COVID-19NCT04438070
COVID Screening Strategies in Homeless Shelters
A study testing COVID-19 Swab in people with COVID-19, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 Swab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 10 Apr 2020to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Various Homeless Shelters
Hamilton, Ontario
Timothy O'Shea, MD, 905-521-2100, osheat@mcmaster.ca
Timothy O'Shea, MD
About this study
Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.
- Conditions
- COVID-19
- Being tested
- COVID-19 Swab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 SwabDiagnostic test
Nasal, Oral-Nasal combined or Nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| Daily active screening only | Placebo comparator | Not described Receives: Diagnostic Test: COVID-19 Swab |
| Daily active screening and self-collected nasal swab | Experimental | Not described Receives: Diagnostic Test: COVID-19 Swab |
| Daily active screening and self-collected oral-nasal swab | Experimental | Not described Receives: Diagnostic Test: COVID-19 Swab |
| Daily active screening and nurse collected nasopharyngeal swab | Experimental | Not described Receives: Diagnostic Test: COVID-19 Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Detection Rate
Measured: 8 weeks
Secondary outcomes (2)
Number of outbreaks
Measured: 8 weeks
Enrollment over time
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start10 Apr 2020
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized multi-center trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Timothy O'Shea, Marek Smieja, Lawrence Mbuagbaw
- Responsible party
- Principal investigator, Marek Smieja, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438070
- Sponsor's protocol ID
- 2020-10864-T
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39732649O'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.
PubMed 33225995
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID Screening Strategies in Homeless Shelters
- ClinicalTrials.gov ID
- NCT04438070
- Acronym / sponsor ID
- 2020-10864-T
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Timothy O'Shea, Marek Smieja, Lawrence Mbuagbaw
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cluster randomized multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Daily active screening only | Placebo comparator | Diagnostic Test: COVID-19 Swab |
| Daily active screening and self-collected nasal swab | Experimental | Diagnostic Test: COVID-19 Swab |
| Daily active screening and self-collected oral-nasal swab | Experimental | Diagnostic Test: COVID-19 Swab |
| Daily active screening and nurse collected nasopharyngeal swab | Experimental | Diagnostic Test: COVID-19 Swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 SwabNasal, Oral-Nasal combined or Nasopharyngeal swab | Diagnostic test | Daily active screening and nurse collected nasopharyngeal swab, Daily active screening and self-collected nasal swab, Daily active screening and self-collected oral-nasal swab, Daily active screening only |
Primary outcome
COVID-19 Detection Rate
Time frame: 8 weeks
2 secondary outcomes
Number of outbreaks
Time frame: 8 weeks
Enrollment over time
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 39732649Mokashi 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.
- Derived from this study: PubMed 33225995O'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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Swab in people with COVID-19, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy O'Shea, MD (905-521-2100, osheat@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Detection Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438070, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.