SARS-CoV-2/COVID-19 Prevalence Study

SARS-CoV-2 Prevalence Study

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 26211

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico
    • St. Louis University VTEU-CAIMED-PHSU
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado CRS
  • Florida
    • Miami, Florida, United States, 33136
      • U of Miami, IDRU at Jackson Memorial Hospital CRS
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • The Ponce de Leon Center CRS
  • Illinois
    • Chicago, Illinois, United States, 60612
      • UIC Project Wish CRS
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • New Orleans Adolescent Trials Unit CRS
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • John's Hopkins CRS
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School CRS
  • New York
    • New York, New York, United States, 10027
      • Harlem Prevention
    • New York, New York, United States, 10032
      • Physicians & Surgeons CRS
    • New York, New York, United States, 10451
      • Bronx Prevention Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention CRS
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adults residing in nursing homes or attending outpatient healthcare facilities in neighborhoods of selected research sites. Adults and children (>2 month of age) in neighborhoods of selected research sites.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Senior Living Facilities; Adults residing in senior living facilities (nursing homes, assisted or independent living facilities)
Outpatient Healthcare Facilities; Adults attending outpatient healthcare in neighborhoods of selected research sites
General Communities; Adults and children (>2 months of age) in neighborhoods of selected research sites

What is the study measuring?

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	Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample for laboratory analysis.	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	Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample for PCR laboratory analysis.	Baseline
To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Presence of Symptoms Consistent With COVID-19	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...).	Baseline
To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Absence of Symptoms Consistent With COVID-19	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...).	Baseline
To Estimate Seroprevalence of SARS-CoV-2 Among Those Without Past or Current Symptoms Consistent With COVID-19	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...).	Baseline
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	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.	Baseline
To Estimate Seroprevalence of SARS-CoV-2 Among Those With History of Co-morbid Medical Conditions	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...)	Baseline
To Assess Association Between Age and SARS-CoV-2 Infection and/or Seroprevalence	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+).	Baseline
To Assess Association Between Sex and SARS-CoV-2 Infection and/or Seroprevalence	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.	Baseline
To Assess Association Between Race and SARS-CoV-2 Infection and/or Seroprevalence	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.	Baseline
To Assess Association Between Ethnicity and SARS-CoV-2 Infection and/or Seroprevalence	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.	Baseline
To Assess Association Between Education and SARS-CoV-2 Infection and/or Seroprevalence	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.	Baseline
To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those With Active COVID-19	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.	Baseline
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	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.	Baseline
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	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.	Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Face-masking	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.	Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Six-feet Distancing	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.	Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Avoiding Public Spaces	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.	Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Vaccine Willingness	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.	Baseline
To Assess Performance Characteristics of PCR-based and Serologic SARS-CoV-2 Tests Using Saliva Samples	Concordance between saliva and nasal SARS-CoV-2 PCR results among a sub-sample of participants.	Baseline

Collaborators and Investigators

• Sponsor: COVID-19 Prevention Network
• Investigators: Study Chair: Jessica Justman, MD, Departments of Epidemiology and Medicine, Columbia University

Publications and helpful links

Helpful Links

• CDC Coronavirus Disease 2019 (COVID-19): Groups at Higher Risk for Severe Illness 2020 [updated 06/25/2020]

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: CoVPN 5002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No