Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06598475
Enrollment
225
Registered
2024-09-19
Start date
2025-03-13
Completion date
2028-08-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus Infection

Keywords

HPV vaccination

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

Interventions

OTHERFacilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 birthdayFrom 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 birthdayFrom 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 clinicFrom 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)

Countries

United States

Contacts

CONTACTDaisy Y Morales-Campos, PhD
Daisy.Y.MoralesCampos@uth.tmc.edu(210) 276 9042
PRINCIPAL_INVESTIGATORDaisy Y Morales Campos, PhD

The University of Texas Health Science Center, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026