Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents

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

RECRUITING

Clinical Phase

NA

Total Enrollment

2142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2028-08-01

Brief Summary

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The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites

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Detailed Description

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Conditions

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Human Papillomavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a stepwise cluster randomized control design study. There will be 3 clusters (FQHC's) having 3 practices each

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Step 1 (3 clinics)-15 months control then 30 months intervention

Group Type EXPERIMENTAL

Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

Intervention Type OTHER

The practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice:

* Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder.
* Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical practice in two additional modules and encourage providers to identify strategies to increase HPV vaccination.
* Training and education for staff (Immunization Navigators): The facilitator will train immunization navigators to implement the plan, and practice immunization navigators will implement the plan.
* Technical assistance plus assessment and feedback: During implementation of the plan, the facilitator will provide technical assistance, ongoing assessment and feedback, and booster trainings.

Step 2 (3 clinics)-21 months control then 24 months intervention

Group Type EXPERIMENTAL

Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

Intervention Type OTHER

The practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice:

* Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder.
* Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical practice in two additional modules and encourage providers to identify strategies to increase HPV vaccination.
* Training and education for staff (Immunization Navigators): The facilitator will train immunization navigators to implement the plan, and practice immunization navigators will implement the plan.
* Technical assistance plus assessment and feedback: During implementation of the plan, the facilitator will provide technical assistance, ongoing assessment and feedback, and booster trainings.

Step 3 (3 clinics)-27 months control then 18 months intervention

Group Type EXPERIMENTAL

Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

Intervention Type OTHER

The practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice:

* Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder.
* Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical practice in two additional modules and encourage providers to identify strategies to increase HPV vaccination.
* Training and education for staff (Immunization Navigators): The facilitator will train immunization navigators to implement the plan, and practice immunization navigators will implement the plan.
* Technical assistance plus assessment and feedback: During implementation of the plan, the facilitator will provide technical assistance, ongoing assessment and feedback, and booster trainings.

Interventions

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Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

The practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice:

* Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder.
* Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical practice in two additional modules and encourage providers to identify strategies to increase HPV vaccination.
* Training and education for staff (Immunization Navigators): The facilitator will train immunization navigators to implement the plan, and practice immunization navigators will implement the plan.
* Technical assistance plus assessment and feedback: During implementation of the plan, the facilitator will provide technical assistance, ongoing assessment and feedback, and booster trainings.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* FQHC's with less than 60% HPV vaccine initiation rate for 11-12 year old adolescents overall at their practice sites
* FQHC's that have family medicine and/or pediatric practices
* a total adolescent patient population at least 50% Latino
* be willing for Health Care Provider (HCP) and staff members to receive education, training, and support; complete standardized measurement, and agree to randomization.
* Providers, aged 18 and over, employed at each FQHC (4 staff per practice)
* Staff, aged 18 and over, employed at each FQHC (5 staff per practice)
* Implementation team members (i.e., administrative designee, health care providers, immunization navigators, and other staff), aged 18 and over, employed at each FQHC (4 members per practice)
* Parents (aged 18 and over) of patients ages 11-17 seeking care at each FQHC (25 per practice).