Implementation in action: Collaborating on the transition to primary HPV screening for cervical cancer in the United States

In July 2020, the American Cancer Society (ACS) released an updated cervical cancer screening guideline calling for primary human papillomavirus (HPV) screening as the preferred strategy.¹ Primary HPV screening refers to cervical cancer screening with an HPV test alone as the initial screening modality. Under this strategy, cervical cytology is reserved for use as one option for a triage test should the HPV test result be positive. The scientific data supporting this recommendation have been reviewed both in the United States and in other countries that have transitioned to primary HPV screening.^{2, 3}

The Primary HPV Screening Initiative (PHSI), nested under the ACS National Roundtable on Cervical Cancer, is a national consortium supported by the ACS that convenes key partners and experts on six workgroups and a Steering Committee charged with identifying critical barriers and opportunities for transitioning to primary HPV screening. The workgroups engage approximately 100 volunteers who began their activities in the fall of 2021. Workgroup members are multiprofessional and include leaders in health care policy, health care delivery, and patient care as well as patient advocates. The project is overseen by a Steering Committee (Figure 1) made up of the co-chairs of each of the six workgroups and other experts identified for their leadership in the areas of cervical cancer screening and health care policy. The final deliverable is an implementation report (roadmap), complete with tools and recommendations to support health systems, laboratories, providers, patients, and payors as they make this transition.

The Provider Needs Workgroup is developing resources in a variety of formats both to educate providers and to help them educate their patients about the benefits and safety of primary HPV screening. The deliverables include tools to aid in the management of patients with abnormal screening results. Success will be defined by change in provider behavior and will depend in large part on the degree to which major professional organizations (e.g., American College of Obstetricians and Gynecologists, American Academy of Family Physicians, Nurse Practitioners in Women's Health, and American Society for Colposcopy and Cervical Pathology) promote primary HPV screening as the standard for excellent care. The US Preventive Services Task Force recommends primary HPV screening as one of three strategies to screen for cervical cancer starting at age 30 years but does not give preference to modality.⁴ As of this writing, updated recommendations from the US Preventive Services Task Force are pending. It is desirable that all organizations agree on preferred screening guidelines to facilitate prevention efforts that are supported by evidence and widely accessible. Providers are most likely to follow guidelines promoted by their professional societies, so they are the audience of many of this workgroup's deliverables.

Currently, there appears to be limited and variable understanding among many stakeholders regarding why primary HPV screening is better than cotesting. Primary HPV screening has been shown to be more effective than screening with cytology alone and performs similarly to and with lower costs than screening with cotesting.⁵ Transitioning laboratories to support the changes needed to implement primary HPV screening in the United States is a major yet necessary undertaking. For many laboratories that do not have a US Food and Drug Administration-approved primary HPV screening platform, the logistics of changes in instrumentation, specimen workflow, implementation of newly approved tests for triage of HPV-positive cases, modification of existing quality-assurance/accreditation requirements for cytology-based testing, and impact on the cytologist workforce all need careful consideration based on size and other laboratory-specific attributes. Furthermore, quality assurance for primary HPV screening, the performance of cytology as a triage test, and that of colposcopic biopsy in vaccinated cohorts are additional challenges that affect laboratory reporting in the primary HPV screening paradigm. The Laboratory Infrastructure Workgroup has been working on developing educational and practical resources to address many of these concerns.

As many as 20% of patients in the United States are currently screened for cervical cancer using cytology alone.⁶ These patients tend to be served by safety-net providers in underserved areas and are more likely to be low-income and from communities of color.⁷ Screening with cytology alone requires more frequent testing, frequent follow-up for minor, low-risk abnormalities, and does not screen for high-risk HPV, the causative agent of virtually all cases of cervical cancer. Although it is more specific in detecting precancer, cytology is less sensitive than HPV screening, has a high number of equivocal results, and has interlaboratory variability. HPV self-sampling, once US Food and Drug Administration-approved, may be especially helpful to improve screening rates in currently underscreened populations. Therefore, changing screening practices from cytology alone to primary HPV screening is essential and may have a different set of challenges than the transition faced by programs performing cotesting, such as access and cost considerations. The Moving from Cytology Alone Workgroup is addressing the specific needs and barriers anticipated for these lower resource programs.

