. 2024 Jul:142:107576.

doi: 10.1016/j.cct.2024.107576. Epub 2024 May 17.

HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial

Affiliations

¹ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Shannon.Christy@moffitt.org.
² College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.
³ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Mariana.Arevalo@moffitt.org.
⁴ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Lindsay.Fuzzell@moffitt.org.
⁵ Non-Therapeutic Research Office, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Ashley.Whitmer@moffitt.org.
⁶ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA. Electronic address: Kea.Turner@moffitt.org.
⁷ Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: lgore@adena.org.
⁸ Health Choice Network, Inc., Miami, FL, USA. Electronic address: KChung@hcnetwork.org.
⁹ Health Choice Network, Inc., Miami, FL, USA. Electronic address: DParras@HCNetwork.org.
¹⁰ Health Choice Network, Inc., Miami, FL, USA. Electronic address: EEndemano@HCNetwork.org.
¹¹ Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: brownstn@musc.edu.
¹² Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Susan.Vadaparampil@moffitt.org.

PMID: 38763306
PMCID: PMC11180554
DOI: 10.1016/j.cct.2024.107576

HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial

Shannon M Christy et al. Contemp Clin Trials. 2024 Jul.

. 2024 Jul:142:107576.

doi: 10.1016/j.cct.2024.107576. Epub 2024 May 17.

Authors

Affiliations

¹ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Shannon.Christy@moffitt.org.
² College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.
³ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Mariana.Arevalo@moffitt.org.
⁴ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Lindsay.Fuzzell@moffitt.org.
⁵ Non-Therapeutic Research Office, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Ashley.Whitmer@moffitt.org.
⁶ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA. Electronic address: Kea.Turner@moffitt.org.
⁷ Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: lgore@adena.org.
⁸ Health Choice Network, Inc., Miami, FL, USA. Electronic address: KChung@hcnetwork.org.
⁹ Health Choice Network, Inc., Miami, FL, USA. Electronic address: DParras@HCNetwork.org.
¹⁰ Health Choice Network, Inc., Miami, FL, USA. Electronic address: EEndemano@HCNetwork.org.
¹¹ Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: brownstn@musc.edu.
¹² Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Susan.Vadaparampil@moffitt.org.

PMID: 38763306
PMCID: PMC11180554
DOI: 10.1016/j.cct.2024.107576

Abstract

Background: This protocol paper describes the overall design for HPV MISTICS, a multilevel intervention to increase human papillomavirus (HPV) vaccination initiation and completion rates among adolescents aged 11-17.

Methods: We will conduct a hybrid type 1 implementation-effectiveness trial using a stepped-wedge cluster randomized trial in eight federally qualified health centers (FQHCs) in Florida. Intervention components target three levels: system, providers, and parents. Outcomes will be assessed using quantitative (e.g., vaccination data, survey data) and qualitative methods (e.g., staff and parent interviews). We expect to quantify changes in HPV vaccine series initiation and completion rates for adolescents ages 11-17 in the eight FQHCs. We have hypothesized a 20-percentage point increase in HPV vaccine series initiation and a 10-percentage point increase in series completion. We also anticipate being able to explore factors at the system, provider, and patient levels as potential covariates. Implementation outcomes, barriers, and facilitators identified in the study will help characterize the implementation process and inform potential future intervention scale-up.

Results: The project is ongoing; effectiveness and implementation outcomes will be determined following project completion.

Conclusions: Findings will provide evidence of an equity-informed research design and implementation procedures that could help improve HPV vaccination rates in similar health systems.

Clinical trials identifier: NCT05677360 (date registered: 2022-12-22); https://clinicaltrials.gov/study/NCT05677360?lead=Moffitt%20Cancer%20Center%20&aggFilters=status:rec&page=2&rank=17.

Keywords: Cluster randomized trial; HPV vaccine; Hybrid implementation-effectiveness trial; Multilevel intervention; Stepped-wedge design; Study protocol.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Dr. Christy is an unpaid advisory board member for HPV Cancers Alliance. All other authors declare no conflicts of interest.

Figures

**Figure 1.**
Organizational chart and information flow

**Figure 2.**
HPV MISTICS Intervention Components

**Figure 3.**
Vaccine Champion Training Overview illustrates the flow of six bi-weekly, live synchronous, one-hour HPV Vaccine Champion training sessions led by Moffitt and HCN study team members, bi-weekly optional drop-in office hours staffed by study team, handouts, assignments, and optional monthly calls.

See this image and copyright information in PMC

References

1. Viens LJ, Henley J, Watson M, Markowitz LE, Thomas CC, Thompson TD, Razzaghi H, Saraiya M, Human Papillomavirus-Associated Cancers-United States, 2008-2012, Morbidity and Mortality Weekly Report (MMWR) 65(26) (2016) 6. - PubMed
1. Centers for Disease Control and Prevention (CDC), TeenVaxView, National Center for Immunization and Respiratory Diseases, Atlanta, GA, 2021.
1. Health Choice Network (HCN), Health Choice Network: A Family of Health Centers, 2021. https://www.hcnetwork.org. (Accessed May 3, 2021.
1. Jaen CR, Stange KC, Nutting PA, Competing demands of primary care: a model for the delivery of clinical preventive services, Journal of family practice 38(2) (1994) 166–174. - PubMed
1. Vollrath K, Thul S, Holcombe J, Meaningful Methods for Increasing Human Papillomavirus Vaccination Rates: An Integrative Literature Review, J Pediatr Health Care 32 (2018) 14. - PubMed

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HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial

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HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial

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Conflict of interest statement

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