Grant: Project Grant

Cervical screening programs across Canada are transitioning to primary Human Papillomavirus (HPV) screening, which is more sensitive than cytology, leading to improved detection of cervical precancer and the ability to extend screening intervals. However, there are currently no data-driven protocols to guide when to safely exit primary HPV screening. Current guidance is based on historical experience with cytology and expert opinion. Evidence to guide care for midlife women and individuals with a cervix (WIC) is lacking across virtually all medical fields, and cervical screening is no exception. A robust evaluation of evidence for WIC >=50yrs is critically needed to determine the optimal age to exit WIC from HPV primary screening and how to manage HPV positive (HPV+). As primary HPV screening is a relatively new strategy, there is minimal long-term outcome data. This study will use the only North American cohort with ~20yrs of follow-up after HPV screening to address three urgent policy questions in Canada: 1) optimal age to exit WIC from HPV screening; 2) appropriate management strategies for HPV+ WIC >=50yrs at screen exit; and 3) parameters for population-level outcome models to inform HPV screening strategies across the lifespan. Participants from the HPV FOCAL trial (2008-2016), which compared HPV screening to cytology, received one or two rounds of HPV screening, then were returned to cytology testing in the provincial program. Trial participants who were >50yrs at the time of their first negative HPV test (n=9012), will be followed for ~20 years to assess risk of precancer post-HPV testing. As well, we will invite all FOCAL participants currently 67-75 (n=5439) (screening exit age is 69 in BC) to participate in HPV self-screening, with extended genotyping, which may act as a potential triage test among HPV+ WIC. This data will support the development of the first data-driven screening exit protocols for primary HPV screening, applicable in Canada and beyond.