As jurisdictions prepare for HPV-based cervical cancer screening, programs cannot ignore operational concerns, such as compliance with colposcopy referral for timely disease detection. Colposcopy programs traditionally prioritize women with high-grade cytological abnormalities. With HPV-based screening and cytology triage, traditional patterns for colposcopy prioritization may need to be re-assessed. We present colposcopy compliance and procedure wait times by referral result from HPV FOCAL, a large primary HPV testing RCT.
HPV FOCAL compared primary HPV testing with liquid based cytology (LBC) triage (for HPV positives) every 4 years to LBC screening every 2 years. Women 25-65yrs (n=18,948) were randomized to the control (CTRL) and intervention (IA) arms. IA: baseline HPVpos received reflex LBC and were referred to colposcopy if >ASCUS; if baseline HPVneg or <CIN2, exit trial at 48mos. CTRL: baseline ASCUS receive reflex HPV and referred to colposcopy if HPVpos. Baseline >LSIL were directly referred to colposcopy; those baseline LBCneg or <CIN2 were rescreened with LBC at 24mos; if LBCneg or <CIN2, exit trial at 48mos. Both arms co-tested with HPV/LBC at 48mos and referred to colposcopy if positive on either test. To enhance colposcopy compliance and standardization, colposcopy procedures occurred primarily at two high volume clinics.
Overall trial colposcopy compliance was 96% within 12 months of referral compared to the provincial program rate of 86%. At 48mos, where both arms received HPV/LBC co-testing, the shortest median wait times from referral to procedure were in those HPVneg/>HSIL (3.6mos) and HPVpos/>HSIL (3.7mos). Time to colposcopy for >HSIL patients, irrespective of HPV outcome was significantly shorter than other referrals; median wait time, >HSIL: 3.7mos, other: 4.7mos (p= <0.0001). At 48mos, the largest number of CIN2+ (42%) was detected in those HPVpos/NILM. The trend for prioritization by cytology regardless of HPV positivity was also observed in Round 1 of the trial. Trial colposcopy clinics reported confusion regarding how to prioritize HPV positive results accompanied by low grade or normal cytology.
Trial colposcopy compliance for HPV FOCAL was high (96%) compared to program rates (86%), and median wait times for any referral result were less than 6mos. However, longer wait times were observed in those HPVpos/NILM, where the highest burden of CIN2+ was detected at 48 months. As programs plan for HPV-based screening with cytology triage, protocols for prioritizing colposcopy procedures may need to be re-evaluated based on the combination of both HPV and cytology results.