SARS-CoV-2/COVID-19 Prevalence Study

Study Overview
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Brief Summary
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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
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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: Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) and attending outpatient healthcare facilities in neighborhoods of selected research sites 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): senior living facilities (nursing homes, assisted or independent living facilities; n = 500) outpatient healthcare facilities (n = 500) 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: 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 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.

Official Title
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SARS-CoV-2 Prevalence Study

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Senior Living Facilities<br>Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) | |
| Outpatient Healthcare Facilities<br>Adults attending outpatient healthcare in neighborhoods of selected research sites | |
| General Communities<br>Adults and children (>2 months of age) in neighborhoods of selected research sites | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing |  | Baseline | 
| To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19 |  | Baseline | 
| To estimate seroprevalence of SARS-CoV-2 | Among: Those without past or current symptoms consistent with COVID-19 Those with no prior positive SARS-CoV-2 testing, but who report close contact with confirmed or presumed cases Those with history of co-morbid medical conditions | Baseline | 
| To assess association between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence, with particular interest in racial and ethnic health disparities. | Logistic regression using survey weights will be used to infer associations between the hypothesized socioeconomic, demographic and clinical predictors of SARS-CoV-2 infection and seroprevalence. | Baseline | 
| To estimate potential size of populations for referral to COVID-19 prevention and treatment studies |  | Baseline | 
| To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire |  | Baseline | 
| To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples |  | Baseline |