Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT04490057
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D000074164', 'term': 'Nicotine Chewing Gum'}, {'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ejennifer.edelman@yale.edu', 'phone': '203-727-7115', 'title': 'E. Jennifer Edelman, MD, MHS', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1\\. The COVID-19 pandemic delayed enrollment leading to a reduction in sample size and change in endpoint to reduction in # of cigarettes/day. Due to these changes, we may have been underpowered to detect improved abstinence in Stage 2. 2. Participants were given prescriptions for medication, not actual medication and we observed access issues. 3. The study was conducted in urban HIV clinics in the Northeast US which may limit generalizability.'}}, 'adverseEventsModule': {'timeFrame': 'Stage 1: up to 12 weeks; Stage 2: up to 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: NRT', 'description': 'Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 6, 'seriousNumAtRisk': 163, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Stage 1: NRT+CM', 'description': 'Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 14, 'seriousNumAtRisk': 160, 'deathsNumAffected': 2, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Stage 2: NRT Responders', 'description': 'Responders from Stage 1 remain on nicotine replacement therapy for Stage 2', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Stage 2: Varenicline or Bupropion', 'description': 'Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 2, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Stage 2: NRT+CM', 'description': 'Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Stage 2: NRT+CM Responders', 'description': 'Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 1, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Stage 2: Varenicline or Bupropion + CM', 'description': 'Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 3, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Stage 2: NRT+CM Plus', 'description': 'Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 2, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Gastrointestinal Gastrointestinal (nausea, diarrhea, abdominal pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac illness or injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver injury or dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory disorders including pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reaction to nicotine replacement therapy', 'notes': 'Anticipated side effects of nicotine replacement therapy: sleep disturbances, jittery/shaking, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastrointestinal (nausea, diarrhea, abdominal pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - pathogen unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain or connective tissue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver injury or dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological disorders (sedation, lethargy, dizziness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory disorders including pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol withdrawal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac illness or injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Nicotine Replacement Only (NRT)', 'description': 'Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling'}, {'id': 'OG001', 'title': 'Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)', 'description': 'Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '18.7'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '36.8'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks from baseline', 'description': 'Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: NRT Responders', 'description': 'Responders from Stage 1 remain on nicotine replacement therapy for Stage 2'}, {'id': 'OG001', 'title': 'Stage 2: Varenicline or Bupropion', 'description': 'Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).'}, {'id': 'OG002', 'title': 'Stage 2: NRT+CM', 'description': 'Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).'}, {'id': 'OG003', 'title': 'Stage 2: NRT+CM Responders', 'description': 'Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).'}, {'id': 'OG004', 'title': 'Stage 2: Varenicline or Bupropion + CM', 'description': 'Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)'}, {'id': 'OG005', 'title': 'Stage 2: NRT+CM Plus', 'description': 'Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4.55', 'upperLimit': '59.91'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4.58', 'upperLimit': '32.82'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '6.43', 'upperLimit': '32.21'}, {'value': '23', 'groupId': 'OG003', 'lowerLimit': '47.77', 'upperLimit': '89.36'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '11.58', 'upperLimit': '48.44'}, {'value': '8', 'groupId': 'OG005', 'lowerLimit': '15.61', 'upperLimit': '53.04'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks from baseline', 'description': 'Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VACS Index 2.0 Score', 'timeFrame': '24 weeks from baseline', 'description': 'The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'CD4 Count', 'timeFrame': '24 weeks from baseline', 'description': 'Median CD4 count adjusting for baseline', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'PRIMARY', 'title': 'Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Nicotine Replacement Only (NRT)', 'description': 'Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling'}, {'id': 'OG001', 'title': 'Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)', 'description': 'Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6.5'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '6.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Self reported reduction in average cigarettes smoked per day at 12 weeks', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: NRT Responders', 'description': 'Responders from Stage 1 remain on nicotine replacement therapy for Stage 2'}, {'id': 'OG001', 'title': 'Stage 2: Varenicline or Bupropion', 'description': 'Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).'}, {'id': 'OG002', 'title': 'Stage 2: NRT+CM', 'description': 'Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).'