The efficiency of a screening program is significantly influenced by its attendance rate. About 30% of women living in Switzerland do not undergo cervical cancer screening, thus running a higher risk of developing cervical cancer. Our aim was to assess the feasibility and efficacy of HPV self-sampling in reaching women who do not regularly attend cervical cancer screening with the traditional strategy.
Recruitment took place in Geneva between September 2011 and November 2015. All women between the age of 25 and 69 years, who had not undergone Pap testing in the preceding 3 years, not pregnant and with no prior hysterectomy, were considered eligible to take part in the study. The enrolled participants were then randomized into either the control group, in which they were asked to come to the hospital for a Pap test, or the study group, in which they were invited to perform a home-based HPV self-test. All statistical analyses were done with Stata/IC, Version 14.0.
A total of 667 women were enrolled in the study, of which 336 were randomized into the study group and 331 were assigned to the control group. The mean age of participants was 42.2 ± 10.9 years. Only 218 (32.9 %) women were European, while the majority (n=443, 67.0%) had a foreign nationality. When considering the participants who underwent further clinical management based on their primary screening results, the drop-out rates were 10.4% and 8.8% in the study and in the control group, respectively (p=0.468). The prevalence of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) found in the HPV group was 2.9%, comparing to the 1.2% of CIN2+ found in the Pap test group (p=0.032). HPV-test positivity to HPV-16 was associated to 60.0% of CIN2+ lesions (p=0.054). HPV positivity and ASCUS+ prevalence declined with increasing age.
The HPV self-test is a feasible mean of reaching women who don’t regularly attend cervical cancer screening. With a significantly higher sensitivity in detecting CIN2+, this primary screening tool represents a valid substitute to physician-performed Pap testing.