Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02808832
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An HPV Vaccine Provider Intervention in Safety Net Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 806}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of children participants who completed the 3-dose HPV vaccine series', 'timeFrame': '12 months', 'description': 'Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.'}], 'secondaryOutcomes': [{'measure': 'Number of mother participants who received appropriate cervical cancer screening', 'timeFrame': '12 months', 'description': 'Cervical cancer screening is no longer recommended annually so the investigators measured receipt of a Pap smear as needed within a 12 month period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human papillomavirus (HPV) vaccine', 'Cervical cancer screening', 'Provider intervention'], 'conditions': ['Human Papillomavirus', 'Uterine Cervical Neoplasms']}, 'referencesModule': {'references': [{'pmid': '28153042', 'type': 'DERIVED', 'citation': 'Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics. BMC Public Health. 2017 Feb 2;17(1):158. doi: 10.1186/s12889-017-4094-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.', 'detailedDescription': 'In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being seen as a pediatric patient at a study clinic on the day of enrollment\n* Self-identified African American or Hispanic\n* Aged 9-18 years (mother accompanying child to clinic visit had no age limit)\n* Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit\n\nExclusion Criteria:\n\n* Already having received two or more doses of HPV vaccine\n* Mother or female guardian (referred to as "mother" henceforth) not accompanying the child\n* Plans to move away from the clinic catchment area within the next 12 months\n* Not completing the baseline assessment prior to entering the exam room\n* Mother not providing or unable to give consent\n* Child not giving assent.'}, 'identificationModule': {'nctId': 'NCT02808832', 'briefTitle': 'An HPV Vaccine Provider Intervention in Safety Net Clinics', 'organization': {'class': 'OTHER', 'fullName': 'Meharry Medical College'}, 'officialTitle': 'Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention', 'orgStudyIdInfo': {'id': 'U54CA153708', 'link': 'https://reporter.nih.gov/quickSearch/U54CA153708', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational materials', 'description': '5-minute video and information sheet with a list of suggested questions to ask the provider', 'interventionNames': ['Behavioral: Educational materials']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care'}], 'interventions': [{'name': 'Educational materials', 'type': 'BEHAVIORAL', 'description': '5-minute video and information sheet with a list of suggested questions to ask the provider', 'armGroupLabels': ['Educational materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Meharry Medical College', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Maureen Sanderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meharry Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meharry Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'Matthew Walker Comprehensive Health Center', 'class': 'UNKNOWN'}, {'name': 'Memphis Health Center', 'class': 'UNKNOWN'}, {'name': 'Southside/Dodson Avenue Community Health Centers', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}