}, {'id': 'OG003', 'title': 'Stage 2: NRT+CM Responders', 'description': 'Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).'}, {'id': 'OG004', 'title': 'Stage 2: Varenicline or Bupropion + CM', 'description': 'Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)'}, {'id': 'OG005', 'title': 'Stage 2: NRT+CM Plus', 'description': 'Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.90', 'groupId': 'OG000', 'lowerLimit': '4.355', 'upperLimit': '11.44'}, {'value': '6.23', 'groupId': 'OG001', 'lowerLimit': '4.45', 'upperLimit': '8.02'}, {'value': '2.97', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '4.44'}, {'value': '10.92', 'groupId': 'OG003', 'lowerLimit': '8.40', 'upperLimit': '13.43'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '2.48', 'upperLimit': '5.52'}, {'value': '4.20', 'groupId': 'OG005', 'lowerLimit': '2.60', 'upperLimit': '5.80'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Self reported reduction in cigarettes smoked per day at 24 weeks', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load', 'timeFrame': '24 weeks from baseline', 'description': 'The proportion of participants with HIV viral load suppression.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: NRT', 'description': 'Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12'}, {'id': 'FG001', 'title': 'Stage 1: NRT+CM', 'description': 'Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)'}, {'id': 'FG002', 'title': 'Stage 2: NRT Responders', 'description': 'Responders from Stage 1 remain on nicotine replacement therapy for Stage 2'}, {'id': 'FG003', 'title': 'Stage 2: Varenicline or Bupropion', 'description': 'Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).'}, {'id': 'FG004', 'title': 'Stage 2: NRT+CM', 'description': 'Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).'}, {'id': 'FG005', 'title': 'Stage 2: NRT+CM Responders', 'description': 'Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).'}, {'id': 'FG006', 'title': 'Stage 2: Varenicline or Bupropion + CM', 'description': 'Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)'}, {'id': 'FG007', 'title': 'Stage 2: NRT+CM Plus', 'description': 'Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '74'}, {'groupId': 'FG005', 'numSubjects': '36'}, {'groupId': 'FG006', 'numSubjects': '60'}, {'groupId': 'FG007', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '39'}, {'groupId': 'FG007', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '21'}, {'groupId': 'FG007', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '21'}, {'groupId': 'FG007', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Participants were consented, completed baseline and randomized to one of 2 arms in Stage 1: nicotine replacement therapy (NRT) or NRT+ CM (contingency management). At week 12, participants who were abstinent remained in their original arm. Participants who were not abstinent were re-randomized. If NRT in Stage 1, re-randomized to NRT+CM or varenicline (VAR). If NRT+CM Stage 1, re-randomized to NRT+CM intensified or VAR+CM.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: Nicotine Replacement Only (NRT)', 'description': 'Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling'}, {'id': 'BG001', 'title': 'Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)', 'description': 'Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.71', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '54.42', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '55.08', 'spread': '10.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age in years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes per day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'BG000', 'lowerLimit': '8.0', 'upperLimit': '20.0'}, {'value': '10.0', 'groupId': 'BG001', 'lowerLimit': '7.0', 'upperLimit': '17.5'}, {'value': '10.0', 'groupId': 'BG002', 'lowerLimit': '7.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Number of cigarettes smoked per day', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Exhaled carbon monoxide at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'BG000', 'lowerLimit': '6.0', 'upperLimit': '16.0'}, {'value': '10.0', 'groupId': 'BG001', 'lowerLimit': '6.0', 'upperLimit': '16.0'}, {'value': '10.0', 'groupId': 'BG002', 'lowerLimit': '6.0', 'upperLimit': '16.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'exhaled carbon monoxide at baseline, measured in parts per million (ppm)', 'unitOfMeasure': 'parts per million (ppm)', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'eCO was not collected for 5 participants at baseline due to staff error.'}, {'title': 'VACS 2.0 score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'BG000', 'lowerLimit': '31.0', 'upperLimit': '58.0'}, {'value': '42.0', 'groupId': 'BG001', 'lowerLimit': '33.0', 'upperLimit': '53.0'}, {'value': '43.0', 'groupId': 'BG002', 'lowerLimit': '32.0', 'upperLimit': '56.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '8 participants were missing a lab value required to calculate VACS 2.0'}, {'title': 'HIV viral load, detectable', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Viral load detectable', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Viral load not detectable', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HIV viral load greater than 200 copies per milliliter of blood and detectable on standard lab test', 'unitOfMeasure': 'Participants', 'populationDescription': 'HIV viral load was not available at baseline for 3 participants'}, {'title': 'CD4 cell count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '600.0', 'groupId': 'BG000', 'lowerLimit': '331.0', 'upperLimit': '875.0'}, {'value': '596.5', 'groupId': 'BG001', 'lowerLimit': '356.0', 'upperLimit': '867.5'}, {'value': '596.5', 'groupId': 'BG002', 'lowerLimit': '352.0', 'upperLimit': '875.