- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878007
Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Nairobi, Kenya, P.O. Box 43640 - 00100
- Kemri-Wellcome Trust Programme
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Pupils unwilling to participate in the study;
- Known allergy or history of adverse reaction to study medications;
- Known or suspected sickle-cell trait
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 4
|
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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. |
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.
|
Experimental: 2
Enhanced teacher training on literacy instruction.
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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.
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Experimental: 3
Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction
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Schools will receive both IST and the literacy instruction programme
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anaemia
Time Frame: 2 years
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2 years
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Education achievement assessed by a battery of tests of reading, writing and arithmetic
Time Frame: 2 years
|
2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of malaria parasitemia
Time Frame: 2 years
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2 years
|
|
Concentration as assessed by classroom-based tests of sustained attention
Time Frame: 2 years
|
2 years
|
|
School attendance as assessed by class attendance registers
Time Frame: 2 years
|
2 years
|
|
Examination results as assessed by government examination scores
Time Frame: 2 years
|
2 years
|
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Cost-effectiveness
Time Frame: 2 years
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Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia
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2 years
|
Community acceptability
Time Frame: 2 years
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A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.
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2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Simon Brooker, DPhil, London School of Hygiene and Tropical Medicine
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5503
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