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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06598475
Status
Recruiting

Conditions

  • Human Papillomavirus Infection

Eligibility Criteria

Sex
ALL
Age
11 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 13, 2025
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Step 1 (3 clinics)-15 months control then 30 months intervention
  • Experimental: Step 2 (3 clinics)-21 months control then 24 months intervention
  • Experimental: Step 3 (3 clinics)-27 months control then 18 months intervention

Primary Outcome Measure

Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday. [ Time Frame: From baseline to end of study ( about 60 months from baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Daisy Y Morales-Campos, PhD
210-276-9042

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