Colaboración Evita: Cervical Cancer Prevention Partnership Center

PROJECT SUMMARY/ABSTRACT In the Year 6 Extension (8/1/25-7/31/26), the Colaboración Evita (CE) Partnership Center will complete two trials, ULACNet 301 and 302, at clinical sites in four Latin American countries: Peru, Brazil, Haiti, and the Dominican Republic (DR). ULACNet 301 and 302 will use the support provided by this supplement to finish data collection, perform assays, assemble datasets, analyze findings for publication in manuscripts and disseminate important study results to stakeholders. The ULACNet Trials 301 and 302 are focused on two approaches for improving HPV cancer prevention: Trial 301 focuses on vaccination and Trial 302 on screening. Trial 301 investigates several dosing regimens of the 9-valent HPV vaccine in children living with HIV (CLWH) in Peru, Brazil and Haiti, with specific focus on HPV16 and HPV18 responses after 3 vs 2 doses in CLWH and on responses after a single dose in children with vs without HIV. Trial 302 will evaluate whether there is compelling evidence to support changing cervical cancer screening from cytology to HPV testing for primary screening in the DR, where cytology has long been the standard of care. It is especially key to show results directly comparing cytology to HPV testing for women with HIV and to compare new algorithms for triage of HPV positive women by molecular assays. Trials 301 and 302 will provide evidence to inform clinical practice relating to primary and secondary prevention of HPV infection and HPV-related disease in people living with HIV. In this year 6 extension, both trials will continue follow-up of enrolled participants with emphasis on retention of participants and completion of all participant data collection. Data analysis, and preparation of presentations, publications, and dissemination of trial results will be a priority during this final year.