Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-28 @ 12:03 PM
Study NCT ID:
NCT05030766
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing Integrative Smoking Cessation for HIV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tasfar@miami.edu', 'phone': '+1 (901) 371-7229', 'title': 'Dr. Taghrid Asfar', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Training (MT) and NRT (Phase 1)', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Contingency Management (CM) and NRT (Phase 1)', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)', 'description': 'Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Contingency Management (CM) and NRT + Additional MT Group (Phase 2)', 'description': 'Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting 7-day Point-prevalence Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT) and NRT (Phase 1)', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.'}, {'id': 'OG001', 'title': 'Contingency Management (CM) and NRT (Phase 1)', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'OG002', 'title': 'Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)', 'description': 'Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'OG003', 'title': 'Contingency Management (CM) and NRT + Additional MT Group (Phase 2)', 'description': 'Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}], 'classes': [{'title': '4 weeks (end of treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks (end of treatment), and 3 months', 'description': 'Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \\< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those who participated in their treatment (completed at least one session).'}, {'type': 'SECONDARY', 'title': 'Retention Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT) and NRT (Phase 1)', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.'}, {'id': 'OG001', 'title': 'Contingency Management (CM) and NRT (Phase 1)', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'OG002', 'title': 'Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)', 'description': 'Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'OG003', 'title': 'Contingency Management (CM) and NRT + Additional MT Group (Phase 2)', 'description': 'Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.83', 'groupId': 'OG000'}, {'value': '32.61', 'groupId': 'OG001'}, {'value': '50.00', 'groupId': 'OG002'}, {'value': '80.00', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who enrolled and were randomized.'}, {'type': 'SECONDARY', 'title': 'Treatment Specific Adherence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT) and NRT (Phase 1)', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.'}, {'id': 'OG001', 'title': 'Contingency Management (CM) and NRT (Phase 1)', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'OG002', 'title': 'Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)', 'description': 'Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'OG003', 'title': 'Contingency Management (CM) and NRT + Additional MT Group (Phase 2)', 'description': 'Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}], 'classes': [{'title': '0 check-ins', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Less than half the check-ins', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Half of the check-ins', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'More than half the check-ins but did not complete all', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Completed all check-ins', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized to a treatment arm. Note that Phase 1 and Phase 2 participants are not mutually exclusive (Phase 2 participants come from Phase 1). Mindfulness Training participants did one call per week of treatment, 4 calls in total. Contingency management did 3 calls per week of treatment for a total of 12 calls.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Training (MT) and NRT (Phase 1)', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.'}, {'id': 'FG001', 'title': 'Contingency Management (CM) and NRT (Phase 1)', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'FG002', 'title': 'Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)', 'description': 'Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'FG003', 'title': 'Contingency Management (CM) and NRT + Additional MT Group (Phase 2)', 'description': 'Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}], 'periods': [{'title': 'Phase 1 Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Did not attend sessions after being randomized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Phase 2 Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Phase 2 participants are participants that did not quit smoking in their respective Phase 1 group, who were then assigned to the opposite group in Phase 2. Phase 1 MT participants who did not quit smoking go to Phase 2 CM, Phase 1 CM participants who did not quit smoking go to Phase 2 MT. Those participants who quit smoking do not get randomized again.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Training (MT) and NRT (Phase 1)', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nMindfulness Training Smoking Cessation Intervention: Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.'}, {'id': 'BG001', 'title': 'Contingency Management (CM) and NRT (Phase 1)', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.\n\nNicotine Replacement Therapy: 6 weeks of Nicotine replacement patches\n\nContingency Management Smoking Cessation Intervention: Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.54', 'spread': '8.49', 'groupId': 'BG000'}, {'value': '51.59', 'spread': '11.63', 'groupId': 'BG001'}, {'value': '53.07', 'spread': '10.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Asian/ Asian American / Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-09', 'size': 507149, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-09T16:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2021-08-26', 'resultsFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-16', 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting 7-day Point-prevalence Abstinence', 'timeFrame': '4 weeks (end of treatment), and 3 months', 'description': 'Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \\< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Retention Rate', 'timeFrame': '3 months', 'description': 'Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.'}, {'measure': 'Treatment Specific Adherence Rates', 'timeFrame': '3 months', 'description': 'Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness Training', 'Contingency Management'], 'conditions': ['Smoking', 'Smoking Cessation', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with HIV (based on self-report).\n* Be 18 years and older\n* Have smoked ≥ 5 cigarettes/day in the past year\n* Be interested in making a quit attempt in the next 30 days\n* Own a smartphone (apple/android), and plan to keep it active for the next 6 months\n* Able to consent\n* Have no plans to move in the next 6 months\n* Are not pregnant or planning to be pregnant in the following 6 months\n* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements\n\nExclusion Criteria:\n\n* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)\n* Are currently being treated for a psychiatric condition.\n* Are currently being treated for smoking cessation, alcoholism, or illicit drug use\n* Are adults unable to consent\n* Are individuals who are not yet adults\n* Are pregnant women\n* Are prisoners'}, 'identificationModule': {'nctId': 'NCT05030766', 'briefTitle': 'Testing Integrative Smoking Cessation for HIV Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients', 'orgStudyIdInfo': {'id': '20201296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT plus NRT Group-Phase 1', 'description': 'Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.', 'interventionNames': ['Drug: Nicotine Replacement Therapy', 'Behavioral: Mindfulness Training Smoking Cessation Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'CM plus NRT Group-Phase1', 'description': 'Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.', 'interventionNames': ['Drug: Nicotine Replacement Therapy', 'Behavioral: Contingency Management Smoking Cessation Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'MT plus NRT with additional CM Group-Phase2', 'description': 'Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.', 'interventionNames': ['Drug: Nicotine Replacement Therapy', 'Behavioral: Mindfulness Training Smoking Cessation Intervention', 'Behavioral: Contingency Management Smoking Cessation Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'CM plus NRT with additional MT Group-Phase2', 'description': 'Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.', 'interventionNames': ['Drug: Nicotine Replacement Therapy', 'Behavioral: Mindfulness Training Smoking Cessation Intervention', 'Behavioral: Contingency Management Smoking Cessation Intervention']}], 'interventions': [{'name': 'Nicotine Replacement Therapy', 'type': 'DRUG', 'description': '6 weeks of Nicotine replacement patches', 'armGroupLabels': ['CM plus NRT Group-Phase1', 'CM plus NRT with additional MT Group-Phase2', 'MT plus NRT Group-Phase 1', 'MT plus NRT with additional CM Group-Phase2']}, {'name': 'Mindfulness Training Smoking Cessation Intervention', 'type': 'BEHAVIORAL', 'description': 'Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.', 'armGroupLabels': ['CM plus NRT with additional MT Group-Phase2', 'MT plus NRT Group-Phase 1', 'MT plus NRT with additional CM Group-Phase2']}, {'name': 'Contingency Management Smoking Cessation Intervention', 'type': 'BEHAVIORAL', 'description': 'Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.', 'armGroupLabels': ['CM plus NRT Group-Phase1', 'CM plus NRT with additional MT Group-Phase2', 'MT plus NRT with additional CM Group-Phase2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Taghrid A. Asfar, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Taghrid Asfar', 'investigatorAffiliation': 'University of Miami'}}}}