Incidence of clinical malaria and asymptomatic parasitaemia among African children living with sickle cell disease: a multicentre prospective longitudinal cohort study protocol.

INTRODUCTION: Sickle cell disease is a monogenic blood disorder prevalent in Africa, where malaria poses a health risk for affected individuals. Individuals with sickle cell disease are susceptible to malaria, which can be complicated by vaso-occlusive episodes, severe anaemia and death. Understanding the intersection of malaria and sickle cell disease in African countries with high co-prevalence is essential for developing effective management and prevention strategies, including clinical guidelines on the use of malaria chemoprophylaxis in this population. This study will determine the monthly incidence of malaria in children living with sickle cell disease in each of two clusters of African countries.

METHODS AND ANALYSIS: This 1-year observational study will enrol 2808 children with sickle cell disease, aged 6 months to 17 years, at Sickle Pan-African Research Consortium clinical sites in Ghana, Mali, Nigeria (West), Tanzania, Uganda, Zimbabwe and Zambia (East-South). Malaria infection will be assessed at monthly visits and unscheduled sick visits over 12 months. Data collected will include socio-demographic characteristics, beta-globin genotype, medical history, clinical symptoms and malaria blood smear or rapid diagnostic test results. The primary outcome is monthly incidence of clinical malaria; a secondary outcome is incidence of asymptomatic malaria.

ETHICS AND DISSEMINATION: This study was developed with input from patients with sickle cell disease and their caregivers. The study will be conducted according to the principles of the Declaration of Helsinki. Written informed consent from guardians and assent from child participants age 7 or above will be provided before enrolling in the study. This protocol has been reviewed and approved by local and national ethics committees at each study site. The findings of this study will be provided to participants and the general public through presentations at the annual Sickle Cell Day community events at each study site, local media and open access publication in peer-reviewed journals.The full names of the ethics committees are as follows. Ghana: Komfo Anokye Teaching Hospital Institutional Review Board; Mali: Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako; Nigeria: National Health Research Ethics Committee of Nigeria; Tanzania: Muhimbili University of Health and Allied Sciences Research Ethics Committee and National Health Research Ethics Committee; Uganda: Makerere School of Medicine Research and Ethic Committee; Zambia: National Health Research Authority and Excellence in Research Ethics and Science Converge Institutional Review Board; and Zimbabwe: Joint Research Ethics Committee and the Medical Research Council of Zimbabwe.