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Multicenter Study
. 2025 Oct 1;117(10):2124-2129.
doi: 10.1093/jnci/djaf054.

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

Brian Befano  1   2 , Jayashree Kalpathy-Cramer  3 , Didem Egemen  4 , Federica Inturrisi  4 , José Jeronimo  4 , Ana Cecilia Rodríguez  4 , Nicole Campos  5 , Miriam Cremer  6 , Ana Ribeiro  7 , Kayode Olusegun Ajenifuja  8 , Andrew Goldstein  9 , Amna Haider  10 , Karen Yeates  11 , Margaret Madeleine  1   12 , Teresa Norris  13 , Jacqueline Figueroa  14 , Karla Alfaro  6 , Tainá Raiol  7 , Clement Adepiti  8 , Judith Norman  15 , George Kassim Chilinda  16 , Bariki Mchome  17 , Yeycy Donastorg  18 , Xolisile Dlamini  19 , Gabriel Conzuelo  6 , Adekunbiola A Banjo  8 , Pauline Chone  20 , Alex Mremi  17 , Arismendy Benitez  18   21 , Zeev Rosberger  22 , Te Vantha  23 , Ignacio Prieto-Egido  24   25 , Jen Boyd-Morin  2 , Christopher Clark  3 , Scott Kinder  3 , Nicolas Wentzensen  4 , Kanan Desai  4 , Rebecca Perkins  26 , Silvia de Sanjosé  4   27 , Mark Schiffman  4 ; PAVE Consortium
Collaborators, Affiliations
Multicenter Study

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

Brian Befano et al. J Natl Cancer Inst. .

Abstract

The HPV-Automated Visual Evaluation Consortium is validating a cervical screening strategy enabling accurate cervical screening in resource-limited settings. A rapid, low-cost human papillomavirus (HPV) assay permits sensitive HPV testing of self-collected vaginal specimens; HPV-negative women are reassured. Triage of positive participants combines HPV genotyping (4 groups in order of cancer risk) and visual inspection assisted by automated cervical visual evaluation 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 HPV-Automated Visual Evaluation risk level (HPV genotype crossed by automated cervical visual evaluation classification) from 9 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 automated cervical visual evaluation classification strongly and independently predict risk of histologic CIN3+. The combination of these low-cost tests provided excellent risk stratification, warranting pre-implementation demonstration projects.

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Conflict of interest statement

Brian Befano –NCI/NIH Grant T32CA09168.

Jayashree Kalpathy-Cramer—Nothing to disclose.

Didem Egemen—Nothing to disclose.

Federica Inturrisi—Nothing to disclose.

José Jeronimo—Nothing to disclose.

Ana Cecilia Rodríguez—Nothing to disclose.

Nicole Campos—NCI Intramural Research Program, including supplemental funding from the Cancer Cures Moonshot Initiative. NCI grants U01CA199334/U01CA253912.

Miriam Cremer—Nothing to disclose.

Ana Ribeiro—Nothing to disclose.

Kayode Olusegun Ajenifuja—Nothing to disclose.

Andrew Goldstein—Nothing to disclose.

Amna Haider—Nothing to disclose.

Karen Yeates—Nothing to disclose.

Margaret Madeleine—U54 CA242977. ScreenFire Assay, Attila—Swabs/Copan. IRIS, Liger—Scanner, Motic.

Teresa Norris—HPV Global Action has received a contract from the Public Health Agency of Canada for the 2024-2026 period. Merck has provided unrestricted grants for projects aimed at raising awareness and educating various populations. These projects include producing white papers, reports, materials, organizing think tanks, webinars, expert symposiums, social media campaigns, school presentations, and a pride campaign. Roche has provided an unrestricted grant for a project focused on self-sampling for cervical screening in underserved populations and for hosting a symposium. Hologic has also given an unrestricted grant for a webinar. Pfizer has provided an unrestricted grant for vaccine education initiatives. The Azrieli Foundation has made a donation to support the general mission of HPV Global Action, as has PayPal Giving Fund Canada. Various high schools across Canada have made donations to support sexual health presentations. Merck has sponsored an HPV vaccine-related event, in exchange for expert consultation. Hologic has funded attendance at the Eurogin conference in Stockholm and supported a Patient Advocacy Group Day event in Brussels. Additionally, the President of HPV Global Action is involved with the organization as a registered charity in both Canada and the European Union, and serves as the Treasurer for Coalition Priorité Cancer au Québec, a registered charity in Quebec. There was also a donation of McDonald's gift cards from McDonald Incentives, which were distributed during sexual health presentations.

