Search

Broad accessibility to cervical cancer screening and high participation rate is essential to reduce cervical cancer incidence. HPV self-sampling is an alternative to clinician collected cervical samples to increase accessibility and screening coverage. To inform on deployment strategies of HPV self-sampling, this large-scale, randomized, pragmatic study compared two invitation modalities; direct-mail and opt-in. The study included screening non-attenders from the Capital Region of Denmark randomly allocated (1:4) to a direct-mail or opt-in invitation for cervical screening by HPV self-sampling. Primary endpoint was screening participation; secondary endpoints were HPV prevalence and histology outcome. Adherence to follow-up and cost were also evaluated. After exclusion of hysterectomized/non-accessible women, 49,393 women were invited: 9639 by direct-mail, and 39,754 by the opt-in offer. A direct-mail invitation for HPV self-sampling yielded a significant higher participation than an opt-in invitation. HPV self-sample participation for direct-mail was 25.2% (n = 2426), opt-in participation was 20.2% (n = 8047), adjusted OR = 1.27, 95% CI 1.20-1.34. Participation increased with age (p < .0001) for both strategies and decreased with screening history of non-attendance (p < .0001). Interaction between invitation strategy and age/screening history was found; more women below 50 years of age participated by direct-mail compared to opt-in (p < .0001) and higher participation by direct-mail group was found in women with a short history of non-attendance (p < .0001). Participation of long-term unscreened women was similar between arms. The relative cost was ≈14 HPV self-sample kits distributed per additional participant by direct-mail over opt-in. HPV prevalence, adherence to follow-up, and detection of high-grade cervical intraepithelial neoplasia was similar between invitation strategies., (© 2024 The Author(s). International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Whereas HPV16 and HPV18 have been the focus in current risk-based cervical cancer screening algorithms using HPV genotype information, mounting evidence suggests that oncogenic HPV types such as HPV31, 33, 52 and 58 pose a ≥CIN3 risk equivalent to or greater than that of HPV18, and the combined risk of HPV31 and HPV33 rivals even HPV16 in women above 30 years of age. Here, we evaluate the baseline risk of CIN2 and CIN3 by genotype in a colposcopy referral population from Denmark and Italy. In total, 655 women were enrolled upon a referral to colposcopy after a positive screening sample. All samples were HPV analyzed using Onclarity HPV assay with extended genotyping and combined with the histology outcomes, a Bayesian probability modeling was used to determine the risk per genotype assessed. The combined data for this referral population showed that the ≥CIN2 risk of HPV16 was 69.1%, HPV31 at 63.3%, HPV33/58 at 52.7%, HPV18 at 46.6% and HPV52 at 40.8%. For ≥CIN3, the risks were 44.3%, 38.5%, 36.8%, 30.9% and 16.8% for HPV16, HPV31, HPV18, HPV33/58 and HPV52, respectively, indicating that the baseline risk of disease arising from HPV16 is, not surprisingly, the highest among the oncogenic HPV genotypes. We find that the HPV genotype-specific ≥CIN2 and ≥CIN3 risk-patterns are so distinct that, for example, 35/39/68 and 56/59/66 should be considered only for low intensive follow-up, thereby proposing active use of this information in triage strategies for screening HPV-positive women., (© 2019 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)