HPV FOCAL
HPV FOCAL: randomised trial of primary HPV testing alone versus liquid-based cytology in an organized cervical screening programme in British Columbia, Canada
N = 19,009
- Population
- Women aged 25 to 65 years with no history of CIN2+ in the past 5 years, no invasive cervical cancer, no hysterectomy, no Papanicolaou test in the past 12 months and not receiving immunosuppressive therapy.
- Design
- Randomised clinical trial in an organized cervical screening programme in Canada; participants were recruited through 224 collaborating clinicians from January 2008 to May 2012, with follow-up through December 2016. Women in the intervention group received HPV testing, with HPV-negative women returning at 48 months. Women in the control group received liquid-based cytology (LBC), with negative women returning at 24 months and again at 48 months. At the 48-month exit both groups received HPV and LBC co-testing. The abstract gives the registry number ISRCTN79347302; no NCT identifier is recorded.
- Primary endpoint
- Cumulative incidence of CIN3+
- Arms
- Primary HPV testing (experimental, n = 9,552): HPV testing alone; negative women return at 48 months
- Liquid-based cytology (control, n = 9,457): LBC; negative women return at 24 months and again at 48 months
- People
- Ogilvie GS, senior author Coldman AJ