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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- choice of action to take with negative test
研究概览
简要总结
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).
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be >18 years old, communicate in English, reside in the United States.
排除标准
- •Respondents who complete the survey in under a minute.
结局指标
主要结局
choice of action to take with negative test
时间窗: 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
次要结局
- Likelihood of COVID-19 infection (qualitative)(day 1)
- usefulness of information rating(day 1)
- ease of use of information rating(day 1)
- helpfulness of information for what to do given positive test result(day 1)
- Likelihood of COVID-19 infection (quantitative)(day 1)
- safe practices(day 1)
- helpfulness of information for what to do given negative test result(day 1)
- Assess effect of the FDA authorized description of test accuracy(day 1)
研究者
Barry Dewitt
Postdoctoral Research Associate
Carnegie Mellon University