COVID-19: The Effectiveness of Free Face Mask Distribution
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Distribution of free face masks
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Face masks, Infection control, Behavioral intervention
Eligibility Criteria
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).
Sites / Locations
- Stover District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Distribution of free face masks
Control
Arm Description
Face masks will be handed out for free to all customers entering the grocery stores.
Business as usual.
Outcomes
Primary Outcome Measures
Face mask use
Proportion of customers wearing a face mask
Secondary Outcome Measures
Correct use of face masks
Proportion of customers wearing a face mask correctly (i.e. covering mouth and nose)
Full Information
NCT ID
NCT04866589
First Posted
April 15, 2021
Last Updated
April 19, 2022
Sponsor
Norwegian Institute of Public Health
Collaborators
Stovner District, City of Oslo, Norway
1. Study Identification
Unique Protocol Identification Number
NCT04866589
Brief Title
COVID-19: The Effectiveness of Free Face Mask Distribution
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Institute of Public Health
Collaborators
Stovner District, City of Oslo, Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Face masks, Infection control, Behavioral intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking Description
The analyst will receive a dataset in a format which makes it impossible for him/her to know which of the two arms in the dataset represents intervention or control.
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distribution of free face masks
Arm Type
Experimental
Arm Description
Face masks will be handed out for free to all customers entering the grocery stores.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Business as usual.
Intervention Type
Behavioral
Intervention Name(s)
Distribution of free face masks
Intervention Description
"Corona hosts" will be placed at the entrance of the intervention stores, and hand out face masks to customers entering the store.
Primary Outcome Measure Information:
Title
Face mask use
Description
Proportion of customers wearing a face mask
Time Frame
Through study completion, 3 weeks.
Secondary Outcome Measure Information:
Title
Correct use of face masks
Description
Proportion of customers wearing a face mask correctly (i.e. covering mouth and nose)
Time Frame
Through study completion, 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atle Fretheim, PhD
Organizational Affiliation
Norwegian Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stover District
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
From early June 2021, and for all foreseeable future.
IPD Sharing Access Criteria
None - anyone will have access to the dataset.
Citations:
PubMed Identifier
35285811
Citation
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.
Results Reference
derived
Learn more about this trial
COVID-19: The Effectiveness of Free Face Mask Distribution
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