Covid19NCT04866589
COVID-19: The Effectiveness of Free Face Mask Distribution
A study testing Distribution of free face masks in people with Covid19, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The investigators will carry out a randomised trial of free face mask distribution in Stovner District, Oslo, Norway. Ten grocery stores will serve as study sites. Over three weeks the stores will be randomised daily to having "corona hosts" outside their entrance, handing out face masks to customers. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Distribution of free face masks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- 3 May 2021to 21 May 2021
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
All grocery stores in the Stovner district are eligible as long as they have not, or only sporadically, had free distribution of face masks previously.
At the customer level, we will only include those 12 years or older (age based on the outcome assessor's judgement).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Distributing Free Face Masks to Increase Use of Face Masks During the COVID-19 Pandemic. A Randomised Experiment in Stovner District, Oslo, Norway
The investigators will carry out a randomised trial of free face mask distribution in Stovner District, Oslo, Norway. Ten grocery stores will serve as study sites. Over three weeks the stores will be randomised daily to having "corona hosts" outside their entrance, handing out face masks to customers. The investigators will compare the proportion of customers who wear face masks as they enter the store in stores with or without face mask distribution.
- Conditions
- Covid19
- Being tested
- Distribution of free face masks
- Keywords
- Face masks, Infection control, Behavioral intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distribution of free face masksBehavioural
"Corona hosts" will be placed at the entrance of the intervention stores, and hand out face masks to customers entering the store.
| Study group | Role | What they receive |
|---|---|---|
| Distribution of free face masks | Experimental | Face masks will be handed out for free to all customers entering the grocery stores. Receives: Behavioral: Distribution of free face masks |
| Control | No intervention | Business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face mask use
Proportion of customers wearing a face mask
Measured: Through study completion, 3 weeks.
Secondary outcomes (1)
Correct use of face masks
Proportion of customers wearing a face mask correctly (i.e. covering mouth and nose)
Measured: Through study completion, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start3 May 2021
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The team members from the Stovner district-administration will send a numbered list to Norwegian Institute of Public Health-team, with the names of the stores. The ordering of the stores will define the numbers used to represent each store in the randomisation process. Using Stata software, we will carry out 13 separate and independent randomisations, each assigning the intervention to half the included stores. An additional randomisation to the treatment or control group will be carried out for a marginal store each day in the event of an odd number of stores. Unless it proves too logistically cumbersome, we will also randomise the corona hosts, i.e. the store they are allocated to will be decided through randomisation.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Stovner District, City of Oslo, Norway
- Responsible party
- Sponsor
- Investigators
- Atle Fretheim, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866589
- Sponsor's protocol ID
- FaceMaskRCT Stovner
- Status last verified
- May 2021
- First submitted
- 15 Apr 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share the full dataset as soon as it as ready. All data are anonymous, so there are no person data issues to take into consideration.
Publications
Elgersma IH, Fretheim A, Indseth T, Munch AT, Johannessen LB, Hansen CE. The Evaluation of a Social Media Campaign to Increase COVID-19 Testing in Migrant Groups: Cluster Randomized Trial. J Med Internet Res. 2022 Mar 24;24(3):e34544. doi: 10.2196/34544.
PubMed 35285811
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Distributing Free Face Masks to Increase Use of Face Masks During the COVID-19 Pandemic. A Randomised Experiment in Stovner District, Oslo, Norway
- ClinicalTrials.gov ID
- NCT04866589
- Acronym / sponsor ID
- FaceMaskRCT Stovner
- Conditions
- Covid19
- Keywords
- Face masks, Infection control, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Stovner District, City of Oslo, Norway
- Study start
- 3 May 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 30 Apr 2021 (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.
The investigators will carry out a randomised trial of free face mask distribution in Stovner District, Oslo, Norway. Ten grocery stores will serve as study sites. Over three weeks the stores will be randomised daily to having "corona hosts" outside their entrance, handing out face masks to customers. The investigators will compare the proportion of customers who wear face masks as they enter the store in stores with or without face mask distribution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The team members from the Stovner district-administration will send a numbered list to Norwegian Institute of Public Health-team, with the names of the stores. The ordering of the stores will define the numbers used to represent each store in the randomisation process. Using Stata software, we will carry out 13 separate and independent randomisations, each assigning the intervention to half the included stores. An additional randomisation to the treatment or control group will be carried out for a marginal store each day in the event of an odd number of stores. Unless it proves too logistically cumbersome, we will also randomise the corona hosts, i.e. the store they are allocated to will be decided through randomisation.
| Arm | Type | Receives |
|---|---|---|
| Distribution of free face masks | Experimental | Behavioral: Distribution of free face masksFace masks will be handed out for free to all customers entering the grocery stores. |
| Control | No intervention | –Business as usual. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Distribution of free face masks"Corona hosts" will be placed at the entrance of the intervention stores, and hand out face masks to customers entering the store. | Behavioural | Distribution of free face masks |
Primary outcome
Face mask use
Time frame: Through study completion, 3 weeks.
Proportion of customers wearing a face mask
1 secondary outcome
Correct use of face masks
Time frame: Through study completion, 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 35285811Elgersma IH, Fretheim A, Indseth T, Munch AT, Johannessen LB, Hansen CE. The Evaluation of a Social Media Campaign to Increase COVID-19 Testing in Migrant Groups: Cluster Randomized Trial. J Med Internet Res. 2022 Mar 24;24(3):e34544. doi: 10.2196/34544.
- Individual participant dataSharing planned: Yes. The investigators will share the full dataset as soon as it as ready. All data are anonymous, so there are no person data issues to take into consideration.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Atle Fretheim, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distribution of free face masks in people with Covid19, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 27 Apr 2022. 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 Norway. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face mask use (time frame: Through study completion, 3 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 NCT04866589, which also lists 1 linked publication.
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 27 Apr 2022.