Impact of School-based Delivery of Long Lasting Insecticide Nets
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
School-based delivery of long lasting insecticide nets
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring malaria, long lasting insecticide nets, anaemia, schools
Eligibility Criteria
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.
Sites / Locations
- KEMRI-Wellcome Trust Programme
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Free distribution of long lasting insecticide nets to school children and their younger siblings
No school-based delivery of long lasting insecticide nets in the first year, followed by free delivery in the second year
Outcomes
Primary Outcome Measures
Anaemia
Secondary Outcome Measures
Household coverage and use of long lasting insecticide nets
Full Information
NCT ID
NCT00878397
First Posted
April 7, 2009
Last Updated
April 9, 2014
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Wellcome Trust
1. Study Identification
Unique Protocol Identification Number
NCT00878397
Brief Title
Impact of School-based Delivery of Long Lasting Insecticide Nets
Official Title
Evaluating the Impact of Delivering Long Lasting Insecticide Nets Through Schools on Household Access and the Health of School Children in North Eastern Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Wellcome Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, long lasting insecticide nets, anaemia, schools
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Free distribution of long lasting insecticide nets to school children and their younger siblings
Arm Title
2
Arm Type
Experimental
Arm Description
No school-based delivery of long lasting insecticide nets in the first year, followed by free delivery in the second year
Intervention Type
Device
Intervention Name(s)
School-based delivery of long lasting insecticide nets
Intervention Description
Free distribution of long lasting insecticide nets to school children and their younger siblings
Primary Outcome Measure Information:
Title
Anaemia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Household coverage and use of long lasting insecticide nets
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Brooker, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine / KEMRI-Wellcome Trust Programme
Official's Role
Principal Investigator
Facility Information:
Facility Name
KEMRI-Wellcome Trust Programme
City
Nairobi
ZIP/Postal Code
P.O. Box 43640 - 00100
Country
Kenya
12. IPD Sharing Statement
Learn more about this trial
Impact of School-based Delivery of Long Lasting Insecticide Nets
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