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

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.

Application of CytoPath®Easy Vials in Cervical Cancer Screening: Self-Sampling Approach

“…[ 12 13 14 15 ] Drawing from this information, several European nations have already incorporated the utilization of self-sampling kits into their strategies to enhance the coverage of screening programs. [ 13 16 ]…”

Evaluating Opt-In Vaginal Human Papillomavirus Self-Sampling: Participation Rates and Detection of High-Grade Lesions (CIN2+) among Unscreened Japanese Women Aged 30–39

“…Previous studies have reported that 79.5% and 63.2% of participants who were unscreened for 4 and 10 years, respectively, who agreed to opt-in HPV self-sampling returned the kit, with respective return rates of 20.7% and 8.15% [ 26 , 27 ]. In a report from Norway, the participation rates with reminders to attend regular screening, opt-in HPV self-sampling, and opt-out HPV self-sampling were 4.8%, 17.0%, and 27.7%, respectively [ 45 ]. In the present study, opt-in HPV self-sampling had a good return rate, as in other studies.…”

Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits

“…An additional trial of underscreened individuals in Norway evaluated opt-in and mail-to-all (with 1 reminder call) groups. Screening was increased by 12.3% over usual care for participants randomized to the opt-in group, but direct mail increased screening by 22.9% . We did not evaluate an opt-in group among overdue participants because international trial data supported direct-mail superiority .…”

“…Results may not generalize to non–English-speaking individuals or those without health insurance. The opt-in participants did not receive postinvitation reminders, but some data suggest that reminders boost opt-in effectiveness . Finally, STEP launched during the COVID-19 pandemic.…”