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

Study Overview
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Brief Summary
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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
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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,

Official Title
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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

Conditions
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COVID-19 Testing, Decision Making

Intervention / Treatment
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* Other: decision science-based design


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>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<br>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<br>* decision science-based design explaining actions to take for a negative or positive COVID-19 test<br>|

What is the study measuring?
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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 home Outside 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 |