Human Papillomavirus InfectionNCT03442062
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination
A study testing Assessment Feedback Incentives and eXchange and Physician-to-physician engagement in people with Human Papillomavirus Infection, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial summary
HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Assessment Feedback Incentives and eXchange and Physician-to-physician engagement
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 May 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona with at least 200 active records for patients, ages 11-17, in their states' immunization information systems.
Who cannot join
- Less than 200 active records for patients between 11-17
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York State Department of Health
Albany, New York, 12237
Wisconsin Department of Health Services
Madison, Wisconsin, 53703
Arizona Department of Health Services
Phoenix, Arizona, 85007
About this study
Official title: Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial
HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics.
Read the detailed description
The University of North Carolina will test the effectiveness of the Center for Disease Control and Prevention's AFIX model, physician-to-physician engagement, and both strategies in combination, for increasing HPV vaccination coverage among adolescents in primary care clinics. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of physician educators providing feedback about clinics' current HPV vaccination coverage and in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers via remote webinar consultations. Physician educators will also use immunization registry data to provide feedback on clinics' vaccine coverage. The investigators will compare changes in HPV vaccination coverage before and after intervention for high-volume primary care clinics in four study conditions: AFIX consultations delivered in-person by state health department immunization specialists (AFIX group), physician-to-physician consultations delivered remotely by trained physician educators (P2P group), both AFIX and P2P consultations in combination (AFIX + P2P group), or no HPV quality improvement intervention (control group). In each state, 30 clinics will be randomly assigned to each study arm, for a total of 120 clinics per state, or 360 clinics overall. As a secondary endpoint, we proposed to evaluate the impact of intervention "booster" visits delivered at 12-months post-intervention. However, the CDC has recently changed the AFIX program so that the desired comparison is no longer possible. Therefore, we have eliminated booster visits. This change does not affect our primary endpoint. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 12-month follow-up. Secondarily, the study will compare the change in coverage for other vaccines, age groups and time periods.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Assessment Feedback Incentives and eXchange, Physician-to-physician engagement, Active Intervention Control
- Keywords
- quality improvement, HPV vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment Feedback Incentives and eXchangeOther
Also called AFIX
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
Physician-to-physician engagementOther
Also called P2P
Physician-to-physician engagement is a quality improvement strategy in which trained physician educators deliver a 60 minute consultation via interactive webinar. The consultations will be delivered to providers in primary care clinics and will include didactic instruction on HPV-related cancers, HPV vaccination, communication training, and assessment and feedback about each clinics' vaccination coverage.
Active Intervention ControlOther
Also called Control
Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.
| Study group | Role | What they receive |
|---|---|---|
| AFIX | Experimental | Clinics randomly assigned to this arm will receive an Assessment Feedback Incentives and eXchange (AFIX) consultation delivered in-person by a state health department immunization specialist.This arm includes ~ 90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). Receives: Other: Assessment Feedback Incentives and eXchange |
| Physician-to-physician engagement | Experimental | Clinics randomly assigned to this arm will receive physician-to-physician (P2P) consultations delivered remotely to providers by physician educators. This arm includes ~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). Receives: Other: Physician-to-physician engagement |
| AFIX + P2P | Experimental | Clinics randomly assigned to this arm will receive both an Assessment Feedback Incentives and eXchange (AFIX) consultation and a physician-to-physician (P2P) consultation.This arm includes ~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). Receives: Other: Assessment Feedback Incentives and eXchange; Other: Physician-to-physician engagement |
| Active Intervention Control | Other | Clinics randomly assigned to this arm will receive a brief non-HPV vaccine related quality improvement consultation. This arm includes ~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). Receives: Other: Active Intervention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination (≥1 dose), 11-12 year olds at 12 months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records
Measured: Twelve months
Secondary outcomes (17)
HPV vaccination (≥1 dose), 11-12 year olds at 6 months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records
Measured: Six months
HPV vaccination (≥1 dose), 11-12 year olds at six months by state
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI or AZ)
Measured: Six months
HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI or AZ)
Measured: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds at 18 months
Coverage change from baseline to eighteen months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records
Measured: Eighteen months
HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state
Coverage change from baseline to eighteen months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, or AZ).
Measured: Eighteen months
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months
Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
Measured: Six months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at six months by state
Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, or AZ)
Measured: Six months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months
Coverage change from baseline to twelve months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
Measured: Twelve months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state
Coverage change from baseline to twelve months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, or AZ)
Measured: Twelve months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months
Coverage change from baseline to eighteen months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
Measured: Eighteen months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state
Coverage change from baseline to eighteen months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY, WI, AZ)
Measured: Eighteen months
HPV vaccination (≥1 dose), 13-17 year olds at six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
Measured: Six months
HPV vaccination (≥1 dose), 13-17 year olds at 12 months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
Measured: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds at 18 months
Coverage change from baseline to eighteen months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
Measured: Eighteen months
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months
Coverage change from baseline to six months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records
Measured: Six months
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 months
Coverage change from baseline to twelve months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records
Measured: Twelve months
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 months
Coverage change from baseline to eighteen months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records
Measured: Eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start7 May 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, New York State Department of Health, Wisconsin Department of Health and Family Services, Arizona Department of Health Services, Association of Immunization Managers
- Responsible party
- Sponsor
- Investigators
- Noel T Brewer, PhD, Principal investigator, University of North CarolinaMelissa B Gilkey, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442062
- Sponsor's protocol ID
- 18-0146a
- Other IDs
- 1U01IP001073-01
- Status last verified
- May 2020
- First submitted
- 15 Feb 2018
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03442062
- Acronym / sponsor ID
- 18-0146a
- Conditions
- Human Papillomavirus Infection
- Keywords
- quality improvement, HPV vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, New York State Department of Health, Wisconsin Department of Health and Family Services, Arizona Department of Health Services, Association of Immunization Managers
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 22 Feb 2018 (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.
HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics.
Detailed description
The University of North Carolina will test the effectiveness of the Center for Disease Control and Prevention's AFIX model, physician-to-physician engagement, and both strategies in combination, for increasing HPV vaccination coverage among adolescents in primary care clinics. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of physician educators providing feedback about clinics' current HPV vaccination coverage and in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers via remote webinar consultations. Physician educators will also use immunization registry data to provide feedback on clinics' vaccine coverage. The investigators will compare changes in HPV vaccination coverage before and after intervention for high-volume primary care clinics in four study conditions: AFIX consultations delivered in-person by state health department immunization specialists (AFIX group), physician-to-physician consultations delivered remotely by trained physician educators (P2P group), both AFIX and P2P consultations in combination (AFIX + P2P group), or no HPV quality improvement intervention (control group). In each state, 30 clinics will be randomly assigned to each study arm, for a total of 120 clinics per state, or 360 clinics overall. As a secondary endpoint, we proposed to evaluate the impact of intervention "booster" visits delivered at 12-months post-intervention. However, the CDC has recently changed the AFIX program so that the desired comparison is no longer possible. Therefore, we have eliminated booster visits. This change does not affect our primary endpoint. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 12-month follow-up. Secondarily, the study will compare the change in coverage for other vaccines, age groups and time periods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AFIX | Experimental | Other: Assessment Feedback Incentives and eXchangeClinics randomly assigned to this arm will receive an Assessment Feedback Incentives and eXchange (AFIX) consultation delivered in-person by a state health department immunization specialist.This arm includes ~ 90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). |
| Physician-to-physician engagement | Experimental | Other: Physician-to-physician engagementClinics randomly assigned to this arm will receive physician-to-physician (P2P) consultations delivered remotely to providers by physician educators. This arm includes ~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). |
| AFIX + P2P | Experimental | Other: Assessment Feedback Incentives and eXchange, Other: Physician-to-physician engagementClinics randomly assigned to this arm will receive both an Assessment Feedback Incentives and eXchange (AFIX) consultation and a physician-to-physician (P2P) consultation.This arm includes ~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). |
| Active Intervention Control | Other | Other: Active Intervention ControlClinics randomly assigned to this arm will receive a brief non-HPV vaccine related quality improvement consultation. This arm includes ~90 high-volume primary care clinics in three states (New York, Wisconsin, Arizona). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona with at least 200 active records for patients, ages 11-17, in their states' immunization information systems.
Key exclusion criteria (1 listed)
- Less than 200 active records for patients between 11-17
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 |
|---|---|---|
| Assessment Feedback Incentives and eXchangeAlso: AFIXThe adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components. | Other | AFIX, AFIX + P2P |
| Physician-to-physician engagementAlso: P2PPhysician-to-physician engagement is a quality improvement strategy in which trained physician educators deliver a 60 minute consultation via interactive webinar. The consultations will be delivered to providers in primary care clinics and will include didactic instruction on HPV-related cancers, HPV vaccination, communication training, and assessment and feedback about each clinics' vaccination coverage. | Other | AFIX + P2P, Physician-to-physician engagement |
| Active Intervention ControlAlso: ControlActive Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination. | Other | Active Intervention Control |
Primary outcome
HPV vaccination (≥1 dose), 11-12 year olds at 12 months
Time frame: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records
17 secondary outcomes
HPV vaccination (≥1 dose), 11-12 year olds at 6 months
Time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds at six months by state
Time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state
Time frame: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds at 18 months
Time frame: Eighteen months
HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state
Time frame: Eighteen months
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months
Time frame: Six months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at six months by state
Time frame: Six months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months
Time frame: Twelve months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state
Time frame: Twelve months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months
Time frame: Eighteen months
HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state
Time frame: Eighteen months
HPV vaccination (≥1 dose), 13-17 year olds at six months
Time frame: Six months
HPV vaccination (≥1 dose), 13-17 year olds at 12 months
Time frame: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds at 18 months
Time frame: Eighteen months
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months
Time frame: Six months
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 months
Time frame: Twelve months
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 months
Time frame: Eighteen months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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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.
Noel T Brewer, PhD principal investigator
University of North Carolina
Melissa B Gilkey, PhD principal investigator
University of North Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment Feedback Incentives and eXchange and Physician-to-physician engagement in people with Human Papillomavirus Infection, run by University of North Carolina, Chapel Hill at 3 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HPV vaccination (≥1 dose), 11-12 year olds at 12 months (time frame: Twelve 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 11 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.