Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

Study Overview
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Brief Summary
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This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.Within this sub-study, we 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 study hypothesis is that positive at-home test results will be associated withaltered self-reported social interactions and altered health behaviors compared to negative test results. Surveys and questionnaires will be completed by participants through the smartphone app or via call center phone calls according to the schedule of events.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> 8 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: 8 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People who use the self administered SARs-CoV-2 antigen testing kits<br> | Behavioral: Behavioral questionaires<br>* Behavioral surveys and questionaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Not Following Social Distancing Guidelines | Number of participants who reported at their first follow-up assessment as having close contact (within 6 feet) with people who do not live with them. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure | Number of participants who reported at their first follow-up assessment as having avoided public spaces, gatherings, or crowds as a prevention measure. | 2 weeks | 
| Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection |  | 4 months | 
| Number of Participants With Positive SARs-CoV-2 Antigen Test Results |  | 4 months | 
| Number of Healthcare Utilization Measures |  | 4 months |