HPV self-sampling in the follow-up of women after treatment of cervical intra-epithelial neoplasia: A prospective study in a high-income country

Abstract

Current follow-up strategy for women after large loop excision of the transformation zone (LLETZ) for cervical intra-epithelial neoplasia (CIN) is burdened by a low compliance. We evaluated the performance of home-based Human Papillomavirus (HPV) self-sampling (Self-HPV) after treatment for CIN with the aim to assess the (i) feasibility and (ii) follow-up compliance. This study took place at the Geneva University Hospitals between May 2016 and September 2020. Women aged 18 years or older, undergoing LLETZ for a biopsy-proven cervical intraepithelial neoplasia grade 1 or worse (CIN1 + ) were invited to participate. Agreement statistics, interpreted according to the scale of κ values, were calculated for Self-HPV and HPV performed by the physician (Dr-HPV). The samples were analyzed using GeneXpert and Cobas. Sample size was calculated to provide a 10% precision to estimate the kappa coefficient. A total of 127 women were included, with a median age of 35 years (interquartile range 30–41 years). There was a substantial agreement between Self-HPV and Dr-HPV using GeneXpert at 6 and 12 months, with a κ value of 0.63 (95%CI: 0.47–0.79) and 0.66 (95%CI: 0.50–0.82), respectively. Up to 9/10 (90%) women who did not come to their follow-up visit did not send their Self-HPV, either. In the follow-up after LLETZ treatment, home-based self-HPV is feasible, with substantial agreement between the two groups, however, concern remains regarding adherence to Self-HPV performance at home and loss to follow-up.The trial was registered on clinicaltrials.gov with the identifier NCT02780960.