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, Lily Patel, Mariana Arevalo, Lindsay Fuzzell, Ashley Whitmer, Kea Turner, L Robert Gore, Katherine Chung-Bridges, Daniel Parras, Edelise Y Endemano, Naomi C Brownstein, Susan T Vadaparampil
Author Information
Shannon M Christy: 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.
Lily Patel: College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.
Mariana Arevalo: Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Mariana.Arevalo@moffitt.org.
Lindsay Fuzzell: Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Lindsay.Fuzzell@moffitt.org.
Ashley Whitmer: Non-Therapeutic Research Office, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Ashley.Whitmer@moffitt.org.
Kea Turner: 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.
L Robert Gore: 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.
Katherine Chung-Bridges: Health Choice Network, Inc., Miami, FL, USA. Electronic address: KChung@hcnetwork.org.
Daniel Parras: Health Choice Network, Inc., Miami, FL, USA. Electronic address: DParras@HCNetwork.org.
Edelise Y Endemano: Health Choice Network, Inc., Miami, FL, USA. Electronic address: EEndemano@HCNetwork.org.
Naomi C Brownstein: Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: brownstn@musc.edu.
Susan T Vadaparampil: 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.
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.
