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

Yale University

Status: Withdrawn

Conditions: Covid19

Treatments: Device: Face mask; Behavioral: Face mask promotion through community values or individual information; Behavioral: Face mask awareness

Study type: Interventional

Funder types: Other

Identifiers

NCT05197725

2000028482_asymp

INV-037905 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Live in selected village

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Mask intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Face mask awareness

Device: Face mask

Behavioral: Face mask promotion through community values or individual information

Control

No Intervention group

Description:

Control individuals will receive no masks or behavior change communication.