Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05709002
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2023-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smoking, Stress, HIV and Mobile Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050606', 'term': 'Mannose-Binding Protein-Associated Serine Proteases'}, {'id': 'D054547', 'term': 'National Cancer Institute (U.S.)'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D050577', 'term': 'Complement C3-C5 Convertases'}, {'id': 'D003166', 'term': 'Complement Activating Enzymes'}, {'id': 'D003165', 'term': 'Complement System Proteins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009316', 'term': 'National Institutes of Health (U.S.)'}, {'id': 'D000047', 'term': 'Academies and Institutes'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D014492', 'term': 'United States Public Health Service'}, {'id': 'D014483', 'term': 'United States Dept. of Health and Human Services'}, {'id': 'D037041', 'term': 'United States Government Agencies'}, {'id': 'D035082', 'term': 'Federal Government'}, {'id': 'D006076', 'term': 'Government'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically verified smoking abstinence', 'timeFrame': 'Weeks 1,2,3,4,5,6, & 28', 'description': 'Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \\< 7 ppm. This will be used to verify smoking status, as well as change in smoking behaviors throughout the study. As well, self-report measures of the Smoking History questionnaire (SHQ) will also be used to assess self-reported abstinence.'}], 'secondaryOutcomes': [{'measure': 'Index of Engagement in HIV Care', 'timeFrame': 'Weeks 1 & 28', 'description': 'The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care.'}, {'measure': 'World Health Organization Quality of Life HIV (WHOQOL-HIV)', 'timeFrame': 'Weeks 1 & 28', 'description': 'The WHOQOL-HIV questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS.'}, {'measure': 'ART Adherence', 'timeFrame': 'Weeks 1 & 28', 'description': 'The Antiretroviral (ART) Adherence questionnaire is a brief scale used to assess frequency of missed ART medication doses and HIV care appointments among HIV+ patients/participants.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Minority Stress', 'mHealth', 'Smoking Cessation', 'Anxiety Sensitivity'], 'conditions': ['Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '38657227', 'type': 'DERIVED', 'citation': 'Bizier A, Jones A, Businelle M, Kezbers K, Hoeppner BB, Giordano TP, Thai JM, Charles J, Montgomery A, Gallagher MW, Cheney MK, Zvolensky M, Garey L. An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 24;13:e52090. doi: 10.2196/52090.'}]}, 'descriptionModule': {'briefSummary': 'The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.', 'detailedDescription': 'The current trial aims to refine and conduct a comprehensive cultural and HIV-sensitive adaptation of an initially tested, novel mobile intervention (MASP+) targeting anxiety sensitivity (AS) among Black/African American (daily) cigarette users with HIV/AIDS. The MASP+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. When respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos.\n\nThe MASP+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the Black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infection (via self-report and picture of medication, lab tests, or diagnosis)\n* 18+ years of age\n* Self-identify as Black / African American\n* Daily smoking (minimum of 10 cigarettes per day on average for at least 2 years)\n* Motivated to quit smoking (≥ 5 on a 10-point scale)\n* Willingness to discontinue cigarette use two weeks after baseline visit.\n* English literacy (score of 4 or greater on REALM-SF)\n* Moderate to high anxiety sensitivity (score of 5 or greater on SSASI)\n* Provide a current picture of their cigarette package to verify smoking status\n* Willing to complete all study surveys/assessments\n* Agree to use nicotine replacement medications (NRT; nicotine patch and lozenges)\n* Agree to attempt to quit smoking two weeks after completion of the baseline survey and receipt of study materials\n\nExclusion Criteria:\n\n* Actively receiving (ongoing) pharmacotherapy or psychotherapy directly focused on the treatment of smoking cessation, and/or substance use, not provided by the study\n* Non-fluent/limited English proficiency\n* Self-reported pregnancy or intentions to become pregnant in near future\n* Legal status that would interfere with participation\n* Being non-Black\n* Cognitive impairment (assessed via the 6-item Cognitive Impairment Test)'}, 'identificationModule': {'nctId': 'NCT05709002', 'briefTitle': 'Smoking, Stress, HIV and Mobile Technology', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV', 'orgStudyIdInfo': {'id': 'QKWEF8XLMTT3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MASP+ app & NRT', 'description': 'MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.\n\nNicotine patches will be made available to provide adjunctive support.', 'interventionNames': ['Behavioral: MASP+']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'QuitGuide app + NRT', 'description': 'The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages.\n\nNicotine patches will be made available to provide adjunctive support.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'MASP+', 'type': 'BEHAVIORAL', 'description': 'mHealth (mobile app) for smoking cessation', 'armGroupLabels': ['MASP+ app & NRT']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'otherNames': ['National Cancer Institute (NCI) QuitGuide app'], 'description': 'A mobile app designed to assist the general population with smoking cessation.', 'armGroupLabels': ['QuitGuide app + NRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street at Quentin Mease Health Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lorra Garey, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}, {'name': 'Michael Businelle, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Oklahoma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-director of the RESTORE Lab, Research Assistant professor at the University of Houston', 'investigatorFullName': 'Lorra Garey', 'investigatorAffiliation': 'University of Houston'}}}}