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

NCT ID: NCT04471766

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Respiratory Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Certified cloth face mask plus preventive information

Certified cloth face mask

Group Type EXPERIMENTAL

Certified cloth face mask plus preventive information

Intervention Type OTHER

Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents \> 10 years old

Preventive information

Intervention Type BEHAVIORAL

Advice on how to prevent COVID-19 according to the government´ policy

Information on COVID-19 prevention

Advice on how to prevent COVID-19 according to the government´ policy.

Group Type ACTIVE_COMPARATOR

Preventive information

Intervention Type BEHAVIORAL

Advice on how to prevent COVID-19 according to the government´ policy

Interventions

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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

Intervention Type OTHER

Preventive information

Advice on how to prevent COVID-19 according to the government´ policy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Household resident
* Age: 10 years and older

Exclusion Criteria

* Refusal to participate
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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Nanque LM, Jensen AM, Diness A, Nielsen S, Cabral C, Cawthorne D, Martins JSD, Ca EJC, Jensen K, Martins CL, Rodrigues A, Fisker AB. Effect of distributing locally produced cloth facemasks on COVID-19-like illness and all-cause mortality-a cluster-randomised controlled trial in urban Guinea-Bissau. PLOS Glob Public Health. 2024 Feb 13;4(2):e0002901. doi: 10.1371/journal.pgph.0002901. eCollection 2024.

Reference Type DERIVED
PMID: 38349910 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BHP MASK01

Identifier Type: -

Identifier Source: org_study_id