Condition category
Infections and Infestations
Date applied
08/11/2010
Date assigned
10/01/2011
Last edited
04/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Malaria is an infectious disease which is common in tropical and subtropical countries, caused by a microscopic parasite which is spread from person to person by mosquitos. It can be serious disease if it is not treated quickly and effectively. School-aged children are rarely targeted by malaria control, yet the prevalence (commonness) of malaria infection in this age group often exceeds that seen in younger children and could affect school participation and performance. This study is evaluating the impact of a school based malaria control program which involves distribution and promotion of long lasting insecticidal nets (LLINs), malaria education and treatment. The aim of this study is to find out if the malaria prevention program can reduce levels of malaria infection, anaemia (low levels of haemoglobin – the protein in blood that binds to oxygen) and improve attention and performance in school.

Who can participate?
Children aged 5-15 who attend participating primary schools in the Sikasso Region of Southern Mali.

What does the study involve?
Participating schools are randomly allocated to one of two groups. In the first group, all school children are given two long lasting insecticidal nets (one for themselves and one for their younger siblinds) and are trained to promote their use in their homes. They also receive one dose of malaria treatment at the end of the malaria season and start of the school year (referred to as intermittent parasite clearance –IPC). In the second group, participants continue as normal, but are given a change to receive the nets and treatment at the end of the study. At the start of the study, mid-term (after the LLIN distribution and promotion) and endline (after the IPC) participants in both groups have a finger prick test to take a sample of blood, which is then tested for haemoglobin levels and levels of the malaria parasite in the blood. In addition, attention in the classroom is also measured using concentration tests.

What are the possible benefits and risks of participating?
Participants benefit from receiving long lasting insecticidal nets (LLINs), malaria prevention education lessons and a malaria treatment. The main risk of participating is the risk of pain when having blood samples taken.

Where is the study run from?
80 primary schools in Sikasso region, Southern Mali (Mali)

When is the study starting and how long is it expected to run for?
February 2010 to April 2013

Who is funding the study?
Save the Children (USA)

Who is the main contact?
Ms Natalie Roschnik
n.roschnik@savethechildren.org.uk

Trial website

http://www.savethechildren.org/site/c.8rKLIXMGIpI4E/b.6115947/k.8D6E/Official_Site.htm

Contact information

Type

Scientific

Primary contact

Ms Natalie Roschnik

ORCID ID

Contact details

71 Chemin des Choseaux
Menthon St Bernard
74290
France
+33 450 44 80 02
n.roschnik@savethechildren.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Malaria control programme in schools: a cluster randomised study evaluating the health and educational benefits in Mali

Acronym

Study hypothesis

Study hypothesis as of 19/09/2016:
Distributing and promoting Long Lasting Insecticide-treated Nets (LLINs) and intermittent malaria clearance through schools reduces the prevalence of Plasmodium falciparum infection and anaemia and improves school attention and performance amongst school children.

Original hypothesis:
Distributing and promoting Long Lasting Insecticide-treated Nets (LLINs) through schools reduces the prevalence of Plasmodium falciparum infection and anaemia and improves school attention and performance amongst school children.

Ethics approval

Ethics approval statement added 19/09/2016:
Ethical Committee of the National Institute of Research in Public Health in Mali, 05/11/2010, ref: 00013/10/CE-INRSP (following an amendment to the study protocol, a second approval was received on 01/12/2011)

Original ethical approval statement:
Ethical Committee of the Institut National de Recherche en Santé Publique (INRSP) approved on the 25th October 2010 (preliminary approval)

Study design

Cluster randomised waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malaria, anaemia

Intervention

Interventions as of 19/09/2016
Two LLINs were provided freely to each child enrolled in the study, one for him/herself and another for another member of the family (preferably a younger sibling). Children were taught about malaria using active participatory methods encouraging children to use of LLINs and promote their use in their homes. All school children also received a single annual treatment of artesunate plus sulfadoxine-pyrimethamine (AS/SP) at the end of the malaria transmission season, to clear them of malaria parasites (intermittent parasite clearance).

Save the Children also used the Community Action Cycle, a proven community mobilisation approach developed by Save the Children and other partners to mobilise the community to increase bed net use generally.

The LLIN distribution and promotion was conducted in the intervention group in April 2011 and the intermittent parasite clearance was conducted in December 2011 in all intervention schools. The control schools received the same interventions the following school year (October-April 2012).


Original interventions:
Two LLINs will be provided freely to each child enrolled in the study, one for him/herself and another for another member of the family (preferably a younger sibling). A pupil booklet and teachers guide on the effective use of LLINs by schoolchildren and their families, developed and evaluated by Population Services International in Kenya, will be adapted to the Malian context and teachers trained to use it with their class.

Save the Children will also use the Community Action Cycle, a proven community mobilisation approach developed by Save the Children and other partners to mobilise the community to increase bed net use generally.

The duration of the treatment in the intervention group will be the FY11 school year: December 2010 - June 2011 and the duration of treatment in the control group will be the FY12 school year: December 2011 - June 2012.

Intervention type

Drug

Phase

Not Applicable

Drug names

Artesunate plus sulfadoxine-pyrimethamine (AS/SP)

Primary outcome measures

Prevalence of anaemia, assessed through finger prick blood sample taken at the point of survey to record haemoglobin concentrations using a portable HemoCue photometer (HemoCue, Angelhom, Sweden). Measured at baseline and one year.

Secondary outcome measures

Measured at baseline and one year:
1. Prevalence and incidence of Plasmodium falciparum parasitemia, assessed through finger-prick blood samples for the preparation of a thick and thin blood smear as well as a rapid diagnostic test (RDT)
2. Classroom attention assessed by concentration tests adapted from the TEA-Ch (Tests of Everyday Attention for Children) battery for group administration in groups of 15 or fewer

Removed 19/09/2016:
3. School absenteeism assessed through random spot checks

Overall trial start date

01/02/2010

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

The target population in this evaluation includes children (aged 5 - 15 years, either sex) attending primary schools and the accessible population includes the children attending the participating primary schools in classes 1 - 6 in the districts of Sikasso and Yorosso in Sikasso Region. Inclusion criteria are:
1. Pupil enrolled at participating schools
2. Provision of informed consent from parent or guardian
3. Provision of assent by student

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1900 children

Participant exclusion criteria

Pupils unwilling to participate in the study

Recruitment start date

01/11/2010

Recruitment end date

01/05/2012

Locations

Countries of recruitment

Mali

Trial participating centre

Save the Children International
Hamdallaye ACI 2000
Bamako
B.P. 3105
Mali

Sponsor information

Organisation

Save the Children

Sponsor details

2000 L Street NW
Suite 500
Washington
DC 20036
United States of America
+1 202 794 1668
slee@savechildren.org

Sponsor type

Charity

Website

www.SavetheChildren.org

Funders

Funder type

Charity

Funder name

Save the Children

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal by December 2016.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sian Clarke: Sian.Clarke@lshtm.ac.uk

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/102/2016: The following changes have been made to the record: 1. The overall trial dates have been updated from 01/11/2010 - 01/05/2012 to 01/02/2010 - 01/04/2013 2. The publication and dissemination plan and availability of participant level data have been added 3. The plain English summary has been added 19/09/2016: The following changes have been made to the record: 1. The scientific title has been updated (originally "Distributing and promoting insecticide treated nets through schools: a cluster randomised study evaluating the health and educational benefits in Mali") 2. The hypothesis, ethical approval statement, interventions and outcome measures have been updated 3. The overall trial end date and recruitment end dates have been updated from 01/12/2011 to 01/05/2012 4. The target number of participants has been updated from 2300 to 1900