Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT06487806
Status:
SUSPENDED
Last Update Posted:
2025-07-11
First Post:
2024-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority(SGM) Groups Preferring Spanish Language
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D018452', 'term': 'Homosexuality, Female'}, {'id': 'D006716', 'term': 'Homosexuality'}, {'id': 'D001727', 'term': 'Bisexuality'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'We are hiring staff', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Usability as Assessed by the System Usability Scale (SUS)', 'timeFrame': 'end of intervention (1month after quit date)', 'description': 'This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater usability and a score above 75 indicating better outcome'}, {'measure': 'Engagement with the text-messaging program as assessed by number of text messages a participant sends, including replies to the bidirectional texts messages of SmokefreeSGM Español program', 'timeFrame': 'end of intervention (1month after quit date)'}, {'measure': 'Acceptability at 1 month as Assessed by the System Usability Scale (SUS)', 'timeFrame': 'end of intervention (1month after quit date)', 'description': 'This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater acceptability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["lesbian, gay, bisexual, transgender, queer/questioning (one's sexual or gender identity), and intersex(LGBTQI)"], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the usability, engagement and acceptability of SmokefreeSGM Español, a culturally and linguistically tailored version of SmokefreeSGM, among Spanish-speaking SGM smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identify as an LGBTQ+ individual', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently live in the United States\n* Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke ≥ 5 cigarettes a day\n* Are willing to quit smoking in the next 15 days\n* Have a cell phone number with an unlimited short message service (SMS) plan\n* Have a positive cotinine saliva test to indicate their smoking status\n* Speak fluent Spanish\n\nExclusion Criteria:\n\n* Have a prepaid cell phone plan (pay-as-you-go plan)\n* Have a cell phone number that does not work and/or is registered to someone else\n* Have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via Microsoft Teams, Webex, or Zoom AND cannot meet in-person\n* Pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development)\n* Contraindication for nicotine patches. Absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. Study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. If the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study.\n* Current use of tobacco cessation medications\n* Current use of tobacco products other than cigarettes or electronic nicotine delivery systems (ENDS) (i.e., (e.g., cigar, cigarillo, little cigar, pipe, Hookah)\n* Enrollment in another smoking cessation study'}, 'identificationModule': {'nctId': 'NCT06487806', 'briefTitle': 'SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority(SGM) Groups Preferring Spanish Language', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups Preferring Spanish Language', 'orgStudyIdInfo': {'id': 'HSC-SPH-23-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta testing group', 'interventionNames': ['Behavioral: SmokefreeSGM']}], 'interventions': [{'name': 'SmokefreeSGM', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to set a quit date within the next 15 days before being enrolled in the SmokefreeSGM Español text messaging program. They will be mailed a 6-week supply of nicotine patches. The participants will get daily text messages for 6 weeks that will encourage them to quit smoking.', 'armGroupLabels': ['Beta testing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Irene Tami-Maury, DMD, MSc, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Irene Tami-Maury', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}