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CompletedNCT00878007Updated Feb 17, 2014

Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

An interventional study of Intermittent screening and treatment for malaria and Teacher training on literacy instruction in Anaemia and Malaria, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Kenya. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-17.

Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5,177
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
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Study summary

While malaria represents one of the main health problems afflicting schoolchildren, the evidence base for policy development and programme implementation for school-based malaria control remains inadequate. A recent study in western Kenya showed that delivering intermittent preventive treatment (IPT) to schoolchildren improved rates of anaemia and classroom concentration, but did not improve school performance. This study aims to (i) investigate the impact of malaria prevention using a strategy of periodic screening using malaria rapid diagnostic tests and treatment positives using artemether-lumefantrine (AL) on health and education among schoolchildren and (ii) determine the interaction between health and improved literacy instruction. The study hypothesis is that that school-based malaria prevention will reduce rates of anaemia or improve educational outcomes in Kenyan schoolchildren, when compared to comparison schools. In addition, a programme of training for primary school teachers to improve literacy instruction will improve literacy rates and there will be no interaction between the malaria intervention and the education intervention, such that learning will not be improved when teaching is effective and children are healthy. The study will be undertaken in 101 randomly selected primary schools in Kwale District. The malaria intervention consists of screening all children using rapid diagnostic tests (RDTs) for malaria. Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with AL according to national guidelines. Screening and treatment will be administered by district public health staff once a school term, observed by the evaluation research team. This intervention has been changed from IPT due to the withdrawal of amodiaquine in Kenya. The education intervention includes a programme of training for primary school teachers to improve literacy instruction. The study is designed to detect a 25% reduction in anaemia and an improvement of 0.2 standard deviations in mathematics and literacy tests. Additional outcomes will also be measured including malaria parasitaemia, classroom attention and school attendance. Cost-effectiveness and community acceptability of the interventions will be assessed. Anaemia and educational outcomes will be assessed before interventions and 12 and 24 months later. Malaria parasitaemia using blood slides will only be assessed at follow-up.

Read the detailed description

This study will be a factorial-design, cluster-randomised trial with a comparison group to assess the impact of (i) malaria prevention, based on screening and treatment, and (ii) enhanced literacy instruction by teachers on the health and educational achievement of healthy schoolchildren.

The target population in this study includes children attending primary schools in Kenya. The accessible population includes the children attending the participating primary schools in classes 1 and 5 in Kwale district. Schools will be randomized to one of four groups, receiving either the screening and treatment intervention alone, the education intervention alone, the malaria and education interventions combined, or neither intervention. 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 each intervention.

02

Conditions studied

  • Anaemia
  • Malaria

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Keywords

  • Anaemia
  • Malaria
  • Literacy
  • Kenya
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 5,177 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pupil enrolled at participating schools in classes 1 and 5;
  • Provision of informed consent from parent or guardian;
  • Provision of assent by student

Exclusion criteria

Exclusion Criteria:

  • Pupils unwilling to participate in the study;
  • Known allergy or history of adverse reaction to study medications;
  • Known or suspected sickle-cell trait
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
5,177 participants (actual)

Study arms

  • Experimental
    1

    Intermittent screening and treatment (IST) for malaria. This intervention is a change from a previous intervention based on intermittent preventive treatment for malaria owning to the withdrawal of amodiaquine (one of the previous IPT drugs) in Kenya in 2009.

    Drug: Intermittent screening and treatment for malaria

  • Experimental
    2

    Enhanced teacher training on literacy instruction.

    Behavioral: Teacher training on literacy instruction

  • Experimental
    3

    Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction

    Other: IST plus literacy instruction programme

  • No intervention
    4

Interventions

  • DrugIntermittent screening and treatment for malaria

    All children will be screened for malaria using rapid diagnostic tests (RDTs) once a term (thrice yearly). Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with artemether-lumefantrine according to national guidelines. Screening and treatment will be administered by district public health staff once a school term, observed by the evaluation research team.

