Health Care Policy Implementation Trial of Primary Human Papillomavirus-Based Cervical Screening in Denmark.

On mandate from the Danish Health Authority, a nationwide health care policy trial (HCP) of primary HPV screening for women aged 30-59 was initiated in 2021. The aim was to inform on the performance of HPV screening in comparison to existing cytology practice. The HCP trial included all Danish women between 30 and 59 years of age undergoing cervical cancer screening in 2021 (n = 178,323). Women with odd birthdays were screened with HPV screening (n = 91,517), while women born on even dates were screened with cytology (n = 86,806). The follow-up period was individually censored at 18 months from the screening date. Outcomes and intention-to-treat analysis are reported. Overall, 9.1% and 3.0% were HPV or cytology positive on the index sample. Referral to colposcopy upon index sample was 1.9% with HPV and 2.1% with cytology screening. Referral to retest after a positive HPV index sample result was 7.7 higher for HPV than cytology. Combining index and retest rounds, 6.3% women had colposcopy in the HPV arm (RR 1.28) versus 4,9% in the cytology arm. HPV screening detected both more disease ≥ CIN2 (RR 1.51) and ≥ CIN3 (RR1.35). The national-scale health care policy implementation trial showed that HPV-based cervical cancer screening increased detection of histologically defined disease compared to the previous policy of cytology-based screening for women 30-59 years of age. The HCP demonstrated the real-life effect of HPV-based screening over cytology-based screening in detection of disease, but also details what to be expected in terms of health care resource requirements.