HPV self-sampling among long-term non-attenders to cervical cancer screening in Norway: a pragmatic randomised controlled trial

Gunvor Aasbø, Ameli Tropè, Mari Nygård, Irene Kraus Christiansen, Ingrid Baasland, Grete Alrek Iversen, Ane Cecilie Munk, Marit Halonen Christiansen, Gro Kummeneje Presthus, Karina Undem, Tone Bjørge, Philip E Castle, Bo T Hansen, Gunvor Aasbø, Ameli Tropè, Mari Nygård, Irene Kraus Christiansen, Ingrid Baasland, Grete Alrek Iversen, Ane Cecilie Munk, Marit Halonen Christiansen, Gro Kummeneje Presthus, Karina Undem, Tone Bjørge, Philip E Castle, Bo T Hansen

Abstract

Background: Cervical cancer screening participation is suboptimal in most settings. We assessed whether human papillomavirus (HPV) self-sampling may increase screening participation among long-term non-attenders in Norway.

Methods: A pragmatic randomised controlled trial with participation as the primary outcome was initiated in the national cervical screening programme in March 2019. A random sample of 6000 women aged 35-69 years who had not attended screening for at least 10 years were randomised 1:1:1 to receive either (i) a reminder to attend regular screening (control), (ii) an offer to order a self-sampling kit (opt-in) for HPV testing or (iii) a self-sampling kit unsolicited (send-to-all) for HPV testing.

Results: Total participation was 4.8%, 17.0% and 27.7% among control, opt-in and send-to-all (P < 0.0001; participation difference (%) send-to-all vs. control: 22.9 (95%CI: 20.7, 25.2); opt-in vs. control: 12.3 (95%CI: 10.3, 14.2); send-to-all vs. opt-in: 10.7 (95% CI: 8.0, 13.3)). High-risk HPV was detected in 11.5% of self-samples and 9.2% of clinician-collected samples (P = 0.40). Most women (92.5%) who returned a positive self-sample attended the clinic for triage testing. Of the 933 women screened, 33 (3.5%) had CIN2 + (1.1%, 3.7%, 3.8% among control, opt-in, and send-to-all, respectively), and 11 (1.2%) had cervical cancer (0%, 1.2%, 1.3% among control, opt-in, send-to-all, respectively).

Conclusion: Opt-in and send-to-all self-sampling increased screening participation among long-term, higher-risk non-attenders.

Clinical trial registration: ClinicalTrials.gov NCT03873376.

Conflict of interest statement

Dr. Castle has received HPV tests and assays for research at a reduced or no cost from Roche, Becton Dickinson, Cepheid, and Arbor Vita Corporation. The remaining authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1. Study flowchart.
Fig. 1. Study flowchart.
Excluded women were either not reached, not eligible or declined to participate in the study.
Fig. 2. Participation rate (%) during 6…
Fig. 2. Participation rate (%) during 6 months following the invitation.
Total participation was 4.8% in the control arm, 17.0% in the opt-in arm and 27.7% in the send-to-all arm.

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