Table 1

SPIRIT flow chart for Trial23

Study period
Enrolment/
allocation
PostallocationClose-out
Baseline screenSecond screenThird screen
TimepointJanuary 2017*February 2017–September 2018January 2020–September 2021January 2023– September 20241 October 2025†
Enrolment
 EligibilityX
 AllocationX
Intervention
 HPV arm (CYT+HPV)<—> <—>‡<—>
 Present programme arm (CYT)<—> <—> <—>
Assessment
 Baseline screenX
 Second screenX
 Third screenX
 FinalX
  • *All women born in 1994 living in Denmark in January 2017 were randomly allocated to HPV or present programme arm.

  • †End-of-study allowing for 1 year extra for women followed up due to abnormal cytology in former screening rounds.

  • ‡Women with positive HPV test and normal cytology at baseline are retested after 3 years for both HPV and cytology.

  • CYT, cytology; HPV, human papillomavirus; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.