Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-02 @ 3:58 AM
Study NCT ID:
NCT00725959
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2008-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Online Social Networking for HIV Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '303-724-1238', 'title': 'Dr. Sheana Bull', 'organization': 'Colorado School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'throughout entire enrollment and study follow up periods', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Group exposed to dynamic content on Facebook re: HIV Prevention', 'otherNumAtRisk': 942, 'deathsNumAtRisk': 942, 'otherNumAffected': 0, 'seriousNumAtRisk': 942, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Attention Control exposed to a current events Facebook page', 'otherNumAtRisk': 636, 'deathsNumAtRisk': 636, 'otherNumAffected': 0, 'seriousNumAtRisk': 636, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Condom Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Group exposed to dynamic content on Facebook re: HIV Prevention'}, {'id': 'OG001', 'title': 'Arm 2'}], 'classes': [{'categories': [{'measurements': [{'value': '.68', 'groupId': 'OG000', 'lowerLimit': '.56', 'upperLimit': '.74'}, {'value': '.56', 'groupId': 'OG001', 'lowerLimit': '.48', 'upperLimit': '.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'two months', 'description': 'number of times condom used divided by number of times person had sex in past 60 days', 'unitOfMeasure': 'proportion of condom use', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions', 'timeFrame': 'two months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': 'Group exposed to dynamic content on Facebook re: HIV Prevention'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Attention Control exposed to a current events Facebook page'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '942'}, {'groupId': 'FG001', 'numSubjects': '636'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '653'}, {'groupId': 'FG001', 'numSubjects': '439'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '197'}]}]}], 'recruitmentDetails': 'Recruitment began October 2010 and Ended May 2011 in community settings'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '942', 'groupId': 'BG000'}, {'value': '636', 'groupId': 'BG001'}, {'value': '1578', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1', 'description': 'Group exposed to dynamic content on Facebook re: HIV Prevention'}, {'id': 'BG001', 'title': 'Arm 2', 'description': 'Attention Control exposed to a current events Facebook page'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '20.2', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Years of age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '521', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '912', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1578}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2008-07-29', 'resultsFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2008-07-29', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-01', 'studyFirstPostDateStruct': {'date': '2008-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Condom Usage', 'timeFrame': 'two months', 'description': 'number of times condom used divided by number of times person had sex in past 60 days'}], 'secondaryOutcomes': [{'measure': 'Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions', 'timeFrame': 'two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV Prevention', 'Social Networking', 'Technology Based Intervention'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '23079168', 'type': 'DERIVED', 'citation': 'Bull SS, Levine DK, Black SR, Schmiege SJ, Santelli J. Social media-delivered sexual health intervention: a cluster randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):467-74. doi: 10.1016/j.amepre.2012.07.022.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized controlled trial, we will identify social networks on Facebook, an randomly assign each network to control or intervention status. We will then intervene at the level of the network with dynamic, interactive HIV prevention messages (intervention) or static messages about HIV prevention (control). We will develop the intervention content with input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month assessments of condom use and abstinence among all participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Facebook user with an existing Facebook page\n* at least 16\n* no older than 24\n* English speaker\n\nExclusion Criteria:\n\n* older than 24 or younger than 16\n* non English speaker\n* does not have a Facebook page'}, 'identificationModule': {'nctId': 'NCT00725959', 'briefTitle': 'Online Social Networking for HIV Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Colorado School of Public Health'}, 'officialTitle': 'Online Social Networking for HIV Prevention', 'orgStudyIdInfo': {'id': 'COMIRB 07-0459'}, 'secondaryIdInfos': [{'id': 'R01NR010492', 'link': 'https://reporter.nih.gov/quickSearch/R01NR010492', 'type': 'NIH'}, {'id': '1R01NR01492-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facebook Arm', 'description': 'Participants in this arm will have exposure to innovative, dynamic and regularly updated HIV Prevention messages on Facebook', 'interventionNames': ['Behavioral: Online social networking HIV prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Participants in this arm will have exposure to static information on HIV prevention currently available online', 'interventionNames': ['Behavioral: Online social networking HIV prevention']}], 'interventions': [{'name': 'Online social networking HIV prevention', 'type': 'BEHAVIORAL', 'description': 'messages about HIV posted in online social networking sites', 'armGroupLabels': ['Control arm', 'Facebook Arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sheana Bull, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado at Denver and Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'Internet Sexuality Information Services (ISIS)', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Rutgers University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sheana Bull', 'investigatorAffiliation': 'Colorado School of Public Health'}}}}