Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02370459
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2015-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AFIX to Improve HPV Vaccination
Sponsor:
Organization:
Raw JSON
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'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Six months', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Six months', 'description': "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."}, {'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Six months', 'description': '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).'}, {'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': "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."}, {'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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).'}, {'measure': 'HPV vaccination (3 doses), 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Tdap vaccination, 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Tdap vaccination, 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Tdap vaccination, 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Tdap vaccination, 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Tdap vaccination, 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Six months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Tdap vaccination, 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 11-12 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'HPV vaccination (3 doses), 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Tdap vaccination, 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}, {'measure': 'Meningococcal vaccination (≥1 dose), 13-17 year olds', 'timeFrame': 'Twelve months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Papillomavirus Vaccines', 'Immunization', 'Quality Improvement', 'Adolescent Health Services'], 'conditions': ['Papillomavirus Vaccines', 'Adolescent Health Services']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria: Pediatric or family medicine clinics or practices in WA, IL, or MI with\n\n* at least 500 active records for patients, ages 11-17, in their states' immunization information systems."}, 'identificationModule': {'nctId': 'NCT02370459', 'acronym': 'AFIX', 'briefTitle': 'AFIX to Improve HPV Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': "Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices", 'orgStudyIdInfo': {'id': '13-3599'}, 'secondaryIdInfos': [{'id': '71272', 'type': 'OTHER_GRANT', 'domain': 'Robert Wood Johnson Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive no AFIX consultation.'}, {'type': 'EXPERIMENTAL', 'label': 'AFIX in-person consultation', 'description': 'This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive an in-person AFIX consultation. Consultations will be delivered by state health department staff.', 'interventionNames': ['Other: AFIX in-person consultation']}, {'type': 'EXPERIMENTAL', 'label': 'AFIX webinar consultation', 'description': 'This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90. Clinics randomly assigned to this arm will receive an AFIX consultation via interactive webinar. Consultations will be delivered by state health department staff.', 'interventionNames': ['Other: AFIX webinar consultation']}], 'interventions': [{'name': 'AFIX in-person consultation', 'type': 'OTHER', 'otherNames': ['AFIX, Assessment, Feedback, Incentives, and eXchange Program'], 'description': "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.", 'armGroupLabels': ['AFIX in-person consultation']}, {'name': 'AFIX webinar consultation', 'type': 'OTHER', 'otherNames': ['AFIX, Assessment, Feedback, Incentives, and eXchange Program'], 'description': "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.", 'armGroupLabels': ['AFIX webinar consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62761', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Department of Public Health', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '48909', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Department of Community Health', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '98504', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Washington State Department of Health', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}], 'overallOfficials': [{'name': 'Melissa B Gilkey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}, {'name': 'Noel T Brewer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No raw data will be shared with the general public or other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}, {'name': 'Washington State, Department of Health', 'class': 'OTHER_GOV'}, {'name': 'Illinois Department of Public Health', 'class': 'OTHER'}, {'name': 'Michigan Department of Community Health', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}