The overall objective of the Clinical Laboratory Core will be to provide support for all laboratory needs of the clinical trials described in Projects 1 and 2 of this Program Project. This will include the collection of biological specimens from study participants, facilitating clinical laboratory testing needed for patient management and assessment of drug safety and tolerability, routine storage of biological samples for future use, malaria specific laboratory testing from blood specimens, and the collection and process of placental samples including histopathology. The clinical laboratory core will also be responsible for supporting the collection of biological samples for the immunology studies described in Project 3 ofthe Program Project. Performance sites will include a phlebotomy center and clinical laboratory within our study clinic located on the Tororo District Hospital (TDH) campus, a placental histopathology laboratory located near our study clinic on the TDH campus, and the Joint Clinical Research Center (JCRC) referral laboratory where clinical laboratory testing will be performed. The specific objectives oithe Clinical Laboratory Core will be as follows: Objective 1: To collect, transport and store all biological specimens from study participants. Objective 2: To perform all malaria diagnostic testing. Malaria microscopy will be performed by experienced technicians including double reading of blood smears for quality control purposes. Malaria microscopy results will be available in real time for patient management. A PCR based assay will be available for the detection of asymptomatic parasitemia using dried blood spots collected on filter paper. Objective 3: To collect placental specimens and perform histopathology studies. The gold standard for classification of placental malaria is based on histopathological assessment of placental tissue collected at the time of birth. Our research center has established local capacity for the collection, processing, and staining of histopathology specimens for the diagnosis of placental malaria, one of the primary outcome measures for the studies outlined in this Program Project.
The success of the proposed Program Project, which includes two randomized clinical trials and supporting immunology studies, requires a strong Clinical Laboratory Core that includes proper collection of biological specimens, transport of specimens to our reference laboratory, and performance of on-site laboratory testing to ensure that study participants are managed properly and study outcomes accurately assessed.
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