COVID-19
Conditions
Brief summary
The COVID-19 Prevention Network (CoVPN) is doing a study to estimate the number of people who have or have had the SARS-CoV-2 virus in different communities in the United States. This study is being done to help determine the best places to perform future research studies that will test new drugs for treatment or prevention of COVID-19.
Detailed description
Design: Cross-sectional surveys of (1) adults residing in senior living facilities and attending outpatient healthcare facilities, and (2) the general population in each selected research site community. Population: 1. Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) and attending outpatient healthcare facilities in neighborhoods of selected research sites 2. Adults and children (\> 2 months of age) in neighborhoods of selected research sites Study Size: For each research site, up to 3,920 individuals will be enrolled from one, two, or all three of the following populations (must include at least community venues): 1. senior living facilities (nursing homes, assisted or independent living facilities; n = 500) 2. outpatient healthcare facilities (n = 500) 3. community venues distributed across four age categories (0-17, 18-39, 40-59, 60+ years) (n = 730 per stratum or 2920) Total sample size = 3,920 x up to 20 clinical research sites Study Duration: Approximately sixteen (16) months for overall project. Two (2) months for protocol development and institutional review board (IRB) approval, followed by: 1. Facility-based surveys: 12 months (3 months for site preparation and initiation, 3 months for enrollment/sample collection, 4 months for shipping and laboratory testing\*, 2 months for close-out), concurrent with 2. Time-location sampling (TLS) surveys: 14 months (3 months for site preparation and initiation, 6 months for enrollment/sample collection, 6 months for shipping and laboratory testing\*, 2 months for close-out) * Some activities will be concurrent with enrollment Study Location: Catchment areas surrounding US-based Clinical Research Sites (CRSs) of the: HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), Infectious Diseases Clinical Research Consortium (IDCRC), International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT), and the AIDS Clinical Trials Group (ACTG); to be specified in the Site Announcement Memo Study Methods: Blood collection for SARS-CoV-2 antibody testing and characterization of the serologic response to SARS-CoV-2 infection; nasal mid-turbinate swab collection for SARS-CoV-2 RNA testing; collection of saliva in a subset of participants to evaluate the performance of diagnostic SARS-CoV-2 assays using these matrices; administration of tablet-based survey. Medical records abstraction for senior living facility participants who are unable to respond to the study survey.
Interventions
None listed
Sponsors
COVID-19 Prevention Network
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
2 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adults residing in senior living facilities or attending outpatient healthcare facilities: * At least 18 years of age * Willing and able to provide informed consent or consent has been provided by legal representative (for those with mental incapacity in senior living facilities) * Recruited from a selected facility Adults and children from select neighborhoods of research site communities: * Adults and children \> 2 months of age * For individuals \< 18 years old, a guardian must be present (in person or by phone for those 15 - 17 years old) * Willing and able to provide consent (or assent for individuals 7-17 years old, parent/guardian will provide consent for all minors) * Recruited from a selected venue
Exclusion criteria
* Previous enrollment in this study, either from the same or another CRS community. * Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Estimate the Prevalence of SARS-CoV-2 IgG Seropositivity Among Individuals in Communities Surrounding Selected NIAID Clinical Research Sites | Baseline | Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample for laboratory analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Estimate Prevalence of SARS-CoV-2 Infection Based on Results of SARS-CoV-2 RNA Testing | Baseline | Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample for PCR laboratory analysis. |
| To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Presence of Symptoms Consistent With COVID-19 | Baseline | Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample, had a result from PCR laboratory analysis, and reported any symptom consistent with COVID-19 (symptoms include fever, headache, cough, congestion, etc...). |
| To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Absence of Symptoms Consistent With COVID-19 | Baseline | Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample, had a result from PCR laboratory analysis, and reported no symptoms consistent with COVID-19 (symptoms include fever, headache, cough, congestion, etc...). |
| To Estimate Seroprevalence of SARS-CoV-2 Among Those Without Past or Current Symptoms Consistent With COVID-19 | Baseline | Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample, had a result from laboratory analysis, and reported no past or current symptoms consistent with COVID-19 (symptoms include fever, headache, cough, congestion, etc...). |
| To Estimate Seroprevalence of SARS-CoV-2 Among Those With no Prior Positive SARS-CoV-2 Testing, But Who Report Close Contact With Confirmed or Presumed Cases | Baseline | Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample, had a result from laboratory analysis, and reported no prior positive SARS-CoV-2 testing but did report close contact with confirmed or presumed cases. |
| To Estimate Seroprevalence of SARS-CoV-2 Among Those With History of Co-morbid Medical Conditions | Baseline | Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample, had a result from laboratory analysis, and reported any co-morbid medical condition (which includes asthma, hypertension, diabetes, etc...) |
| To Assess Association Between Age and SARS-CoV-2 Infection and/or Seroprevalence | Baseline | Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by age group (0-17, 18-39, 40-59, 60+). |
