<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/NCT04501458</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT04501458</nct_id>
  </id_info>
  <brief_title>Western Kenya Integrated COVID-19 Response</brief_title>
  <official_title>Western Kenya Integrated COVID-19 Response Leveraging the Community Health Strategy, Youth, and Technology to Flatten the COVID-19 Curve and Improve COVID-19 Case Detection, Isolation and Management in Western Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Surgical Systems Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tropical Institute of Community Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Surgical Systems Research Group</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To respond to the COVID-19 pandemic, investigators will be deploying community health&#xD;
      workers, equipped with mobile technology, and accompanied by youth to visit households door&#xD;
      to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of&#xD;
      COVID-19. The community health workers and youth will educate households about preventive&#xD;
      measures including frequent handwashing and home management of mild cases. Simultaneously,&#xD;
      investigators will work with nurses, doctors, and clinical officers, to test and treat more&#xD;
      severe cases of COVID-19 in health facilities. Our goals are: to visit every household in&#xD;
      Siaya county covering a population of close to 1 million, and to train and support health&#xD;
      workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity&#xD;
      and mortality related to COVID19 and other conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 months</time_frame>
    <description>Mortality related to COVID-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of confirmed COVID-19 cases in Siaya</measure>
    <time_frame>3 months</time_frame>
    <description>Number of confirmed COVID-19 cases in Siaya</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200000</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Functional community health units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community health units with active community health workers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non functional community health units</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Community health units without active community health workers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health facilities with oxygen capacity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health facility with regular oxygen capacity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health facilities without oxygen capacity</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training of youth, community health assistants and community health workers.</intervention_name>
    <description>Training of youth, community health assistants, and community health workers in the screening, detection, contact tracing, prevention, and management of COVID-19 with concurrent maintenance of essential health services.</description>
    <arm_group_label>Functional community health units</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training clinicians in basic critical care and the management of severe COVID-19 cases</intervention_name>
    <description>Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.</description>
    <arm_group_label>Health facilities with oxygen capacity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Youth aged 18 to 30 years old.&#xD;
&#xD;
          -  Active community health workers.&#xD;
&#xD;
          -  Facilities with oxygen capacity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals younger than 18 or older than 30 years old.&#xD;
&#xD;
          -  Inactive community health workers.&#xD;
&#xD;
          -  Facilities without oxygen capacity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neema Kaseje, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Surgical Systems Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Surgical Systems Research Group/Tropical Institute of Community Health</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <link>
    <url>https://wellcomeopenresearch.org/articles/6-15/v1</url>
    <description>Full protocol</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Surgical Systems Research Group</investigator_affiliation>
    <investigator_full_name>Neema Kaseje</investigator_full_name>
    <investigator_title>Founding Director</investigator_title>
  </responsible_party>
  <keyword>youth, community health, digital tools, capacity building</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>Yes</sharing_ipd>
    <ipd_description>De-identified participant data will be available when results are reported.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Immediately following publication; indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Anyone with an approved proposal who wishes to access the data.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04501458
org study id: 001
nct id: NCT04501458
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To respond to the COVID-19 pandemic, investigators will be deploying community health
      workers, equipped with mobile technology, and accompanied by youth to visit households door
      to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of
      COVID-19. The community health workers and youth will educate households about preventive
      measures including frequent handwashing and home management of mild cases. Simultaneously,
      investigators will work with nurses, doctors, and clinical officers, to test and treat more
      severe cases of COVID-19 in health facilities. Our goals are: to visit every household in
      Siaya county covering a population of close to 1 million, and to train and support health
      workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity
      and mortality related to COVID19 and other conditions.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mortality
time frame: 3 months
description: Mortality related to COVID-19
measure: Number of confirmed COVID-19 cases in Siaya
time frame: 3 months
description: Number of confirmed COVID-19 cases in Siaya
arm group label: Functional community health units
arm group type: Experimental
description: Community health units with active community health workers.
arm group label: Non functional community health units
arm group type: No Intervention
description: Community health units without active community health workers.
arm group label: Health facilities with oxygen capacity
arm group type: Experimental
description: Health facility with regular oxygen capacity.
arm group label: Health facilities without oxygen capacity
arm group type: No Intervention
intervention type: Other
intervention name: Training of youth, community health assistants and community health workers.
description: Training of youth, community health assistants, and community health workers in the screening, detection, contact tracing, prevention, and management of COVID-19 with concurrent maintenance of essential health services.
arm group label: Functional community health units
intervention type: Other
intervention name: Training clinicians in basic critical care and the management of severe COVID-19 cases
description: Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.
arm group label: Health facilities with oxygen capacity
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Neema Kaseje, MD
role: Principal Investigator
affiliation: Surgical Systems Research Group
facility: 
country: Kenya
url: https://wellcomeopenresearch.org/articles/6-15/v1
description: Full protocol
responsible party type: Principal Investigator
investigator affiliation: Surgical Systems Research Group
investigator full name: Neema Kaseje
investigator title: Founding Director
mesh term: COVID-19
sharing ipd: Yes
ipd description: De-identified participant data will be available when results are reported.
ipd info type: Study Protocol
ipd time frame: Immediately following publication; indefinitely.
ipd access criteria: Anyone with an approved proposal who wishes to access the data.