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): 26741

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
• Genders Eligible for Study: All

• 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	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

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

• COVID-19 Nursing Home Data [Internet].2020 [cited 06/08/2020]
• 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): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; 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