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