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

NCT05677360 | Suspended

• 1 other identifier: MCC-21902
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus (HPV) Vaccine

Keywords

Human Papillomavirus; Vaccination; Multi-level intervention; Community Health Centers; Behavioral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

Wave 1: Initial Community Health Centers

EXPERIMENTAL

Initial group of community health centers to receive intervention

Behavioral: HPV MISTICS -Provider Level; Behavioral: HPV MISTICS - Parent Level; Behavioral: HPV MISTICS- HPV Vaccine Champion Level

Wave 2: Second Community Health Centers

EXPERIMENTAL

Second group of community health centers to receive intervention

Behavioral: HPV MISTICS -Provider Level; Behavioral: HPV MISTICS - Parent Level; Behavioral: HPV MISTICS- HPV Vaccine Champion Level

Interventions

HPV MISTICS -Provider Level BEHAVIORAL

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.

Wave 1: Initial Community Health Centers; Wave 2: Second Community Health Centers

HPV MISTICS - Parent Level BEHAVIORAL

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.

Wave 1: Initial Community Health Centers; Wave 2: Second Community Health Centers

HPV MISTICS- HPV Vaccine Champion Level BEHAVIORAL

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

Wave 1: Initial Community Health Centers; Wave 2: Second Community Health Centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Staff:
• years of age or older
• Working within the participating Federally Qualified Health Center system
• Able to read, write and speak English
• For Providers:
• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Florida Department of Health: collaborator
• Health Choice Network: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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.

  PMID: 38763306 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Behavior

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan T Vadaparampil, PhD, MPH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Shannon Christy, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 1 implementation design which will allow the team to examine both effectiveness of HPV MISTICS and implementation outcomes in a single study. Implementation outcomes will be evaluated using the RE-AIM Qualitative Evaluation for Systematic Translation (RE-AIM QuEST) framework, a mixed-methods framework to identify implementation barriers and facilitators while assessing implementation outcomes (e.g., reach, adoption, implementation, maintenance/sustainability) with a focus on evaluating equity across these outcomes.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 10, 2023
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)