Journal Article

Value of a catch-up HPV test in women aged 65 and above: A Danish population-based nonrandomized intervention study

Andersen, Berit, Blaakær, Jan, Jensen, Jørgen Skov, Hammer, Anne, Petersen, Lone Kjeld, Jørgensen, Susanne Fogh, Tranberg, Mette, Elfström, Miriam, Bennetsen, Mary Holten

2023

Overview

High-risk human papillomavirus (HPV) test is replacing cytology as the primary cervical cancer screening test due to superior sensitivity, but in most countries women ≥65 years have never had an HPV test despite they account for around 50% of cervical cancer deaths. We explored the effect of a catch-up HPV test among 65- to 69-year-old women without previous record of HPV-based screening. This population-based nonrandomized intervention study (quasi-experimental design) included Danish women aged 65 to 69 with no record of cervical cancer screening in the last ≥5.5 years and no HPV-exit test at age 60 to 64 at the time of study inclusion. Eligible women residing in the Central Denmark Region were invited for HPV screening either by attending clinician-based sampling or requesting a vaginal self-sampling kit (intervention group, n = 11,192). Women residing in the remaining four Danish regions received standard care which was the opportunity to have a cervical cytology collected for whatever reason (reference group, n = 33,387). Main outcome measures were detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+) per 1,000 women eligible for the screening offer and the benefit-harm ratio of the intervention and standard practice measured as the number of colposcopies needed to detect one CIN2+ case. The minimum follow-up time was 13 months for all tested women (range: 13 to 25 months). In the intervention group, 6,965 (62.2%) were screened within 12 months from the date of study inclusion and 743 (2.2%) women had a cervical cytology collected in the reference group. The CIN2+ detection was significantly higher in the intervention group (3.9, 95% confidence interval (CI): [2.9, 5.3]; p < 0.001; n = 44/11,192) as compared to the reference group (0.3, 95% CI: [0.2, 0.6]; n = 11/33,387). For the benefit-harm ratio, 11.6 (95% CI: [8.5, 15.8]; p = 0.69; n = 511/44) colposcopies were performed to detect one CIN2+ in the intervention group as compared to 10.1 (95% CI: [5.4, 18.8]; n = 111/11) colposcopies in the reference group. The study design entails a risk of confounding due to the lack of randomization. The higher CIN2+ detection per 1,000 eligible women in the intervention group supports that a catch-up HPV test could potentially improve cervical cancer prevention in older women. This study informs the current scientific debate as to whether women aged 65 and above should be offered a catch-up HPV test if they never had an HPV test. ClinicalTrials.gov NCT04114968.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Age / Aged / Analysis / Biology and life sciences / Biopsy / Cancer / Cancer screening / Care and treatment / Cellular biology / Cervical cancer / Colposcopy / Committees / Cytology / Denmark - epidemiology / Diagnosis / Early Detection of Cancer - methods / Female / Health aspects / Human papillomavirus / Humans / Hysterectomy / Mass Screening - methods / Medical screening / Medical tests / Medicine and Health Sciences / Middle Aged / Oncology, Experimental / Papillomaviridae / Papillomavirus infections / Papillomavirus Infections - diagnosis / Papillomavirus Infections - epidemiology / Papillomavirus Infections - prevention & control / Pathology / People and Places / Population studies / Population-based studies / Prevention / Risk factors / Sampling / Sensitivity analysis / Uterine Cervical Dysplasia - diagnosis / Uterine Cervical Neoplasms - diagnosis / Uterine Cervical Neoplasms - epidemiology / Uterine Cervical Neoplasms - prevention & control / Vagina / Vaginal Smears / Women / Womens health