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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).

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).

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).

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).

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.

Assessment Feedback Incentives and eXchange

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.

Physician-to-physician engagement

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

Active Intervention Control

Noel T Brewer, PhD

Melissa B Gilkey, PhD

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.

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.

Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination

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

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

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

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

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

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)

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)

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

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).

Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records

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)

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

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)

Coverage change from baseline to eighteen months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records

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)

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

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

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

Coverage change from baseline to six months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records

Coverage change from baseline to twelve months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records

Coverage change from baseline to eighteen months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination	NCT03442062	Human Papilloma...	Assessment Feed... Physician-to-ph... Active Interven...	-	University of North Carolina, Chapel Hill
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination	NCT03442062	Human Papilloma...	Assessment Feed... Physician-to-ph... Active Interven...	-	University of North Carolina, Chapel Hill

Spots Global Cancer Trial Database for assessment feedback incentives and exchange