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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People who use the self administered SARs-CoV-2 antigen testing kits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral questionaires | Behavioral | Behavioral surveys and questionaires |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria: None if above are met
-
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Adults and children > 8 years of age living within pre-identified communities participating in the public health intervention
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| Name | Affiliation | Role |
|---|---|---|
| christoph Hornik, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Pitt County | Greenville | North Carolina | 27705 | United States | ||
| Hamilton County |
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The project team utilized a robust communications campaign and mobilized community partners to assist with outreach and to organize COVID-19 (SARs-CoV-2) antigen testing kit distribution events. Community members received tests via online order (distributed by Amazon), and in person at local distribution centers and events.
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| ID | Title | Description |
|---|---|---|
| FG000 | People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits | The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits | The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not collected on 116 participants. | Posted | Count of Participants | Participants | 2 weeks |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits | The observational sub-study was open to the general population of targeted counties, and embedded within the larger public health intervention that distributed at-home, self-administered COVID tests. The sub-study looked at potential socio-behavioral mechanisms of SARS-CoV-2 Community Transmission: social interactions, health behaviors, healthcare utilization, knowledge, disease burden, feasibility of at-home testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saira Siddiqui, MPH | Duke University | 919-688-8464 | saira.siddiqui@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2021 | Nov 3, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 11, 2021 | Jan 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 4 months |
| Number of Participants With Positive SARs-CoV-2 Antigen Test Results | 4 months |
| Number of Healthcare Utilization Measures | 4 months |
| Chattanooga |
| Tennessee |
| 37341 |
| United States |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Data not collected on 114 participants. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection | Data not collected. | Posted | 4 months |
|
|
| Secondary | Number of Participants With Positive SARs-CoV-2 Antigen Test Results | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Number of Healthcare Utilization Measures | Data not collected. | Posted | 4 months |
|
|
| 0 |
| 338 |
| 0 |
| 338 |
| 0 |
| 338 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |