Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention
Primary Purpose
COVID-19, Respiratory Illness
Status
Unknown status
Phase
Not Applicable
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
Certified cloth face mask plus preventive information
Preventive information
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Face mask, COVID-19, Respiratory illness, Mortality
Eligibility Criteria
Inclusion Criteria:
- Household resident
- Age: 10 years and older
Exclusion Criteria:
- Refusal to participate
Sites / Locations
- Bandim Health Project
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Certified cloth face mask plus preventive information
Information on COVID-19 prevention
Arm Description
Certified cloth face mask
Advice on how to prevent COVID-19 according to the government´ policy.
Outcomes
Primary Outcome Measures
Reported COVID-like illness
Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
Consultation
Consultation for COVID-19 like illness or/and reported positive test
Severe illness
Self reported COVID-19 like illness plus hospitalization or death
Mortality
Any death during the follow-up period
Secondary Outcome Measures
Full Information
NCT ID
NCT04471766
First Posted
July 14, 2020
Last Updated
October 5, 2021
Sponsor
Bandim Health Project
Collaborators
University of Southern Denmark, Engineers without Borders, Denmark (https://iug.dk/en)
1. Study Identification
Unique Protocol Identification Number
NCT04471766
Brief Title
Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention
Official Title
Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bandim Health Project
Collaborators
University of Southern Denmark, Engineers without Borders, Denmark (https://iug.dk/en)
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 number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level.
In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone.
Follow-up will be implemented through telephone calls and post-epidemic home visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Respiratory Illness
Keywords
Face mask, COVID-19, Respiratory illness, Mortality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Certified cloth face mask plus preventive information
Arm Type
Experimental
Arm Description
Certified cloth face mask
Arm Title
Information on COVID-19 prevention
Arm Type
Active Comparator
Arm Description
Advice on how to prevent COVID-19 according to the government´ policy.
Intervention Type
Other
Intervention Name(s)
Certified cloth face mask plus preventive information
Intervention Description
Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old
Intervention Type
Behavioral
Intervention Name(s)
Preventive information
Intervention Description
Advice on how to prevent COVID-19 according to the government´ policy
Primary Outcome Measure Information:
Title
Reported COVID-like illness
Description
Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
Time Frame
Four months follow-up
Title
Consultation
Description
Consultation for COVID-19 like illness or/and reported positive test
Time Frame
Four months follow-up
Title
Severe illness
Description
Self reported COVID-19 like illness plus hospitalization or death
Time Frame
Four months follow-up
Title
Mortality
Description
Any death during the follow-up period
Time Frame
Four months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Household resident
Age: 10 years and older
Exclusion Criteria:
Refusal to participate
Facility Information:
Facility Name
Bandim Health Project
City
Bissau
State/Province
Bissau Codex
Country
Guinea-Bissau
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention
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