Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT07181551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Acceptability', 'timeFrame': '3 months post-baseline', 'description': "We will assess participants' perceptions of information quality and usefulness as well as overall satisfaction with the intervention. If the average score across all items is \\>=6 on a 7-point scale for 90% of participants after using intervention for 3 months, we will consider intervention to be acceptable."}, {'measure': 'Intervention feasibility', 'timeFrame': '3 months post-baseline', 'description': 'Feasibility will be met if retention rates are at least 80%.'}, {'measure': 'Remote biochemical data collection acceptability', 'timeFrame': '3 month post-baseline', 'description': "We will measure participants' perceived difficulty, satisfaction, and comfort with remote biochemical verification. If scores are \\>=6 on a 7-point scale for 90% of participants, we will consider remote biochemical verification to be acceptable."}, {'measure': 'Remote biochemical data collection feasibility', 'timeFrame': '3 months post-baseline', 'description': 'Completion rate (percentage of eligible participants who submit biochemical samples for verification of tobacco abstinence)'}], 'secondaryOutcomes': [{'measure': 'Smoking cessation', 'timeFrame': '3 month post-baseline', 'description': 'Participants will be categorized as abstinent or not abstinent based on self-report.'}, {'measure': 'Conceptual model covariates', 'timeFrame': '3 months post-baseline', 'description': 'Nicotine dependence and other conceptual model covariates will be assessed with validated survey items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility, acceptability, and preliminary efficacy of "Forward to Quit" (F2Q), a person-centered mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. The intervention was developed in collaboration with transgender individuals and gender-affirming healthcare providers. The study includes usability testing and a remote single-arm pilot trial. Primary outcomes include feasibility and acceptability of both the intervention and remote biochemical verification of smoking cessation. Secondary outcomes include self-reported and biochemically verified smoking cessation, as well as changes in psychosocial factors such as social support and gender affirmation. The goal is to inform a future large-scale trial and address tobacco-related health disparities in transgender populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify with a gender different from sex assigned at birth\n* 18+ years of age\n* Report smoking at least 5 cigarettes per day\n* Have smoked 100+ cigarettes in their lifetime\n* Own a device that can access the Internet (e.g., tablet, smartphone)\n* Speak English\n* Be willing to submit biochemical samples to verify cessation\n* Be willing to use a website-based intervention to help with quit attempt\n* Be willing to set a quit date within 1 month of baseline assessment\n* Be willing to complete 3 months post-baseline and 6 months post-baseline assessments\n\nExclusion Criteria:\n\n* Do not meet inclusion criteria\n* Medical conditions precluding use of the carbon monoxide (CO) monitor or salivary cotinine testing\n* Current use of pharmacotherapies for nicotine dependence\n* Enrollment in another tobacco cessation program'}, 'identificationModule': {'nctId': 'NCT07181551', 'acronym': 'F2Q', 'briefTitle': 'Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults', 'orgStudyIdInfo': {'id': '22-2296'}, 'secondaryIdInfos': [{'id': '5R34DA058191-03', 'link': 'https://reporter.nih.gov/quickSearch/5R34DA058191-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F2Q Intervention', 'description': 'Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults', 'interventionNames': ['Behavioral: Forward to Quit (F2Q)']}], 'interventions': [{'name': 'Forward to Quit (F2Q)', 'type': 'BEHAVIORAL', 'description': 'A mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. Delivered via a secure website accessible by smartphone or tablet.', 'armGroupLabels': ['F2Q Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christina Sun, PhD', 'role': 'CONTACT', 'email': 'Christina.Sun@cuanschutz.edu', 'phone': '303-724-3601'}], 'overallOfficials': [{'name': 'Christina Sun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universtiy of Colorado Anschutz Medical Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Unsure of where or how IPD would be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}