Two Strategies for the Delivery of IPTc in an Area of Seasonal Malaria Transmission in The Gambia: A Randomised Controlled Trial

Bojang and colleagues report a randomized trial showing that delivery of intermittent preventive treatment for malaria in children by village health workers is more effective than delivery by reproductive and child health trekking clinics. Background: The Expanded Programme on Immunisation (EPI) provides an effective way of delivering intermittent preventive treatment for malaria (IPT) to infants. However, it is uncertain how IPT can be delivered most effectively to older children. Therefore, we have compared two approaches to the delivery of IPT to Gambian children: distribution by village health workers (VHWs) or through reproductive and child health (RCH) trekking teams. In rural areas, RCH trekking teams provide most of the health care to children under the age of 5 years in the Infant Welfare Clinic, and provide antenatal care for pregnant women. Methods and Findings: During the 2006 malaria transmission season, the catchment populations of 26 RCH trekking clinics in The Gambia, each with 400–500 children 6 years of age and under, were randomly allocated to receive IPT from an RCH trekking team or from a VHW. Treatment with a single dose of sulfadoxine pyrimethamine (SP) plus three doses of amodiaquine (AQ) were given at monthly intervals during the malaria transmission season. Morbidity from malaria was monitored passively throughout the malaria transmission season in all children, and a random sample of study children from each cluster was examined at the end of the malaria transmission season. The primary study endpoint was the incidence of malaria. Secondary endpoints included coverage of IPTc, mean haemoglobin (Hb) concentration, and the prevalence of asexual malaria parasitaemia at the end of malaria transmission period. Financial and economic costs associated with the two delivery strategies were collected and incremental cost and effects were compared. A nested case-control study was used to estimate efficacy of IPT treatment courses. Conclusions: In this setting in The Gambia, delivery of IPTc to children 6 years of age and under by VHWs is more effective and less costly than delivery through RCH trekking clinics. Trial Registration: ClinicalTrials.gov NCT00376155 : Please see later in the article for the Editors' Summary Background: In sub-Saharan Africa, malaria kills 800,000 people, the majority of whom are children, every year. Intermittent preventive treatment (IPT) of malaria is an effective malaria control strategy. IPT involves administration of antimalarial drugs at defined time intervals to individuals regardless of whether they are known to be infected with malaria to prevent morbidity and mortality from the infection. IPT was initially recommended for pregnant women (IPTp) who are given at least two doses of suphadoxine pyrimethamine (SP) during antenatal visits after the first trimester of pregnancy. IPT is also effective in infants (IPTi) and recently IPTi has been rolled out with the administration of three doses of an antimalarial drug during the expanded program of immunization visits. Clinical studies have also shown that IPT is effective at reducing malaria incidence in children (IPTc) by administering SP alone, or in combination with artesunate (AS) or amodiaquine (AQ,) over three intervals during the peak malarial season. Why Was This Study Done?: The inclusion of IPTp in antenatal visits and IPTi in the expanded program of immunization has effectively scaled up these interventions to the population level. So far, IPTc has only been administered to children within the confines of clinical trials—there is currently no established system for delivery of IPTc. For the scale-up of IPTc to be successful, there needs to be an appropriate point of entry and the roll out of a delivery system that can be generalized to most settings in sub-Saharan Africa. In order to address this issue, the researchers conducted a randomized trial to compare the effectiveness of IPTc delivery to children up to 6 y of age by village health workers (VHW) or by reproductive and child health (RCH) trekking teams (run by the Ministry of Health) in rural areas of The Gambia. What Did the Researchers Do and Find?: During the 2006 malaria transmission season, the researchers randomly allocated the catchment populations of 26 RCH clinics, each with 400–500 children 6 y of age and under, to receive IPT from an RCH trekking team or from a VHW. Before the trial started, the researchers, accompanied by the district health team, visited all villages in the study area to explain the purpose and methods of the study and to obtain consent from the elders of all participating villages. Eligible children were treated with a single dose of SP plus three doses of AQ given at monthly intervals during the malaria transmission season. The researchers passively monitored malaria incidence throughout the transmission season and at the end of the malaria season, examined a random sample of 40 children from each cluster to measure their temperature, height, and weight and to take a finger-prick blood sample to measure blood hemoglobin and parasite levels (by microscopy of thick blood smears). The researchers recorded the financial costs associated with each delivery strategy (mostly on the basis of staff pay and the financial incentives given to VHWs). What Do These Findings Mean?: The results of this study show that in rural areas of The Gambia, delivery of IPTc by VHWs is more effective and less costly than delivery by RCH trekking teams through RCH clinics. Delivering IPTc through community-based VHWs versus monthly visits by the RCH team has several advantages: VHWs are resident in the community, making drug administration easy and flexible (as children were able to receive their medication on any day of the month), and they can remind mothers/guardians to attend for treatment. Therefore, operationally, VHW delivery is less restrictive and more convenient for parents and guardians. Additional Information: Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000409.