AnaemiaNCT00878007
Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
A study testing Intermittent screening and treatment for malaria, Teacher training on literacy instruction and IST plus literacy instruction programme in people with Anaemia and Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Intermittent screening and treatment for malaria, Teacher training on literacy instruction and IST plus literacy instruction programme
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,177 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pupil enrolled at participating schools in classes 1 and 5;
- Provision of informed consent from parent or guardian;
- Provision of assent by student
Who cannot join
- Pupils unwilling to participate in the study;
- Known allergy or history of adverse reaction to study medications;
- Known or suspected sickle-cell trait
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Intermittent screening and treatment for malaria, Teacher training on literacy instruction, IST plus literacy instruction programme
- Keywords
- Anaemia, Malaria, Literacy, Kenya
- Medical subject headings
- Anemia, Malaria, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent screening and treatment for malariaDrug
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.
Teacher training on literacy instructionBehavioural
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.
IST plus literacy instruction programmeOther
Schools will receive both IST and the literacy instruction programme
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intermittent screening and treatment for malaria |
| 2 | Experimental | Enhanced teacher training on literacy instruction. Receives: Behavioral: Teacher training on literacy instruction |
| 3 | Experimental | Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction Receives: Other: IST plus literacy instruction programme |
| 4 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaemia
Measured: 2 years
Education achievement assessed by a battery of tests of reading, writing and arithmetic
Measured: 2 years
Secondary outcomes (6)
Prevalence of malaria parasitemia
Measured: 2 years
Concentration as assessed by classroom-based tests of sustained attention
Measured: 2 years
School attendance as assessed by class attendance registers
Measured: 2 years
Examination results as assessed by government examination scores
Measured: 2 years
Cost-effectiveness
Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia
Measured: 2 years
Community acceptability
A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 5,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank
- Responsible party
- Sponsor
- Investigators
- Simon Brooker, DPhil, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878007
- Sponsor's protocol ID
- 5503
- Status last verified
- Feb 2014
- First submitted
- 7 Apr 2009
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 20929566Okello 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 23680181Halliday 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 24492859Halliday 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 22950512Drake 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 21933376Okello 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
- ClinicalTrials.gov ID
- NCT00878007
- Acronym / sponsor ID
- 5503
- Keywords
- Anaemia, Malaria, Literacy, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,177 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- World Bank
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Intermittent screening and treatment for malariaIntermittent 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. |
| 2 | Experimental | Behavioral: Teacher training on literacy instructionEnhanced teacher training on literacy instruction. |
| 3 | Experimental | Other: IST plus literacy instruction programmeIntermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction |
| 4 | No intervention | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pupil enrolled at participating schools in classes 1 and 5;
- Provision of informed consent from parent or guardian;
- Provision of assent by student
Key exclusion criteria (3 listed)
- Pupils unwilling to participate in the study;
- Known allergy or history of adverse reaction to study medications;
- Known or suspected sickle-cell trait
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent screening and treatment for malariaAll 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. | Drug | 1 |
| Teacher training on literacy instructionEducation 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. | Behavioural | 2 |
| IST plus literacy instruction programmeSchools will receive both IST and the literacy instruction programme | Other | 3 |
Primary outcome
Anaemia
Time frame: 2 years
Education achievement assessed by a battery of tests of reading, writing and arithmetic
Time frame: 2 years
6 secondary outcomes
Prevalence of malaria parasitemia
Time frame: 2 years
Concentration as assessed by classroom-based tests of sustained attention
Time frame: 2 years
School attendance as assessed by class attendance registers
Time frame: 2 years
Examination results as assessed by government examination scores
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Community acceptability
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Background: PubMed 20929566Brooker 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.
- Background: PubMed 23680181Okello 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 publication: PubMed 24492859Halliday 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 publication: PubMed 22950512Halliday 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 publication: PubMed 21933376Drake 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 publication: PubMed 22681850Okello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Brooker, DPhil principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent screening and treatment for malaria, Teacher training on literacy instruction and IST plus literacy instruction programme in people with Anaemia and Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaemia (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878007, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.