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

NCT06598475 | Recruiting

• 1 other identifier: HSC-SPH-24-0335
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Papillomavirus Infection

Keywords

HPV vaccination

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline to end of study ( about 60 months from baseline)

• Percentage of vaccine-eligible males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after their first dose and before their 13th birthday.

  From baseline to end of study ( about 60 months from baseline)

Secondary Outcomes (6)

• Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 18th birthday.

  From baseline to end of study ( about 60 months from baseline)

• Percentage of vaccine-eligible 13-14 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after first dose and before their 15th birthday

  From baseline to end of study ( about 60 months from baseline)

• Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 2 months after first dose and before their 18th birthday

  From baseline to end of study ( about 60 months from baseline)

• Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the third valid dose of the HPV vaccine series 4 months after second dose and before their 18th birthday.

  From baseline to end of study ( about 60 months from baseline)

• Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17 by clinic

  From baseline to end of study ( about 60 months from baseline)

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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.

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

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• FQHCs that participated in the pilot study were excluded.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Morales-Campos DY, Adsul P, Liang Y, Donovan E, Moczygemba LR, Kahn JA. Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers. BMC Public Health. 2025 Apr 9;25(1):1331. doi: 10.1186/s12889-025-22273-7.

  PMID: 40205591 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daisy Y Morales Campos, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daisy Y Morales-Campos, PhD

CONTACT

(210) 276 9042; Daisy.Y.MoralesCampos@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)