Impact of School-based Delivery of Long Lasting Insecticide Nets

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878397
• Other study ID #: 5482
• Status: Completed
• Phase: N/A
• First received: April 7, 2009
• Last updated: April 9, 2014
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: April 2014
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5113
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Malaria

Intervention

Device:
• School-based delivery of long lasting insecticide nets
Free distribution of long lasting insecticide nets to school children and their younger siblings

Locations

Country	Name	City	State
Kenya	KEMRI-Wellcome Trust Programme	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Wellcome Trust

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaemia		2 years	No
Secondary	Household coverage and use of long lasting insecticide nets		2 years	No