An interventional study of Face mask and Face mask awareness in Covid19, sponsored by Yale University. Completed at 1 site in Bangladesh. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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.
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 350,000 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
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Exclusion Criteria:
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 · Behavioral: Face mask awareness
Control individuals will receive no masks or behavior change communication.
Intervention individuals will be given cloth or surgical face masks.
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.
Symptomatic SARS-CoV2 infection
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
Time frame: 12 weeks
SARS-CoV2 infection
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
Time frame: 12 weeks
Observed prevalence of proper mask wearing
Wearing a mask of the nose, mouth, and chin
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
Respiratory infection prevalence
Prevalence of self-reported symptoms of COVID-19, including fever, cough, sore throat, shortness of breath, difficulty breathing, nasal congestion, and runny nose.
Time frame: 5 and 9 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not plan to share individual participant data with other researchers
Ran from Nov 2020 to primary completion in Jun 2021, 7 months.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 7 months is below that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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