Impact of School-based Delivery of Long Lasting Insecticide Nets
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2009 | ||||
Last Updated Date | June 21, 2011 | ||||
Start Date ICMJE | May 2009 | ||||
Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Anaemia [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00878397 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Household coverage and use of long lasting insecticide nets [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of School-based Delivery of Long Lasting Insecticide Nets | ||||
Official Title ICMJE | Evaluating the Impact of Delivering Long Lasting Insecticide Nets Through Schools on Household Access and the Health of School Children in North Eastern Kenya | ||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE | Malaria | ||||
Intervention ICMJE | Device: School-based delivery of long lasting insecticide nets
Free distribution of long lasting insecticide nets to school children and their younger siblings |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 5000 | ||||
Completion Date | November 2010 | ||||
Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 5 Years to 18 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Kenya | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878397 | ||||
Other Study ID Numbers ICMJE | 5482 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Simon Brooker, London School of Hygiene and Tropical Medicine | ||||
Study Sponsor ICMJE | London School of Hygiene and Tropical Medicine | ||||
Collaborators ICMJE | Wellcome Trust | ||||
Investigators ICMJE |
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Information Provided By | London School of Hygiene and Tropical Medicine | ||||
Verification Date | June 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |