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

Not Applicable

Recruiting

• Conditions: Human Papilloma Virus (HPV) Vaccine

• Registration Number: NCT05677360
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

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 Timeline

• Study First Submitted: 2022-12-22
• Study Start: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 564

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Effectiveness: HPV Vaccine series initiation rates	at 5 years	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.
Effectiveness: HPV Vaccine series completion rates	at 5 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States