Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26741 participants
OBSERVATIONAL
2021-02-04
2021-08-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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Senior Living Facilities
Adults residing in senior living facilities (nursing homes, assisted or independent living facilities)
No interventions assigned to this group
Outpatient Healthcare Facilities
Adults attending outpatient healthcare in neighborhoods of selected research sites
No interventions assigned to this group
General Communities
Adults and children (\>2 months of age) in neighborhoods of selected research sites
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Months
ALL
Yes
Sponsors
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COVID-19 Prevention Network
NETWORK
Responsible Party
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Principal Investigators
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Jessica Justman, MD
Role: STUDY_CHAIR
Departments of Epidemiology and Medicine, Columbia University
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Related Links
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COVID-19 Nursing Home Data \[Internet\].2020 \[cited 06/08/2020\]
Other Identifiers
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CoVPN 5002
Identifier Type: -
Identifier Source: org_study_id
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