Community-effectiveness of the distribution of insecticide-treated bed nets through social marketing antenatal care services in malaria control in rural Burkina Faso

ISRCTN	ISRCTN07985309
DOI	https://doi.org/10.1186/ISRCTN07985309
Protocol serial number	D4
Sponsor	University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Funder	German Research Foundation (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - Special Research Area of Control of Tropical Infectious Diseases (Sonderforschungsbereich [SFB] 544)

Submission date: 16/07/2007
Registration date: 19/07/2007
Last edited: 19/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Olaf Mueller
Scientific

Im Neuenheimer Feld 324
Heidelberg
69120
Germany

Study information

Primary study design	Interventional
Study design	Cluster-randomised controlled trial. Evaluation takes place through annual representative household surveys.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	There is the highly controversial question how African programmes can best reach a sustainable high coverage with Insecticide-Treated bed Nets (ITNs) in young children and pregnant women. Against this background a cluster randomised controlled trial is implemented in Nouna Health District in Burkina Faso to compare two different forms of distribution of ITNs.
Ethics approval(s)	The protocol has been reviewed and approved by the Ethics Committee of the University of Heidelberg (date: 12 th November 2004, ref: L-357/2004) and the local Ethics Committee in Nouna, Burkina Faso.
Health condition(s) or problem(s) studied	Malaria
Intervention	Twenty-four peripheral health centres and their catchment areas were 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 total duration of the intervention will be three years, and participants will be followed up for a further two years.
Intervention type	Other
Primary outcome measure(s)	1. ITN coverage in households 12 and 24 months after the start of the interventions 2. ITN use during pregnancy and infancy
Key secondary outcome measure(s)	1. Costs per malaria case and per Disability Adjusted Life Years (DALY) prevented 2. Self-reported information on Antenatal Clinic (ANC) visits 3. Insecticide content on ITN and mortality of vector mosquitoes over time 4. Acceptance of health staff and population Outcomes will be measured at 12 and 24 months after the start of the interventions
Completion date	30/12/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1000
Key inclusion criteria	Households with children under five years of age.
Key exclusion criteria	No exclusion criteria.
Date of first enrolment	01/08/2006
Date of final enrolment	30/12/2008

Locations

Countries of recruitment

Burkina Faso
Germany

Study participating centre

Im Neuenheimer Feld 324

Heidelberg
69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	11/09/2008		Yes	No