NCT05677360|Active Not Recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
HPV MISTICS
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HPV MISTICS
Sponsor study identifier
interventional
148
1 country
1
Study Start
January 9, 2023
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2022
Actual (reported)January 9, 2023
Actual (reported)January 10, 2023
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Effectiveness: HPV Vaccine series initiation rates
HPV vaccine series initiation (1st dose) rates among adolescents ages 11-17 will be determined on a monthly basis as well as annually. Providers' vaccination rate data for their patient panel (using Florida SHOTS - a free, statewide centralized online immunization information system) will be compared to the National Immunization Survey-Teen (NIS-TEEN) data for the state of Florida.
at 5 years
Effectiveness: HPV Vaccine series completion rates
HPV vaccine series completion (2nd and 3rd dose) rates among adolescents ages 11-17 will be determined on a monthly basis as well as annually. Providers' vaccination rate data for their patient panel (using Florida SHOTS - a free, statewide centralized online immunization information system) will be compared to the National Immunization Survey-Teen (NIS-TEEN) data for the state of Florida.
at 5 years
Implementation outcome: Reach
at 5 years
Implementation outcome: Reach demographics
at 5 years
Proportion of Healthcare providers who participate in the intervention
at 5 years
Proportion of Healthcare Providers, Rural vs Urban
at 5 years
Proportion of Health Care providers who complete training
at 5 years
Initial group of community health centers to receive intervention
Second group of community health centers to receive intervention
The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) provider-level intervention for all clinical staff (e.g., physicians, nurses, medical assistants) includes a 1-hour online training session on the Announcement Approach (i.e., presumptive recommendation) to recommend adolescent vaccinations.
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Christy SM, Patel L, Arevalo M, Fuzzell L, Whitmer A, Turner K, Gore LR, Chung-Bridges K, Parras D, Endemano EY, Brownstein NC, Vadaparampil ST. HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial. Contemp Clin Trials. 2024 Jul;142:107576. doi: 10.1016/j.cct.2024.107576. Epub 2024 May 17.
Susan T Vadaparampil, PhD, MPH
Moffitt Cancer Center
Shannon Christy, PhD
Moffitt Cancer Center
148 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2022
First Posted
January 10, 2023
The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) parent-level intervention includes a low literacy pre-visit HPV vaccine notification post card in the parent's preferred language.
The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) system-level intervention involves training an HPV Vaccine Champion at each FQHC on the provider and parent EBIs to monitor and share clinic HPV initiation and completion rates with providers, and to implement reminder/recall systems for subsequent vaccine doses
Contact the study team to confirm eligibility.
Study Start
January 9, 2023
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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