Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter

P Giorgi Rossi, C Fortunato, P Barbarino, S Boveri, S Caroli, A Del Mistro, A Ferro, C Giammaria, M Manfredi, T Moretto, A Pasquini, M Sideri, M C Tufi, C Cogo, E Altobelli, HPV Self-sampling Italian Working Group, Tina Moretto, Carmen Barro, Sandro Cinquetti, Lucia Bittesini, Gianpiero Fantin, Antonio Ferro, Gabriella Penon, Sandra Bertazzo, Laura Toniolo, Angelo Farrugio, Patrizia Cocco, Pierfrancesco Gerace, Sonia Capuzzo, Mariangela Vitaliani, Milena Fioravanti, Cristina Benvegnù, Annarosa Del Mistro, Helena Frayle, Martina Rizzi, Rossana Trevisan, Carla Cogo, Manuel Zorzi, Chiara Fedato, Carmine Fortunato, Giorgio Scarselli, Emma Altobelli, Amedeo Lattanzi, Stefania Caroli, Paolo Giorgi Rossi, Katiuscia La Terra, Paolo Barbarino, Maria Concetta Tufi, Carla Gimmaria, Marilena Manfredi, Adriana Pasquini, Mario Sideri, Sara Boveri, P Giorgi Rossi, C Fortunato, P Barbarino, S Boveri, S Caroli, A Del Mistro, A Ferro, C Giammaria, M Manfredi, T Moretto, A Pasquini, M Sideri, M C Tufi, C Cogo, E Altobelli, HPV Self-sampling Italian Working Group, Tina Moretto, Carmen Barro, Sandro Cinquetti, Lucia Bittesini, Gianpiero Fantin, Antonio Ferro, Gabriella Penon, Sandra Bertazzo, Laura Toniolo, Angelo Farrugio, Patrizia Cocco, Pierfrancesco Gerace, Sonia Capuzzo, Mariangela Vitaliani, Milena Fioravanti, Cristina Benvegnù, Annarosa Del Mistro, Helena Frayle, Martina Rizzi, Rossana Trevisan, Carla Cogo, Manuel Zorzi, Chiara Fedato, Carmine Fortunato, Giorgio Scarselli, Emma Altobelli, Amedeo Lattanzi, Stefania Caroli, Paolo Giorgi Rossi, Katiuscia La Terra, Paolo Barbarino, Maria Concetta Tufi, Carla Gimmaria, Marilena Manfredi, Adriana Pasquini, Mario Sideri, Sara Boveri

Abstract

Background: We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter.

Methods: Women aged 30-64 non-responding to screening invitation were eligible. Response rate to first invitation ranged from 30% to 60% between centres. The control was the standard reminder letter to undergo the test used by the programme (Pap test in three centres and HPV DNA test in three other centres). Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV. The analysis was intention-to-treat.

Results: In all, 14 041 women were randomised and recruited: 5012 in the control arm, 4516 to receive the self-sampler at home, and 4513 to pick up the self-sampler at a pharmacy. Participation was 11.9% in the control, 21.6% (relative participation: 1.75; 95% CI 1.60-1.93) in home, and 12.0% (relative participation: 0.96; 95% CI 0.86-1.07) in the pharmacy arms, respectively. The heterogeneity between centres was high (excess heterogeneity of that expected due to chance, i.e., I(2), 94.9% and 94.1% for home and pharmacy arm, respectively). The estimated impact on the overall coverage was +4.3% for home mail self-sampling compared with +2.2% for standard reminder.

Conclusions: Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes, even in those with HPV as primary testing. Picking up at pharmacies showed effects varying from centre to centre.

Trial registration: ClinicalTrials.gov NCT01647724.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Results: (A) self-samplers mailed home; (B) self-sampler from pharmacy, random effects.

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