Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-04 @ 11:54 PM
Study NCT ID:
NCT03259360
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Facebook Intervention for Young Sexual and Gender Minority Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-26', 'size': 197102, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-24T21:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day point prevalence abstinence at 3 months', 'timeFrame': '3 months post baseline', 'description': 'Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.'}, {'measure': '7-day point prevalence abstinence at 6 months', 'timeFrame': '6 months post baseline', 'description': 'Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.'}], 'secondaryOutcomes': [{'measure': 'Reduction in cigarettes smoked by at least 50%', 'timeFrame': '3 and 6 months post baseline', 'description': 'Reduction will be assessed at 3 and 6 month follow-ups.'}, {'measure': 'Tobacco use quit attempts', 'timeFrame': '3 and 6 months post baseline', 'description': 'Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.'}, {'measure': 'Readiness to quit tobacco', 'timeFrame': '3 and 6 months post baseline', 'description': 'Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months'}, {'measure': 'Thoughts About Tobacco Abstinence', 'timeFrame': '3 and 6 months post baseline', 'description': 'Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco', 'Gender Identity Minority', 'Sexual Identity Minority', 'Cessation', 'Intervention', 'Young Adults', 'Social Media', 'Internet', 'Cigarette'], 'conditions': ['Tobacco Use', 'Smoking', 'Tobacco Dependence', 'Tobacco Use Disorder', 'Tobacco Use Cessation', 'Tobacco Smoking', 'Smoking Cessation', 'Smoking, Cigarette', 'Smoking, Tobacco']}, 'referencesModule': {'references': [{'pmid': '26721211', 'type': 'BACKGROUND', 'citation': 'Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.'}, {'pmid': '26561529', 'type': 'BACKGROUND', 'citation': 'Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.'}, {'pmid': '26374203', 'type': 'BACKGROUND', 'citation': 'Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.'}, {'pmid': '25045624', 'type': 'BACKGROUND', 'citation': 'Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.'}, {'pmid': '24575728', 'type': 'BACKGROUND', 'citation': "Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27."}, {'pmid': '31562765', 'type': 'BACKGROUND', 'citation': 'Vogel EA, Ramo DE, Meacham MC, Prochaska JJ, Delucchi KL, Humfleet GL. The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1614-1621. doi: 10.1093/ntr/ntz184.'}]}, 'descriptionModule': {'briefSummary': 'The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 mos.', 'detailedDescription': "Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.\n\nAssessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* read English\n* between 18 and 25 years of age\n* indicate they use Facebook "most" (≥ 4) days per week\n* have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week\n* identifies as SGM\n\nExclusion Criteria:\n\n* do not read English\n* are not between 18 and 25 years of age\n* indicate they do not use Facebook "most" (≥ 4) days per week\n* have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week\n* does not identify as SGM'}, 'identificationModule': {'nctId': 'NCT03259360', 'acronym': 'POP', 'briefTitle': 'A Facebook Intervention for Young Sexual and Gender Minority Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Facebook Intervention for Young Sexual and Gender Minority Smokers', 'orgStudyIdInfo': {'id': 'PA-15-263'}, 'secondaryIdInfos': [{'id': 'R21MD011765', 'link': 'https://reporter.nih.gov/quickSearch/R21MD011765', 'type': 'NIH'}, {'id': 'K23DA032578', 'link': 'https://reporter.nih.gov/quickSearch/K23DA032578', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Put It Out Project (POP):', 'description': 'a culturally tailored intervention developed for SGM young adults on Facebook', 'interventionNames': ['Behavioral: POP:']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco Status Project (TSP):', 'description': 'the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook', 'interventionNames': ['Behavioral: TSP:']}], 'interventions': [{'name': 'POP:', 'type': 'BEHAVIORAL', 'description': '90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults', 'armGroupLabels': ['The Put It Out Project (POP):']}, {'name': 'TSP:', 'type': 'BEHAVIORAL', 'description': '90 days of Facebook messaging, weekly live sessions targeting tobacco use', 'armGroupLabels': ['Tobacco Status Project (TSP):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Department of Psychiatry', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Gary L. Humfleet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}