<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/NCT03014167</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000180</org_study_id>
    <secondary_id>1R01AI155739-01A1</secondary_id>
    <nct_id>NCT03014167</nct_id>
  </id_info>
  <brief_title>Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)</brief_title>
  <official_title>Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche Clinique du Bénin (IRCB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Christian Medical College, Vellore, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Blantyre Institute for Community Ophthalmology (BICO)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Tropical &amp; Public Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH&#xD;
      guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted&#xD;
      populations, including pre-school age children and school-age children. However mathematical&#xD;
      models suggests that current MDA strategies are not sufficient for interrupting disease&#xD;
      transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have&#xD;
      successfully treated entire populations with albendazole (in combination with ivermectin or&#xD;
      diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project&#xD;
      will conduct a series of community-based cluster randomized trials in India, Malawi, and&#xD;
      Benin to determine if maintaining three years of MDA with albendazole to entire communities&#xD;
      following the cessation of LF programs can interrupt STH transmission in focal geographic&#xD;
      areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus&#xD;
      targeted MDA of children in interrupting the transmission of STH. Nested implementation&#xD;
      science research will be used to optimize the intervention, identify contextual factors&#xD;
      influencing trial efficacy, and evaluate the feasibility of sustaining and scaling&#xD;
      community-wide MDA for STH. These data will provide evidence necessary to inform future&#xD;
      guidelines, policies, and operational plans as country partners engage in intensified&#xD;
      approaches to eliminate these disabling diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>STH transmission interruption</measure>
    <time_frame>5 years (Three years of drug administration and two years of surveillance)</time_frame>
    <description>Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">380000</enrollment>
  <condition>Helminthiasis</condition>
  <condition>Filariasis</condition>
  <arm_group>
    <arm_group_label>Community-wide deworming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice-yearly community-wide treatment delivered by drug distributors door to door or via community gatherings, depending upon the format of the prior LF program, for three years. All individuals above the age of 12 months will receive a single dose of albendazole.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Targeted deworming</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pre-school (pre-SAC) and school-age children (SAC) 12 months of age and older will receive albendazole delivered in accordance with national Ministry of Health guidelines for three years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albendazole</intervention_name>
    <description>All eligible individuals will receive a single dose of 400 mg albendazole.</description>
    <arm_group_label>Community-wide deworming</arm_group_label>
    <arm_group_label>Targeted deworming</arm_group_label>
    <other_name>Albenza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Treatment Inclusion Criteria:&#xD;
&#xD;
          -  Ages 12 months and older&#xD;
&#xD;
        Treatment Exclusion Criteria:&#xD;
&#xD;
          -  Children under 12 months of age&#xD;
&#xD;
          -  Pregnant women in their first trimester&#xD;
&#xD;
          -  History of adverse reaction to benzimidazoles&#xD;
&#xD;
        Outcome Sampling Inclusion Criteria:&#xD;
&#xD;
          -  Resident of study clusters&#xD;
&#xD;
          -  Ages 12 months and older&#xD;
&#xD;
          -  Willingness of adult aged 18 years and above (or age as per country specific ethical&#xD;
             guidelines) or parent/guardian of child to provide written informed consent&#xD;
&#xD;
          -  Provision of written assent to participate from children aged 8 years and above (or&#xD;
             age as per country specific ethical guidelines)&#xD;
&#xD;
        Outcome Sampling Exclusion Criteria:&#xD;
&#xD;
          -  Less than 12 months of age&#xD;
&#xD;
          -  Individuals who do not typically reside in the study cluster&#xD;
&#xD;
          -  Nonconsenting or assenting individuals, as applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judd L Walson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington Department of Global Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Judd L Walson, MD, MPH</last_name>
    <phone>206-744-3695</phone>
    <phone_ext>43695</phone_ext>
    <email>walson@uw.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arianna Means, PhD, MPH</last_name>
