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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.
Christy, Shannon M; Patel, Lily; Arevalo, Mariana; Fuzzell, Lindsay; Whitmer, Ashley; Turner, Kea; Gore, L Robert; Chung-Bridges, Katherine; Parras, Daniel; Endemano, Edelise Y; Brownstein, Naomi C; Vadaparampil, Susan T.
Afiliação
  • Christy SM; 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.or
  • Patel L; College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.
  • Arevalo M; Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Mariana.Arevalo@moffitt.org.
  • Fuzzell L; Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Lindsay.Fuzzell@moffitt.org.
  • Whitmer A; Non-Therapeutic Research Office, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Ashley.Whitmer@moffitt.org.
  • Turner K; 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.
  • Gore LR; 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.
  • Chung-Bridges K; Health Choice Network, Inc., Miami, FL, USA. Electronic address: KChung@hcnetwork.org.
  • Parras D; Health Choice Network, Inc., Miami, FL, USA. Electronic address: DParras@HCNetwork.org.
  • Endemano EY; Health Choice Network, Inc., Miami, FL, USA. Electronic address: EEndemano@HCNetwork.org.
  • Brownstein NC; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: brownstn@musc.edu.
  • Vadaparampil ST; 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
Contemp Clin Trials ; 142: 107576, 2024 Jul.
Article em En | MEDLINE | ID: mdl-38763306
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=statusrec&page=2&rank=17.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pais / Infecções por Papillomavirus / Vacinas contra Papillomavirus Limite: Adolescent / Child / Female / Humans / Male País/Região como assunto: America do norte Idioma: En Revista: Contemp Clin Trials Assunto da revista: MEDICINA / TERAPEUTICA Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pais / Infecções por Papillomavirus / Vacinas contra Papillomavirus Limite: Adolescent / Child / Female / Humans / Male País/Região como assunto: America do norte Idioma: En Revista: Contemp Clin Trials Assunto da revista: MEDICINA / TERAPEUTICA Ano de publicação: 2024 Tipo de documento: Article