COVID-19
Conditions
Brief summary
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.
Interventions
BEHAVIORALBehavioral questionaires
Behavioral surveys and questionaires
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Self-reported primary residence within the pre-identified communities 2. Age\> 8 years at enrollment 3. Provision of signed and dated informed consent form
Exclusion criteria
None if above are met \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Not Following Social Distancing Guidelines | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure | 2 weeks | Number of participants who reported at their first follow-up assessment as having avoided public spaces, gatherings, or crowds as a prevention measure. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 338 |
| Total | 338 |
Baseline characteristics
| Characteristic | People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits |
|---|---|
| Age, Continuous | 47.10 years STANDARD_DEVIATION 14.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 295 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants |
| Race (NIH/OMB) White | 252 Participants |
| Region of Enrollment United States | 338 Participants |
| Sex/Gender, Customized Sex Female | 226 Participants |
| Sex/Gender, Customized Sex Male | 88 Participants |
| Sex/Gender, Customized Sex Not Indicated | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 338 |
| other Total, other adverse events | 0 / 338 |
| serious Total, serious adverse events | 0 / 338 |
Outcome results
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.
Time frame: 2 weeks
Population: Data not collected on 116 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits | Number of Participants Who Reported Not Following Social Distancing Guidelines | 164 Participants |
Secondary
Number of Healthcare Utilization Measures
Time frame: 4 months
Population: Data not collected.
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.
Time frame: 2 weeks
Population: Data not collected on 114 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits | Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure | 84 Participants |
Secondary
Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection
Time frame: 4 months
Population: Data not collected.
Secondary
Number of Participants With Positive SARs-CoV-2 Antigen Test Results
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| People Who Use the Self Administered SARs-CoV-2 Antigen Testing Kits | Number of Participants With Positive SARs-CoV-2 Antigen Test Results | 7 Participants |