Face Masks to Reduce COVID-19 in Bangladesh

January 12, 2022 updated by: Yale University

Can Face Masks Reduce Transmission of SARS-CoV-2 in Bangladesh? A Cluster Randomized Controlled Trial

The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level COVID-19 seroconversion. The individual experiment assess whether masks protect against COVID-19 seroconversion. It also assesses the efficacy of high-quality cloth vs. surgical masks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Can community mask-wearing reduce COVID-19 seroconversions?

Can mask wearing reduce COVID-19 seroconversions for the wearer?

Are high-quality cloth or "surgical" masks more effective in reducing COVID-19 seroconversions?

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, as well as a separate trial where masks are randomized at the individual level among high-risk indoor market vendors.

In the community experiment, control communities will receive no intervention and treatment communities will receive an extensive intervention combining several elements. The investigators will distribute free face masks through door-to-door visits and at markets and mosques. Some communities will receive cloth masks and some will wear surgical 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. Communities will receive an incentive if >75% are observed to wear masks by mask surveillance staff that conduct discrete observations on days when mask promotion is and is not occurring. The project will enroll 600 communities and create matched pairs based on population size; half of which will be randomized to receive the intervention.

In the individual experiment, the investigators will identify 5,000 high-risk individuals (vendors at indoor market). and randomizing them at the individual level to receive our mask intervention or not. In each indoor market, there will be both control and treatment individuals. Individuals in the treatment arm will receive a free face mask (cloth or surgical). Investigators will enroll individuals from 350-500 markets that are not in the communities that are participating in the community experiment.

Communities will be surveilled at 0, 1, 2, 4, 6, 8, and 12 weeks to assess mask wearing. Participants in the indvidual experiment will be surveilled at 0, 1, 2, 4, 6, weeks to assess mask wearing.

In both experiments, we will assess seroprevalence of COVID-19 at baseline and endline. Endline is planned for 12 weeks after the intervention begins, but may be shifted according to seroprevalence trends.

Study Type

Interventional

Enrollment (Actual)

350000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1213
        • Innovations for Poverty Action

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community experiment: Live in selected village
  • Individual experiment: Work in selected market

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mask Intervention

Communities and individuals randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use.

In the community experiment, 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 the individual experiment, individuals randomized to the intervention arm will not be asked to recommend masks to others, but will also not be discouraged from recommending mask use to others.
Device: Face mask
Intervention individuals will be given cloth or surgical face masks.
Behavioral: Face mask awareness
Intervention individuals will be told about the importance of wearing face masks that cover the nose, mouth, and chin. Mask by mask promoters and community and religious leaders will encourage mask wearing.
No Intervention: Control
Control individuals will receive no masks or behavior change communication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic SARS-CoV2 infection
Time Frame: 12 weeks
Symptomatic SARS-CoV2 infection, assessed via antibody testing 12 weeks after baseline, among individuals who report symptoms consistent with COVID-19 at 5 weeks or 9 weeks after baseline
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV2 infection
Time Frame: 12 weeks

Community experiment: Symptomatic SARS-CoV2 infection, assessed via antibody testing 12 weeks after baseline relative to baseline tests, among 25,000 high-risk individuals from randomly selected households

Individual experiment: Symptomatic SARS-CoV2 infection, assessed via serological testing 10 weeks after baseline, among all 5,000 individuals in individual experiment
12 weeks
Observed prevalence of proper mask wearing
Time Frame: intervention weeks 0, 1, 2, 4, 6, 8, and 12 in the community experiment and intervention weeks 0, 1, 2, 4, and 6 in the individual experiment
Wearing a mask of the nose, mouth, and chin
intervention weeks 0, 1, 2, 4, 6, 8, and 12 in the community experiment and intervention weeks 0, 1, 2, 4, and 6 in the individual experiment
Respiratory infection prevalence
Time Frame: 5 and 9 weeks
Prevalence of self-reported symptoms of COVID-19, including fever, cough, sore throat, shortness of breath, difficulty breathing, nasal congestion, and runny nose.
5 and 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Stanford University
Innovations for Poverty Action
North South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000028482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not plan to share individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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