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NCT Number: NCT06256718

Implementation of Evidence-Based Strategy (PC TEACH) for the Optimization of HPV Vaccination in Rural Primary Care

This study evaluates the implementation of evidence based strategies to optimize HPV vaccination in rural primary care settings. Some of the largest disparities in human papillomavirus vaccination (HPVV) rates exist in rural communities, which represent missed opportunities for cancer prevention. Primary care provider visits in these communities serve as a crucial opportunity to communicate the importance of timely vaccination that is essential to effective cancer prevention. This study implements and tests a practice-level intervention (PC TEACH) using practice facilitation of evidence-based strategies to expand reach to rural community-based primary care settings to optimize delivery and increase HPVV rates. PC TEACH program may help rural communities overcome access and awareness factors that keep them from receiving HPVV.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

PRIMARY OBJECTIVES:

I. Identify practices from across 20 rural counties in central and western New York (CWNY) using registry data from New York State Immunization Information System.

II. Leverage established community network contacts of primary care practices across 20 rural counties in CWNY to support and enhance recruitment and retention activities.

III. Establish a Rural Cancer Health Equity Community Advisory Board (CAB) to enhance capacity to implement evidence-based cancer prevention activities in rural primary care settings (like primary care practice-level, medical office-based intervention [PC-TEACH] for Human Papilloma Virus Vaccine [HPVV]).

IV. Recruit rural primary care practices to implement PC TEACH intervention and contribute practice, provider, and patient-level data including adolescent vaccination rates.

V. Implement systematic practice-level changes (i.e., PC TEACH strategies) in rural community-based primary care practices.

V. Evaluate effectiveness of PC TEACH intervention and quality improvement within the practices using process and outcome evaluation measures.

OUTLINE:

Primary practice providers sites receive PC TEACH over 3.5 hours for 12 months.

After completion of study, primary care provider sites are followed up for 3-6 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • PRACTICES: Are located in the 20-county target region
  • PRACTICES: Have an adolescent patient population >= 150 (aged 9-18)
  • PRACTICES: Administer adolescent vaccines (e.g., HPV, Tdap, MCV4)
  • PRACTICES: Are willing to share aggregate practice and patient-level data (e.g., electronic health record [EHR], surveys)
  • PARTICIPANTS: Medical providers and medical staff >= 18 years of age
  • PARTICIPANTS: Primary care providers and medical office staff who deliver adolescent care at community-based primary care practice sites across 20 rural counties in central and western New York
  • PARTICIPANTS: Age >= 18 years of age (no upper limit)
  • PARTICIPANTS: English speaking
  • PARENT/GUARDIAN SURVEY: Adult accompanying a child or children aged 9 to 17
  • PARENT/GUARDIAN SURVEY: English speaking
  • PARENT/GUARDIAN SURVEY: Presenting to the participating clinic for an outpatient well child visit or regular checkup
  • PARENT/GUARDIAN SURVEY: Willing to complete an anonymous survey while visiting the clinic

Exclusion criteria

  • Unwilling or unable to follow protocol requirements
  • Adults unable to complete study measures in English
  • Individuals who are not yet adults (infants, children, teenagers)
  • Cognitively impaired adults/adults with impaired decision-making capacity
  • Prisoners

Treatment and study plan

Educational Intervention

Other

Evidence-based strategy (PC TEACH)

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Primary outcomes

  1. Change in Adolescent HPV vaccination rates

    Time frame: Up to 5 years (60 months)

    To evaluate the impact (short and long-term) of the proposed PC TEACH (primary care practice-level, medical office-based intervention) intervention on human papilloma virus vaccine (HPVV) uptake and completion rates using a staggered (stepped-wedge) intervention schedule. Briefly, practice-specific vaccine rates data will be modeled as a function of time in intervention (0, 6, 12, 18, or 24 months), while adjusting for baseline rates collected prior to intervention for each practice. For vaccine rates, an additional factor for calendar time will be included in the model to address potential seasonal effects.

Secondary outcomes

  1. Age at vaccination

    Time frame: Up to 5 years (60 months)

    will evaluate the impact of the proposed PC TEACH intervention on age at using a staggered (stepped-wedge) intervention schedule. Briefly, practice-specific vaccine rates data will be modeled as a function of time in intervention (0, 6, 12, 18, or 24 months), while adjusting for baseline rates collected prior to intervention for each practice.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Implementation of Evidence-Based Strategies to Optimize HPV Vaccination in Rural Primary Care Settings

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2024
Registry last updated
Mar 17, 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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