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

Not Applicable

• Conditions: COVID-19; Respiratory Illness
• Interventions: Other: Certified cloth face mask plus preventive information; Behavioral: Preventive information

• Registration Number: NCT04471766
• Lead Sponsor: Bandim Health Project

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-15
• Study Start: 2020-07-20
• Status Verified: 2021-03
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

• Household resident
• Age: 10 years and older

Exclusion Criteria

• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Certified cloth face mask plus preventive information	Certified cloth face mask plus preventive information	Certified cloth face mask
Information on COVID-19 prevention	Preventive information	Advice on how to prevent COVID-19 according to the government´ policy.
Certified cloth face mask plus preventive information	Preventive information	Certified cloth face mask

Primary Outcome Measures

Name	Time	Method
Severe illness	Four months follow-up	Self reported COVID-19 like illness plus hospitalization or death
Mortality	Four months follow-up	Any death during the follow-up period
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)
Consultation	Four months follow-up	Consultation for COVID-19 like illness or/and reported positive test

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Bissau Codex, Guinea-Bissau