COVID-19
Conditions
Keywords
Rapid test, COVID-19
Brief summary
Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.
Detailed description
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.
Interventions
BEHAVIORALBehavioral questionaires
Behavioral surveys and questionnaires
Sponsors
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Reason for Testing for COVID-19 | Baseline | 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 |
| Number of Positive COVID-19 Test Results | Baseline | — |
| Number of Participants Who Responded That They Have Received a COVID Vaccine | Baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report COVID Symptoms During Previous Week | Baseline | — |
| Likelihood of Future COVID-19 Vaccination | Baseline | 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. |
| Reasons for Not Getting a COVID-19 Vaccine | Baseline | 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. |
| Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place | Baseline | — |
| Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | Baseline | 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. |
| Method Used to Test for COVID-19 | Baseline | 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. |
| Reasons for Getting a COVID-19 Vaccine | Baseline | 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. |
| 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 | — |
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 in person at local distribution centers and events.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Questionnaires 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. | 1,001 |
| Total | 1,001 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Invalid test result | 125 |
Baseline characteristics
| Characteristic | Behavioral Questionnaires |
|---|---|
| Age, Continuous | 39 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 529 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 434 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 35 Participants |
| Race (NIH/OMB) Asian | 74 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants |
| Race (NIH/OMB) More than one race | 36 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 266 Participants |
| Race (NIH/OMB) White | 546 Participants |
| Region of Enrollment United States | 1001 Participants |
| Sex/Gender, Customized Female | 687 Participants |
| Sex/Gender, Customized Male | 280 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | I wanted to be sure I/my child did not have COVID-19 before being around others | 1632 Participants |
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | I/my child had COVID-19 like symptoms | 493 Participants |
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | I/my child was in close contact with someone who might have COVID-19 | 238 Participants |
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | I/my child was in close contact with someone who tested positive for COVID-19 | 343 Participants |
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | Someone in my household might have COVID-19 | 118 Participants |
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | Someone in my household tested positive for COVID-19 | 152 Participants |
| Behavioral Questionnaires | Main Reason for Testing for COVID-19 | Other | 209 Participants |
Comparison: Comparison of the likelihood to test before gathering for age \< 18 vs. age \>= 18.95% CI: [0.8, 1.3]
Primary
Number of Participants Who Responded That They Have Received a COVID Vaccine
Time frame: Baseline
Population: Participants who completed the baseline survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Questionnaires | Number of Participants Who Responded That They Have Received a COVID Vaccine | 850 Participants |
Primary
Number of Positive COVID-19 Test Results
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Questionnaires | Number of Positive COVID-19 Test Results | 269 Participants |
Secondary
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.
Time frame: Baseline
Population: Participants with front door survey entries that indicated the responder had not received a COVID-19 vaccine.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Questionnaires | Likelihood of Future COVID-19 Vaccination | Very likely | 119 Participants |
| Behavioral Questionnaires | Likelihood of Future COVID-19 Vaccination | Somewhat likely | 140 Participants |
| Behavioral Questionnaires | Likelihood of Future COVID-19 Vaccination | Not very likely | 59 Participants |
| Behavioral Questionnaires | Likelihood of Future COVID-19 Vaccination | Not at all likely | 92 Participants |
| Behavioral Questionnaires | Likelihood of Future COVID-19 Vaccination | Prefer not to answer/missing | 79 Participants |
Secondary
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.
Time frame: Baseline
Population: Participants who indicated that they have tested for COVID-19.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Questionnaires | Method Used to Test for COVID-19 | Nasal swab | 783 Participants |
| Behavioral Questionnaires | Method Used to Test for COVID-19 | Throat swab | 15 Participants |
| Behavioral Questionnaires | Method Used to Test for COVID-19 | Blood sample | 4 Participants |
| Behavioral Questionnaires | Method Used to Test for COVID-19 | Saliva | 17 Participants |
| Behavioral Questionnaires | Method Used to Test for COVID-19 | Missing | 2 Participants |
Secondary
Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place
Time frame: Baseline
Population: Participants who completed the baseline survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Questionnaires | Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place | 475 Participants |
Secondary
Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime
Time frame: Baseline
Population: Participants who completed the baseline survey and indicated having tested for COVID.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Questionnaires | Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime | 237 Participants |
Secondary
Number of Participants Who Report COVID Symptoms During Previous Week
Time frame: Baseline
Population: Participants who completed the baseline survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Questionnaires | Number of Participants Who Report COVID Symptoms During Previous Week | 627 Participants |
Secondary
Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community
Time frame: Baseline
Population: Participants who completed the baseline survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Questionnaires | Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community | 757 Participants |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | An urgent care center | 503 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A doctor's or other health professional's office | 526 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A mobile health unit | 189 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A drug store / pharmacy | 1225 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A grocery store | 209 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A community center | 87 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A place of worship | 38 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A community park | 50 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | A neighborhood school | 116 Participants |
| Behavioral Questionnaires | Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications | Other | 25 Participants |
Secondary
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.
Time frame: Baseline
Population: Participants who indicated they have received a COVID-19 vaccine on the baseline survey. More than one answer can be selected by an individual participant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I want to keep my family safe | 712 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I want to keep my community safe | 477 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I want to keep myself safe | 557 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I have a chronic health problem, like asthma or diabetes | 135 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | My doctor told me to get a COVID-19 vaccine | 86 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I don't want to get really sick from COVID-19 | 378 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I want to feel safe around other people | 404 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | I believe life won't go back to normal until most people get a COVID-19 vaccine | 313 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | Required by my school or workplace | 169 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | Required for travel | 126 Participants |
| Behavioral Questionnaires | Reasons for Getting a COVID-19 Vaccine | Other | 24 Participants |
Secondary
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.
Time frame: Baseline
Population: Participants who indicated they have not received a COVID-19 vaccine on the baseline survey. More than one answer can be selected by an individual participant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I'm allergic to vaccines | 5 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I don't like needles | 22 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I'm not concerned about getting really sick from COVID-19 | 3 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I'm concerned about side effects from the vaccines | 47 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I don't think vaccines work very well | 7 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I don't trust that the vaccines will be safe | 34 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I don't believe the COVID-19 pandemic is as bad as some people say it is | 4 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I don't want to pay for it | 3 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | I don't know enough about how well a COVID-19 vaccine works | 16 Participants |
| Behavioral Questionnaires | Reasons for Not Getting a COVID-19 Vaccine | Other | 15 Participants |