Design of the Hpv-Automated Visual Evaluation (Pave) Study: Validating a Novel Cervical Screening Strategy

Authors

Silvia de Sanjosé, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Rebecca B. Perkins, University Chobanian and Avedisian School of Medicine/Boston Medical Center, Boston, United States.
Nicole Campos, Center for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, United States.
Federica Inturrisi, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Didem Egemen, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Brian Befano, Information Management Services Inc, Calverton, United States.
Ana Cecilia Rodriguez, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Jose Jerónimo, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Li C. Cheung, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Kanan Desai, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Paul Han, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, Rockville, United States.
Akiva P. Novetsky, Westchester Medical Center/New York Medical College, Valhalla, United States.
Abigail Ukwuani, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Jenna Marcus, Feinberg School of Medicine at Northwestern University, Chicago, United States.
Syed Rakin Ahmed, Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Boston, United States.
Nicolas Wentzensen, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.
Jayashree Kalpathy-Cramer, Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Boston, United States.
Mark Schiffman, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, United States.

Author Type(s)

Faculty

Journal Title

ELife

Document Type

Article

Publication Date

1-15-2024

Department

Obstetrics and Gynecology

Abstract

BACKGROUND: The HPV-automated visual evaluation (PAVE) Study is an extensive, multinational initiative designed to advance cervical cancer prevention in resource-constrained regions. Cervical cancer disproportionally affects regions with limited access to preventive measures. PAVE aims to assess a novel screening-triage-treatment strategy integrating self-sampled HPV testing, deep-learning-based automated visual evaluation (AVE), and targeted therapies. METHODS: Phase 1 efficacy involves screening up to 100,000 women aged 25-49 across nine countries, using self-collected vaginal samples for hierarchical HPV evaluation: HPV16, else HPV18/45, else HPV31/33/35/52/58, else HPV39/51/56/59/68 else negative. HPV-positive individuals undergo further evaluation, including pelvic exams, cervical imaging, and biopsies. AVE algorithms analyze images, assigning risk scores for precancer, validated against histologic high-grade precancer. Phase 1, however, does not integrate AVE results into patient management, contrasting them with local standard care.Phase 2 effectiveness focuses on deploying AVE software and HPV genotype data in real-time clinical decision-making, evaluating feasibility, acceptability, cost-effectiveness, and health communication of the PAVE strategy in practice. RESULTS: Currently, sites have commenced fieldwork, and conclusive results are pending. CONCLUSIONS: The study aspires to validate a screen-triage-treat protocol utilizing innovative biomarkers to deliver an accurate, feasible, and cost-effective strategy for cervical cancer prevention in resource-limited areas. Should the study validate PAVE, its broader implementation could be recommended, potentially expanding cervical cancer prevention worldwide. FUNDING: The consortial sites are responsible for their own study costs. Research equipment and supplies, and the NCI-affiliated staff are funded by the National Cancer Institute Intramural Research Program including supplemental funding from the Cancer Cures Moonshot Initiative. No commercial support was obtained. Brian Befano was supported by NCI/ NIH under Grant T32CA09168.

Recommended Citation

de Sanjosé, S., Perkins, R. B., Campos, N., Inturrisi, F., Egemen, D., Befano, B., Rodriguez, A. C., Jerónimo, J., Cheung, L. C., Desai, K., Han, P., Novetsky, A. P., Ukwuani, A., Marcus, J., Ahmed, S. R., Wentzensen, N., Kalpathy-Cramer, J., & Schiffman, M. (2024). Design of the Hpv-Automated Visual Evaluation (Pave) Study: Validating a Novel Cervical Screening Strategy. ELife, 12. https://doi.org/10.7554/eLife.91469