Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

This study has been completed.
Sponsor:
Collaborator:
World Bank
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00878007
First received: April 7, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Anaemia
Malaria
Drug: Intermittent screening and treatment for malaria
Behavioral: Teacher training on literacy instruction
Other: IST plus literacy instruction programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Anaemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Education achievement assessed by a battery of tests of reading, writing and arithmetic [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of malaria parasitemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Concentration as assessed by classroom-based tests of sustained attention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • School attendance as assessed by class attendance registers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Examination results as assessed by government examination scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia

  • Community acceptability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.


Enrollment: 5177
Study Start Date: January 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Behavioral: Teacher 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.
Experimental: 3
Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction
Other: IST plus literacy instruction programme
Schools will receive both IST and the literacy instruction programme
No Intervention: 4

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878007

Locations
Kenya
KEMRI-Wellcome Trust Programme
Nairobi, Kenya, P.O. Box 43640 - 00100
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
World Bank
Investigators
Principal Investigator: Simon Brooker, DPhil London School of Hygiene and Tropical Medicine
  More Information

Publications:

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00878007     History of Changes
Other Study ID Numbers: 5503
Study First Received: April 7, 2009
Last Updated: February 14, 2014
Health Authority: Kenya: Ethical Review Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Anaemia
Malaria
Literacy
Kenya

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on October 01, 2014