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

NCT ID: NCT06256718

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papillomavirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Health services research (PC TEACH)

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

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Evidence-based strategy (PC TEACH)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational Intervention

Evidence-based strategy (PC TEACH)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisa Rodriguez

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Elisa M. Rodriguez

Role: primary

716-845-5953

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2021-12381

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 1998021

Identifier Type: OTHER

Identifier Source: secondary_id

R01MD016850

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 1998021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Impact of Standing Orders Optimization
NCT05742386 ACTIVE_NOT_RECRUITING NA
Elimisha HPV (Human Papillomavirus)
NCT05736588 COMPLETED NA