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

NCT05197725 | Withdrawn

• 2 other identifiers: 2000028482_asympINV-037905
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Masks; Transmission; Bangladesh; Behavioral psychology

Outcome Measures

Primary Outcomes (1)

• Asymptomatic and asymptomatic SARS-CoV-2 infection

  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

  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

Secondary Outcomes (3)

• 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.

• 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

• 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.

Study Arms (2)

Mask intervention

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

Control individuals will receive no masks or behavior change communication.

Interventions

Face mask DEVICE

Individuals in intervention communities will be given surgical or KF94 face masks.

Mask intervention

Face mask awareness BEHAVIORAL

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.

Mask intervention

Face mask promotion through community values or individual information BEHAVIORAL

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)

Mask intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Live in selected village

You may not qualify if:

• None

Sponsors & Collaborators

• Yale University: lead
• Stanford University: collaborator
• University of California, Berkeley: collaborator
• Innovations for Poverty Action: collaborator
• North South University: collaborator

Study Sites (1)

Innovations for Poverty Action

Dhaka, 1213, Bangladesh

Location

MeSH Terms

Conditions

COVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The intervention involves wearing a face mask so participants will know if they are in the intervention group. The investigators will be blinded as to intervention assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial with an equal number of intervention and control villages enrolled each day.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 19, 2022
• Study Start: February 4, 2023
• Primary Completion: March 30, 2023
• Study Completion: May 30, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)