Covid19NCT04630054
Face Masks to Reduce COVID-19 in Bangladesh
A study testing Face mask and Face mask awareness in people with Covid19, run by Yale University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Face mask and Face mask awareness
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350,000 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Nov 2020to 29 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community experiment: Live in selected village
- Individual experiment: Work in selected market
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Face Masks Reduce Transmission of SARS-CoV-2 in Bangladesh? A Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Face mask, Face mask awareness
- Keywords
- Masks, Transmission, Seroprevalence, Bangladesh
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face maskDevice
Intervention individuals will be given cloth or surgical face masks.
Face mask awarenessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mask Intervention | Experimental | 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. Receives: Device: Face mask; Behavioral: Face mask awareness |
| Control | No intervention | Control individuals will receive no masks or behavior change communication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: 12 weeks
Observed prevalence of proper mask wearing
Wearing a mask of the nose, mouth, and chin
Measured: 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.
Measured: 5 and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start15 Nov 2020
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Innovations for Poverty Action, North South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630054
- Sponsor's protocol ID
- 2000028482
- Status last verified
- Jan 2022
- First submitted
- 13 Nov 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data with other researchers
Publications
Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
PubMed 38597249Abaluck J, Kwong LH, Styczynski A, Haque A, Kabir MA, Bates-Jefferys E, Crawford E, Benjamin-Chung J, Raihan S, Rahman S, Benhachmi S, Bintee NZ, Winch PJ, Hossain M, Reza HM, Jaber AA, Momen SG, Rahman A, Banti FL, Huq TS, Luby SP, Mobarak AM. Impact of community masking on COVID-19: A cluster-randomized trial in Bangladesh. Science. 2022 Jan 14;375(6577):eabi9069. doi: 10.1126/science.abi9069. Epub 2022 Jan 14.
PubMed 34855513
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Face Masks Reduce Transmission of SARS-CoV-2 in Bangladesh? A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04630054
- Acronym / sponsor ID
- 2000028482
- Conditions
- Covid19
- Keywords
- Masks, Transmission, Seroprevalence, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350,000 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Stanford University, Innovations for Poverty Action, North South University
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mask Intervention | Experimental | Device: Face mask, Behavioral: Face mask awarenessCommunities 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. |
| Control | No intervention | –Control individuals will receive no masks or behavior change communication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community experiment: Live in selected village
- Individual experiment: Work in selected market
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face maskIntervention individuals will be given cloth or surgical face masks. | Device | Mask Intervention |
| Face mask awarenessIntervention 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. | Behavioural | Mask Intervention |
Primary outcome
Symptomatic SARS-CoV2 infection
Time frame: 12 weeks
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
3 secondary outcomes
SARS-CoV2 infection
Time frame: 12 weeks
Observed prevalence of proper mask wearing
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
Time frame: 5 and 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 38597249Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
- Derived from this study: PubMed 34855513Abaluck J, Kwong LH, Styczynski A, Haque A, Kabir MA, Bates-Jefferys E, Crawford E, Benjamin-Chung J, Raihan S, Rahman S, Benhachmi S, Bintee NZ, Winch PJ, Hossain M, Reza HM, Jaber AA, Momen SG, Rahman A, Banti FL, Huq TS, Luby SP, Mobarak AM. Impact of community masking on COVID-19: A cluster-randomized trial in Bangladesh. Science. 2022 Jan 14;375(6577):eabi9069. doi: 10.1126/science.abi9069. Epub 2022 Jan 14.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face mask and Face mask awareness in people with Covid19, run by Yale University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic SARS-CoV2 infection (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04630054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.