Table 1.
SPIRIT flow chart for Trial23
| Study period | |||||
| Enrolment/ allocation |
Postallocation | Close-out | |||
| Baseline screen | Second screen | Third screen | |||
| Timepoint | January 2017* | February 2017–September 2018 | January 2020–September 2021 | January 2023– September 2024 | 1 October 2025† |
| Enrolment | |||||
| Eligibility | X | ||||
| Allocation | X | ||||
| Intervention | |||||
| HPV arm (CYT+HPV) | <—> | <—>‡ | <—> | ||
| Present programme arm (CYT) | <—> | <—> | <—> | ||
| Assessment | |||||
| Baseline screen | X | ||||
| Second screen | X | ||||
| Third screen | X | ||||
| Final | X | ||||
*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.