Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits
- Conditions
- Decision MakingCOVID-19 Testing
- Interventions
- Other: decision science-based design
- Registration Number
- NCT04758299
- Lead Sponsor
- Barry Dewitt
- 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,
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- Participants must be >18 years old, communicate in English, reside in the United States.
- Respondents who complete the survey in under a minute.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision science-based design 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
- Primary Outcome Measures
Name Time Method choice of action to take with negative test 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
- Secondary Outcome Measures
Name Time Method Likelihood of COVID-19 infection (qualitative) 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 notusefulness of information rating 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 uselessease of use of information rating 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 easyhelpfulness of information for what to do given positive test result 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 disagreeLikelihood of COVID-19 infection (quantitative) day 1 Judgments about the likelihood of COVID-19 infection with a negative ot positive test result
Response using a "slider" to capture numeric estimatesafe practices 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 anyonehelpfulness of information for what to do given negative test result 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 disagreeAssess effect of the FDA authorized description of test accuracy 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
Trial Locations
- Locations (1)
Carnegie Mellon University
🇺🇸Pittsburgh, Pennsylvania, United States