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Although cytology‐based screening programs have significantly reduced mortality and morbidity from cervical cancer, the global consensus is that primary human papillomavirus ( HPV ) testing for cervical screening increases detection of high‐grade cervical intraepithelial neoplasia ( CIN ) and invasive cancer. However, the optimal triage strategy for  HPV ‐positive women to avoid over‐referral to colposcopy may be setting specific. As Japan requires data that have been generated domestically to modify screening guidelines, we conducted a 3‐year prospective study,  COM parison of  HPV  genotyping And Cytology Triage ( COMPACT ), to evaluate the potential role of  HPV 16/18 partial genotyping and cytology for primary  HPV  screening. In total, 14 642 women aged 20 to 69 years undergoing routine screening at 3 centers in Hokkaido were enrolled. Conventional cytology and  HPV  testing were carried out. Women with abnormal cytology or  HPV 16/18 positivity underwent colposcopy. Those with 12 other high‐risk (hr)  HPV  types underwent repeat cytology after 6 months. Primary study endpoints were detection of high‐grade cervical disease defined as  CIN 2/ CIN 3 or greater as determined by consensus pathology. Prevalence of cytological abnormalities was 2.4%. hr HPV ,  HPV  16, and  HPV  18 were detected in 4.6%, 0.9%, and 0.3% of women, respectively.  HPV 16/18 were detected in all (8/8) invasive cervical cancers and in all (2/2) adenocarcinomas in situ. Both cytological abnormalities and hr HPV  positivity declined with increasing age. This is the first Japanese study to investigate the role of partial genotyping and cytology in an  HPV ‐based screening program. Results should help policy‐makers develop guidelines for future cervical screening programs and management of cervical abnormalities based on  HPV  genotype.

Comparison of human papillomavirus genotyping and cytology triage, COMPACT Study: Design, methods and baseline results in 14 642 women