A randomised controlled HPV self-sampling study was implemented in Slovenia with the aim to increase participation of non-responders to the organised population based cervical cancer screening programme ZORA. The study is still ongoing; it is coordinated by the national coordination office of programme ZORA and financed by Ministry of Health and Slovenian Research Agency (No. L3-5512). The objective of this analysis is to assess the acceptance of HPV self-sampling among Slovenian non-responders and association of response rate with a type of self-sampling device.
Non-responders aged 30−64 were randomly sampled from the national screening registry. They were allocated to the control arm (C) and two intervention arms for HPV self-sampling at home: I1 (n = 14.400, opt-in) and I2 (n = 9.556, opt-out). Women in I2 were randomly allocated to three groups I2-Q (n = 3,284), I2-H (n = 3,284) and I2-D (n = 2.988). Women who did not opted-out for self- sampling received one of three self-sampling devices (testers): women in I2-Q received Qvintip® (tester Q, Aprovix AB, Uppsala, Sweden), women in I2-H received HerSwabTM (tester H, Eve Medical Inc, Toronto, Canada) and women in I2-D received Delphi Screener (tester D, Rovers Medical Devices, Netherlands). In I1 only tester Q was used.
Intention to screen response rate (no. of self-taken samples/no. women randomised with the intention to screen) and per-protocol response rate (no. of self-taken samples/no. of women who received tester per protocol) in intervention arms I1 and I2 will be analysed. Multivariate logistic regression in SPSS 16.0 will be used with the type of tester and age of women as predictors for the response of women in I2.
HPV self-sampling is well accepted by Slovenian non-responders. The tester used for self-sampling can be a significant predictor of the response rate regardless the age of the women. To evaluate the clinical significance of these results the additional response that will include women without self-taken sample but with a Pap smear (after they were invited for self-sampling) will be assessed as well as the high-grade lesions detection rate.