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| ID | Type | Description | Link |
|---|---|---|---|
| 3U24MD016258-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral questionaires | Behavioral | Behavioral surveys and questionnaires |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-None if above are met
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Adults and children >12 years of age living within pre-identified communities participating in the public health intervention
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hornik, MD, PhD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merced County | Merced | California | 95340 | United States |
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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 in person at local distribution centers and events.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed the baseline questionnaire.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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" | Posted | Count of Participants | Participants | Baseline |
|
Adverse Event data was not collected.
Adverse Event data was not collected.
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saira Siddiqui, M.P.H. | 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 | Yes | No | No | Study Protocol | Dec 28, 2021 | Mar 8, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2022 | Mar 8, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 4, 2021 | Mar 21, 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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| 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 |
| years |
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| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Number of Positive COVID-19 Test Results | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Number of Participants Who Responded That They Have Received a COVID Vaccine | Participants who completed the baseline survey. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place | Participants who completed the baseline survey. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime | Participants who completed the baseline survey and indicated having tested for COVID. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community | Participants who completed the baseline survey. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Report COVID Symptoms During Previous Week | Participants who completed the baseline survey. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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". | Participants with front door survey entries that indicated the responder had not received a COVID-19 vaccine. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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". | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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". | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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". | Participants who indicated that they have tested for COVID-19. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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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 |
| Not at all likely |
|
| Prefer not to answer/missing |
|
| Title | Measurements |
|---|---|
|
| 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 |
|
| I don't know enough about how well a COVID-19 vaccine works |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| 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 |
|
| Required for travel |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| A drug store / pharmacy |
|
| A grocery store |
|
| A community center |
|
| A place of worship |
|
| A community park |
|
| A neighborhood school |
|
| Other |
|
| Saliva |
|
| Missing |
|