The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600)

P Giorgi Rossi, L M Marsili, L Camilloni, A Iossa, A Lattanzi, C Sani, C Di Pierro, G Grazzini, C Angeloni, P Capparucci, A Pellegrini, M L Schiboni, A Sperati, M Confortini, C Bellanova, A D'Addetta, E Mania, C B Visioli, E Sereno, F Carozzi, Self-Sampling Study Working Group, Paolo Giorgi Rossi, Alessandra Sperati, Laura Camilloni, Laila Maria Marsili, Paola Capparucci, Concetta Bellanova, Piero Borgia, Claudio Angeloni, Amedeo Lattanzi, Tatiana Reggi, Patrizia Bruni, Clara Monaco, Anna Iossa, Massimo Confortini, Francesca Maria Carozzi, Elena Burroni, Giovanni Pontenani, Carmen Beatriz Visioli, Cristina Sani, Carmelina Di Pierro, Elisa Sereno, P Giorgi Rossi, L M Marsili, L Camilloni, A Iossa, A Lattanzi, C Sani, C Di Pierro, G Grazzini, C Angeloni, P Capparucci, A Pellegrini, M L Schiboni, A Sperati, M Confortini, C Bellanova, A D'Addetta, E Mania, C B Visioli, E Sereno, F Carozzi, Self-Sampling Study Working Group, Paolo Giorgi Rossi, Alessandra Sperati, Laura Camilloni, Laila Maria Marsili, Paola Capparucci, Concetta Bellanova, Piero Borgia, Claudio Angeloni, Amedeo Lattanzi, Tatiana Reggi, Patrizia Bruni, Clara Monaco, Anna Iossa, Massimo Confortini, Francesca Maria Carozzi, Elena Burroni, Giovanni Pontenani, Carmen Beatriz Visioli, Cristina Sani, Carmelina Di Pierro, Elisa Sereno

Abstract

Background: In Italy, cervical cancer screening programmes actively invite women aged 25-64 years. Programmes are hindered by low participation.

Methods: A sample of non-responder women aged 35-64 years, belonging to three different programmes (in Rome, Florence and Teramo), was randomly split into four arms: two control groups received standard recall letters to perform either Pap-test (first group) or human papillomavirus (HPV) test (second group) at the clinic. A third arm was sent letters offering a self-sampler for HPV testing, to be requested by phone, whereas a fourth group was directly sent the self-samplers home.

Results: Compliance with standard recall was 13.9% (N619). Offering HPV test at the clinic had a nonsignificant effect on compliance (N616, relative risk (RR)=1.08; 95% CI=0.82-1.41). Self-sampler at request had the poorest performance, 8.7% (N622, RR=0.62; 95% CI=0.45-0.86), whereas direct mailing of the self-sampler registered the highest compliance: 19.6% (N616, RR=1.41; 95% CI=1.10-1.82). This effect on compliance was observed only in urban areas, Florence and Rome (N438, RR=1.69; 95% CI=1.24-2.30), but not in Abruzzo (N178, RR=0.95; 95% CI=0.61-1.50), a prevalently rural area.

Conclusions: Mailing self-samplers to non-responders may increase compliance as compared with delivering standard recall letters. Nevertheless, effectiveness is context specific and the strategy costs should be carefully considered.

Figures

Figure 1
Figure 1
Flowchart of the study design. ASC-US+, women with cytology atypical squamous cells of unknown significance or more severe; HPV+, women with high-risk HPV DNA test positive.

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Source: PubMed

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