Clinical trial NCT05677360: HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Official title: HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus (HPV) Vaccine
Keywords: Human Papillomavirus
Vaccination
Multi-level intervention
Community Health Centers
Behavioral
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
name: Health Choice Network
First posted: 2023-01-10
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

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.

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, or Haitian Creole

Primary outcomes:
measure: Effectiveness: HPV Vaccine series initiation rates
timeFrame: at 5 years
measure: Effectiveness: HPV Vaccine series completion rates
timeFrame: at 5 years
Secondary outcomes:
measure: Implementation outcome: Reach
timeFrame: at 5 years
measure: Implementation outcome: Reach demographics
timeFrame: at 5 years
measure: Proportion of Healthcare providers who participate in the intervention
timeFrame: at 5 years
measure: Proportion of Healthcare Providers, Rural vs Urban
timeFrame: at 5 years
measure: Proportion of Health Care providers who complete training
timeFrame: at 5 years
measure: Intervention Sustainability: Health care Providers
timeFrame: at 5 years
measure: Intervention Sustainability: Healthcare staff
timeFrame: at 5 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Susan T Vadaparampil, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Shannon Christy, PhD
role: PRINCIPAL_INVESTIGATOR
References: