Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention

October 5, 2021 updated by: Bandim Health Project

Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guinea-Bissau
    • Bissau Codex
      • Bissau, Bissau Codex, Guinea-Bissau
        • Bandim Health Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Household resident
  • Age: 10 years and older

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Certified cloth face mask plus preventive information
Certified cloth face mask
Other: Certified cloth face mask plus preventive information
Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old
Behavioral: Preventive information
Advice on how to prevent COVID-19 according to the government´ policy
ACTIVE_COMPARATOR: Information on COVID-19 prevention
Advice on how to prevent COVID-19 according to the government´ policy.
Behavioral: Preventive information
Advice on how to prevent COVID-19 according to the government´ policy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported COVID-like illness
Time Frame: Four months follow-up
Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
Four months follow-up
Consultation
Time Frame: Four months follow-up
Consultation for COVID-19 like illness or/and reported positive test
Four months follow-up
Severe illness
Time Frame: Four months follow-up
Self reported COVID-19 like illness plus hospitalization or death
Four months follow-up
Mortality
Time Frame: Four months follow-up
Any death during the follow-up period
Four months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandim Health Project

Collaborators

University of Southern Denmark
Engineers without Borders, Denmark (https://iug.dk/en)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 20, 2020

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (ACTUAL)

July 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHP MASK01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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