COVID Screening Strategies in Homeless Shelters

June 17, 2020 updated by: Marek Smieja, St. Joseph's Healthcare Hamilton
Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Various Homeless Shelters
        • Contact:
        • Principal Investigator:
          • Timothy O'Shea, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Daily active screening only
Diagnostic test: COVID-19 Swab
Nasal, Oral-Nasal combined or Nasopharyngeal swab
Experimental: Daily active screening and self-collected nasal swab
Diagnostic test: COVID-19 Swab
Nasal, Oral-Nasal combined or Nasopharyngeal swab
Experimental: Daily active screening and self-collected oral-nasal swab
Diagnostic test: COVID-19 Swab
Nasal, Oral-Nasal combined or Nasopharyngeal swab
Experimental: Daily active screening and nurse collected nasopharyngeal swab
Diagnostic test: COVID-19 Swab
Nasal, Oral-Nasal combined or Nasopharyngeal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
COVID-19 Detection Rate
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of outbreaks
Time Frame: 8 weeks
8 weeks
Enrollment over time
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Timothy O'Shea
Marek Smieja
Lawrence Mbuagbaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-10864-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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