HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS) (HPV MISTICS)

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.

Study Overview

• Status: Suspended
• Conditions: Human Papilloma Virus (HPV) Vaccine
• Intervention / Treatment: Behavioral: HPV MISTICS -Provider Level; Behavioral: HPV MISTICS - Parent Level; Behavioral: HPV MISTICS- HPV Vaccine Champion Level

Detailed Description

The goals of this multi-level intervention study are to: 1) test whether HPV MISTICS intervention increases human papillomavirus (HPV) vaccine initiation and completion rates among 11-17-year-old adolescents in 8 Health Choice Network-affiliated community health centers in Florida. 2) Explore other factors related to the intervention effect. 3) Explore implementation outcomes (i.e., reach, adoption, implementation, maintenance, and sustainability) and identify implementation barriers and facilitators with a focus on equity. The study will use parent-, provider-, and health center-level strategies to promote HPV vaccination.

• Study Type: Interventional
• Enrollment (Estimated): 564
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For Staff:
• 18 years of age or older
• Working within the participating Federally Qualified Health Center system
• Able to read, write and speak English
• For Providers:
• 18 years of age or older
• Working within the participating Federally Qualified Health Center system
• Interacting with parents of adolescents ages 11-17
• Able to read, write and speak English
• For parents:
• Parent of 11-17 year old child that has received care within the prior two months at one of the participating Federally Qualified Health Centers
• Whose child has not initiated or completed the HPV vaccine series at the time of their last visit
• Able to read, write and speak English or Spanish, or Haitian Creole

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wave 1: Initial Community Health Centers; Initial group of community health centers to receive intervention	Behavioral: HPV MISTICS -Provider Level; 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.; Behavioral: HPV MISTICS - Parent Level; 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.; Behavioral: HPV MISTICS- HPV Vaccine Champion Level; 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
Experimental: Wave 2: Second Community Health Centers; Second group of community health centers to receive intervention	Behavioral: HPV MISTICS -Provider Level; 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.; Behavioral: HPV MISTICS - Parent Level; 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.; Behavioral: HPV MISTICS- HPV Vaccine Champion Level; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation outcome: Reach	The intervention's implementation will be evaluated for reach - proportion of eligible patients that receive the intervention.	at 5 years
Implementation outcome: Reach demographics	The intervention's implementation will be evaluated for reach - demographics of patients reached.	at 5 years
Proportion of Healthcare providers who participate in the intervention	The proportion of health care providers who participate in the intervention, measured by contact log data.	at 5 years
Proportion of Healthcare Providers, Rural vs Urban	The proportion of health care providers in rural vs urban Federally Qualified Health Centers in network that participate.	at 5 years
Proportion of Health Care providers who complete training	The proportion of participating health care providers and staff who complete training per site will be measured using the training attendance log	at 5 years
Intervention Sustainability: Health care Providers	Long term intervention effects and use over time will be determined semi-structured interviews of providers	at 5 years
Intervention Sustainability: Healthcare staff	Long term intervention effects and use over time will be determined semi-structured interviews of health care staff.	at 5 years

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Florida Department of Health; Health Choice Network
• Investigators: Principal Investigator: Susan T Vadaparampil, PhD, MPH, Moffitt Cancer Center; Principal Investigator: Shannon Christy, PhD, Moffitt Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Vaccination; Community Health Centers; Behavioral; Human Papillomavirus; Multi-level intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Papillomavirus Infections; Behavior
• Other Study ID Numbers: MCC-21902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No