- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00355225
Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso
October 6, 2006 updated by: Heidelberg University
The study aims at assessing which of two distribution channels for insecticide treated bendnets (ITNs), social marketing vs. social marketing coupled with free distribution through ante-natal care, is most effective in reaching groups at high risk of malaria, i.e. pregnant women and children under 5.
Study Overview
Detailed Description
The hypothesis that insecticide-treated bed net (ITN) effects may not be long-lasting in young children living in areas of intense malaria transmission due to interactions with the immunologi-cal development has now been refuted in a number of studies including the D4 study.
The highly controversial question remains how African programmes can best reach a sustainable high coverage with ITNs in young children and pregnant women.
Against this background it is planned to implement a cluster randomised controlled trial in Nouna Health District in Burkina Faso.
Twenty-two peripheral health centres and their catchment areas will be randomised to (1) ITN provision to the general population through social marketing and (2) ITN provision to the general population through social marketing plus free provision to all pregnant women through antenatal services.
The primary outcomes are ITN coverage in households and ITN use during pregnancy and infancy.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
Exclusion Criteria:
- Being outside one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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ITN coverage in households 12 and 24 months after the start of the interventions
|
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ITN use during pregnancy and infancy
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Secondary Outcome Measures
Outcome Measure |
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Costs per malaria case and per DALY prevented
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Self-reported information on ANC visits
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Insecticide content on ITN and mortality of vector mosquitoes over time
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Acceptance of health staff and population
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olaf Mueller, MD, MPH, Heidelberg University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 19, 2006
First Submitted That Met QC Criteria
July 20, 2006
First Posted (Estimate)
July 21, 2006
Study Record Updates
Last Update Posted (Estimate)
October 9, 2006
Last Update Submitted That Met QC Criteria
October 6, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFB544D4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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