<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/NCT03280771</url>
  </required_header>
  <id_info>
    <org_study_id>1952:BURNSFW</org_study_id>
    <nct_id>NCT03280771</nct_id>
  </id_info>
  <brief_title>The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa</brief_title>
  <official_title>The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abdul Latif Jameel Poverty Action Lab</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cape Town</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 Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in&#xD;
      which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a&#xD;
      colourful, translucent bar of soap with a toy embedded in its centre.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">December 15, 2015</completion_date>
  <primary_completion_date type="Actual">December 15, 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Direct observation of hand washing prior to eating a snack</measure>
    <time_frame>8 weeks</time_frame>
    <description>Hands washed unprompted prior to eating a snack</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire data on hand washing after using the toilet (scale of 1-10)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A score of 1-10 of hand washing after using the toilet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire data on hand washing prior to meals (scale of 1-10)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A score of 1-10 of hand washing prior to eating meals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire data on general soap usage when washing hands (scale of 1-10)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A score of 1-10 of soap usage when hands are washed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire data on experience of illness (13 items)</measure>
    <time_frame>2 weeks</time_frame>
    <description>A score of 1-13 based on self-reported symptoms of illness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">288</enrollment>
  <condition>Hand-washing Behavior</condition>
  <condition>Diarrhea</condition>
  <arm_group>
    <arm_group_label>Hope Soap group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children in control households received a colourful, translucent bar or soap with the toy alongside it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Hope Soap</intervention_name>
    <description>HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.</description>
    <arm_group_label>Hope Soap group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Control group soap</intervention_name>
    <description>A colourful, translucent bar or soap with the toy alongside it</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the Family-in-Focus program&#xD;
&#xD;
          -  Caregiver provided informed consent&#xD;
&#xD;
          -  the age-eligible children were not involved in any other sort of ECD program (e.g.&#xD;
             crèche or other day-care)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrollment in an ECD program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cape Town</investigator_affiliation>
    <investigator_full_name>Brendan Maughan-Brown</investigator_full_name>
    <investigator_title>Senior Research Officer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_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/NCT03280771
org study id: 1952:BURNSFW
nct id: NCT03280771
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in
      which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a
      colourful, translucent bar of soap with a toy embedded in its centre.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Direct observation of hand washing prior to eating a snack
time frame: 8 weeks
description: Hands washed unprompted prior to eating a snack
measure: Questionnaire data on hand washing after using the toilet (scale of 1-10)
time frame: 8 weeks
description: A score of 1-10 of hand washing after using the toilet
measure: Questionnaire data on hand washing prior to meals (scale of 1-10)
time frame: 8 weeks
description: A score of 1-10 of hand washing prior to eating meals
measure: Questionnaire data on general soap usage when washing hands (scale of 1-10)
time frame: 8 weeks
description: A score of 1-10 of soap usage when hands are washed
measure: Questionnaire data on experience of illness (13 items)
time frame: 2 weeks
description: A score of 1-13 based on self-reported symptoms of illness
arm group label: Hope Soap group
arm group type: Experimental
description: Children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre
arm group label: Control group
arm group type: Active Comparator
description: Children in control households received a colourful, translucent bar or soap with the toy alongside it.
intervention type: Combination Product
intervention name: Hope Soap
description: HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.
arm group label: Hope Soap group
intervention type: Combination Product
intervention name: Control group soap
description: A colourful, translucent bar or soap with the toy alongside it
arm group label: Control group
criteria: 
gender: All
minimum age: 3 Years
maximum age: 9 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Cape Town
investigator full name: Brendan Maughan-Brown
investigator title: Senior Research Officer
mesh term: Diarrhea