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Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

Primary Purpose

Anaemia, Malaria

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Intermittent screening and treatment for malaria
Teacher training on literacy instruction
IST plus literacy instruction programme
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaemia focused on measuring Anaemia, Malaria, Literacy, Kenya

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KEMRI-Wellcome Trust Programme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

4

Arm Description

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.

Enhanced teacher training on literacy instruction.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence of malaria parasitemia
Concentration as assessed by classroom-based tests of sustained attention
School attendance as assessed by class attendance registers
Examination results as assessed by government examination scores
Cost-effectiveness
Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia
Community acceptability
A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.

Full Information

First Posted
April 7, 2009
Last Updated
February 14, 2014
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
World Bank
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1. Study Identification

Unique Protocol Identification Number
NCT00878007
Brief Title
Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
Official Title
Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
World Bank

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaemia, Malaria
Keywords
Anaemia, Malaria, Literacy, Kenya

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
Enhanced teacher training on literacy instruction.
Arm Title
3
Arm Type
Experimental
Arm Description
Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction
Arm Title
4
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Intermittent screening and treatment for malaria
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teacher training on literacy instruction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
IST plus literacy instruction programme
Intervention Description
Schools will receive both IST and the literacy instruction programme
Primary Outcome Measure Information:
Title
Anaemia
Time Frame
2 years
Title
Education achievement assessed by a battery of tests of reading, writing and arithmetic
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Prevalence of malaria parasitemia
Time Frame
2 years
Title
Concentration as assessed by classroom-based tests of sustained attention
Time Frame
2 years
Title
School attendance as assessed by class attendance registers
Time Frame
2 years
Title
Examination results as assessed by government examination scores
Time Frame
2 years
Title
Cost-effectiveness
Description
Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia
Time Frame
2 years
Title
Community acceptability
Description
A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Brooker, DPhil
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
KEMRI-Wellcome Trust Programme
City
Nairobi
ZIP/Postal Code
P.O. Box 43640 - 00100
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
20929566
Citation
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.
Results Reference
background
PubMed Identifier
23680181
Citation
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.
Results Reference
background
PubMed Identifier
24492859
Citation
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.
Results Reference
result
PubMed Identifier
22950512
Citation
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.
Results Reference
result
PubMed Identifier
21933376
Citation
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.
Results Reference
result
PubMed Identifier
22681850
Citation
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.
Results Reference
result

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Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

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