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

NCT06256718 | Active Not Recruiting

• 3 other identifiers: I 1998021NCI-2021-12381R01MD016850
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Age at vaccination

  Up to 5 years (60 months)

Study Arms (1)

Health services research (PC TEACH)

OTHER

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

Other: Educational Intervention

Interventions

Educational Intervention OTHER

Evidence-based strategy (PC TEACH)

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Health services research (PC TEACH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Elisa Rodriguez

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 13, 2024
• Study Start: May 24, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)