Melanie Gibson

Human Papillomavirus (HPV) Screening With Universal Access to Vaginal Self‐Testing: Outcomes of an Implementation Trial

ABSTRACTObjectiveDetermine the feasibility of high‐risk human papillomavirus (HPV)‐based cervical screening that included the option of a vaginal swab HPV test (vaginal self‐test).DesignImplementation trial.Setting17 primary care practices.Population or SamplePeople due for a cervical screening test.MethodsParticipants 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 MeasuresProportion 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.Results3121 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.ConclusionThis 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 RegistrationAustralia and New Zealand Clinical Trial Register. ANZCTR Reference number: ACTRN12622000699763 (https://anzctr.org.au/)