Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of School-based Delivery of Long Lasting Insecticide Nets

This study has been completed.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Simon Brooker, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00878397
First received: April 7, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Malaria
Device: School-based delivery of long lasting insecticide nets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Anaemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Household coverage and use of long lasting insecticide nets [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 5113
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Free distribution of long lasting insecticide nets to school children and their younger siblings
Device: School-based delivery of long lasting insecticide nets
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
Device: School-based delivery of long lasting insecticide nets
Free distribution of long lasting insecticide nets to school children and their younger siblings

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878397

Locations
Kenya
KEMRI-Wellcome Trust Programme
Nairobi, Kenya, P.O. Box 43640 - 00100
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Wellcome Trust
Investigators
Principal Investigator: Simon Brooker, PhD London School of Hygiene and Tropical Medicine / KEMRI-Wellcome Trust Programme
  More Information

No publications provided

Responsible Party: Simon Brooker, Professor of Epidemiology, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00878397     History of Changes
Other Study ID Numbers: 5482
Study First Received: April 7, 2009
Last Updated: April 9, 2014
Health Authority: Kenya: Ethical Review Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
malaria
long lasting insecticide nets
anaemia
schools

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on November 27, 2014