Objective The aim of this research is to implement and reliably evaluate primary human papillomavirus (HPV) screening in an established and routinely running organised, large-scale population-based screening programme.
Participants Resident women in the Stockholm/Gotland region of Sweden, aged 56–60 years were randomised to either (1) screening with cervical cytology, with HPV test in triage of low-grade cytological abnormalities (old policy) or (2) screening with HPV testing, with cytology in triage of HPV positives (new policy).
Outcome The primary evaluation was the detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
Results During January 2012–May 2014, the organised screening programme sent 42 752 blinded invitations with a prebooked appointment time to the women in the target age group. 7325 women attended in the HPV policy arm and 7438 women attended in the cytology arm. In the new policy, the population HPV prevalence was 5.5%, using an accredited HPV test (Cobas 4800). HPV16 prevalence was 1.0% (73/7325) and HPV18 prevalence was 0.3% (22/7325). In the HPV policy arm, 78/405 (19%) HPV-positive women were also cytology positive. There were 19 cases of CIN2+ in histopathology, all among women who were both HPV positive and cytology positive. The positive predictive value for CIN2+ in this group was 33.3% (19/57). In the cytology policy, 153 women were cytology positive and there were 18 cases of CIN2+ in histopathology. Both the total number of cervical biopsies and the number of cervical biopsies with benign histopathology were much lower in thepositive predictive value policy (49 benign, 87 total vs 105 benign, 132 total).
Conclusion Primary HPV screening had a similar detection rate for CIN2+ as cytology-based screening, already before follow-up of HPV-positive, cytology-negative women with new HPV test and referral of women with persistence.
Trial registration number NCT01511328.
- HPV primary screening
- cervical cancer
- organised screening programme
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Contributors HL aquired HPV testing data, coordinated the project and the writing of the paper. CE assisted in planning of the project and its quality assurance. KME assisted with registry linkages and interpretation of data. ACT coordinated the sample taking stations and assisted in planning of the project. MH performed registry linkages. KE performed the clinical follow-up of HPV-positive women, assisted with planning of the project. ST was the coordinator of the screening programme, participated in project planning, was responsible for implementation and provided supervision. JD designed the study and provided supervision. All authors contributed to the writing of the manuscript by providing important intellectual input.
Funding This study was supported by the Swedish Foundation for Strategic Research.
Competing interests None declared.
Patient consent The act of participating at the screening visit the woman had been invited to was, by the REC, regarded as consent for participation in the programme.
Ethics approval Regional ethics committee (REC) in Stockholm.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Individual-level data will be shared on request, to be sent to the corresponding author.
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