<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/NCT02213211</url>
  </required_header>
  <id_info>
    <org_study_id>QA475</org_study_id>
    <secondary_id>1057</secondary_id>
    <secondary_id>6432</secondary_id>
    <nct_id>NCT02213211</nct_id>
  </id_info>
  <brief_title>School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi</brief_title>
  <official_title>Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Save the Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malaria is an important contributor to ill-health experienced by school-children and may have&#xD;
      profound consequences for their learning and educational achievement, and there is a small,&#xD;
      but growing, body of evidence that suggests malaria control can help improve educational&#xD;
      outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks&#xD;
      of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children.&#xD;
      To avert this health burden and potential education consequences, Save the Children in&#xD;
      partnership with the Malawian Ministry of Health is providing treatment of symptomatic&#xD;
      malaria cases in schools in southern Malawi, as part of the provision of first aid kits&#xD;
      (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this&#xD;
      intervention, a cluster randomised trial is being conducted among 58 schools in Traditional&#xD;
      Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive&#xD;
      LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination&#xD;
      therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group.&#xD;
      The primary outcome is school attendance, with secondary outcomes of grade repetition, school&#xD;
      drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The&#xD;
      study aims to conduct several quantitative and qualitative assessments to help evaluate the&#xD;
      external validity of the findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a cluster-randomised trial with a comparison group to assess the impact of&#xD;
      school-based malaria case management, with malaria rapid diagnostic tests (RDTs) for&#xD;
      diagnosis and artemisinin-based combination therapy (ACT) for treatment of uncomplicated&#xD;
      malaria incorporated into first aid kits (Learner Treatment Kits) also containing treatment&#xD;
      and management for other common minor health issues. A seven day teacher training in the&#xD;
      diagnosis and treatment of malaria, other contents of the kit and referral process is&#xD;
      provided for the two teachers selected to act as the LTK dispensers in the school, as well as&#xD;
      the head teacher. The target population in this study includes children attending the 58&#xD;
      participating primary schools in Traditional Authority Chikowi, Zomba District, Malawi.&#xD;
      Twenty nine schools are randomly selected to receive Learner Treatment Kits (LTKs) including&#xD;
      RDTs and ACTs to treat uncomplicated malaria, and 29 schools serve as the control group. All&#xD;
      children attending schools in the intervention arm have access to the LTK and are eligible&#xD;
      for treatment on an opt-out basis, but the accessible study population includes the children&#xD;
      randomly selected from classes 2, 4 and 6. The study hypothesis is that that school-based&#xD;
      malaria case-management as part of LTKs will reduce rates of absenteeism in Malawian&#xD;
      schoolchildren, when compared to those in control schools. The primary outcome is school&#xD;
      attendance, with secondary outcomes of grade repetition, school drop-out and enrolment as&#xD;
      well as morbidity, Plasmodium falciparum infection and anaemia. The study is designed to&#xD;
      provide 80% power to detect a 16% reduction (53% relative reduction) in absenteeism in the&#xD;
      intervention group compared to the control group at 5% level of significance. The unit of&#xD;
      analysis is the school, but individual-level analysis using suitable generalised linear&#xD;
      models, adjusted for clustering by school, will also be undertaken to explore differences in&#xD;
      impact of the interventions according to child age, sex, home environment, school quality as&#xD;
      well as differences in the uptake of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>School attendance</measure>
    <time_frame>1 year</time_frame>
    <description>School attendance as assessed by class registers and independent spot-checks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasmodium falciparum parasitaemia</measure>
    <time_frame>1 year</time_frame>
    <description>Presence of malaria parasites in blood sample using microscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaemia</measure>
    <time_frame>1 year</time_frame>
    <description>Anaemia based on haemoglobin concentration assessed using Hemocue photometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child wellbeing</measure>
    <time_frame>1 year</time_frame>
    <description>Child-recorded wellbeing charts completed by each child three days per week between May and July 2015</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>1 year</time_frame>
    <description>Cost effectiveness analysis will consider reductions in absenteeism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stakeholder perceptions of LTK intervention</measure>
    <time_frame>End of intervention period</time_frame>
    <description>Perceptions of intervention from teachers, school children and healthcare workers as well as key policy makers obtained through focus group discussions and in-depth interviews</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3667</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>Diagnosis and treatment of malaria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>School-based diagnosis and treatment of uncomplicated malaria using malaria RDTs and Artemether lumefantrine as part of Learner Treatment Kits (LTK) used by teachers.&#xD;
Drug: Artemether lumefantrine (artemisinin-based combination therapy [ACT], Coartem). Three-day doses of 20mg/120mg, 40mg/240mg, 60mg/360mg and 80mg/480mg Coartem are provided, according to weight, upon a positive rapid diagnostic test (RDT) result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention provided</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Artemether lumefantrine</intervention_name>
    <arm_group_label>Diagnosis and treatment of malaria</arm_group_label>
    <other_name>artemisinin-based combination therapy (ACT)</other_name>
    <other_name>Coartem</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Student enrolled at participating schools in standards 2, 4 and 6&#xD;
&#xD;
          -  Provision of informed consent from parent or guardian&#xD;
&#xD;
          -  Provision of assent by student&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Student unwilling to participate in the study&#xD;
&#xD;
          -  Student known to have a chronic medical condition, which will affect their school&#xD;
             attendance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Don P Mathanga, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaria Alert Centre, College of Medicine, Malawi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine E Halliday, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Simon J Brooker, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malaria Alert Centre, College of Medicine</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <link>
    <url>http://www.youtube.com/watch?v=MBVzoIk7cFY</url>
    <description>Social Innovation in Health Initiative (SIHI). This short film forms part of the SIHI case series, showcasing selected social innovations improving healthcare delivery from Africa, Asia and Latin America</description>
  </link>
  <results_reference>
    <citation>Mathanga DP, Halliday KE, Jawati M, Verney A, Bauleni A, Sande J, Ali D, Jones R, Witek-McManus S, Roschnik N, Brooker SJ. The High Burden of Malaria in Primary School Children in Southern Malawi. Am J Trop Med Hyg. 2015 Oct;93(4):779-789. doi: 10.4269/ajtmh.14-0618. Epub 2015 Aug 17.</citation>
    <PMID>26283750</PMID>
  </results_reference>
  <results_reference>
    <citation>Witek-McManus S, Mathanga DP, Verney A, Mtali A, Ali D, Sande J, Mwenda R, Ndau S, Mazinga C, Phondiwa E, Chimuna T, Melody D, Roschnik N, Brooker SJ, Halliday KE. Design, implementation and evaluation of a training programme for school teachers in the use of malaria rapid diagnostic tests as part of a basic first aid kit in southern Malawi. BMC Public Health. 2015 Sep 17;15:904. doi: 10.1186/s12889-015-2228-x.</citation>
    <PMID>26377070</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>April 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malawi</keyword>
  <keyword>Case management</keyword>
  <keyword>Rapid diagnostic tests</keyword>
  <keyword>Artemether lumefantrine</keyword>
  <keyword>School children</keyword>
  <keyword>School health services</keyword>
  <keyword>Attendance</keyword>
  <keyword>Anaemia</keyword>
  <keyword>Parasitic diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lumefantrine</mesh_term>
    <mesh_term>Artemether</mesh_term>
    <mesh_term>Artemether, Lumefantrine Drug Combination</mesh_term>
    <mesh_term>Artemisinins</mesh_term>
    <mesh_term>Artemisinin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In order to maximise the usefulness of the study results, it is intended that individual participant data (IPD) will be shared with the wider research community for scientific purposes only, as anonymized, non-personal, individual and summary information. The information will be shared in ways that do not reveal individual participant's identities or household location. The data will be available, on request, through The &quot;Data Compass&quot;: the London School of Hygiene &amp; Tropical Medicine (LSHTM) curated digital repository of research data. This will be made available at the stage of publication of the impact results in 2017.</ipd_description>
  </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/NCT02213211
org study id: QA475
secondary id: 1057
secondary id: 6432
nct id: NCT02213211
lead sponsor: 
collaborator: 
has dmc: No
Malaria is an important contributor to ill-health experienced by school-children and may have
      profound consequences for their learning and educational achievement, and there is a small,
      but growing, body of evidence that suggests malaria control can help improve educational
      outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks
      of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children.
      To avert this health burden and potential education consequences, Save the Children in
      partnership with the Malawian Ministry of Health is providing treatment of symptomatic
      malaria cases in schools in southern Malawi, as part of the provision of first aid kits
      (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this
      intervention, a cluster randomised trial is being conducted among 58 schools in Traditional
      Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive
      LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination
      therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group.
      The primary outcome is school attendance, with secondary outcomes of grade repetition, school
      drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The
      study aims to conduct several quantitative and qualitative assessments to help evaluate the
      external validity of the findings.
This study is a cluster-randomised trial with a comparison group to assess the impact of
      school-based malaria case management, with malaria rapid diagnostic tests (RDTs) for
      diagnosis and artemisinin-based combination therapy (ACT) for treatment of uncomplicated
      malaria incorporated into first aid kits (Learner Treatment Kits) also containing treatment
      and management for other common minor health issues. A seven day teacher training in the
      diagnosis and treatment of malaria, other contents of the kit and referral process is
      provided for the two teachers selected to act as the LTK dispensers in the school, as well as
      the head teacher. The target population in this study includes children attending the 58
      participating primary schools in Traditional Authority Chikowi, Zomba District, Malawi.
