COVID Screening Strategies in Homeless Shelters

NCT ID: NCT04438070

Last Updated: 2020-06-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-06-30

Brief Summary

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Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized multi-center trial
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Daily active screening only

Group Type PLACEBO_COMPARATOR

COVID-19 Swab

Intervention Type DIAGNOSTIC_TEST

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Daily active screening and self-collected nasal swab

Group Type EXPERIMENTAL

COVID-19 Swab

Intervention Type DIAGNOSTIC_TEST

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Daily active screening and self-collected oral-nasal swab

Group Type EXPERIMENTAL

COVID-19 Swab

Intervention Type DIAGNOSTIC_TEST

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Daily active screening and nurse collected nasopharyngeal swab

Group Type EXPERIMENTAL

COVID-19 Swab

Intervention Type DIAGNOSTIC_TEST

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Interventions

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COVID-19 Swab

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18
* Able to provide oral consent
* Able to perform a self-collected swab if in the relevant intervention arm

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Timothy O'Shea

UNKNOWN

Sponsor Role collaborator

Marek Smieja

UNKNOWN

Sponsor Role collaborator

Lawrence Mbuagbaw

UNKNOWN

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Marek Smieja

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Various Homeless Shelters

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Timothy O'Shea, MD

Role: CONTACT

905-521-2100

Marek Smieja, MD, PhD

Role: CONTACT

905-521-6021

Facility Contacts

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Timothy O'Shea, MD

Role: primary

905-521-2100

References

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Mokashi V, Gilchrist J, Smieja N, Maciejewski J, Marttala S, Beal K, Mbuagbaw L, Bulir D, Smieja M, O'Shea T. Four COVID-19 screening strategies for early case identification within the homeless shelter population: a cluster randomized controlled trial. BMC Infect Dis. 2024 Dec 28;24(1):1478. doi: 10.1186/s12879-024-10148-y.

Reference Type DERIVED
PMID: 39732649 (View on PubMed)

O'Shea T, Mbuagbaw L, Mokashi V, Bulir D, Gilchrist J, Smieja N, Chong S, Marttala S, Vera V, Cvetkovic A, Smieja M. Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 23;21(1):941. doi: 10.1186/s13063-020-04890-2.

Reference Type DERIVED
PMID: 33225995 (View on PubMed)

Other Identifiers

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2020-10864-T

Identifier Type: -

Identifier Source: org_study_id

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