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

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256718
• Other study ID #: I 1998021
• Secondary ID: NCI-2021-12381I
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: February 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• Educational Intervention
Evidence-based strategy (PC TEACH)

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)