Clinical features, immunological interactions and household determinants of visceral leishmaniasis and malaria coinfections in West Pokot, Kenya: protocol for an observational study.

INTRODUCTION

Visceral leishmaniasis (VL) and malaria are two deadly parasitic diseases that coexist in West Pokot County, Kenya. The local population is at considerable risk of coinfection with VL and malaria; however, few studies have described the clinical implications of this comorbidity. Questions remain regarding the immune responses responsible for possible predisposing or protective effects. Moreover, characterisation of environmental and household risk factors for co-acquiring VL and malaria is warranted to increase awareness and guide implementation of targeted control strategies. This protocol intends to address these knowledge gaps concerning VL-malaria coinfections.

METHODS AND ANALYSIS

This observational research project will have a multimethod approach, starting with a cross-sectional study at Kacheliba Sub-County Hospital in West Pokot, Kenya. Patients with laboratory confirmation of a VL and/or malaria infection will be clinically assessed and symptomatology of monoinfections and coinfections will be compared. Second, a questionnaire will be addressed to all included patients and to healthy controls in local communities. This case-control study will aim to describe household and environmental determinants associated with VL-malaria coinfection. Lastly, blood samples will be collected from a small cohort of VL and malaria monoinfected and coinfected patients during treatment of their infection(s), and from healthy controls and asymptomatic VL and malaria cases recruited in local communities. These specimens will be used for serum cytokine measurements and molecular quantitation of and . In this way, the immune response and parasite dynamics during VL-malaria coinfection will be characterised longitudinally and compared with those observed in clinical and asymptomatic monoinfections.

ETHICS AND DISSEMINATION

Ethical approval was obtained from the Ethics and Scientific Research Committee of Amref Health Africa. The study findings will be presented at international conferences and published in open-access, peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ISRCTN Registry (ISRCTN15023306).