Building the foundations for an organized population-based cervical cancer screening program with primary HPV self-sampling in Catalonia, Spain: findings from a pilot implementation study

Paula Peremiquel-Trillas^1,2,3,4,5*Esther Roura^1,2,6Valentina Rangel^1,2,3Francisca Morey^1,2Rebeca Font^1,7Maite Carvajal^1,2Claudia Robles^1,2Raquel Ibañez^1,2,5Lara Pijuan⁸Lourdes Tamarit⁹Dolça Cortasa²Daniel Fernandez⁹Josep Alfons Espinàs⁷Laia Bruni^1,2,3,5*Catalan Cervical Cancer Screening Program working group²

• ¹Bellvitge Biomedical Research Institute – IDIBELL, L’Hospitalet de Llobregat, Spain, L'Hospitalet de Llobregat, Barcelona, Spain
• ²Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain
• ³Faculty of Medicine, University of Barcelona, Barcelona, Spain
• ⁴Faculty of Nursing and Health Sciences, University of Barcelona, L'Hospitalet de Llobregat, Spain
• ⁵Center for Biomedical Research in Epidemiology and Public Health Network, Carlos III Health Institute (ISCIII), Madrid, Madrid, Spain
• ⁶Consortium for Biomedical Research in Epidemiology and Public Health – CIBERESP, Carlos III Institute of Health, Madrid, Asturias, Spain
• ⁷Catalan Cancer Plan, Department of Health, Barcelona, Balearic Islands, Spain
• ⁸Department of Pathology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain
• ⁹Barcelona Metropolitan South Health Region, Catalan Health Service, Barcelona, Balearic Islands, Spain

As part of the transition from opportunistic cytology-based screening to an organized, population-based HPV screening program, Catalonia, Spain, launched an implementation pilot in 2021. The pilot combined home-based HPV self-sampling with pharmacy-based distribution, coordinated by a screening office using an SMS-based for invitation and reminders, alongside structured follow-up of HPV-positive cases by midwives. From July 2021 to December 2023, 6,355 women seeking cervical cancer screening were invited to participate in HPV self-sampling via SMS, with high participation (80.9%). Among HPV-positive women (11.8%), compliance with triage cytology was high (98.7%), as with colposcopy referrals when indicated (97.2%). CIN2+ detection rates were (3.6% overall, 13.1% in HPV-16 positive) aligned with international studies, reinforcing the value of genotype-specific risk stratification and risk-adapted follow-up pathways in our setting. This organized approach facilitated timely case management and demonstrated the feasibility, acceptability, and effectiveness of the model. While conducted in an opportunistic screening context with a relatively short follow-up time, these findings support HPV self-sampling as an effective primary screening strategy, including women who regularly attend cervical cancer screening, and provide key insights for its scalability within a population-based program, which began its pilot phase in 2024 and is set for full implementation in 2025.