KUMASI - GHANA

Intermittent preventive treatment of malaria in pregnancy trial in Ghana

This cluster randomised trial aims to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 - 59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study has been conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in the HMM programme or HMM programme alone.

The study has been implemented to run in three phases: a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey and data evaluation and dissemination. A cohort of 800 study children, randomly selected to receive three full treatment courses of AS+AQ intermittently during the April-November 2007 transmission season. Community-based drug distributors (CDDs) administered all courses of IPTc. The first dose of each course was directly observed by the CDDs who educated mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes were carried out by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 800 study children who did not receive IPTc but would be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.