R01CA255872

Effectiveness and Mechanisms of Multilevel Implementation Strategies to Improve Provider Recommendation and Advance HPV Vaccination: A Cluster Randomized Trial - Project Abstract

Millions of US teens remain at risk of developing human papillomavirus (HPV)-related cancers due to inadequate HPV vaccine uptake, despite strong endorsement in clinical guidelines and substantial prior intervention efforts. A 2018 national survey showed that HPV vaccine complete series coverage for teens age 13-15 years was only 50%, far below the 80% target of Healthy People 2020. Prior research has identified strong provider recommendation as the most powerful facilitator of HPV vaccine uptake. Yet, little is known about how to leverage this and other facilitators.

Additionally, studies have also revealed multilevel, multifactorial barriers to improving HPV vaccination including negative parental perceptions and limitations of health system support. Furthermore, evidence suggests that HPV vaccine barriers can vary across demographic subgroups, communities, and clinics. Despite this knowledge, many prior intervention studies focus on single-level, single component interventions, leaving many barriers unaddressed. Of studies that are multilevel and/or multi-component, interventions are often pre-selected to address "typical" barriers but are not responsive to unique local barriers and local context.

To address this critical gap, we propose a 3-arm cluster randomized controlled trial (RCT) to compare implementation strategies that are multilevel and multicomponent and guided by in-depth understanding of how multilevel factors in the practice settings modify the impact of key facilitators such as provider recommendation. We will use mixed methods (surveys, interviews, electronic health records) throughout; initially, we will evaluate baseline associations between patient-, provider-, and clinic-level factors and variations in HPV vaccination rates and the quality of the provider recommendation (Aim 1).

In Aim 2, we will compare the effectiveness of: 1) a novel "local-tailored" implementation strategy, co-designed with local care teams to address local barriers and contexts; versus 2) a "prescribed" strategy, typical of most health systems, that involves pre-specified interventions addressing pre-selected vaccination barriers; versus 3) usual care. We will evaluate the effectiveness of these strategies on improving HPV vaccination (primary outcome) and strengthening provider recommendation (secondary outcome) as well as analyzing cost-effectiveness. We will also study mechanisms of effect of the implementation strategies (Aim 3).

Although the need for local tailoring seems intuitive, it is unknown if local tailoring will yield superior outcomes that could offset the extra investment required, supporting the need for this RCT. We will conduct the study within Kaiser Permanente Southern California, one of the largest community-based pediatric care organizations in the US. Our study will be guided by the Consolidated Framework for Implementation Research and the Multilevel Factors Across the Cancer Care Continuum Framework.

Completion of these aims will generate important insights into the multilevel factors associated with provider recommendation and HPV vaccine uptake. This study has high potential to generate guidance for diverse healthcare settings to improve HPV vaccination.

Kaiser Foundation Hospitals

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]

Pasadena, California 911012453 United States

Single Zip Code

Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake (R01 Clinical Trial Optional) (PAR-19-360)

Amendment Since initial award the total obligations have increased 359% from $691,976 to $3,174,560.