Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

SARS-CoV-2/COVID-19 Prevalence Study

29. september 2021 opdateret af: COVID-19 Prevention Network

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

26741

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado CRS
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • U of Miami, IDRU at Jackson Memorial Hospital CRS
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • The Ponce de Leon Center CRS
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • UIC Project WISH CRS
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70118
        • New Orleans Adolescent Trials Unit CRS
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21218
        • John's Hopkins CRS
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07103
        • New Jersey Medical School CRS
    • New York
      • New York, New York, Forenede Stater, 10027
        • Harlem Prevention
      • New York, New York, Forenede Stater, 10032
        • Physicians & Surgeons CRS
      • New York, New York, Forenede Stater, 10451
        • Bronx Prevention Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Penn Prevention CRS
      • Pittsburgh, Pennsylvania, Forenede Stater, 15260
        • University of Pittsburgh
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
  • Puerto Rico
      • Ponce, Puerto Rico
        • St. Louis University VTEU-CAIMED-PHSU

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 måneder og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites
Tidsramme: Baseline
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing
Tidsramme: Baseline
Baseline
To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19
Tidsramme: Baseline
Baseline
To estimate seroprevalence of SARS-CoV-2
Tidsramme: Baseline

Among:

  1. Those without past or current symptoms consistent with COVID-19
  2. Those with no prior positive SARS-CoV-2 testing, but who report close contact with confirmed or presumed cases
  3. 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.
Tidsramme: 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.
Baseline
To estimate potential size of populations for referral to COVID-19 prevention and treatment studies
Tidsramme: Baseline
Baseline
To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire
Tidsramme: Baseline
Baseline
To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

COVID-19 Prevention Network

Efterforskere

  • Studiestol: Jessica Justman, MD, Departments of Epidemiology and Medicine, Columbia University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. februar 2021

Primær færdiggørelse (Faktiske)

12. august 2021

Studieafslutning (Faktiske)

12. august 2021

Datoer for studieregistrering

Først indsendt

19. november 2020

Først indsendt, der opfyldte QC-kriterier

4. december 2020

Først opslået (Faktiske)

8. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CoVPN 5002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med COVID-19

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cyprus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner