Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213211
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
Save the Children
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE April 7, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date January 4, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
School attendance [ Time Frame: 1 year ]
School attendance as assessed by class registers and independent spot-checks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02213211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Plasmodium falciparum parasitaemia [ Time Frame: 1 year ]
    Presence of malaria parasites in blood sample using microscopy
  • Anaemia [ Time Frame: 1 year ]
    Anaemia based on haemoglobin concentration assessed using Hemocue photometer
  • Child wellbeing [ Time Frame: 1 year ]
    Child-recorded wellbeing charts completed by each child three days per week between May and July 2015
  • Cost effectiveness [ Time Frame: 1 year ]
    Cost effectiveness analysis will consider reductions in absenteeism
  • Stakeholder perceptions of LTK intervention [ Time Frame: End of intervention period ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • Plasmodium falciparum parasitaemia [ Time Frame: 1 year ]
    Presence of malaria parasites in blood sample using microscopy
  • Anaemia [ Time Frame: 1 year ]
    Anaemia based on haemoglobin concentration assessed using Hemocue photometer
  • Cost effectiveness [ Time Frame: 1 year ]
    Cost effectiveness analysis will consider reductions in absenteeism
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi
Official Title  ICMJE Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE Drug: Artemether lumefantrine
Other Names:
  • artemisinin-based combination therapy (ACT)
  • Coartem
Study Arms  ICMJE
  • Experimental: Diagnosis and treatment of malaria

    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.

    Intervention: Drug: Artemether lumefantrine
  • No Intervention: No intervention
    No intervention provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
3667
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2014)
3480
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Student enrolled at participating schools in standards 2, 4 and 6
  • Provision of informed consent from parent or guardian
  • Provision of assent by student

Exclusion Criteria:

  • Student unwilling to participate in the study
  • Student known to have a chronic medical condition, which will affect their school attendance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213211
Other Study ID Numbers  ICMJE QA475
1057 ( Other Identifier: National Health Sciences Research Committee (NHSRC) Malawi )
6432 ( Other Identifier: LSHTM ethics reference number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan 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.
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE Save the Children
Investigators  ICMJE
Principal Investigator: Don P Mathanga, MBBS Malaria Alert Centre, College of Medicine, Malawi
Principal Investigator: Katherine E Halliday, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Simon J Brooker, DPhil London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP