<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471766</url>
  </required_header>
  <id_info>
    <org_study_id>BHP MASK01</org_study_id>
    <nct_id>NCT04471766</nct_id>
  </id_info>
  <brief_title>Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention</brief_title>
  <official_title>Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bandim Health Project</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Engineers without Borders, Denmark (https://iug.dk/en)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bandim Health Project</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to&#xD;
      occur mainly through person-to-person transmission through respiratory droplets, indirect&#xD;
      contact with infected people and surfaces. The use of face masks is recommended as a public&#xD;
      health measure, but in many settings only domestic cloth made masks are available to the&#xD;
      majority of the people. However, masks can be of different quality and very little is known&#xD;
      about the utility of cloth face masks at the community level.&#xD;
&#xD;
      In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the&#xD;
      effect of providing locally produced cloth face masks on severity of COVID-19 like illness&#xD;
      and mortality in an urban population. The locally produced cloth mask is made according to a&#xD;
      laboratory certified model and will be provided to the intervention group alongside&#xD;
      information of how the risk of transmission can be reduced. The control group will receive&#xD;
      information alone.&#xD;
&#xD;
      Follow-up will be implemented through telephone calls and post-epidemic home visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reported COVID-like illness</measure>
    <time_frame>Four months follow-up</time_frame>
    <description>Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consultation</measure>
    <time_frame>Four months follow-up</time_frame>
    <description>Consultation for COVID-19 like illness or/and reported positive test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severe illness</measure>
    <time_frame>Four months follow-up</time_frame>
    <description>Self reported COVID-19 like illness plus hospitalization or death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Four months follow-up</time_frame>
    <description>Any death during the follow-up period</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40000</enrollment>
  <condition>COVID-19</condition>
  <condition>Respiratory Illness</condition>
  <arm_group>
    <arm_group_label>Certified cloth face mask plus preventive information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Certified cloth face mask</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information on COVID-19 prevention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Advice on how to prevent COVID-19 according to the government´ policy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Certified cloth face mask plus preventive information</intervention_name>
    <description>Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents &gt; 10 years old</description>
    <arm_group_label>Certified cloth face mask plus preventive information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preventive information</intervention_name>
    <description>Advice on how to prevent COVID-19 according to the government´ policy</description>
    <arm_group_label>Certified cloth face mask plus preventive information</arm_group_label>
    <arm_group_label>Information on COVID-19 prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Household resident&#xD;
&#xD;
          -  Age: 10 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bandim Health Project</name>
      <address>
        <city>Bissau</city>
        <state>Bissau Codex</state>
        <country>Guinea-Bissau</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guinea-Bissau</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Face mask</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Respiratory illness</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT04471766/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471766
org study id: BHP MASK01
nct id: NCT04471766
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to
      occur mainly through person-to-person transmission through respiratory droplets, indirect
      contact with infected people and surfaces. The use of face masks is recommended as a public
      health measure, but in many settings only domestic cloth made masks are available to the
      majority of the people. However, masks can be of different quality and very little is known
      about the utility of cloth face masks at the community level.

      In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the
      effect of providing locally produced cloth face masks on severity of COVID-19 like illness
      and mortality in an urban population. The locally produced cloth mask is made according to a
      laboratory certified model and will be provided to the intervention group alongside
      information of how the risk of transmission can be reduced. The control group will receive
      information alone.

      Follow-up will be implemented through telephone calls and post-epidemic home visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Reported COVID-like illness
time frame: Four months follow-up
description: Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)
measure: Consultation
time frame: Four months follow-up
description: Consultation for COVID-19 like illness or/and reported positive test
measure: Severe illness
time frame: Four months follow-up
description: Self reported COVID-19 like illness plus hospitalization or death
measure: Mortality
time frame: Four months follow-up
description: Any death during the follow-up period
arm group label: Certified cloth face mask plus preventive information
arm group type: Experimental
description: Certified cloth face mask
arm group label: Information on COVID-19 prevention
arm group type: Active Comparator
description: Advice on how to prevent COVID-19 according to the government´ policy.
intervention type: Other
intervention name: Certified cloth face mask plus preventive information
description: Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old
arm group label: Certified cloth face mask plus preventive information
intervention type: Behavioral
intervention name: Preventive information
description: Advice on how to prevent COVID-19 according to the government´ policy
arm group label: Certified cloth face mask plus preventive information
arm group label: Information on COVID-19 prevention
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Guinea-Bissau
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
provided document: 