SARS-CoV-2/COVID-19 Prevalence Study
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ClinicalTrials.gov Identifier: NCT04658121 |
Recruitment Status :
Enrolling by invitation
First Posted : December 8, 2020
Last Update Posted : February 9, 2021
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Condition or disease |
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COVID-19 |
Design:
Cross-sectional surveys of (1) nursing home and outpatient healthcare facilities, and (2) the general population in each selected research site community through time-location sampling
Population:
- Adults residing in nursing homes or 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, 3,920 individuals will be enrolled from:
- nursing homes/assisted living facilities (n = 500) and outpatient healthcare facilities (n = 500), and
- community surveys distributed across four age strata (0-17, 18-39, 40-59, 60+ years) (n = 730 per stratum or 2920)
Total sample size = 3,920 x approximately 20-25 clinical research sites
Study Duration:
Approximately one (1) year for overall project. Two (2) months for protocol development and institutional review board (IRB) approval, followed by:
- Facility-based surveys: 9 months (2 months for site preparation and initiation, 1 month for enrollment/sample collection, 4 months for shipping and laboratory testing, 2 months for close-out), concurrent with
- Time-location sampling (TLS) surveys: 12 months (2 months for site preparation and initiation, 2 months for enrollment/sample collection, 6 months for shipping and laboratory testing, 2 months for close-out)
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 and/or oral fluid and dried blood spot samples (DBS) 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 healthcare facility participants.
Study Type : | Observational |
Estimated Enrollment : | 3920 participants |
Observational Model: | Ecologic or Community |
Time Perspective: | Cross-Sectional |
Official Title: | SARS-CoV-2 Prevalence Study |
Actual Study Start Date : | February 4, 2021 |
Estimated Primary Completion Date : | May 30, 2021 |
Estimated Study Completion Date : | May 30, 2021 |
Group/Cohort |
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Nursing Homes
Adults residing in nursing homes.
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Healthcare Facilities
Adults attending outpatient healthcare in neighborhoods of selected research sites.
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General Communities
Adults and children (>2 months of age) in neighborhoods of selected research sites.
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- To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites [ Time Frame: Baseline ]
- To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing [ Time Frame: Baseline ]
- To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19 [ Time Frame: Baseline ]
- To estimate seroprevalence of SARS-CoV-2 [ Time Frame: 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.
- To assess correlation between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence [ Time Frame: Baseline ]
- To estimate potential size of populations for referral to COVID-19 prevention and treatment studies [ Time Frame: Baseline ]
- To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire [ Time Frame: Baseline ]
- To compare performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva and/or oral fluid and DBS samples [ Time Frame: Baseline ]
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
- 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.
Inclusion Criteria:
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Adults residing in nursing homes/assisted 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)
- Recruited from a selected facility
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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
- Willing and able to provide consent (or assent for individuals < 18 years, parent/guardian will provide consent)
- Resident of the CRS catchment area or recruited from a selected venue
Exclusion Criteria:
- Prior or current enrollment in any interventional COVID-19 clinical trial, including studies involving prophylactic, therapeutic or immune modulating agents.
- 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 objective.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658121
United States, Colorado | |
Children's Hospital Colorado CRS | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
U of Miami, IDRU at Jackson Memorial Hospital CRS | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
The Ponce de Leon Center CRS | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
UIC Project Wish CRS | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
New Orleans Adolescent Trials Unit CRS | |
New Orleans, Louisiana, United States, 70118 | |
United States, Maryland | |
John's Hopkins CRS | |
Baltimore, Maryland, United States, 21218 | |
United States, New Jersey | |
New Jersey Medical School CRS | |
Newark, New Jersey, United States, 07103 | |
United States, New York | |
Harlem Prevention | |
New York, New York, United States, 10027 | |
Bronx Prevention Center | |
New York, New York, United States, 10451 | |
United States, North Carolina | |
Chapel Hill CRS | |
Chapel Hill, North Carolina, United States, 37034 | |
United States, Ohio | |
Cincinnati CRS | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
Penn Prevention CRS | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15260 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Puerto Rico | |
St. Louis University VTEU-CAIMED-PHSU | |
Ponce, Puerto Rico |
Study Chair: | Jessica Justman, MD | Departments of Epidemiology and Medicine, Columbia University |
Responsible Party: | COVID-19 Prevention Network |
ClinicalTrials.gov Identifier: | NCT04658121 |
Other Study ID Numbers: |
CoVPN 5002 |
First Posted: | December 8, 2020 Key Record Dates |
Last Update Posted: | February 9, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |