MalariaNCT00878397
Impact of School-based Delivery of Long Lasting Insecticide Nets
A study testing School-based delivery of long lasting insecticide nets in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- School-based delivery of long lasting insecticide nets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,113 participants
- Where
- 1 siteKenya
- Study dates
- May 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pupil enrolled at participating schools in standards 1-7;
- Provision of informed consent from parent or guardian; AND
- Provision of assent by student.
Who cannot join
- Non-provision of informed consent; OR
- Pupils unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Malaria
- Being tested
- School-based delivery of long lasting insecticide nets
- Keywords
- malaria, long lasting insecticide nets, anaemia, schools
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based delivery of long lasting insecticide netsDevice
Free distribution of long lasting insecticide nets to school children and their younger siblings
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Free distribution of long lasting insecticide nets to school children and their younger siblings Receives: Device: School-based delivery of long lasting insecticide nets |
| 2 | Experimental | No school-based delivery of long lasting insecticide nets in the first year, followed by free delivery in the second year Receives: Device: School-based delivery of long lasting insecticide nets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaemia
Measured: 2 years
Secondary outcomes (1)
Household coverage and use of long lasting insecticide nets
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Principal investigator, Simon Brooker, London School of Hygiene and Tropical Medicine
- Investigators
- Simon Brooker, PhD, Principal investigator, London School of Hygiene and Tropical Medicine / KEMRI-Wellcome Trust Programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878397
- Sponsor's protocol ID
- 5482
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2009
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00878397
- Acronym / sponsor ID
- 5482
- Conditions
- Malaria
- Keywords
- malaria, long lasting insecticide nets, anaemia, schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,113 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: School-based delivery of long lasting insecticide netsFree distribution of long lasting insecticide nets to school children and their younger siblings |
| 2 | Experimental | Device: School-based delivery of long lasting insecticide netsNo school-based delivery of long lasting insecticide nets in the first year, followed by free delivery in the second year |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pupil enrolled at participating schools in standards 1-7;
- Provision of informed consent from parent or guardian; AND
- Provision of assent by student.
Key exclusion criteria (2 listed)
- Non-provision of informed consent; OR
- Pupils unwilling to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based delivery of long lasting insecticide netsFree distribution of long lasting insecticide nets to school children and their younger siblings | Device | 1, 2 |
Primary outcome
Anaemia
Time frame: 2 years
1 secondary outcome
Household coverage and use of long lasting insecticide nets
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Brooker, PhD principal investigator
London School of Hygiene and Tropical Medicine / KEMRI-Wellcome Trust Programme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based delivery of long lasting insecticide nets in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaemia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.