HPV FOCAL is a RCT conducted within the organized cervical cancer screening program in British Columbia (BC) Canada. HPV FOCAL is comparing
the efficacy of high-risk HPV DNA testing, with Liquid Based Cytology (LBC) triage for HPV positives , to LBC testing with HPV triage for ASCUS,
for the detection of >CIN3 over 48 months. Presented are age stratified preliminary CIN detection rates at the 48 month exit.
Over 18,000 women aged 25-65 were randomized into the Control and Intervention arms. Intervention Arm (IA): Baseline HPV testing,
if HPV negative (HPV-) exit at 48 months with both HPV and LBC (co-testing). Control Arm (CA): Baseline LBC testing, if LBC negative (NILM),
rescreened at 24 months with LBC and exit at 48 months with co-testing. This analysis includes 48 month exit data for women randomized
before July 1, 2011 with baseline screen negative (HPV- or NILM) results. Co-test results and detection rates of ≥CIN2 and ≥CIN3 are reported.
There were 13091women (6538 Control and 6553 Intervention) randomized by July 1, 2011 with baseline negative results.
The exit co-test positivity rate was 6.0% for Control versus 4.6% for the Intervention (P<.001) arm. For women of all ages,
the >CIN2 rate was significantly higher in the Control than the Intervention arm (CA: 7.0/1000 [95%CI: 5.2, 9.4] vs.
IA: 3.4 [95% CI: 2.1, 5.1], p-value 0.003). The CIN3 rate was also higher in the Control arm but not significant
(CA: 2.9 [95%CI: 1.8, 4.5] vs. IA: 1.4 [95%CI: 0.6, 2.6] p-value 0.06). The most >CIN2 detected in either arm was in women
25-29yrs at baseline (CA 32.2/1000 vs. 1A 14.7/1000), the lowest >50yrs (CA 3.7 vs IA 1.7). Across all ages, the
highest >CIN2 and CIN3 rates were in women HPV+ but LBC- at 48 months.
Four years after initial testing, more >CIN2 was identified in women who screened LBC negative at baseline than HPV negative,
illustrating the safety of the extended interval with a negative HPV result. The highest >CIN2 and CIN3 exit findings for women
of any age were in those with HPV+/NILM results, demonstrating that HPV, not cytology results are predictive of dysplasia.
These findings are highly informative for programs planning for HPV-based testing with an extended screening interval of 4 years.