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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Human Papilloma Virus (HPV) Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Wave 1: Initial Community Health Centers

Initial group of community health centers to receive intervention

Group Type EXPERIMENTAL

HPV MISTICS -Provider Level

Intervention Type BEHAVIORAL

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.

HPV MISTICS - Parent Level

Intervention Type BEHAVIORAL

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.

HPV MISTICS- HPV Vaccine Champion Level

Intervention Type BEHAVIORAL

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

Wave 2: Second Community Health Centers

Second group of community health centers to receive intervention

Group Type EXPERIMENTAL

HPV MISTICS -Provider Level

Intervention Type BEHAVIORAL

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.

HPV MISTICS - Parent Level

Intervention Type BEHAVIORAL

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.

HPV MISTICS- HPV Vaccine Champion Level

Intervention Type BEHAVIORAL

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

Interventions

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HPV 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.

Intervention Type BEHAVIORAL

HPV 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.

Intervention Type BEHAVIORAL

HPV 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes