NCT00878397

Brief Summary

Insecticide-treated nets (ITNs), and more recently long lasting insecticide nets (LLINs), have been shown to effectively protect those groups most biologically vulnerable to the burden of malaria across Africa. However, achieving universal coverage, especially in poor and remote areas, has proved a particular challenge and there remains a need to explore alternative delivery mechanisms. The recent introduction of universal primary education in Kenya has meant that even the poorest households are sending at least one child to school, providing a complementary, potentially equitable, mechanism through which to distribute LLINs. The delivery of LLINs through schools will be piloted by Population Services International in schools situated along the Tana River in North Eastern Kenya. This proposal seeks to evaluate the impact of this programme on both household use of school donated, free LLINs and the health of schoolchildren. The study hypothesis is that the free delivery of long lasting insecticide nets (LLINs) through schools will increase household LLIN coverage among younger siblings not enrolled in school and will reduce rates of malaria infection and anaemia among school children. The study will be an impact evaluation of a programme delivering LLINs through schools, which is to be implemented by Population Services International (PSI)-Kenya. The programme will be implemented in 50 schools and due to PSI-Kenya's roll out, the programme will be phased in over two years. will be phased in over two years. The 50 schools will be randomly divided into two groups, the first 25 schools will receive LLINs in 2009 and the second group will receive them in 2010. In each school, five households will be randomly selected and household surveys will be conducted to collect information on household net use and household demographic and socio-economic status. School health surveys will be completed at the end of the programme to assess programme impact on malaria infection and anaemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,113

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

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

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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
23 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

April 7, 2009

Last Update Submit

April 9, 2014

Conditions

Keywords

malarialong lasting insecticide netsanaemiaschools

Outcome Measures

Primary Outcomes (1)

  • Anaemia

    2 years

Secondary Outcomes (1)

  • Household coverage and use of long lasting insecticide nets

    2 years

Study Arms (2)

1

EXPERIMENTAL

Free distribution of long lasting insecticide nets to school children and their younger siblings

Device: School-based delivery of long lasting insecticide nets

2

EXPERIMENTAL

No school-based delivery of long lasting insecticide nets in the first year, followed by free delivery in the second year

Device: School-based delivery of long lasting insecticide nets

Interventions

Free distribution of long lasting insecticide nets to school children and their younger siblings

12

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 standards 1-7;
  • Provision of informed consent from parent or guardian; AND
  • Provision of assent by student.

You may not qualify if:

  • Non-provision of informed consent; OR
  • Pupils unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI-Wellcome Trust Programme

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

Location

MeSH Terms

Conditions

MalariaAnemia

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Simon Brooker, PhD

    London School of Hygiene and Tropical Medicine / KEMRI-Wellcome Trust Programme

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations