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MalariaNCT02213211

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

A study testing Artemether lumefantrine in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
Artemether lumefantrine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,667 participants
Where
1 siteMalawi
Study dates
Apr 2014to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Student unwilling to participate in the study
  • Student known to have a chronic medical condition, which will affect their school attendance

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • Malaria Alert Centre, College of Medicine

    Blantyre

Other trials in Malawi

About this study

Official title: Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi

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.

Read the 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.

Conditions
Malaria
Being tested
Artemether lumefantrine
Keywords
Malawi, Case management, Rapid diagnostic tests, Artemether lumefantrine, School children, School health services, Attendance, Anaemia, Parasitic diseases
Medical subject headings
Malaria, Anemia, Parasitic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artemether lumefantrineDrug

    Also called artemisinin-based combination therapy (ACT), Coartem

Study groups in NCT02213211
Study groupRoleWhat they receive
Diagnosis and treatment of malariaExperimentalSchool-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.
Receives: Drug: Artemether lumefantrine
No interventionNo interventionNo intervention provided

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. School attendance

    School attendance as assessed by class registers and independent spot-checks

    Measured: 1 year

Secondary outcomes (5)

  1. Plasmodium falciparum parasitaemia

    Presence of malaria parasites in blood sample using microscopy

    Measured: 1 year

  2. Anaemia

    Anaemia based on haemoglobin concentration assessed using Hemocue photometer

    Measured: 1 year

  3. Child wellbeing

    Child-recorded wellbeing charts completed by each child three days per week between May and July 2015

    Measured: 1 year

  4. Cost effectiveness

    Cost effectiveness analysis will consider reductions in absenteeism

    Measured: 1 year

  5. Stakeholder perceptions of LTK intervention

    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

    Measured: End of intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213211
Sponsor's protocol ID
QA475
Other IDs
1057, 6432
Status last verified
Aug 2014
First submitted
7 Apr 2014
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 26283750

  • 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.

    PubMed 26377070

  • Halliday KE, Witek-McManus SS, Opondo C, Mtali A, Allen E, Bauleni A, Ndau S, Phondiwa E, Ali D, Kachigunda V, Sande JH, Jawati M, Verney A, Chimuna T, Melody D, Moestue H, Roschnik N, Brooker SJ, Mathanga DP. Impact of school-based malaria case management on school attendance, health and education outcomes: a cluster randomised trial in southern Malawi. BMJ Glob Health. 2020 Jan 14;5(1):e001666. doi: 10.1136/bmjgh-2019-001666. eCollection 2020.

    PubMed 32133163

Questions about this trial

What is this clinical trial studying?

A study testing Artemether lumefantrine in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

School attendance (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213211, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.

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