BJOG : an international journal of obstetrics and gynaecology · 2025
Human Papillomavirus (HPV) Screening With Universal Access to Vaginal Self-Testing: Outcomes of an Implementation Trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Sykes Peter, Innes Carrie, Bell Rebecca, Nip Janine, McMenamin John, McBain Lynn, Hudson Ben, Gibson Melanie, Te Whaiti Sarah, Tino Alexandria, Williman Jonathan, Miller Andrew, Lawton Beverley
Аннотация
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/).
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/).