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

Not Applicable
Recruiting
Conditions
Human Papilloma Virus (HPV) Vaccine
Interventions
Behavioral: HPV MISTICS -Provider Level
Behavioral: HPV MISTICS - Parent Level
Behavioral: HPV MISTICS- HPV Vaccine Champion Level
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.

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
Arm && Interventions
GroupInterventionDescription
Wave 2: Second Community Health CentersHPV MISTICS -Provider LevelSecond group of community health centers to receive intervention
Wave 2: Second Community Health CentersHPV MISTICS - Parent LevelSecond group of community health centers to receive intervention
Wave 1: Initial Community Health CentersHPV MISTICS - Parent LevelInitial group of community health centers to receive intervention
Wave 1: Initial Community Health CentersHPV MISTICS- HPV Vaccine Champion LevelInitial group of community health centers to receive intervention
Wave 2: Second Community Health CentersHPV MISTICS- HPV Vaccine Champion LevelSecond group of community health centers to receive intervention
Wave 1: Initial Community Health CentersHPV MISTICS -Provider LevelInitial group of community health centers to receive intervention
Primary Outcome Measures
NameTimeMethod
Effectiveness: HPV Vaccine series initiation ratesat 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 ratesat 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
NameTimeMethod
Implementation outcome: Reach demographicsat 5 years

The intervention's implementation will be evaluated for reach - demographics of patients reached.

Proportion of Healthcare Providers, Rural vs Urbanat 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 trainingat 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 staffat 5 years

Long term intervention effects and use over time will be determined semi-structured interviews of health care staff.

Implementation outcome: Reachat 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 interventionat 5 years

The proportion of health care providers who participate in the intervention, measured by contact log data.

Intervention Sustainability: Health care Providersat 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

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