Initial evaluation of a new cervical screening strategy combining human papillomavirus genotyping and automated visual evaluation: the Human Papillomavirus-Automated Visual Evaluation Consortium

Abstract

The HPV-Automated Visual Evaluation (PAVE) Consortium is validating a cervical screening strategy enabling accurate cervical screening in resource-limited settings. A rapid, low-cost HPV assay permits sensitive HPV testing of self-collected vaginal specimens; HPV-negative women are reassured. Triage of positives combines HPV genotyping (four groups in order of cancer risk) and visual inspection assisted by automated cervical visual evaluation (AVE) that classifies cervical appearance as severe, indeterminate, or normal. Together, the combination predicts which women have precancer, permitting targeted management to those most needing treatment. We analyzed CIN3+ yield for each PAVE risk level (HPV genotype crossed by AVE classification) from nine clinical sites (Brazil, Cambodia, Dominican Republic, El Salvador, Eswatini, Honduras, Malawi, Nigeria, and Tanzania). Data from 1832 HPV-positive participants confirmed that HPV genotype and AVE classification each strongly and independently predict risk of histologic CIN3+. The combination of these low-cost tests provided excellent risk stratification, warranting pre-implementation demonstration projects.