Investigator
Kaiser Permanente
A pragmatic randomized trial to compare strategies for implementing primary HPV testing for routine cervical cancer screening in a large healthcare system
Recent updates to national guidelines recommend primary human papillomavirus (HPV) screening for routine cervical cancer screening alongside previously recommended screening options. However, limited guidance exists for implementation approaches that best facilitate cancer screening practice substitution and achieve optimal stakeholder-centered outcomes. We compared "centrally-administered + locally-tailored" (here after referred to as locally-tailored) vs. "centrally-administered + usual care" (here after referred to as centrally-administered) approaches for achieving substitution of HPV and cytology co-testing with primary HPV screening for routine cervical cancer screening to examine the effect of local tailoring on implementation and stakeholder-centered outcomes. We conducted a pragmatic, cluster randomized trial embedded in the Kaiser Permanente Southern California (KPSC) health system, randomly assigning site groups to study arms at the level of the geographic service area (12 service area randomized). The study took place between 2020-2022. Centrally-administered implementation strategy bundles included physician and staff educational activities. Sites in the locally-tailored arm underwent local needs assessment followed by local selection, tailoring and deployment of implementation strategy bundles. The primary outcome was the proportion of primary HPV screenings among all screenings performed. Secondary stakeholder-centered outcomes included patient (knowledge, emotional reaction, satisfaction, volume of patient inquiries) and provider outcomes (perception, knowledge, acceptance, and satisfaction) measured via repeated surveys or electronic health records. The generalized estimating equation framework and the difference-in-differences approach were used to compare outcomes across study arms. The proportion of appropriate screenings (i.e., use of primary HPV screening) during the post-intervention period was high, with no observed difference between study arms: 98.4% (95% confidence interval [CI] 96.3%-100%) for the locally-tailored arm and 99.1% (95% CI: 97.8%-100%) for the centrally-administered arm (p = 0.34). There were no statistically or clinically significant differences in patient- and provider- outcomes between study arms. Primary HPV screening was feasible and demonstrated high fidelity in all KPSC service areas. The locally-tailored practice substitution approach and centrally-administered practice substitution approach both achieved near complete uptake of primary HPV screening. Further, similar effects on stakeholder-centered outcomes were observed for both approaches. However, generalizability of our findings may be limited due to unique features of our integrated health system. NCT04371887. Registered 30 April 2020, URL: https://clinicaltrials.gov/study/NCT04371887?cond=primary%20HPV%20screening&rank=5 .
Cervical Cancer Screening: Patient Perspectives on Transitioning to Primary High-Risk Human Papillomavirus Testing Alone
In 2018, the US Preventive Services Task Force updated cervical cancer screening recommendations to allow for screening every 5 years with primary human papillomavirus (HPV) testing in combination with cytology (cotesting) or every 5 years with primary HPV screening alone. Despite these changes, the uptake of primary HPV screening has been lower than expected. The purpose of this study was to evaluate the patient perspective of an integrated health system transition from cotesting to primary HPV testing among a 30- to 65-year-old cohort. Semistructured phone interviews were conducted from July to December 2023 at Kaiser Permanente Colorado with 16 members aged 30-65 years. Interviews asked about reactions to the forthcoming change in cervical cancer screening, personal concern about cervical cancer risk, feedback on patient-facing education materials, and preference on communication timing and modality. Participants reported concerns about cervical cancer screening intervals, primarily the reduction in frequency leading to underdiagnosis of sexually transmitted infections (STIs). Participants recommended defining the rationale for the change to primary HPV testing in the patient education materials. Participants preferred communication about the change in-clinic between practitioner and patient. The interviews identified key themes, including the differentiation between cervical cancer and STI screening methodologies, potential underdiagnosis of STI and cervical cancer, and the rationale supporting primary HPV testing and associated screening intervals. These qualitative findings can inform health systems of potential patient concerns to address when considering the transition from cotesting every 3 years to primary HPV testing every 5 years for cervical cancer screening.
