Fig 1.
Process description of the AVC test. Adapted with permission from [15].
Fig 2.
Flowchart of the clinical trial.
Abbreviations: TZ = Transformation zone, LLETZ = Large loop excision of the transformation zone.
Fig 3.
3T study data management plan.
Cameroon: participants will be pseudonymized with an identification key consisting of a code number and the participant’s initials. A paper Case Report Form (pCRF) will be created for each research subject: it will contain its personal, medical and screening-related information. These data will also be electronically stored (eCRF) in a RDBMS (Relational Database Management System) using a dedicated CDMS software (Clinical Database Management System) called secuTrial®. This software will also be used to save VA images, AVC test results and delimitation maps. University Hospitals of Geneva: a secure password-protected PC at the Department of Pediatrics, Gynecology and Obstetrics (DFEA) will store all collected data (dashed rectangle) and eCRFs will be accessible on secuTrial®. Data management will be performed by the Unit of Clinical Investigation (UIC), a unit which is part of the Clinical Research Center (CRC) at HUG as well as by designated research assistants at the DFEA. Cytological and histopathological samples will be transported by aircraft and analyzed at the Division of Clinical Pathology of the HUG, in conformity with Swiss standards and international recommendations. Smartphone videos will be shared by SWITCH drive (https://www.switch.ch/drive/) in the form of 120 frames. The last frame will be labelled by a colposcopy specialist of HUG who will also manually delimitate any visible lesion. EPFL: Final results (positive/negative), lesion delimitation maps and probability maps (PNG format) obtained during the AVC test will be stored in a secure NAS server in EPFL.
Fig 4.
Project schedule and milestones.