Back to resultsHPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS) (HPV MISTICS)
Primary Purpose
Human Papilloma Virus (HPV) Vaccine
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV MISTICS -Provider Level
HPV MISTICS - Parent Level
HPV MISTICS- HPV Vaccine Champion Level
Sponsored by
About this trial
This is an interventional prevention trial for Human Papilloma Virus (HPV) Vaccine focused on measuring Human Papillomavirus, Vaccination, Multi-level intervention, Community Health Centers, Behavioral
Eligibility Criteria
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
Sites / Locations
- Moffitt Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Wave 1: Initial Community Health Centers
Wave 2: Second Community Health Centers
Arm Description
Initial group of community health centers to receive intervention
Second group of community health centers to receive intervention
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Implementation outcome: Reach
The intervention's implementation will be evaluated for reach - proportion of eligible patients that receive the intervention.
Implementation outcome: Reach demographics
The intervention's implementation will be evaluated for reach - demographics of patients reached.
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.
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.
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
Intervention Sustainability: Health care Providers
Long term intervention effects and use over time will be determined semi-structured interviews of providers
Intervention Sustainability: Healthcare staff
Long term intervention effects and use over time will be determined semi-structured interviews of health care staff.
Full Information
NCT ID
NCT05677360
First Posted
December 22, 2022
Last Updated
October 12, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Florida Department of Health, Health Choice Network
1. Study Identification
Unique Protocol Identification Number
NCT05677360
Brief Title
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Acronym
HPV MISTICS
Official Title
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Florida Department of Health, Health Choice Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus (HPV) Vaccine
Keywords
Human Papillomavirus, Vaccination, Multi-level intervention, Community Health Centers, Behavioral
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wave 1: Initial Community Health Centers
Arm Type
Experimental
Arm Description
Initial group of community health centers to receive intervention
Arm Title
Wave 2: Second Community Health Centers
Arm Type
Experimental
Arm Description
Second group of community health centers to receive intervention
Intervention Type
Behavioral
Intervention Name(s)
HPV MISTICS -Provider Level
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HPV MISTICS - Parent Level
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HPV MISTICS- HPV Vaccine Champion Level
Intervention Description
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
Primary Outcome Measure Information:
Title
Effectiveness: HPV Vaccine series initiation rates
Description
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.
Time Frame
at 5 years
Title
Effectiveness: HPV Vaccine series completion rates
Description
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.
Time Frame
at 5 years
Secondary Outcome Measure Information:
Title
Implementation outcome: Reach
Description
The intervention's implementation will be evaluated for reach - proportion of eligible patients that receive the intervention.
Time Frame
at 5 years
Title
Implementation outcome: Reach demographics
Description
The intervention's implementation will be evaluated for reach - demographics of patients reached.
Time Frame
at 5 years
Title
Proportion of Healthcare providers who participate in the intervention
Description
The proportion of health care providers who participate in the intervention, measured by contact log data.
Time Frame
at 5 years
Title
Proportion of Healthcare Providers, Rural vs Urban
Description
The proportion of health care providers in rural vs urban Federally Qualified Health Centers in network that participate.
Time Frame
at 5 years
Title
Proportion of Health Care providers who complete training
Description
The proportion of participating health care providers and staff who complete training per site will be measured using the training attendance log
Time Frame
at 5 years
Title
Intervention Sustainability: Health care Providers
Description
Long term intervention effects and use over time will be determined semi-structured interviews of providers
Time Frame
at 5 years
Title
Intervention Sustainability: Healthcare staff
Description
Long term intervention effects and use over time will be determined semi-structured interviews of health care staff.
Time Frame
at 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan T Vadaparampil, PhD, MPH
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shannon Christy, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Fuzzell
Phone
813-799-6112
Email
Lindsay.Fuzzell@moffitt.org
First Name & Middle Initial & Last Name & Degree
Susan T Vadaparampil, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Shannon Christy, PhD
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD, MPH, MA
12. IPD Sharing Statement
Learn more about this trial
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
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