Recruiting

HPV Vaccination

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06598475

Conditions

Human Papillomavirus Infection

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06598475

Start date

Mar 13, 2025

Status verified date

Apr, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

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

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Facilitator-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.

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) ]
  • 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. [ Time Frame: From baseline to end of study ( about 60 months from baseline) ]

Central Contacts and Locations

Central contacts

Daisy Y Morales-Campos, PhD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Daisy Y Morales-Campos, PhD

210-276-9042Daisy.Y.MoralesCampos@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • HPV vaccination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-04.