Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers.
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BACKGROUND: Despite the availability of highly effective HPV vaccines that can reduce HPV-associated cancer mortality, HPV vaccination rates in Texas rank 48th nationwide. Although evidence shows Latino parents are more accepting of HPV vaccination than non-Hispanic parents, this disparity in vaccination rates underscores the importance of understanding Latino parental HPV vaccine hesitancy. Latinos/as typically receive healthcare at Federally Qualified Health Centers (FQHCs), which often need support implementing and improving access to evidence based preventive services. However, the current literature around implementation comes from large integrated healthcare systems and there is limited research around what works in the FQHC settings with Latino/a patients. Preliminary data from our previous work suggest practice facilitation is a feasible approach for building the capacity in FQHCs to select and implement provider- and practice-level strategies for increasing vaccination rates. METHODS: This proposal considers the HPV vaccine as the evidence-based intervention and describes the rational and study design for "TRUsted hEalth SYstem implementatioN stratEGIes to increase vaccination (TRUE SYNERGI)", a hybrid type 2 study that uses previously-piloted implementation strategies (i.e., practice facilitation, provider education, among others) to influence provider recommendations (implementation outcome) and practice-level vaccination rates (effectiveness outcome). To test whether these facilitator-driven implementation strategies influence our implementation and effectiveness outcomes, we will use a stepped-wedge cluster randomized trial and randomize three FQHCs (n = 9 practices, 3 per FQHC) to three clusters. We will conduct baseline assessments at each practice, which will provide data to assist the practice facilitator in engaging with the providers and leadership to develop a tailored implementation plan for each practice. In addition, we will employ theory-guided, qualitative methods, to assess the complexity associated with context and the recipients involved in the implementation of strategies in practices, along with sustainability. DISCUSSION: The study will advance our understanding of what it means to conduct implementation research in resource limited practices that work with populations experiencing substantial disparities. Findings from the current study will inform national implementation efforts and contribute towards future research targeting dissemination and scale-up, key foci for health equity focused implementation research. TRIAL REGISTRATION: Registered in ClinicalTrials.gov (NCT06598475) on September 9, 2024.