Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT02248558
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'weimingtangscience@gmail.com', 'phone': '+86-15920567132', 'title': 'Weiming Tang', 'organization': 'UNC Project-China'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Conventional Video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.\n\nConventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.', 'otherNumAtRisk': 369, 'otherNumAffected': 0, 'seriousNumAtRisk': 369, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Crowdsourced Video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.\n\nCrowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.', 'otherNumAtRisk': 352, 'otherNumAffected': 0, 'seriousNumAtRisk': 352, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'First-Time HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.\n\nConventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.\n\n111 of 317 (35%) in the health marketing arm reported testing for HIV'}, {'id': 'OG001', 'title': 'Crowdsourced Video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.\n\nCrowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.\n\nIn the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks following the video intervention', 'description': 'All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Likelihood of HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.\n\nConventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.'}, {'id': 'OG001', 'title': 'Crowdsourced Video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.\n\nCrowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to one day', 'description': 'All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be "very unlikely", 1 will be "unlikely", 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost-effectiveness of Developing HIV Testing Promotional Videos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.\n\nConventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.\n\n111 of 317 (35%) in the health marketing arm reported testing for HIV'}, {'id': 'OG001', 'title': 'Crowdsourced Video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.\n\nCrowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.\n\nIn the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV.'}], 'classes': [{'title': 'The incremental unit cost for promoting HIV testin', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}, {'title': 'The incremental unit costs per newly diagnosed HIV', 'categories': [{'measurements': [{'value': '799', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to one year', 'description': 'Cost-effectiveness of developing the crowdsourced video compared to the conventional video', 'unitOfMeasure': 'USD', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.\n\nConventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.'}, {'id': 'FG001', 'title': 'Crowdsourced Video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.\n\nCrowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '369'}, {'groupId': 'FG001', 'numSubjects': '352'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '45'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.\n\nConventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.'}, {'id': 'BG001', 'title': 'Crowdsourced Video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.\n\nCrowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '16-20', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}, {'title': '21-25', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}, {'title': '26-30', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': '31-35', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': '>35', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '685', 'groupId': 'BG002'}]}]}, {'title': 'Transgender', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': 'High School or below', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': 'College', 'categories': [{'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}]}, {'title': 'Graduate Education', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Income (SD)', 'classes': [{'title': '<3000', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}, {'title': '3000-6000', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': '6001-9500', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': '9501-15000', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': '>15000', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'title': 'Never married', 'categories': [{'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}]}, {'title': 'Married/Engaged', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Separated/divorced/Widowed', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual orientation disclosure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ever used gay mobile application', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recent Condomless anal sex', 'classes': [{'title': 'No recent sex', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'Condomless anal sex', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Anal sex with a condom', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 721}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2014-09-17', 'resultsFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-26', 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First-Time HIV Testing', 'timeFrame': 'Up to 4 weeks following the video intervention', 'description': 'All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.'}], 'secondaryOutcomes': [{'measure': 'Likelihood of HIV Testing', 'timeFrame': 'Up to one day', 'description': 'All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be "very unlikely", 1 will be "unlikely", 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.'}, {'measure': 'Cost-effectiveness of Developing HIV Testing Promotional Videos', 'timeFrame': 'Up to one year', 'description': 'Cost-effectiveness of developing the crowdsourced video compared to the conventional video'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contest', 'Crowdsourcing', 'Innovation', 'Randomized controlled trial', 'China', 'Social entrepreneurship'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '29183956', 'type': 'DERIVED', 'citation': 'Wang C, Mollan KR, Hudgens MG, Tucker JD, Zheng H, Tang W, Ling L. Generalisability of an online randomised controlled trial: an empirical analysis. J Epidemiol Community Health. 2018 Feb;72(2):173-178. doi: 10.1136/jech-2017-209976. Epub 2017 Nov 28.'}, {'pmid': '27129465', 'type': 'DERIVED', 'citation': 'Tang W, Han L, Best J, Zhang Y, Mollan K, Kim J, Liu F, Hudgens M, Bayus B, Terris-Prestholt F, Galler S, Yang L, Peeling R, Volberding P, Ma B, Xu H, Yang B, Huang S, Fenton K, Wei C, Tucker JD. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China. Clin Infect Dis. 2016 Jun 1;62(11):1436-1442. doi: 10.1093/cid/ciw171. Epub 2016 Apr 29.'}], 'seeAlsoLinks': [{'url': 'http://www.seshglobal.org/', 'label': 'Social Entrepreneurship for Sexual Health'}]}, 'descriptionModule': {'briefSummary': 'Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote HIV testing among key populations such as men who have sex with men (MSM) and transgender (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in China. The crowdsourced video was developed using an open contest, formal transparent judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported first-time HIV testing within 3-4 weeks of watching the video.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born biologically male or identify as transgender\n* 16 years or older\n* Lifetime anal sex with another man\n* Providing informed consent and active mobile phone number\n\nExclusion Criteria:\n\n* HIV-infected\n* HIV-tested ever in the past'}, 'identificationModule': {'nctId': 'NCT02248558', 'briefTitle': 'Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Crowdsourcing Versus Conventional HIV Testing Promotion: A Noninferiority Randomized Controlled Trial to Evaluate Promoting First-Time HIV Testing Among MSM and Transgender Individuals in China', 'orgStudyIdInfo': {'id': '14-1865'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional video', 'description': 'This arm will receive a one-minute conventional video promoting HIV test uptake.', 'interventionNames': ['Behavioral: Conventional Video']}, {'type': 'EXPERIMENTAL', 'label': 'Crowdsourced video', 'description': 'This arm will receive a one-minute crowdsourced video promoting HIV test uptake.', 'interventionNames': ['Behavioral: Crowdsourced Video']}], 'interventions': [{'name': 'Conventional Video', 'type': 'BEHAVIORAL', 'description': 'Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.', 'armGroupLabels': ['Conventional video']}, {'name': 'Crowdsourced Video', 'type': 'BEHAVIORAL', 'description': 'Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.', 'armGroupLabels': ['Crowdsourced video']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'country': 'China', 'facility': 'UNC Project-China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Joseph Tucker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Project-China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Social Entrepreneurship to Spur Health', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Guangdong Provincial Centers for Skin Diseases and STI Control', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Director of UNC Project-China', 'investigatorFullName': 'Joseph Tucker, MD, PhD, MA', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}