| To Assess Association Between Sex and SARS-CoV-2 Infection and/or Seroprevalence | Baseline | Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by sex. |
| To Assess Association Between Race and SARS-CoV-2 Infection and/or Seroprevalence | Baseline | Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by racial category. The racial group "Other" includes responses of Other, Multiple Races, Asian, Native Hawaiian or other Pacific Islander, American Indian or Alaskan Native, as well as don't know/not sure or prefer not to answer. |
| To Assess Association Between Ethnicity and SARS-CoV-2 Infection and/or Seroprevalence | Baseline | Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample, had a result from laboratory analysis, and had a non-missing ethnicity response. Results are reported by site and by ethnicity. |
| To Assess Association Between Education and SARS-CoV-2 Infection and/or Seroprevalence | Baseline | Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by education level. The category of "College Degree" includes college, univesity or post-graduate degree. The category of "Middle School or Under" includes middle School (6th-8th grade), elementary school (1st-5th grade), kindergarten, pre-kindergarten, or no formal education. |
| To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those With Active COVID-19 | Baseline | The purpose of this outcome is to estimate the total number of people in each city's catchment area that had active COVID-19, using data collected January-July 2021 from the CoVPN5002 study and using 2020 US Census Data given the zip codes from defined recruitment catchment area at each city. |
| To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those Who Have Serologic Evidence of Recent and/or Past SARS-CoV-2 Infection | Baseline | The purpose of this outcome is to estimate the total number of people in each city's catchment area who have serologic evidence of recent and/or past SARS-CoV-2 infection, using data collected January-July 2021 from the CoVPN5002 study and using 2020 US Census Data given the zip codes from defined recruitment catchment area at each city. |
| To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those Who Have Negative RNA and Serologic SARS-CoV-2 Tests | Baseline | The purpose of this outcome is to estimate the total number of people in each city's catchment area that have negative RNA and serologic SARS-CoV-2 tests, using data collected January-July 2021 from the CoVPN5002 study and using 2020 US Census Data given the zip codes from defined recruitment catchment area at each city. |
| To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Face-masking | Baseline | Proportions of participants who responded "All of the time" or Most of the time" on a 5-point Likert Scale for a question on whether they wore a face mask in public spaces. |
| To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Six-feet Distancing | Baseline | Proportions of participants who responded "All of the time" or Most of the time" on a 5-point Likert Scale for a question on whether they maintained six feet of distance from others in public spaces. |
| To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Avoiding Public Spaces | Baseline | Proportions of participants who responded "Never" or "Almost Never" on a 5-point Likert Scale for a question on whether they spend time in public spaces, gatherings, and crowds. |
| To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Vaccine Willingness | Baseline | Proportions of participants who responded "Very likely", "Likely", or "Already Received" for a question on their likelihood to receive an approved vaccine for COVID-19. |
| To Assess Performance Characteristics of PCR-based and Serologic SARS-CoV-2 Tests Using Saliva Samples | Baseline | Concordance between saliva and nasal SARS-CoV-2 PCR results among a sub-sample of participants. |
Countries
Puerto Rico, United States
Contacts
STUDY_CHAIRJessica Justman, MD
Departments of Epidemiology and Medicine, Columbia University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized <18 | 2113 Participants |
| Age, Customized 18-39 | 7755 Participants |
| Age, Customized 40-59 | 9554 Participants |
| Age, Customized 60+ | 6764 Participants |
| Age, Customized missing | 15 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1089 Participants |
| Race/Ethnicity, Customized Ethnicity Missing | 244 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 369 Participants |
| Race/Ethnicity, Customized Ethnicity Prefer not to answer/Don't know | 6 Participants |
| Race/Ethnicity, Customized Race Black or African American | 266 Participants |
| Race/Ethnicity, Customized Race Missing | 186 Participants |
| Race/Ethnicity, Customized Race Other | 504 Participants |
| Race/Ethnicity, Customized Race Prefer not to answer/Don't know | 425 Participants |
| Race/Ethnicity, Customized Race White | 496 Participants |
| Region of Enrollment United States Atlanta | 0 Participants |
| Region of Enrollment United States Aurora, CO | 0 Participants |
| Region of Enrollment United States Baltimore | 145 Participants |
| Region of Enrollment United States Bronx | 2560 Participants |
| Region of Enrollment United States Chicago | 1692 Participants |
| Region of Enrollment United States Cincinnati | 35 Participants |
| Region of Enrollment United States Harlem | 503 Participants |
| Region of Enrollment United States Houston | 151 Participants |
| Region of Enrollment United States Miami | 1480 Participants |
| Region of Enrollment United States Newark | 1123 Participants |
| Region of Enrollment United States New Orleans | 1799 Participants |
| Region of Enrollment United States New York - Columbia | 508 Participants |
| Region of Enrollment United States Philadelphia | 2103 Participants |
| Region of Enrollment United States Pittsburgh | 1303 Participants |
| Region of Enrollment United States Ponce, Puerto Rico | 2924 Participants |
| Sex/Gender, Customized Female | 11122 Participants |
| Sex/Gender, Customized Male | 352 Participants |
| Sex/Gender, Customized Missing | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed