The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
This cluster randomised trial is proposed 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 will be conducted in
the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be
randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.
The study will run in three phases; a preparatory phase to set up and obtain baseline
morbidity data from a cross-sectional survey; an intervention phase and a post intervention
phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study
children randomly selected will receive three full treatment courses of AS+AQ intermittently
during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs)
will administer all courses of IPTc. The first dose of each course will be directly observed
by the CDDs who will educate mothers or caregivers to administer subsequent doses
appropriately at home. Follow up visits to homes will be done 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 546 study
children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ
when necessary during the observation period.
Phase:
Phase 4
Details
Lead Sponsor:
Kwame Nkrumah University of Science and Technology
Collaborators:
Center for International Health and Development Department for International Development, United Kingdom Malaria Consortium, UK