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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Human Papillomavirus Infection
• Intervention / Treatment: Other: Educational Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
      • Contact: Elisa M. Rodriguez; Phone Number: 716-845-5953; Email: Elisa.Rodriguez@roswellpark.org
      • Principal Investigator: Elisa M. Rodriguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Health services research (PC TEACH); Primary practice providers sites receive PC TEACH over 3.5 hours for 12 months	Other: Educational Intervention; Evidence-based strategy (PC TEACH); Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adolescent HPV vaccination rates	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.	Up to 5 years (60 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age at vaccination	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.	Up to 5 years (60 months)

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI); National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Elisa Rodriguez, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: I 1998021 (Other Identifier: Roswell Park Cancer Institute); NCI-2021-12381 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01MD016850 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No