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.
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.
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
Children's Hospital Colorado CRS
Aurora, Colorado, United States
U of Miami, IDRU at Jackson Memorial Hospital CRS
Miami, Florida, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
UIC Project Wish CRS
Chicago, Illinois, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States
John's Hopkins CRS
Baltimore, Maryland, United States
New Jersey Medical School CRS
Newark, New Jersey, United States
Harlem Prevention
New York, New York, United States
Physicians & Surgeons CRS
New York, New York, United States
Bronx Prevention Center
New York, New York, United States
Cincinnati CRS
Cincinnati, Ohio, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
St. Louis University VTEU-CAIMED-PHSU
Ponce, Puerto Rico
Jessica Justman, MD, Study Chair
Departments of Epidemiology and Medicine, Columbia University