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Randomized Controlled Trial
. 2025 Apr 9;25(1):1331.
doi: 10.1186/s12889-025-22273-7.

Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers

Daisy Y Morales-Campos  1 , Prajakta Adsul  2 , Yuanyuan Liang  3 , Erin Donovan  4 , Leticia R Moczygemba  5 , Jessica A Kahn  6
Affiliations
Randomized Controlled Trial

Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers

Daisy Y Morales-Campos et al. BMC Public Health. .

Abstract

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.

Keywords: Federally Qualified Health Centers; HPV vaccination; Hybrid type 2 study; Implementation; Latino/a; Stepped-wedge cluster randomized trial; Sustainability.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study is approved by the UTHealth Houston IRB for all participating sites (HSC-SPH-24-0335, Version 1.0, August 14, 2024) and registered in ClinicalTrials.gov (NCT06598475). We developed consent forms in English for provider and staff surveys and implementation team interviews, and English and Spanish for parent interviews (see Supplemental Files 4-7). Research staff will obtain informed consent before pre-post surveys and interviews, document consent in REDCap, and send participants a copy of the consent form via email. We will aggregate data on any reports, presentations or publications reporting results from this study. After the entire study is completed, the PI will destroy any all identifying contact information. All study databases will be de-identified and archived at UTHealth Houston. We will carry out all methods in accordance with relevant guidelines and regulations. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Conceptual framework
Fig. 2
Fig. 2
Federally Qualified Health Center (FQHC) and participant timeline
See this image and copyright information in PMC

References

    1. Centers for Disease Control and Prevention. Cancers associated with human papillomavirus, United States—2014–2018. USCS data brief, no. 26. Atlanta: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2021. https://www.cdc.gov/cancer/uscs/pdf/USCS-DataBrief-No26-December2021-h.pdf. Accessed 12 Dec 2024.
    1. Saraiya M, Unger ER, Thompson TD, Lynch CF, Hernandez BY, Lyu CW, et al. US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines. J Natl Cancer Inst. 2015;107(6):djv086. - DOI - PMC - PubMed
    1. Walker TY, Elam-Evans LD, Yankey D, Markowitz LE, Williams CL, Mbaeyi SA, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13–17 years - United States, 2017. MMWR Morb Mortal Wkly Rep. 2018;67(33):909–17. - DOI - PMC - PubMed
    1. Texas Cancer Registry. Age-adjusted cancer mortality rates by county in Texas – Cervix Uteri, Hispanic, 2019. Cancer mortality file. 2022. http://cancer-rates.info/tx/. Accessed 12 Dec 2024.
    1. Texas Cancer Registry. Age-adjusted invasive cancer incidence rates by county in Texas – cervix uteri, Hispanic, 2019. Cancer incidence file. 2022. http://cancer-rates.info/tx/. Accessed 12 Dec 2024.

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