|5R01CA255872-03 Interpret this number
|Kaiser Foundation Research Institute
|Effectiveness and Mechanisms of Multilevel Implementation Strategies to Improve Provider Recommendation and Advance HPV Vaccination: a Cluster Randomized Trial
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 of 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 health care settings to improve HPV vaccination.
Trends in HPV vaccine administration and HPV vaccine coverage in children by race/ethnicity and socioeconomic status during the COVID-19 pandemic in an integrated health care system in California.
, Xu L.
, Cannizzaro N.
, Bronstein D.
, Choi Y.
, Riewerts R.
, Mittman B.
, Zimmerman R.K.
, Gilkey M.
, Glenn B.
, et al.
Vaccine, 2022-11-02; 40(46), p. 6575-6580.