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

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.

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.

Completed
COVID19

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.

Eligibility Criteria

Inclusion Criteria:

- Community experiment: Live in selected village

- Individual experiment: Work in selected market

Exclusion Criteria:

- None

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Bangladesh
Locations

Innovations for Poverty Action
Dhaka, Bangladesh

Yale University
NCT Number
Keywords
Masks
Transmission
seroprevalence
Bangladesh
MeSH Terms
COVID-19