Abstract
Objective: Determine the feasibility of high-risk human papillomavirus (HPV)-based cervical screening that included the option of a vaginal swab HPV test (vaginal self-test).
Design: Implementation trial.
Setting: 17 primary care practices.
Population or sample: People due for a cervical screening test.
Methods: Participants could choose a clinician-taken cervical test or a vaginal self-test (undertaken in clinic or at home), unless a cervical co-test (HPV and cytology) was clinically indicated.
Main outcome measures: Proportion of participants who had (a) a vaginal self-test, (b) an HPV-detected result and (c) HPV detected on a vaginal self-test and returned for further investigation.
Results: 3121 people were enrolled. Participation rates were high for people of all recorded ethnicities. A vaginal self-test was undertaken by 95% (2954/3121, 95% confidence interval [CI] [93.8, 95.4]) of people. HPV was detected in 12.9% (404/3121, 95% CI [11.8, 14.2]) of people. 95% (384/404, 95% CI [92.5, 97.0]) of people with HPV detected had follow-up cytology or colposcopy. 2.6% (82/3121, 95% CI [2.1, 3.2]) had HPV 16/18 detected, all of whom attended colposcopy. Cytology triage was completed for 92% (276/301, 95% CI [88.0, 94.3]) of people with non-16/18 HPV types (HPV other) detected on a vaginal self-test. This varied by ethnicity and screening history.
Conclusion: This study confirms the feasibility of cervical screening with the universal option of a vaginal self-test and demonstrated a clear preference for the vaginal self-test. Challenges remain in relation to equitable provision of cytology triage. Ongoing programme monitoring is imperative.
Trial registration: Australia and New Zealand Clinical Trial Register. ANZCTR Reference number: ACTRN12622000699763 (https://anzctr.org.au/).