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

NCT04471766 | Unknown

• 1 other identifier: BHP MASK01
• Study Type: interventional
• Target: 40,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Respiratory Illness

Keywords

Face mask; COVID-19; Respiratory illness; Mortality

Outcome Measures

Primary Outcomes (4)

• Reported COVID-like illness

  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

  Consultation for COVID-19 like illness or/and reported positive test

  Four months follow-up

• Severe illness

  Self reported COVID-19 like illness plus hospitalization or death

  Four months follow-up

• Mortality

  Any death during the follow-up period

  Four months follow-up

Study Arms (2)

Certified cloth face mask plus preventive information

EXPERIMENTAL

Certified cloth face mask

Other: Certified cloth face mask plus preventive information; Behavioral: Preventive information

Information on COVID-19 prevention

ACTIVE COMPARATOR

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

Behavioral: Preventive information

Interventions

Certified cloth face mask plus preventive information OTHER

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

Certified cloth face mask plus preventive information

Preventive information BEHAVIORAL

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

Certified cloth face mask plus preventive information; Information on COVID-19 prevention

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Household resident
• Age: 10 years and older

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• Bandim Health Project: lead
• University of Southern Denmark: collaborator
• Engineers without Borders, Denmark (https://iug.dk/en): collaborator

Study Sites (1)

Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau

Location

Related Publications (1)

• 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.

  PMID: 38349910 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 15, 2020
• Study Start: July 20, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)