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

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

NCT ID: NCT05677360

Condition: Human Papilloma Virus (HPV) Vaccine

Conditions: Official terms:
Papilloma

Conditions: Keywords:
Human Papillomavirus
Vaccination
Multi-level intervention
Community Health Centers
Behavioral

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Intervention 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.

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: HPV MISTICS -Provider Level
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.
Arm group label: Wave 1: Initial Community Health Centers
Arm group label: Wave 2: Second Community Health Centers

Intervention type: Behavioral
Intervention name: HPV MISTICS - Parent Level
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.
Arm group label: Wave 1: Initial Community Health Centers
Arm group label: Wave 2: Second Community Health Centers

Intervention type: Behavioral
Intervention name: HPV MISTICS- HPV Vaccine Champion Level
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
Arm group label: Wave 1: Initial Community Health Centers
Arm group label: Wave 2: Second Community Health Centers

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Contact:
Last name: Lindsay Fuzzell

Phone: 813-799-6112
Email: Lindsay.Fuzzell@moffitt.org

Investigator:
Last name: Susan T Vadaparampil, PhD, MPH
Email: Principal Investigator

Investigator:
Last name: Shannon Christy, PhD
Email: Principal Investigator

Investigator:
Last name: Kea Turner, PhD, MPH, MA
Email: Sub-Investigator

Start date: January 9, 2023

Completion date: December 2026

Lead sponsor:
Agency: H. Lee Moffitt Cancer Center and Research Institute
Agency class: Other

Collaborator:
Agency: Florida Department of Health
Agency class: Other

Collaborator:
Agency: Health Choice Network
Agency class: Other

Source: H. Lee Moffitt Cancer Center and Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05677360