Papillomavirus Vaccines Clinical Trial
— AFIXOfficial title:
Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices
Verified date | February 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. 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. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. 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 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.
Status | Completed |
Enrollment | 223 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Pediatric or family medicine clinics or practices in WA, IL, or MI
with - at least 500 active records for patients, ages 11-17, in their states' immunization information systems. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Michigan Department of Community Health | Lansing | Michigan |
United States | Washington State Department of Health | Olympia | Washington |
United States | Illinois Department of Public Health | Springfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Harvard Medical School, Illinois Department of Public Health, Michigan Department of Community Health, Robert Wood Johnson Foundation, Washington State, Department of Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- to 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by electronic immunization information system (IIS) records, controlling for child's sex | Six months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex. | Six months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA). | Six months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex. | Twelve months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA). | Twelve months | |
Secondary | HPV vaccination (3 doses), 11-12 year olds | Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds | Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | Meningococcal vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (3 doses), 13-17 year olds | Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | Tdap vaccination, 13-17 year olds | Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | Meningococcal vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (3 doses), 11-12 year olds | Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | Tdap vaccination, 11-12 year olds | Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | Meningococcal vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (3 doses), 13-17 year olds | Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | Tdap vaccination, 13-17 year olds | Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | Meningococcal vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (3 doses), 11-12 year olds | Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | Tdap vaccination, 11-12 year olds | Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | Meningococcal vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (3 doses), 13-17 year olds | Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | Tdap vaccination, 13-17 year olds | Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | Meningococcal vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Six months | |
Secondary | HPV vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (3 doses), 11-12 year olds | Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | Tdap vaccination, 11-12 year olds | Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | Meningococcal vaccination (=1 dose), 11-12 year olds | Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | HPV vaccination (3 doses), 13-17 year olds | Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | Tdap vaccination, 13-17 year olds | Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months | |
Secondary | Meningococcal vaccination (=1 dose), 13-17 year olds | Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records. | Twelve months |
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