Human Papillomavirus InfectionNCT06256718
Implementation of Evidence-Based Strategy (PC TEACH) for the Optimization of HPV Vaccination in Rural Primary Care
A study testing Educational Intervention in people with Human Papillomavirus Infection, run by Roswell Park Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Implement systematic practice-level changes (i.e., PC TEACH strategies) in rural community-based primary care practices.
- 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
- Human Papillomavirus Infection
- Being tested
- Educational Intervention
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Evidence-based strategy (PC TEACH)
| Study group | Role | What they receive |
|---|---|---|
| Health services research (PC TEACH) | Other | Primary practice providers sites receive PC TEACH over 3.5 hours for 12 months Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years (60 months)
Secondary outcomes (1)
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.
Measured: Up to 5 years (60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start24 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Elisa Rodriguez, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256718
- Sponsor's protocol ID
- I 1998021
- Other IDs
- NCI-2021-12381, I 1998021, R01MD016850
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Evidence-Based Strategies to Optimize HPV Vaccination in Rural Primary Care Settings
- ClinicalTrials.gov ID
- NCT06256718
- Acronym / sponsor ID
- I 1998021
- Conditions
- Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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.
- Implement systematic practice-level changes (i.e., PC TEACH strategies) in rural community-based primary care practices.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (PC TEACH) | Other | Other: Educational InterventionPrimary practice providers sites receive PC TEACH over 3.5 hours for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalEvidence-based strategy (PC TEACH) | Other | Health services research (PC TEACH) |
Primary outcome
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.
1 secondary outcome
Age at vaccination
Time frame: Up to 5 years (60 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for Human Papillomavirus Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Not yet recruiting
The Effect of Health Belief Model-Based HPV Infection and Vaccination Education on University Students' Knowledge and Health Beliefs
Health Belief Model, Nursing Students
Active, not recruitingPhase 3
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-45 Years
HPV InfectioN, HPV-Related Carcinoma
Not yet recruitingPhase 1/2
Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs
HPV Positive Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Rodriguez principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Human Papillomavirus Infection, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adolescent HPV vaccination rates (time frame: Up to 5 years (60 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.