Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-31 @ 2:16 PM
Study NCT ID:
NCT01600560
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2012-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitating Completion of HPV Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV vaccination uptake', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adolescent Immunizations Among Clinic Population']}, 'descriptionModule': {'briefSummary': "With the surge in use of electronic media among adolescents, a strategy that has been utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents. To date, no published study has looked at the effectiveness of texting adolescents themselves (especially boys) rather than their parents OR compared texting to social network sites to increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based interventions targeted at youth are feasible in North Carolina for the following reasons: (1) through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and treatment of sexually transmitted diseases (N.C. Gen. Stat. ยง 90-21.5(a); and (2) many school based health centers can provide immunizations. Since HPV infection is a sexually transmitted infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination).\n\nTo optimize HPV vaccination in young people, especially males, communication strategies are needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to be a feasible, popular, and effective method of sexual health promotion to young people with a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual health knowledge and STI testing (12). Social media communication strategies are a new and potentially effective channel for communicating public health messages about HPV vaccine that are also likely to increase HPV initiation and completion among adolescent girls in addition to boys.\n\nAccording to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had received at least one dose of HPV vaccine. In the investigators continuity clinic less than 50 percent of adolescents are fully immunized. This project will identify social behavioral, emotional, and cognitive correlates and predictors that help explain why teens pursue, complete, and do not complete HPV vaccination, and develop a social media communication intervention collaboratively with teens to increase HPV vaccine initiation and completion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescent males and females age 11-21 at a Pediatric clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incomplete immunization\n\nExclusion Criteria:\n\n* complete immunization'}, 'identificationModule': {'nctId': 'NCT01600560', 'briefTitle': 'Facilitating Completion of HPV Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Facilitating the Completion of the 3-Dose Series of HPV Vaccination in Males and Females', 'orgStudyIdInfo': {'id': '11-1551'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Social media'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Pediatric Clinic', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Tamara Coyne-Beasley, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}