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

Not Applicable

Recruiting

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

• Registration Number: NCT06598475
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2028-02-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2142

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).

Exclusion Criteria

-FQHCs that participated in the pilot study were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Step 1 (3 clinics)-15 months control then 30 months intervention	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	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	Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Percentage of males and females at each clinic who received Tdap and MenACWY at age 11 as a requirement to attend 7th grade in Texas.	From baseline to end of study ( about 60 months from baseline)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States