NCT00878007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 17, 2014

Status Verified

February 1, 2014

Enrollment Period

2.2 years

First QC Date

April 7, 2009

Last Update Submit

February 14, 2014

Conditions

Keywords

AnaemiaMalariaLiteracyKenya

Outcome Measures

Primary Outcomes (2)

  • Anaemia

    2 years

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

    2 years

Secondary Outcomes (6)

  • Prevalence of malaria parasitemia

    2 years

  • Concentration as assessed by classroom-based tests of sustained attention

    2 years

  • School attendance as assessed by class attendance registers

    2 years

  • Examination results as assessed by government examination scores

    2 years

  • Cost-effectiveness

    2 years

  • +1 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

Enhanced teacher training on literacy instruction.

Behavioral: Teacher training on literacy instruction

3

EXPERIMENTAL

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

Other: IST plus literacy instruction programme

4

NO INTERVENTION

Interventions

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.

1

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.

2

Schools will receive both IST and the literacy instruction programme

3

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI-Wellcome Trust Programme

Nairobi, P.O. Box 43640 - 00100, Kenya

Location

Related Publications (6)

  • 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.

    PMID: 20929566BACKGROUND
  • 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.

    PMID: 23680181BACKGROUND
  • 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.

MeSH Terms

Conditions

AnemiaMalariaLiteracy

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesCommunicationBehavior

Study Officials

  • Simon Brooker, DPhil

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 17, 2014

Record last verified: 2014-02

Locations