Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso

Tracking Information
First Submitted Date ICMJE	July 19, 2006
First Posted Date ICMJE	July 21, 2006
Last Update Posted Date	October 9, 2006
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: July 20, 2006)	ITN coverage in households 12 and 24 months after the start of the interventions; ITN use during pregnancy and infancy
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00355225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 20, 2006)	Costs per malaria case and per DALY prevented; Self-reported information on ANC visits; Insecticide content on ITN and mortality of vector mosquitoes over time; Acceptance of health staff and population
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso
Official Title ICMJE	Not Provided
Brief Summary	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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Educational/Counseling/Training
Condition ICMJE	Malaria
Intervention ICMJE	Procedure: ITN distribution channel
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Not Provided
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00355225
Other Study ID Numbers ICMJE	SFB544D4
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Heidelberg University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Olaf Mueller, MD, MPH Heidelberg University
PRS Account	Heidelberg University
Verification Date	July 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP