<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/NCT02968251</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20160619001</org_study_id>
    <nct_id>NCT02968251</nct_id>
  </id_info>
  <brief_title>Designing and Evaluating a School-based Hand Washing Program in Malawi</brief_title>
  <official_title>Designing and Evaluating a School-based Hand Washing Program in Malawi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to design and evaluate a school-based hand washing program for&#xD;
      children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT),&#xD;
      so as to improve proper hand washing, increase knowledge level and also reduce school&#xD;
      absenteeism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions&#xD;
      and follow-up measures will be randomized into intervention or control groups. A simplified&#xD;
      5-steps hand washing program will be implemented in the intervention group while the control&#xD;
      group will continue with their usual practice where schoolchildren do not follow any standard&#xD;
      recommended handwashing technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Proper hand washing</measure>
    <time_frame>9 month</time_frame>
    <description>This will be achieved by giving a score to the amount of fluorescents stain on the hand.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge gain</measure>
    <time_frame>9 month</time_frame>
    <description>A quiz will be administered to assess knowledge of school children.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>School-based, Hand-washing, Program, Malawi</condition>
  <arm_group>
    <arm_group_label>Hand Washing Program (HWP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clusters in this arm will be given a Hand Washing Program (HWP) which will consist of: integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Hand Washing Program (NHWP)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clusters in this arm will be allowed to continue with their usual practice regarding hand washing/hygiene</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hand Washing Program (HWP)</intervention_name>
    <description>HWP consists of integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.</description>
    <arm_group_label>Hand Washing Program (HWP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schools that have piped tap water source situated in Mzuzu City,&#xD;
&#xD;
          -  Private primary schools,&#xD;
&#xD;
          -  Children in elementary one and six,&#xD;
&#xD;
          -  Written parental consent allowing their child to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schools without piped tap water source,&#xD;
&#xD;
          -  Government primary schools,&#xD;
&#xD;
          -  Children whose parents will not give consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Balwani M Chingatichifwe, MPH</last_name>
    <phone>+265 888 159 286</phone>
    <email>balwani-mbakaya.chingatichifwe@connect.polyu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Regina Lee, PhD</last_name>
    <phone>(852) 2766 6388</phone>
    <email>regina.Lee@polyu.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St John's College of Nursing and Midwifery</name>
      <address>
        <city>Mzuzu</city>
        <state>Northern</state>
        <zip>00000</zip>
        <country>Malawi</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Balwani M Chingatichifwe, MPH</last_name>
      <phone>(265) 888 159 286</phone>
      <email>balwani-mbakaya.chingatichifwe@connect.polyu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Regina Lee, PhD</last_name>
      <phone>(852) 2766 6388</phone>
      <email>regina.Lee@polyu.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>May 8, 2017</last_update_submitted>
  <last_update_submitted_qc>May 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02968251
org study id: HSEARS20160619001
nct id: NCT02968251
lead sponsor: 
has dmc: Yes
The aim of the study is to design and evaluate a school-based hand washing program for
      children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT),
      so as to improve proper hand washing, increase knowledge level and also reduce school
      absenteeism.
A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions
      and follow-up measures will be randomized into intervention or control groups. A simplified
      5-steps hand washing program will be implemented in the intervention group while the control
      group will continue with their usual practice where schoolchildren do not follow any standard
      recommended handwashing technique.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Proper hand washing
time frame: 9 month
description: This will be achieved by giving a score to the amount of fluorescents stain on the hand.
measure: Knowledge gain
time frame: 9 month
description: A quiz will be administered to assess knowledge of school children.
arm group label: Hand Washing Program (HWP)
arm group type: Experimental
description: Clusters in this arm will be given a Hand Washing Program (HWP) which will consist of: integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.
arm group label: No Hand Washing Program (NHWP)
arm group type: No Intervention
description: Clusters in this arm will be allowed to continue with their usual practice regarding hand washing/hygiene
intervention type: Behavioral
intervention name: Hand Washing Program (HWP)
description: HWP consists of integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.
arm group label: Hand Washing Program (HWP)
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: Balwani M Chingatichifwe, MPH
phone: +265 888 159 286
email: balwani-mbakaya.chingatichifwe@connect.polyu.hk
last name: Regina Lee, PhD
phone: (852) 2766 6388
email: regina.Lee@polyu.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Malawi
responsible party type: Sponsor