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NCT Number: NCT06598475

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 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

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Key information

Conditions

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

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Daisy Y Morales-Campos, PhD

CONTACT

[email protected]

210-276-9042

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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.

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

  2. 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

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

  3. 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

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

  4. 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.

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

  5. 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

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

  6. 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daisy Y Morales-Campos, PhD

CONTACT

[email protected]

(210) 276 9042

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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