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

Sponsor
Bandim Health Project (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04471766
Collaborator
University of Southern Denmark (Other), Engineers without Borders, Denmark (https://iug.dk/en) (Other)
40,000
1
2
14.4
2779.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Certified cloth face mask plus preventive information
  • Behavioral: Preventive information
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
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
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reported COVID-like illness [Four months follow-up]

    Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)

  2. Consultation [Four months follow-up]

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

  3. Severe illness [Four months follow-up]

    Self reported COVID-19 like illness plus hospitalization or death

  4. Mortality [Four months follow-up]

    Any death during the follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Household resident

  • Age: 10 years and older

Exclusion Criteria:
  • Refusal to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bandim Health Project Bissau Bissau Codex Guinea-Bissau

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT04471766
Other Study ID Numbers:
  • BHP MASK01
First Posted:
Jul 15, 2020
Last Update Posted:
Oct 13, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bandim Health Project
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021