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

The University of Texas System (UT)

Status: Enrolling

Conditions: Human Papillomavirus Infection

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06598475

HSC-SPH-24-0335

Details and patient eligibility

About

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

Enrollment: 2,142 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,142 participants in 3 patient groups

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

Experimental group

Treatment:

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 group

Treatment:

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 group

Treatment:

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