HPV FOCAL was the largest clinical trial of its kind in North America. The goal of this study was to determine if a screening test for Human Papillomavirus (HPV) was better than the standard (the Pap smear, or "cytology") as primary screening for cervical cancer.
More than 25,000 women from Metro Vancouver and Greater Victoria, aged 25-65, consented to participate in HPV FOCAL between 2008 and 2012, and by December 2016, all participating women had completed trial procedures. Women in the HPV testing arm (intervention arm) received HPV testing at study entry, and if negative, returned 4 years later for the final study screen with both HPV and cytology testing. If HPV positive at study entry, cytology testing was also done on the sample collected and women were managed based on the combination of results.
Women in the cytology arm (control arm) received cytology testing at study entry (the standard in BC). If the results were negative/normal, women were asked to return in another 2 years (the standard for cytology testing at the time) for another screen with cytology testing. If negative/normal at the 2 year screen visit, they were asked to return 2 years later (a total of 4 years in the study). As in the HPV arm, at 4 years, women in the cytology arm were also screened with both HPV and cytology testing. If a woman in the control arm had any abnormal cells detected at study entry or the 2 year screen, she was managed based on the type of abnormality detected.
The final results of the HPV FOCAL trial were published in July 2018. Four years after receiving their first test at study entry, significantly fewer high grade pre- cancer cervical changes were detected in women who had HPV testing at study entry, than in women who had cytology testing at entry. In addition, cervical pre-cancer was found earlier in women who had HPV testing than in women who had cytology testing, which provided the opportunity for earlier treatment. In other words, the use of HPV testing for cervical cancer screening resulted in less of a chance of having high-grade cervical pre-cancer 4 years later. Funding has been received from the National Institutes of Health to follow women in HPV FOCAL beyond the 4 year study period to provide long term information regarding the use of HPV testing in cervix screening. If you are a previous FOCAL participant, we may contact you in the near future to see if you would like to participate!
You may be interested in reading some of the news about the HPV FOCAL Study via the links below:
CNN: HPV test more effective than Pap smear in cancer screening, study suggests
CBC: HPV test should replace Pap test for cervical cancer screening, study suggests
Washington Post: HPV test is better than Pap smear at detecting precancerous cervical changes, study says
UBC: HPV test better than Pap test at detecting cervical precancer
The HPV FOCAL Study is no longer managing the screening schedule for any FOCAL Study participants. There are a number of women who did NOT attend their final screen visits. We encourage you to contact these women to return for a cervical screen (and collect with a conventional Pap smear) if they have not already done so.
For any women who have completed the study, the recommendation for future screening and/or management was included on the last set of screen results.
If you have any questions about when your patients should attend for their next cervical screen or other follow-up, please contact the Cervical Cancer Screening Program at: 1-877-747-2522.
If you have any remaining collection kits left in your office, please return them to us.
British Columbia has updated its Cervical Cancer Screening policy. The following changes will be in effect:
Read more here.