Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-03 @ 7:07 PM
Study NCT ID:
NCT04566159
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2020-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Feasibility as assessed by the Feasibility of Intervention Measure', 'timeFrame': '3 months', 'description': '4 item scale, maximum score of 20 with higher score indicating greater feasibility'}, {'measure': 'Intervention Acceptability as assessed by the Acceptability of an Intervention Measure', 'timeFrame': '3 months', 'description': 'Noted as continuous score on 4 item scale, maximum value of 20 with higher score indicating greater acceptability'}], 'secondaryOutcomes': [{'measure': 'Readiness to quit smoking as assessed by a Visual analog scale', 'timeFrame': 'immediately post intervention', 'description': 'Score of 10=Ready to Quit, Score of 1=Not ready to quit. Scale is from 1-10'}, {'measure': 'Uptake of nicotine replacement therapy', 'timeFrame': 'immediately post intervention', 'description': 'Dichotomous yes/no.'}, {'measure': 'Continued use of nicotine replacement therapy 1 month post intervention', 'timeFrame': '30 days post intervention', 'description': 'Dichotomous yes/no.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['Tobacco Smoking']}, 'descriptionModule': {'briefSummary': 'The prevalence of tobacco smoking is high among persons with HIV (PWH). The investigators are piloting a two session computer-delivered intervention (CBI) with linkage to a community health worker (CHW) among hospitalized PWH with tobacco use 1a) To determine feasibility and acceptability of delivering this intervention and 2a) To determine intervention effect on 1) readiness to quit smoking and confidence in ability to quit smoking 2) uptake of smoking cessation therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18,\n* A patient admitted to the Johns Hopkins Hospital\n* Smoked \\>100 cigarettes in their lifetime\n* Current smoker\n* English speaking\n\nExclusion Criteria:\n\n* Contraindication to nicotine replacement therapy including unstable angina and acute coronary syndrome'}, 'identificationModule': {'nctId': 'NCT04566159', 'briefTitle': 'Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention for Hospitalized Persons With HIV', 'orgStudyIdInfo': {'id': 'IRB00117151-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBI + CHW', 'description': '2 Session Computer Delivered Intervention with use of Nicotine Replacement Therapy and Community Health Worker Follow Up', 'interventionNames': ['Behavioral: CBI-CHW']}, {'type': 'OTHER', 'label': 'Routine Care', 'description': 'Routine Tobacco Cessation Advice to Stop Smoking and Nicotine Replacement Therapy as offered by the inpatient team', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'CBI-CHW', 'type': 'BEHAVIORAL', 'description': '2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks', 'armGroupLabels': ['CBI + CHW']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Standard tobacco treatment care offered by the inpatient care', 'armGroupLabels': ['Routine Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Geetanjali Chander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available 12 months after study completion', 'ipdSharing': 'YES', 'description': 'As this is a very small pilot, we will share de-identified data on request.', 'accessCriteria': 'Information will be shared on request. Requests can be made to the study PI who will then work with the data manager to compile a de-identified data set.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}