    <email>aerubin@uw.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut de Recherche pour le Développement</name>
      <address>
        <city>Comé</city>
        <country>Benin</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrian Luty, PhD, DR</last_name>
      <email>adrian.luty@ird.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Christian Medical College</name>
      <address>
        <city>Vellore</city>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gagandeep Kang, MBBS, MD, PhD</last_name>
      <email>gkang@cmcvellore.ac.in</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>London School of Hygiene and Tropical Medicine</name>
      <address>
        <city>Mangochi</city>
        <country>Malawi</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robin Bailey, MA, BM, MRCP, DTM&amp;H, PhD, FRCP</last_name>
      <email>robin.bailey@lshtm.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>Benin</country>
    <country>India</country>
    <country>Malawi</country>
  </location_countries>
  <link>
    <url>http://deworm3.org</url>
    <description>University of Washington DeWorm3 Website</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Judd Walson</investigator_full_name>
    <investigator_title>Professor: Global Health, Allergy and Infectious Diseases, Epidemiology, Public Health, Pediatrics</investigator_title>
  </responsible_party>
  <keyword>transmission interruption</keyword>
  <keyword>intestinal nematodes</keyword>
  <keyword>soil-transmitted helminths</keyword>
  <keyword>mass drug administration</keyword>
  <keyword>Benin</keyword>
  <keyword>India</keyword>
  <keyword>Malawi</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Filariasis</mesh_term>
    <mesh_term>Helminthiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albendazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03014167
org study id: STUDY00000180
secondary id: 1R01AI155739-01A1
nct id: NCT03014167
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH
      guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted
      populations, including pre-school age children and school-age children. However mathematical
      models suggests that current MDA strategies are not sufficient for interrupting disease
      transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have
      successfully treated entire populations with albendazole (in combination with ivermectin or
      diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project
      will conduct a series of community-based cluster randomized trials in India, Malawi, and
      Benin to determine if maintaining three years of MDA with albendazole to entire communities
      following the cessation of LF programs can interrupt STH transmission in focal geographic
      areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus
      targeted MDA of children in interrupting the transmission of STH. Nested implementation
      science research will be used to optimize the intervention, identify contextual factors
      influencing trial efficacy, and evaluate the feasibility of sustaining and scaling
      community-wide MDA for STH. These data will provide evidence necessary to inform future
      guidelines, policies, and operational plans as country partners engage in intensified
      approaches to eliminate these disabling diseases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data
measure: STH transmission interruption
time frame: 5 years (Three years of drug administration and two years of surveillance)
description: Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
arm group label: Community-wide deworming
arm group type: Experimental
description: Twice-yearly community-wide treatment delivered by drug distributors door to door or via community gatherings, depending upon the format of the prior LF program, for three years. All individuals above the age of 12 months will receive a single dose of albendazole.
arm group label: Targeted deworming
arm group type: Active Comparator
description: Pre-school (pre-SAC) and school-age children (SAC) 12 months of age and older will receive albendazole delivered in accordance with national Ministry of Health guidelines for three years.
intervention type: Drug
intervention name: Albendazole
description: All eligible individuals will receive a single dose of 400 mg albendazole.
arm group label: Community-wide deworming
arm group label: Targeted deworming
other name: Albenza
criteria: 
gender: All
minimum age: 12 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Judd L Walson, MD, MPH
role: Principal Investigator
affiliation: University of Washington Department of Global Health
last name: Judd L Walson, MD, MPH
phone: 206-744-3695
phone ext: 43695
email: walson@uw.edu
last name: Arianna Means, PhD, MPH
email: aerubin@uw.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Benin
country: India
country: Malawi
url: http://deworm3.org
description: University of Washington DeWorm3 Website
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Judd Walson
investigator title: Professor: Global Health, Allergy and Infectious Diseases, Epidemiology, Public Health, Pediatrics
mesh term: Filariasis
mesh term: Helminthiasis
mesh term: Albendazole