Abstract Background: Human papillomavirus testing on vaginal self-samples (VSS) has recently been offered in France as an option for women aged 30 to 65 years who are not regularly screened for cervical cancer. Human papillomavirus testing can also be performed on first-void urine. Methods: The CapU4 study is a three-arm randomized controlled trial enrolling 14,997 women aged 30 to 65 years who had no screening test recorded for more than 4 years and who did not respond to an invitation letter 12 months prior. Women were allocated to two experimental arms [mailing of a VSS or a urine self-sampling (USS) kit] or to a control arm (invitation to visit a physician to collect a cervical specimen). Results: A total of 13,061 women were included. The intention-to-treat analysis demonstrated that the participation rate increased in the self-sampling arms (USS: 23.6%; VSS: 23.5%) compared with the control arm (12.9%). The per-protocol analysis did not show a favorable effect (USS: 11.1%; VSS: 12.6%), particularly for USS. Conclusions: Invitations including VSS or USS kits increased participation in cervical cancer screening by approximately 11%. Half of the responding women in the self-sampling arms visited a physician to take a cervical specimen. Impact: There is evidence that sending VSS kits can increase attendance at cervical cancer screening. However, no data exist suggesting that sending urine collection kits may also be effective in triggering participation compared with conventional invitation letters. The results of the CapU4 trial may generate innovative tools that could help optimize attendance at cervical cancer screening.

Abstract Background: Human papillomavirus testing on vaginal self-samples (VSS) has recently been offered in France as an option for women aged 30 to 65 years who are not regularly screened for cervical cancer. Human papillomavirus testing can also be performed on first-void urine. Methods: The CapU4 study is a three-arm randomized controlled trial enrolling 14,997 women aged 30 to 65 years who had no screening test recorded for more than 4 years and who did not respond to an invitation letter 12 months prior. Women were allocated to two experimental arms [mailing of a VSS or a urine self-sampling (USS) kit] or to a control arm (invitation to visit a physician to collect a cervical specimen). Results: A total of 13,061 women were included. The intention-to-treat analysis demonstrated that the participation rate increased in the self-sampling arms (USS: 23.6%; VSS: 23.5%) compared with the control arm (12.9%). The per-protocol analysis did not show a favorable effect (USS: 11.1%; VSS: 12.6%), particularly for USS. Conclusions: Invitations including VSS or USS kits increased participation in cervical cancer screening by approximately 11%. Half of the responding women in the self-sampling arms visited a physician to take a cervical specimen. Impact: There is evidence that sending VSS kits can increase attendance at cervical cancer screening. However, no data exist suggesting that sending urine collection kits may also be effective in triggering participation compared with conventional invitation letters. The results of the CapU4 trial may generate innovative tools that could help optimize attendance at cervical cancer screening.