Jacqueline Figueroa—Nothing to disclose.

Karla Alfaro—Nothing to disclose.

Tainá Raiol—Nothing to disclose.

Clement Adepiti—Nothing to disclose.

Judith Norman—Nothing to disclose.

George Kassim Chilinda—Nothing to disclose.

Bariki Mchome—Nothing to disclose.

Yeycy Donastorg—Nothing to disclose.

Xolisile Dlamini—Nothing to disclose.

Gabriel Conzuelo—NCI—Single Visit Clinical validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (SCALE) (R01CA266059). NCI—PROGRESS: PRevention of cervical cancer using the Genotyping scREening and Same-day Self-sampling. Basic Health International—President and founder. Organon—Trainer. Merck—Advisory board.

Adekunbiola A Banjo—Nothing to disclose.

Pauline Chone—Nothing to disclose.

Alex Mremi—Nothing to disclose.

Arismendy Benitez—Nothing to disclose.

Zeev Rosberger—HPV Global Action (co-applicant) Public Health Agency of Canada (2024-2026) contract to HPV Global Action; small stipend given to me for services rendered. Canadian Immunization Research Network (2023-2024) PI: Samara Perez (co-investigator) – partial funds transferred from the PI at the McGill University Health Centre to the Lady Davis Institute for Medical Research. Quebec Cancer Coalition Payment made to my institution: Lady Davis Institute for Medical Research. Vice-President, Scientific Affairs, HPV Global Action – a registered charity in Canada and the European Union): unpaid position.

Te Vantha—Nothing to disclose.

Ignacio Prieto-Egido—NCI—Contract between the NCI and the EHAS Foundation where EHAS provides data collection tools for this work. Spanish Agency for International Development Cooperation—AECID, Spain/Comunidad de Madrid—Grants for development projects related with primary healthcare in Guatemala and Peru. Fundación EHAS, Madrid, Spain—Unpaid role as director of the foundation.

Jen Boyd-Morin—Nothing to disclose.

Christopher Clark—Nothing to disclose.

Scott Kinder—Nothing to disclose.

Nicolas Wentzensen—Nothing to disclose.

Kanan Desai—Nothing to disclose.

Rebecca Perkins—NCI—contract, American Cancer Society—Travel for academic meetings, American Cancer Society—Steering committee, National Roundtable on Cervical Cancer, National HPV vaccination Roundtable, NCI—Co-Chair, Enduring Guidelines.

Silvia de Sanjose—Nothing to disclose.

Mark Schiffman—Nothing to disclose.

Figures

Figure 1.
Figure 1.
Human Papillomavirus–Automated Visual Evaluation strategy outline from recruitment to treatment. aColor code illustrates a possible management recommendation based on risk of CIN3+, for each cell in the risk table derived by crossing human papillomavirus type group and AVE classification: Low <2%, Medium 2-9.9%, High 10-19.9%, Highest >20% (Table 1). The stability of risk estimates and resultant recommendations is low because of small numbers of participants with high-grade disease, which are expected to increase by more than fourfold by end of study. Abbreviations: AI = artificial intelligence; Neg = negative.
See this image and copyright information in PMC

References

    1. Wei F, Georges D, Man I, Baussano I, Clifford GM. Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature. The Lancet. 2024;404:435-444.
    1. Schiffman M, Doorbar J, Wentzensen N, et al. Carcinogenic human papillomavirus infection. Nat Rev Dis Primers. 2016;2:1-20.
    1. Kreimer AR, Watson-Jones D, Kim JJ, Dull P. Single-dose human papillomavirus vaccination: An update. JNCI Monographs. 2024;2024:313-316.
    1. Campos NG, Lowy DR, de Sanjosé S, Schiffman M. A cervical cancer control strategy for lower-resource settings: Interventions to complement one-dose HPV vaccination. JNCI Monographs. 2024;2024:417-423.
    1. Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO. Accessed April 2, 2025. https://iris.who.int/bitstream/handle/10665/336583/9789240014107-eng.pdf...

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