulness of information for what to do given positive test result	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	day 1
helpfulness of information for what to do given negative test result	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	day 1
Assess effect of the FDA authorized description of test accuracy	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	day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ordering postest probability of infection	correct ordering of posttest probability of infection risk (derived from qualitative and quantitative ratings)	day 1

Collaborators and Investigators

• Sponsor: Barry Dewitt
• Collaborators: University of Pittsburgh; Dartmouth College
• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2021
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STUDY2020_501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No