NCT05197725

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

Face Masks to Reduce Symptomatic and Asymptomatic SARS-CoV-2 Infections in Bangladesh

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DEVICE	Face mask	Individuals in intervention communities will be given surgical or KF94 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.
BEHAVIORAL	Face mask promotion through community values or individual information	In intervention communities randomized to mask promotion through community values, promotional discussions and media will focus on encouraging groups of people to wear masks as a reflection of their values. In intervention communities randomized to mask promotion through individual information, promotional discussions and media will target individuals and focus on the instrumental value of wearing masks (preventing the inhalation of viral particles)

Timeline

• Start date: 2023-02-04
• Primary completion: 2023-03-30
• Completion: 2023-05-30
• First posted: 2022-01-19
• Last updated: 2023-03-20

Locations

1 site across 1 country: Bangladesh