Information technology plays an important role in how health care providers order and manage primary HPV screening tests and how laboratories handle patient specimens and report results. The Information Technology/Electronic Health Records Needs Workgroup is identifying anticipated barriers that health systems may face and outlining recommendations to address them, recognizing that recommendations must be broad enough to apply to different electronic health record (EHR) platforms but specific enough to be useful. The importance of standardized structured data to facilitate implementation of cervical cancer screening and management clinical decision support systems into the EHR will be emphasized and explained. National Current Procedural Terminology codes and Logical Observation Identifiers Names and Codes terminology currently do not differentiate between HPV tests collected for primary HPV screening versus cotesting, which affects accurate test ordering, results tracking, and preventive care tracking tools. This issue is also being addressed by this workgroup.

In the United States, payors significantly affect which screening modalities are used in clinical practice. For a successful transition to the widespread use of primary HPV screening, the Insurance Coverage/Payors Workgroup is providing support for billing and coding for primary HPV screening. It is essential that these billing codes be available to use for patients starting at age 25 years. In addition, insurance plans across the country will need to work with their network providers to support the use of primary HPV screening. One challenge faced by this workgroup is the need to balance efforts to promote the use of primary HPV screening while ascertaining that low-resource health centers providing care to the most at-risk patients are not penalized for anticipated delays in uptake of new screening guidelines based on the costs and logistics of capital investments and implementation.

Implementation processes of previous cervical cancer screening guidelines have demonstrated that patient perception and education are important considerations when implementing new approaches. This will likely be the case for primary HPV screening and screening done using self-collected specimens in the future. The Patient Perceptions Workgroup is creating educational tools for patients that will destigmatize the role of HPV in cervical cancer screening and encourage use of the right test(s) for the right patient at the right time. Although primary HPV screening has been adopted in many countries, this workgroup will focus on issues facing women and people with a cervix in the United States that are often different than those in other countries because of cultural differences and/or different health care delivery models.

The combined efforts of these six workgroups are resulting in the creation of a catalog of resources for providers, professional societies, health systems, patients, payors, and various other stakeholders. There is intentional overlap among the workgroups and the issues that they aim to address. With the support of the Steering Committee, workgroups collaborate on issues and deliverables that are cross-cutting. We will inform partners about our work and outcomes through commentaries like this one as well as through presentations, workshops at professional society meetings, social media and email communications, website announcements, and other stakeholder forums.^{2, 8} Upon dissemination of the implementation report and tools, the members of this initiative hope to see guideline alignment and primary HPV screening being used more across the United States. This initiative will help to advance future cervical cancer areas of work, including preparing for self-sampling, and other guideline implementation opportunities.

The PHSI innovatively accelerates progress beyond guideline development and into the guideline implementation space. This initiative is a crucial step in the successful adoption of primary HPV screening and guideline alignment across organizations. In addition, the initiative is positively contributing to growing synergistic relationships and is a foundation for the newly formed ACS National Roundtable on Cervical Cancer (NRTCC).⁹ The ACS NRTCC aims accelerate progress toward cervical cancer elimination by reducing barriers to care, eliminating disparities, reducing harms, and promoting new technologies that reduce the morbidity and mortality of cervical cancer for everyone. Achieving the Initiative's objectives and harnessing the power of these collaborative relationships over the next year will provide a critical and model infrastructure to support advancements in cervical cancer prevention and elimination in the coming years through the ACS NRTCC and other channels.

To learn more and give comment or input to our efforts, you can visit our website (cervicalroundtable.org).

The authors disclosed no conflicts of interest.