Covid19NCT05197725
Face Masks to Reduce SARS-CoV-2 Infections (COVID-19) in Bangladesh
A study testing Face mask, Face mask awareness and Face mask promotion through community values or individual information 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 asymptomatic and symptomatic SARS-CoV-2 infections, assessed via PCR testing. Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Face mask, Face mask awareness and Face mask promotion through community values or individual information
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBangladesh
- Study dates
- 4 Feb 2023to 30 May 2023
- 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 12 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Live in selected village
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Face Masks to Reduce Symptomatic and Asymptomatic SARS-CoV-2 Infections in Bangladesh
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.
Read the 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
- Being tested
- Face mask, Face mask awareness, Face mask promotion through community values or individual information
- Keywords
- Masks, Transmission, Bangladesh, Behavioral psychology
- 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
Individuals in intervention communities will be given surgical or KF94 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.
Face mask promotion through community values or individual informationBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Percent of people observed in public places wearing a mask over their mouth and nose compared to wearing a mask or face covering that does not cover the mouth and nose or not wearing any mask or face covering. The investigators will include sub-group analyses by age group, gender, and location
Measured: 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
Prevalence of self-reported symptoms of COVID-19, including fever, cough, sore throat, shortness of breath, difficulty breathing, nasal congestion, and runny nose.
Measured: 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
Prevalence of physical distancing among observed individuals wearing or not wearing a mask
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start4 Feb 2023 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 May 2023 (estimated)
Why it stopped: Unable to get Study supplies in time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This is a randomized controlled trial with an equal number of intervention and control villages enrolled each day.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of California, Berkeley, Innovations for Poverty Action, North South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197725
- Sponsor's protocol ID
- 2000028482_asymp
- Other IDs
- INV-037905
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face Masks to Reduce Symptomatic and Asymptomatic SARS-CoV-2 Infections in Bangladesh
- ClinicalTrials.gov ID
- NCT05197725
- Acronym / sponsor ID
- 2000028482_asymp
- Conditions
- Covid19
- Keywords
- Masks, Transmission, Bangladesh, Behavioral psychology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to get Study supplies in time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Stanford University, University of California, Berkeley, Innovations for Poverty Action, North South University
- Study start
- 4 Feb 2023 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 19 Jan 2022 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial with an equal number of intervention and control villages enrolled each day.
| Arm | Type | Receives |
|---|---|---|
| Mask intervention | Experimental | Device: Face mask, Behavioral: Face mask awareness, Behavioral: Face mask promotion through community values or individual informationCommunities 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. |
| Control | No intervention | –Control individuals will receive no masks or behavior change communication. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Live in selected village
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 maskIndividuals in intervention communities will be given surgical or KF94 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 |
| Face mask promotion through community values or individual informationIn 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) | Behavioural | Mask intervention |
Primary outcome
Asymptomatic and asymptomatic SARS-CoV-2 infection
Time frame: 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
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
3 secondary outcomes
Observed prevalence of mask-wearing
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No. The investigators 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, Face mask awareness and Face mask promotion through community values or individual information 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 1 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: withdrawn, as of the sponsor's last update on 20 Mar 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Asymptomatic and asymptomatic SARS-CoV-2 infection (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2023.