R01CA268014

Remark: A multi-level strategy to address disparities in rural HPV-related cancer prevention - 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.

University Of Florida

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Florida United States

State-Wide

Social and Behavioral Intervention Research to Address Modifiable Risk Factors for Cancer in Rural Populations (R01 Clinical Trial Required) (RFA-CA-20-051)

Amendment Since initial award the End Date has been shortened from 08/31/27 to 08/31/25 and the total obligations have increased 367% from $845,405 to $3,944,859.