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

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05677360
Acronym
HPV MISTICS
Enrollment
564
Registered
2023-01-10
Start date
2023-01-09
Completion date
2026-12-31
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus (HPV) Vaccine

Keywords

Human Papillomavirus, Vaccination, Multi-level intervention, Community Health Centers, Behavioral

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.

Interventions

BEHAVIORALHPV MISTICS -Provider Level

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.

BEHAVIORALHPV MISTICS - Parent Level

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.

BEHAVIORALHPV MISTICS- HPV Vaccine Champion Level

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

Sponsors

Florida Department of Health
CollaboratorOTHER_GOV
Health Choice Network
CollaboratorOTHER
H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness: HPV Vaccine series initiation ratesat 5 yearsHPV 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 yearsHPV 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

MeasureTime frameDescription
Proportion of Healthcare providers who participate in the interventionat 5 yearsThe proportion of health care providers who participate in the intervention, measured by contact log data.
Proportion of Healthcare Providers, Rural vs Urbanat 5 yearsThe proportion of health care providers in rural vs urban Federally Qualified Health Centers in network that participate.
Implementation outcome: Reachat 5 yearsThe intervention's implementation will be evaluated for reach - proportion of eligible patients that receive the intervention.
Intervention Sustainability: Health care Providersat 5 yearsLong term intervention effects and use over time will be determined semi-structured interviews of providers
Intervention Sustainability: Healthcare staffat 5 yearsLong term intervention effects and use over time will be determined semi-structured interviews of health care staff.
Proportion of Health Care providers who complete trainingat 5 yearsThe proportion of participating health care providers and staff who complete training per site will be measured using the training attendance log
Implementation outcome: Reach demographicsat 5 yearsThe intervention's implementation will be evaluated for reach - demographics of patients reached.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026