Face Masks to Reduce SARS-CoV-2 Infections (COVID-19) in Bangladesh

Not Applicable

Withdrawn

• Conditions: Covid19
• Interventions: Device: Face mask; Behavioral: Face mask awareness; Behavioral: Face mask promotion through community values or individual information

• Registration Number: NCT05197725
• Lead Sponsor: Yale University

Brief Summary

The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level asymptomatic and symptomatic SARS-CoV-2 infections, assessed via PCR testing. The study also examines if community-based activation through values or individual activation through information results in higher mask-wearing.

Detailed Description

Detailed Description:

This study intends to answer the following research questions:

Can mask distribution and mask promotion at homes, mosques, markets and other public areas successfully change community mask-wearing norms to increase mask-wearing, even years into a pandemic?

Can community mask-wearing reduce SARS-CoV-2 infections (both symptomatic and asymptomatic)?

Is increased prevalence of community-level mask-wearing associated with decreased physical distancing?

To answer these questions, the investigators will conduct a cluster randomized trial which randomizes the proposed intervention at the village level in Bangladesh. Control communities will receive no intervention and treatment communities will receive an extensive intervention combining several elements. Study staff will distribute free face masks through door-to-door visits and at markets and mosques. In some communities groups of people will be encouraged to wear masks by appealing to their shared values and in other communities individuals will be encouraged to wear masks by discussing the biological value of masks (cross-randomized among intervention communities). Mask promoters in the community and at markets in treated villages will remind people about the importance of wearing masks and distribute additional masks. Markets will have signs that masks need to be worn to enter the market. Religious leaders will encourage mask use at religious services. The project will enroll 1200 communities, stratified in geographically proximate groups of 10; half will be randomized to receive the intervention.

Communities will be surveilled through direct observation at 0, 2, and 4 weeks to assess mask-wearing. The investigators will assess symptomatic and asymptomatic SARS-CoV-2 by conducting household visits every 6-10 days to ask about symptoms of COVID-19 and collecting nasal swabs to test by PCR for the presence of SARS-CoV-2. End line is planned for 4 weeks after the intervention begins, but may be shifted according to seroprevalence trends.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-19
• Study Start: 2023-02-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-03-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Live in selected village

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mask intervention	Face mask awareness	Communities randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. Every adult in communities randomized to the intervention arm will be encouraged to wear a mask when outside their housing compound and around other people. In arms randomized to school promotion, secondary school children will also be encouraged to wear masks both inside and outside of school.
Mask intervention	Face mask	Communities randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. Every adult in communities randomized to the intervention arm will be encouraged to wear a mask when outside their housing compound and around other people. In arms randomized to school promotion, secondary school children will also be encouraged to wear masks both inside and outside of school.
Mask intervention	Face mask promotion through community values or individual information	Communities randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. Every adult in communities randomized to the intervention arm will be encouraged to wear a mask when outside their housing compound and around other people. In arms randomized to school promotion, secondary school children will also be encouraged to wear masks both inside and outside of school.

Primary Outcome Measures

Name	Time	Method
Asymptomatic and asymptomatic SARS-CoV-2 infection	approximately weekly for 4 weeks; may be lengthened if the intervention is extended due to low than estimated seroprevalence at the start of the intervention	Asymptomatic and asymptomatic SARS-CoV-2 infection, assessed using PCR testing every 6-10 days after baseline, among individuals regardless of whether they report symptoms of COVID-19

Secondary Outcome Measures

Name	Time	Method
Respiratory infection prevalence	approximately weekly for 4 weeks; may be lengthened if the intervention is extended due to low than estimated seroprevalence at the start of the intervention	Prevalence of self-reported symptoms of COVID-19, including fever, cough, sore throat, shortness of breath, difficulty breathing, nasal congestion, and runny nose.
Physical distancing	Intervention weeks 0, 2, and 4; end line and midline timepoints may be adjusted if the intervention is extended due to low than estimated seroprevalence at the start of the intervention.	Prevalence of physical distancing among observed individuals wearing or not wearing a mask
Observed prevalence of mask-wearing	Intervention weeks 0, 2, and 4; end line and midline timepoints may be adjusted if the intervention is extended due to low than estimated seroprevalence at the start of the intervention.	Percent of people observed in public places wearing a mask over their mouth and nose compared to wearing a mask or face covering that does not cover the mouth and nose or not wearing any mask or face covering. The investigators will include sub-group analyses by age group, gender, and location

Trial Locations

Locations (1)

Innovations for Poverty Action; 🇧🇩 Dhaka, Bangladesh