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Completed

NCT Number: NCT03442062

Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Department of Health Services, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Less than 200 active records for patients between 11-17

Treatment and study plan

Assessment Feedback Incentives and eXchange

Other

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.

Other names: AFIX

Physician-to-physician engagement

Other

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.

Other names: P2P

Active Intervention Control

Other

Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.

Other names: Control

Primary outcomes

  1. 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

Secondary outcomes

  1. HPV vaccination (≥1 dose), 11-12 year olds at 6 months

    Time frame: Six 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

  2. HPV vaccination (≥1 dose), 11-12 year olds at six months by state

    Time frame: Six 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, stratifying by state (NY, WI or AZ)

  3. HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state

    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' IIS records, stratifying by state (NY, WI or AZ)

  4. HPV vaccination (≥1 dose), 11-12 year olds at 18 months

    Time frame: Eighteen 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

  5. HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state

    Time frame: Eighteen 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, stratifying by state (NY, WI, or AZ).

  6. HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months

    Time frame: 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

  7. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at six months by state

    Time frame: 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, stratifying by state (NY, WI, or AZ)

  8. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months

    Time frame: Twelve 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

  9. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state

    Time frame: Twelve 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, stratifying by state (NY, WI, or AZ)

  10. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months

    Time frame: Eighteen 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

  11. HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state

    Time frame: Eighteen 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, stratifying by state (NY, WI, AZ)

  12. HPV vaccination (≥1 dose), 13-17 year olds at six months

    Time frame: 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

  13. HPV vaccination (≥1 dose), 13-17 year olds at 12 months

    Time frame: Twelve 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

  14. HPV vaccination (≥1 dose), 13-17 year olds at 18 months

    Time frame: Eighteen 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

  15. HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months

    Time frame: 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

  16. HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 months

    Time frame: Twelve 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

  17. HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 months

    Time frame: Eighteen 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

Other outcomes

  1. Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds

    Time frame: Twelve months

    Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients, as measured by states' IIS records

  2. Meningococcal vaccination (≥1 dose), 11-12 year olds

    Time frame: Twelve months

    Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Arizona Department of Health Services
  • Association of Immunization Managers
  • Centers for Disease Control and Prevention
  • New York State Department of Health
  • Wisconsin Department of Health and Family Services

Registry information

Official study title

Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2018
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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