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'CD4 lymphocyte cell count. Normal range is 500-1200 cells per cubic millimeter. As HIV infection progresses, CD4 count drops.', 'unitOfMeasure': 'cells per cubic millimeter', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'CD4 count was not available for 1 participant at baseline'}], 'populationDescription': 'Includes all participants who started Stage 1'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-22', 'size': 1342160, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-09T14:07', 'hasProtocol': True}, {'date': '2024-01-05', 'size': 293041, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-23T14:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential multiple assignment randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2020-07-22', 'resultsFirstSubmitDate': '2025-10-15', 'studyFirstSubmitQcDate': '2020-07-25', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks', 'timeFrame': 'Week 12', 'description': 'Self reported reduction in average cigarettes smoked per day at 12 weeks'}, {'measure': 'Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'Self reported reduction in cigarettes smoked per day at 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks', 'timeFrame': '12 weeks from baseline', 'description': 'Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification'}, {'measure': 'Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks', 'timeFrame': '24 weeks from baseline', 'description': 'Number of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification'}, {'measure': 'VACS Index 2.0 Score', 'timeFrame': '24 weeks from baseline', 'description': 'The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.'}, {'measure': 'CD4 Count', 'timeFrame': '24 weeks from baseline', 'description': 'Median CD4 count adjusting for baseline'}, {'measure': 'HIV Viral Load', 'timeFrame': '24 weeks from baseline', 'description': 'The proportion of participants with HIV viral load suppression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Cessation']}, 'referencesModule': {'references': [{'pmid': '33794354', 'type': 'DERIVED', 'citation': 'Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.', 'detailedDescription': 'Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 320 adult PWH who smoke cigarettes and receive care in one of three health systems (targeted enrollment changed from 632 to 320 with NCI approval and IRB protocol amendment). At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide \\[eCO\\] or collateral verification) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to oral medication, varenicline or bupropion, or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule \\["CM plus"\\] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcomes will be self-reported reduction in average cigarettes smoked per day at 24 weeks and 12 weeks (primary outcome changed from eCO-confirmed abstinence to self-reported abstinence with NCI approval and IRB protocol amendment). The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote reduced tobacco use (changed from eCO-confirmed smoking abstinence with NCI approval and protocol amendment) (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive;\n* \\>= 18 years old\n* Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;\n* Have smoked \\>= 100 cigarettes in lifetime;\n* Currently smokes some days or every day;\n* Smokes, on average, \\>= 5 cigarettes per day;\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);\n* Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);\n* Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;\n* Life-threatening or unstable medical, surgical, or psychiatric condition;\n* Inability to provide at least one collateral contact (family member or friend);\n* Living out of state;\n* Unable to read or understand English (except at Mount Sinai site).'}, 'identificationModule': {'nctId': 'NCT04490057', 'acronym': 'SMARTTT', 'briefTitle': 'A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV', 'orgStudyIdInfo': {'id': '2000026332'}, 'secondaryIdInfos': [{'id': 'R01CA243910', 'link': 'https://reporter.nih.gov/quickSearch/R01CA243910', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12 wks NRT+CM / 12 wks NRT+CM', 'description': 'Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.', 'interventionNames': ['Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler', 'Behavioral: Contingency Management']}, {'type': 'EXPERIMENTAL', 'label': '12 wks NRT+CM/ 12 wks VAR or bupropion+CM', 'description': 'Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.', 'interventionNames': ['Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler', 'Drug: Varenicline or bupropion', 'Behavioral: Contingency Management']}, {'type': 'EXPERIMENTAL', 'label': '12 wks NRT+CM/12 wks NRT+CM plus', 'description': 'Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.', 'interventionNames': ['Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler', 'Behavioral: Contingency Management']}, {'type': 'EXPERIMENTAL', 'label': '12 wks NRT/ 12 wks NRT', 'description': 'Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy.', 'interventionNames': ['Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler']}, {'type': 'EXPERIMENTAL', 'label': '12 wks NRT/ 12 wks VAR or bupropion', 'description': 'Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.', 'interventionNames': ['Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler', 'Drug: Varenicline or bupropion']}, {'type': 'EXPERIMENTAL', 'label': '12 wks NRT/ 12 wks NRT+CM', 'description': 'Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.', 'interventionNames': ['Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler', 'Behavioral: Contingency Management']}], 'interventions': [{'name': 'Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler', 'type': 'DRUG', 'description': 'Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.', 'armGroupLabels': ['12 wks NRT+CM / 12 wks NRT+CM', '12 wks NRT+CM/ 12 wks VAR or bupropion+CM', '12 wks NRT+CM/12 wks NRT+CM plus', '12 wks NRT/ 12 wks NRT', '12 wks NRT/ 12 wks NRT+CM', '12 wks NRT/ 12 wks VAR or bupropion']}, {'name': 'Varenicline or bupropion', 'type': 'DRUG', 'description': 'Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).', 'armGroupLabels': ['12 wks NRT+CM/ 12 wks VAR or bupropion+CM', '12 wks NRT/ 12 wks VAR or bupropion']}, {'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'description': 'Participants will be financially rewarded for abstinence to tobacco.', 'armGroupLabels': ['12 wks NRT+CM / 12 wks NRT+CM', '12 wks NRT+CM/ 12 wks VAR or bupropion+CM', '12 wks NRT+CM/12 wks NRT+CM plus', '12 wks NRT/ 12 wks NRT+CM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital Infectious Disease Clinic', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate STAR Clinic', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'E. Jennifer Edelman, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Steven Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}