COVID-19: The Effectiveness of Free Face Mask Distribution

NCT04866589 | Completed

• 1 other identifier: FaceMaskRCT Stovner
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Face masks; Infection control; Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Face mask use

  Proportion of customers wearing a face mask

  Through study completion, 3 weeks.

Secondary Outcomes (1)

• Correct use of face masks

  Through study completion, 3 weeks

Study Arms (2)

Distribution of free face masks

EXPERIMENTAL

Face masks will be handed out for free to all customers entering the grocery stores.

Behavioral: Distribution of free face masks

Control

NO INTERVENTION

Business as usual.

Interventions

Distribution of free face masks BEHAVIORAL

"Corona hosts" will be placed at the entrance of the intervention stores, and hand out face masks to customers entering the store.

Distribution of free face masks

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Stovner District, City of Oslo, Norway: collaborator

Study Sites (1)

Stover District

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 35285811 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Atle Fretheim, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 30, 2021
• Study Start: May 3, 2021
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: April 27, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: From early June 2021, and for all foreseeable future.
• Access Criteria: None - anyone will have access to the dataset.

Locations

NO (1)