  • BehavioralTeacher training on literacy instruction

    Education intervention designed to improved early grade literacy instruction, focusing on phonological awareness \& vocabulary and relationship between letters and sounds in a systematic and explicit fashion. Specific interventions will include training on (i) how to monitor students' progress in large classes (ii) developing and using instructional materials for reading (iii) lesson planning for explicit teaching of letter-sound relationships (iv) instructional techniques for large classes.

  • OtherIST plus literacy instruction programme

    Schools will receive both IST and the literacy instruction programme

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What researchers measure

Primary outcomes

  1. Anaemia

    Time frame: 2 years

  2. Education achievement assessed by a battery of tests of reading, writing and arithmetic

    Time frame: 2 years

Secondary outcomes

  1. Prevalence of malaria parasitemia

    Time frame: 2 years

  2. Concentration as assessed by classroom-based tests of sustained attention

    Time frame: 2 years

  3. School attendance as assessed by class attendance registers

    Time frame: 2 years

  4. Examination results as assessed by government examination scores

    Time frame: 2 years

  5. Cost-effectiveness

    Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia

    Time frame: 2 years

  6. Community acceptability

    A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.

    Time frame: 2 years

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Study locations

1 site
  • KEMRI-Wellcome Trust Programme
    Nairobi, P.O. Box 43640 - 00100, Kenya
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References and documents

Publications

  • Brooker S, Okello G, Njagi K, Dubeck MM, Halliday KE, Inyega H, Jukes MC. Improving educational achievement and anaemia of school children: design of a cluster randomised trial of school-based malaria prevention and enhanced literacy instruction in Kenya. Trials. 2010 Oct 7;11:93. doi: 10.1186/1745-6215-11-93. PubMed 20929566 ↗
  • Okello G, Jones C, Bonareri M, Ndegwa SN, McHaro C, Kengo J, Kinyua K, Dubeck MM, Halliday KE, Jukes MC, Molyneux S, Brooker SJ. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya. Trials. 2013 May 16;14:142. doi: 10.1186/1745-6215-14-142. PubMed 23680181 ↗
  • Halliday KE, Okello G, Turner EL, Njagi K, Mcharo C, Kengo J, Allen E, Dubeck MM, Jukes MC, Brooker SJ. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial. PLoS Med. 2014 Jan 28;11(1):e1001594. doi: 10.1371/journal.pmed.1001594. eCollection 2014 Jan. PubMed 24492859 ↗
  • Halliday KE, Karanja P, Turner EL, Okello G, Njagi K, Dubeck MM, Allen E, Jukes MC, Brooker SJ. Plasmodium falciparum, anaemia and cognitive and educational performance among school children in an area of moderate malaria transmission: baseline results of a cluster randomized trial on the coast of Kenya. Trop Med Int Health. 2012 May;17(5):532-49. doi: 10.1111/j.1365-3156.2012.02971.x. PubMed 22950512 ↗
  • Drake TL, Okello G, Njagi K, Halliday KE, Jukes MCh, Mangham L, Brooker S. Cost analysis of school-based intermittent screening and treatment of malaria in Kenya. Malar J. 2011 Sep 20;10:273. doi: 10.1186/1475-2875-10-273. PubMed 21933376 ↗
  • Okello G, Ndegwa SN, Halliday KE, Hanson K, Brooker SJ, Jones C. Local perceptions of intermittent screening and treatment for malaria in school children on the south coast of Kenya. Malar J. 2012 Jun 8;11:185. doi: 10.1186/1475-2875-11-185. PubMed 22681850 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00878007
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborators
World Bank
Responsible party
Sponsor
First posted
Apr 8, 2009
Start date
Jan 2010
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Feb 17, 2014

Study contacts

Simon Brooker, DPhil
principal investigator · London School of Hygiene and Tropical Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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