The low rates of human papillomavirus (HPV) vaccination within rural areas of the United States present a substantial and disparate missed opportunity to prevent cancer. Florida is a particular concern with the second highest number of HPV-related cancers, yet a rank among the 50 states of 44th in HPV vaccine initiation (≥ 1 dose) and 41st for up to date (i.e., 2 doses when starting the series before age 15 years; 3 doses when starting at 15 years or older). Even greater disparity is present within the 11 rural North Central Florida counties that are the focus of this proposal. Due to the myriad of factors preventing boys and girls living in rural areas from receiving the HPV vaccine, a multilevel approach is needed to increase HPV vaccination. Guided by the Integrated Behavior Model, the overall objective of this proposal is to address the multilevel barriers to HPV vaccination among 9- to 12-year-olds living in rural areas by using a three-arm cluster randomized trial to assess the added clinical- and associated cost-effectiveness on HPV vaccination of each additional nested evidence-based implementation strategy: (1) clinician-targeted recommendation training, (2) parent-targeted motivational aids via facilitation of clinic staff sending reminder/recall messages and conducting phone-based motivational interviewing, when needed, to encourage follow through, (3) community-targeted healthcare access to transportation assistance, mobile vaccination clinics, and navigation to healthcare insurance. Eight community-focused organizations with experience in rural settings will support implementation: University of Florida (UF) Institute of Food and Agricultural Sciences Extension, UF Clinical and Translational Science Institute Community Engagement Program, UF Cancer Center Community Advisory Board, UF OneFlorida Clinical Research Consortium, Suwannee River Area Health Education Center, CommunityHealth IT, a federally designated Rural Health Network, and the Florida Department of Health. The specific aims are: (1) Estimate the added clinical- and associated cost-effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when combined with community-targeted healthcare access assistance beyond the effects of clinician-targeted training; (2) Estimate the differential effectiveness of the implementation strategies by patient-level factors (age, race/ethnicity, biologic sex, distance from home to clinic, social vulnerability); and (3) Measure moderation of implementation strategy effectiveness by clinic-level factors. The proposed research is significant for its potential to prevent cancer by increasing HPV vaccination rates among 9- to 12-year-olds living in rural areas. The project is innovative by: (1) Evaluating effectiveness and cost-effectiveness of layered evidence-based strategies; and (2) Addressing social determinants preventing vaccination in addition to clinician recommendation effectiveness and parent motivation. The proposed approach of layering nested evidence-based implementation strategies to prevent HPV-related cancers can be expanded to prevention of other cancers disproportionately affecting rural areas.

PROJECT NARRATIVE The proposed research is relevant to public health because it has significant promise to increase human papillomavirus (HPV) vaccination rates among 9- to 12-year-olds, and therefore, reduce the HPV-related cancer disparity in rural areas. The project builds upon existing evidence of improving clinicians’ recommendations and increasing parents’ motivations while adding strategies that address common social determinants that inhibit parents’ ability to have their child receive the HPV vaccine. The proposed research is relevant to NIH’s mission to prevent cancer in the United States within all demographics including rural populations.