Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
malaria
MALARIA, BLOOD
Blood samples will be stored in the clinical trial sites in silica gel as a desiccant in −20°C freezers and/or 4°C fridges according to the specific requirements of the processing lab. Samples to be sent to Basel Hospital (Switzerland), KEMRI (Kenya) and ISGlobal (Spain) will be stored separately in different bags, each identified with the corresponding identification number.Samples may be stored by ISGlobal or its contractor/s for a period of 5 years. The samples will be stored in an accredited, secure, access-controlled laboratory. The samples will be identified by a participant ID and visit code until the end of the trials where after which they will be delinked so that they cannot be linked to a specific participant. Additional research regarding the use of ivermectin to control malaria may be conducted to evaluate hypotheses generated during data analysis, i.e., if a direct effect of ivermectin on the parasite is suspected based on epidemiological results. This includes parasite genetics, serological and immune response to the malaria parasite, and NTDs. Additional uses could include re-analyses with methods being developed during the course of the study, and to answer follow-up questions posed by stakeholders.The positive RDTs will not be discarded. They will be stored at −20° for 5 years for the conduct of malaria transmission studies (parasite genetics) relevant to the study site (Mopeia). These studies are not part of the BOHEMIA clinical trial and will have independent protocols and approvals for their conduct