The STOP-HPV Scale-Up Study

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Abstract Human papillomavirus (HPV) causes 33,700 US cancer cases per year, 4,000 deaths and $4 billion in cancer- related medical costs. Despite an effective vaccine, in 2020 less than 60% of US adolescents 13-17 years of age completed their HPV vaccine series. Key barriers are suboptimal clinician communication to address parental vaccine hesitancy, and ineffective office systems causing missed opportunities for vaccination. Our research team tested two promising implementation strategies (ISs) in primary care practices to address these barriers: online clinician communication training (“STOP-HPV-Online”) which trains clinicians on communication techniques and addresses parent hesitancy, and a multi-component IS (“STOP-HPV-LC”) that involves both clinician communication training plus office-based changes in workflow learned on monthly learning collaborative group phone calls. Both ISs were deployed by our research team. Widespread scalability requires the ISs to be deployed by health systems since most primary care practices are now part of health systems. For Aim 1 we will adapt the two ISs for deployment by 8 health systems, and also describe baseline strategies used by these systems. We will partner with the American Medical Group Association® (AMGA),the main national organization of health systems. More than 8 health systems have already expressed interest in the study. We will use a mixed-methods approach and the RE-Aim/PRISM framework to evaluate the effectiveness and implementation processes of the health-system deployed implementation strategies. We will assess how health systems deploy core IS functions and how they and practices adapt specific activities (forms) within each IS. Aims 2-3 will use a 3-arm clustered RCT, randomizing 72 practices within the 8 health systems to STOP-HPV- Online, STOP-HPV-LC, or usual care control. Aim 2 will compare the effectiveness and cost-effectiveness of the two ISs to control and to each other over a 12-month IS period and another 12-month maintenance period. The primary outcome for Aim 2 is HPV vaccine initiation; secondary outcomes are vaccine series completion and cost-effectiveness of the IS. Aim 3 will assess provider, practice, and health system factors relevant to implementation of the two ISs. The primary outcome is adoption (uptake of core IS functions such as clinicians completing the online modules); secondary outcomes include reach (e.g., % clinicians participating), practice/provider factors (e.g., organizational readiness) associated with improvement in rates, and maintenance of core IS functions by practices over 12 additional months. We will develop and disseminate online implementation guides for health systems and practices to use, and AMGA will help spread the ISs to their other health systems. By the end of the study, we will have two scalable ISs for AMGA and any health system to improve HPV vaccination rates and reduce HPV-related cancers.