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 — OTHERThe 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
- Daisy Y Morales-Campos, PhD(210) 276 9042
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 |
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