Non-responders to organised population-based Slovenian cervical cancer screening programme ZORA have higher risk for cervical cancer and also for advanced-stage cancer than regular attendees. With aim to increase the coverage with the screening test among the target population, a randomised controlled HPV self-sampling study was implemented in Slovenia among non-responders aged 30−64 years. The study is still ongoing, it is coordinated by the programme ZORA.
Women in opt-out arm were randomly allocated to three groups, women in same group received the same self-sampling device (tester) by regular mail: Qvintip® (tester Q, Aprovix AB, Uppsala, Sweden), HerSwabTM (tester H, Eve Medical Inc, Toronto, Canada) or Delphi Screener (tester D, Rovers Medical Devices, Netherlands). Self-taken samples were sent to laboratory by mail where they were assessed for adequacy and analysed with Hybrid capture 2 (HC2). Sample was inadequate if cellularity control in HPV-negative sample was negative. HPV-positivity rate of self-taken samples for women invited to perform self-sampling in the period April − October 2015 was analysed. A multivariate logistic regression model with the type of tester as predictor was run in SPSS 16.0. For some women with HPV-positive self-taken samples also gynaecological-taken sample was obtained in Standard Transport Medium in a colposcopy clinic and analysed with HC2. Positive agreement of self-taken and gynaecological-taken samples was also analysed (positive agreement if woman had both samples positive).
Out of 1866 self-taken samples included in this analysis, 25 (1,3 %) were inadequate. HPV-positivity rate of all adequate self-taken samples was 9,2 % (170/1841), it ranged from 7,5 % (60/804, tester H), to 8,5 % (46/54, tester Q) and 13,0 % (64/493, tester D). The difference in HPV-positivity rate among testers D−H and D−Q was statistically significant (p<0,05). In 64,7 % (110/170) of women with positive self-taken samples also gynaecological-taken sample was obtained and analysed. Average time interval between the two samplings was 52 days. Positive agreement of both samples was 40,9 % (45/110), it ranged from 41,9 % (13/31, tester Q) to 41,7 % (15/36; tester H) and 39,5 % (17/43, tester D). We observed a decrease in positive agreement with increasing time interval between the two samplings, probably due to a regression of HPV infection.
HPV positivity rate of self-taken samples among Slovenian non-responders was 9,2 %. The tester used for self-sampling can be a significant predictor of the HPV-positivity rate. Histopathological correlation will be done to evaluate clinical significance of these results.