- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878397
Impact of School-based Delivery of Long Lasting Insecticide Nets
April 9, 2014 updated by: Simon Brooker, London School of Hygiene and Tropical Medicine
Evaluating the Impact of Delivering Long Lasting Insecticide Nets Through Schools on Household Access and the Health of School Children in North Eastern Kenya
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5113
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nairobi, Kenya, P.O. Box 43640 - 00100
- Kemri-Wellcome Trust Programme
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pupil enrolled at participating schools in standards 1-7;
- Provision of informed consent from parent or guardian; AND
- Provision of assent by student.
Exclusion Criteria:
- Non-provision of informed consent; OR
- Pupils unwilling to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Free distribution of long lasting insecticide nets to school children and their younger siblings
|
Free distribution of long lasting insecticide nets to school children and their younger siblings
|
Experimental: 2
No school-based delivery of long lasting insecticide nets in the first year, followed by free delivery in the second year
|
Free distribution of long lasting insecticide nets to school children and their younger siblings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anaemia
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Household coverage and use of long lasting insecticide nets
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Simon Brooker, PhD, London School of Hygiene and Tropical Medicine / KEMRI-Wellcome Trust Programme
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
April 7, 2009
First Submitted That Met QC Criteria
April 7, 2009
First Posted (Estimate)
April 8, 2009
Study Record Updates
Last Update Posted (Estimate)
April 10, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5482
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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