Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-13 @ 11:49 AM
Study NCT ID:
NCT02464358
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2015-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV, Cervical Cancer, and HPV Vaccine Knowledge Questionnaire', 'timeFrame': 'One month', 'description': 'Consistent with studies based on the IMB model,, participants were assessed on their level of knowledge regarding information about HPV, the HPV vaccine, and cervical cancer.'}, {'measure': 'Vaccination Motivation Questionnaire', 'timeFrame': 'One month', 'description': 'Consistent with studies based on the IMB model, motivation to get vaccinated was assessed through five questionnaires to measure different aspects of motivation: perceived motivation, attitudes related to getting vaccinated, perceived social norms to getting vaccinated, behavioral intentions, and perceived risk for HPV/cervical cancer.'}, {'measure': 'Behavioral Skills Questionnaire', 'timeFrame': 'One Month', 'description': "Consistent with studies based on the IMB model, participants' belief and confidence in their ability to get vaccinated were assessed with questions adapted from these studies."}], 'secondaryOutcomes': [{'measure': 'Behavioral uptake of the HPV vaccine Questionnaire', 'timeFrame': 'One month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HPV'], 'conditions': ['Human Papillomavirus Infection']}, 'descriptionModule': {'briefSummary': "HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.", 'detailedDescription': "HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.\n\nMethods: Participants were randomly assigned to a single-session intervention or attention-control arm and were assessed at pre-intervention, post-intervention, and at 1-month follow-up."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrollment in a psychology course at the University of Connecticut\n\nExclusion Criteria:\n\n* Completion of the HPV vaccination series'}, 'identificationModule': {'nctId': 'NCT02464358', 'briefTitle': 'An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'The Impact of an Information-Motivation-Behavioral Skills (IMB) Based Educational Intervention to Improve Gardasil Use in a Population of Undergraduate Women', 'orgStudyIdInfo': {'id': 'H11-272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMB Intervention Group', 'description': 'The IMB group received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, they received the following:\n\n1. Additional educational content related to HPV, Cervical Cancer, and HPV vaccination,\n2. Motivational content to help identify and problem-solve benefits and barriers to vaccination,\n3. Skills-building content, including brief communication skills training and ways to access the vaccine.', 'interventionNames': ['Behavioral: IMB Intervention Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control Group', 'description': "The attention control group also received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, to maintain consistency with the treatment's presentation format, participants watched a set of short video clips encompassing aspects of women's general and sexual health.", 'interventionNames': ['Behavioral: Attention Control']}], 'interventions': [{'name': 'IMB Intervention Group', 'type': 'BEHAVIORAL', 'otherNames': ['IMB Based Educational Program'], 'description': 'Participants in the IMB group received information specific to HPV, cervical cancer, and the HPV vaccine. This information was delivered in a group setting, and it was delivered via a PowerPoint presentation that included short video clips.', 'armGroupLabels': ['IMB Intervention Group']}, {'name': 'Attention Control', 'type': 'BEHAVIORAL', 'description': "Participants in the attention control arm watched a PowerPoint that contained a series of short video clips encompassing aspects of women's general and sexual health. This was also conducted in a group setting.", 'armGroupLabels': ['Attention Control Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dean G Cruess, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}, {'name': 'Giselle K Perez, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dean Cruess', 'investigatorAffiliation': 'University of Connecticut'}}}}