      Twenty nine schools are randomly selected to receive Learner Treatment Kits (LTKs) including
      RDTs and ACTs to treat uncomplicated malaria, and 29 schools serve as the control group. All
      children attending schools in the intervention arm have access to the LTK and are eligible
      for treatment on an opt-out basis, but the accessible study population includes the children
      randomly selected from classes 2, 4 and 6. The study hypothesis is that that school-based
      malaria case-management as part of LTKs will reduce rates of absenteeism in Malawian
      schoolchildren, when compared to those in control schools. The primary outcome is school
      attendance, with secondary outcomes of grade repetition, school drop-out and enrolment as
      well as morbidity, Plasmodium falciparum infection and anaemia. The study is designed to
      provide 80% power to detect a 16% reduction (53% relative reduction) in absenteeism in the
      intervention group compared to the control group at 5% level of significance. The unit of
      analysis is the school, but individual-level analysis using suitable generalised linear
      models, adjusted for clustering by school, will also be undertaken to explore differences in
      impact of the interventions according to child age, sex, home environment, school quality as
      well as differences in the uptake of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: School attendance
time frame: 1 year
description: School attendance as assessed by class registers and independent spot-checks
measure: Plasmodium falciparum parasitaemia
time frame: 1 year
description: Presence of malaria parasites in blood sample using microscopy
measure: Anaemia
time frame: 1 year
description: Anaemia based on haemoglobin concentration assessed using Hemocue photometer
measure: Child wellbeing
time frame: 1 year
description: Child-recorded wellbeing charts completed by each child three days per week between May and July 2015
measure: Cost effectiveness
time frame: 1 year
description: Cost effectiveness analysis will consider reductions in absenteeism
measure: Stakeholder perceptions of LTK intervention
time frame: End of intervention period
description: Perceptions of intervention from teachers, school children and healthcare workers as well as key policy makers obtained through focus group discussions and in-depth interviews
arm group label: Diagnosis and treatment of malaria
arm group type: Experimental
description: School-based diagnosis and treatment of uncomplicated malaria using malaria RDTs and Artemether lumefantrine as part of Learner Treatment Kits (LTK) used by teachers.
Drug: Artemether lumefantrine (artemisinin-based combination therapy [ACT], Coartem). Three-day doses of 20mg/120mg, 40mg/240mg, 60mg/360mg and 80mg/480mg Coartem are provided, according to weight, upon a positive rapid diagnostic test (RDT) result.
arm group label: No intervention
arm group type: No Intervention
description: No intervention provided
intervention type: Drug
intervention name: Artemether lumefantrine
arm group label: Diagnosis and treatment of malaria
other name: artemisinin-based combination therapy (ACT)
other name: Coartem
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Don P Mathanga, MBBS
role: Principal Investigator
affiliation: Malaria Alert Centre, College of Medicine, Malawi
last name: Katherine E Halliday, PhD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: Simon J Brooker, DPhil
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
facility: 
country: Malawi
url: http://www.youtube.com/watch?v=MBVzoIk7cFY
description: Social Innovation in Health Initiative (SIHI). This short film forms part of the SIHI case series, showcasing selected social innovations improving healthcare delivery from Africa, Asia and Latin America
citation: Mathanga DP, Halliday KE, Jawati M, Verney A, Bauleni A, Sande J, Ali D, Jones R, Witek-McManus S, Roschnik N, Brooker SJ. The High Burden of Malaria in Primary School Children in Southern Malawi. Am J Trop Med Hyg. 2015 Oct;93(4):779-789. doi: 10.4269/ajtmh.14-0618. Epub 2015 Aug 17.
PMID: 26283750
citation: Witek-McManus S, Mathanga DP, Verney A, Mtali A, Ali D, Sande J, Mwenda R, Ndau S, Mazinga C, Phondiwa E, Chimuna T, Melody D, Roschnik N, Brooker SJ, Halliday KE. Design, implementation and evaluation of a training programme for school teachers in the use of malaria rapid diagnostic tests as part of a basic first aid kit in southern Malawi. BMC Public Health. 2015 Sep 17;15:904. doi: 10.1186/s12889-015-2228-x.
PMID: 26377070
responsible party type: Sponsor
mesh term: Malaria
mesh term: Lumefantrine
mesh term: Artemether
mesh term: Artemether, Lumefantrine Drug Combination
mesh term: Artemisinins
mesh term: Artemisinin
sharing ipd: Yes
ipd description: In order to maximise the usefulness of the study results, it is intended that individual participant data (IPD) will be shared with the wider research community for scientific purposes only, as anonymized, non-personal, individual and summary information. The information will be shared in ways that do not reveal individual participant's identities or household location. The data will be available, on request, through The "Data Compass": the London School of Hygiene & Tropical Medicine (LSHTM) curated digital repository of research data. This will be made available at the stage of publication of the impact results in 2017.