You and Me COVID Free

Study Overview
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Brief Summary
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Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.

Detailed Description
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This observational, cohort sub-study is embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities through the CCPH. Within this sub-study, the investigators will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The central hypothesis is that focused community intervention will reduce COVID-19 transmission. The secondary hypothesis is that this intervention will increase vaccine uptake. Surveys and questionnaires will be completed by participants via a QR code from the test kits that directs participants to a link. Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.

Official Title
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Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Behavioral questionaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self- reported primary residence within the pre-identified communities Age >12 years at enrollment Provision of signed and dated informed consent form Exclusion Criteria: -None if above are met

Ages Eligible for Study
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Minimum Age: 12 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavioral questionaires|Behavioral surveys and questionnaires|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Reason for Testing for COVID-19 | Those that used a test from a kit were asked to provide the reason why they were doing a test. The possible answers are: I wanted to be sure I/my child did not have COVID-19 before being around others, I/my child had COVID-19 like symptoms, I/my child was in close contact with someone who might have COVID-19, I/my child was in close contact with someone who tested positive for COVID-19, Someone in my household might have COVID-19, Someone in my household tested positive for COVID-19, Other | Baseline | 
| Number of Positive COVID-19 Test Results |  | Baseline | 
| Number of Participants Who Responded That They Have Received a COVID Vaccine |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place |  | Baseline | 
| Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime |  | Baseline | 
| Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community |  | Baseline | 
| Number of Participants Who Report COVID Symptoms During Previous Week |  | Baseline | 
| Likelihood of Future COVID-19 Vaccination | Number of participants with front door survey entries indicating various levels of the likelihood the responder will get vaccinated in the future. Available options: Very likely, Somewhat likely, Not very likely, Not at all likely, and Prefer not to answer. | Baseline | 
| Reasons for Not Getting a COVID-19 Vaccine | Number of participants indicating various reasons for why they have not received a COVID-19 vaccine on the baseline survey. Available options: I'm allergic to vaccines, I don't like needles, I'm not concerned about getting really sick from COVID-19, I'm concerned about side effects from the vaccines, I don't think vaccines work very well, I don't trust that the vaccines will be safe, I don't believe the COVID-19 pandemic is as bad as some people say it is, I don't want to pay for it, and I don't know enough about how well a COVID-19 vaccine works. | Baseline | 
| Reasons for Getting a COVID-19 Vaccine | Number of participants indicating various reasons for why they have received a COVID-19 vaccine on the baseline survey. Available options: I want to keep my family safe, I want to keep my community safe, I want to keep myself safe, I have a chronic health problem, like asthma or diabetes, My doctor told me to get a COVID-19 vaccine, I don't want to get really sick from COVID-19, I want to feel safe around other people, I believe life won't go back to normal until most people get a COVID-19 vaccine, Required by my school or workplace, and Required for travel. | Baseline | 
| Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | Number of front door survey entries indicating various ways in which participants would find it easy to get free COVID-19 oral medications. Available options: An urgent care center. A doctor's or other health professional's office, A mobile health unit, A drug store / pharmacy, A grocery store, A community center, A place of worship, A community park, A neighborhood school, or other. More than one answer can be selected by an individual participant. | Baseline | 
| Method Used to Test for COVID-19 | Number of participants indicating the method used to test for COVID-19 on the baseline survey. Available options: Nasal swab, Throat swab, Blood sample, and Saliva. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid test, COVID-19