SARS-CoV-2/COVID-19 Prevalence Study
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| ClinicalTrials.gov Identifier: NCT04658121 |
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Recruitment Status :
Completed
First Posted : December 8, 2020
Last Update Posted : October 4, 2021
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| Condition or disease |
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| 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:
- 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
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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 |
| Actual Enrollment : | 26741 participants |
| Observational Model: | Ecologic or Community |
| Time Perspective: | Cross-Sectional |
| Official Title: | SARS-CoV-2 Prevalence Study |
| Actual Study Start Date : | February 4, 2021 |
| Actual Primary Completion Date : | August 12, 2021 |
| Actual Study Completion Date : | August 12, 2021 |
| Group/Cohort |
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Senior Living Facilities
Adults residing in senior living facilities (nursing homes, assisted or independent living facilities)
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Outpatient 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 ]
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 association between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence, with particular interest in racial and ethnic health disparities. [ Time Frame: Baseline ]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.
- 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 assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva 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 |
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
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 | |
| Physicians & Surgeons CRS | |
| New York, New York, United States, 10032 | |
| Bronx Prevention Center | |
| New York, New York, United States, 10451 | |
| 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 |
Documents provided by COVID-19 Prevention Network:
| 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: | October 4, 2021 |
| Last Verified: | September 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 |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |