WP3 – Intervention study implementation and evaluation survey
This Work Package is led by Prof. Halidou Tinto from Centre National de la Recherche Scientifique et Technologique (CNRST) and founder of Clinical Research Unit of Nanaro (CRUN) as part of the Institut de Recherche en Science de la Santé (IRSS), in Burkina Faso.
For the management of the WP3, Professor Tinto can count on the close support of Prof. Kassoum Kayentao (USTTB, Mali) and Dr Valérie Briand (IRD/Epicentre, France).
WP3 is the core component of the project.
Indeed, this WP is designed to implement a multicentre, cluster randomized trial of the delivery of IPTp-SP in two parallel arms (ANC and ANC+SMC) in Mali and in Burkina Faso, to ensure its smooth execution whilst complying with the principles of GCP.
Clusters are represented by health facilities and their catchment areas. In each country, 20 clusters in the intervention arm and 20 clusters in the control arm have been selected, for a total of 40 clusters per country.
The intervention consists of the monthly administration of IPTp-SP to pregnant women through the SMC channel delivery during the four monthly rounds of SMC (from July to October) in the malaria transmission season, annually for two years.
Objectives of the WP3
O3.1: To compare the delivery of IPTp-SP through a combined strategy (ANC+SMC) with standard care (ANC)
O3.2: To assess any increase or decrease in SMC or ANC uptake, following the combined SMC + IPTp-SP delivery.
O3.3: To estimate the number of malaria cases in both children and pregnant women.
O3.4: To assess pregnancy outcomes at delivery (birth weight, miscarriage, stillbirth) in both intervention and control arms.
How to reach these objectives?
How to reach O3.1
A pre-intervention baseline and post-intervention endline household survey among women with a child younger than 7 months will be conducted for data on the number of pregnant women receiving SP during the 4-monthly rounds of SMC and outside SMC periods.
How to reach O3.2
In selected clusters in each intervention arm, the number of children who completed a cycle of SMC will be assessed through health center records and coverage of SMC through a household survey in children aged 3-59 months.
How to reach O3.3
Clinical malaria data will be collected from outpatient and inpatient registries at health facilities
How to reach O3.4
Pregnancy outcomes data (birth weight, miscarriage, stillbirth) will be collected from health facilities registries