Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT04587869
Status:
TERMINATED
Last Update Posted:
2025-11-13
First Post:
2020-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063508', 'term': 'Social Discrimination'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lbogart@rand.org', 'phone': '3103930411', 'title': 'Laura Bogart', 'phoneExt': '7281', 'organization': 'RAND'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 0, 'seriousNumAtRisk': 171, 'deathsNumAffected': 1, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'No-treatment Control', 'description': 'Participants who are assigned to the control group will not receive the intervention.', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 0, 'seriousNumAtRisk': 198, 'deathsNumAffected': 0, 'seriousNumAffected': 17}], 'seriousEvents': [{'term': 'Stroke and other nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac-related hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI related hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory related hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'General -surgery due to pre-existing conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'General hospitalization', 'notes': 'reason unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inadequate Healthcare Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).'}, {'id': 'OG001', 'title': 'No-treatment Control', 'description': 'Participants who are assigned to the control group will not receive the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '.73', 'ciUpperLimit': '2.07', 'estimateComment': 'Result is for indicator of assignment to intervention arm (vs. control)', 'groupDescription': 'Nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Result was adjusted for HIV status and age (dichotomized at 50+ vs. \\<50), as those characteristics were used to stratify sampling'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline to 12-month post-baseline', 'description': 'Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization) or at least 1 hospitalization in the past 4 months at any of the 3 follow-up assessments (4, 8, and 12 months post-baseline)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys (nonresponse weights were used to account for potential bias). The outcome was never missing among those who participated in any follow-up surveys.'}, {'type': 'PRIMARY', 'title': 'Proportion of Evidence-based Care Components Received Across Follow-up Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).'}, {'id': 'OG001', 'title': 'No-treatment Control', 'description': 'Participants who are assigned to the control group will not receive the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '.46', 'spread': '.22', 'groupId': 'OG000'}, {'value': '.47', 'spread': '.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'estimateComment': 'Result is for indicator of assignment to intervention arm (vs. control)', 'groupDescription': 'Nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Result was adjusted for HIV status and age (dichotomized at 50+ vs. \\<50), as those characteristics were used to stratify sampling'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post-baseline', 'description': 'For each individual, this measure is the number of components that were received at any time across the 3 follow-up assessments divided by the number of components they were eligible for at any time across the 3 follow-up assessments, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual and follow-up period.', 'unitOfMeasure': 'proportion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys (nonresponse weights were used to account for potential bias). The outcome was never missing among those who participated in any follow-up surveys.'}, {'type': 'SECONDARY', 'title': 'Adaptive Coping Strategies (Social Support Seeking)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).'}, {'id': 'OG001', 'title': 'No-treatment Control', 'description': 'Participants who are assigned to the control group will not receive the intervention.'}], 'classes': [{'title': '4-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': '8-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.77', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': '12-month assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'estimateComment': 'Slope is adjusted regression coefficient for indicator of intervention arm (so mean of outcome across follow-ups was 0.19 higher for intervention vs. control)', 'groupDescription': 'Unlike the two primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant. In addition, nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Result was adjusted for HIV status and age (dichotomized at 50+ vs. \\<50), as those characteristics were used to stratify sampling'}], 'paramType': 'MEAN', 'timeFrame': '4-, 8-, and 12-months post-baseline', 'description': 'Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4)', 'unitOfMeasure': 'units on a scale (range 1-4)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys. The outcome is missing for an additional n=10 (3.2%) participants who did not complete any of the 4 survey items included in the scale.\n\nBecause this measure was analyzed in a repeated measures regression framework where each participant may contribute up to 3 observations (and may or may not complete each assessment), the sample size varies by assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).'}, {'id': 'FG001', 'title': 'No-treatment Control', 'description': 'Participants who are assigned to the control group will not receive the intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Grant Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'too busy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).\n\nCBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).'}, {'id': 'BG001', 'title': 'No-treatment Control', 'description': 'Participants who are assigned to the control group will not receive the intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.73', 'spread': '13.27', 'groupId': 'BG000'}, {'value': '44.73', 'spread': '12.37', 'groupId': 'BG001'}, {'value': '44.73', 'spread': '12.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Inadequate healthcare utilization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization), or at least 1 hospitalization in the past 4 months before baseline', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'This outcome was missing for 5 participants (1.4%) who did not respond to at least one of 3 items asking about hospital visits, ER visits, and urgent care visits'}, {'title': 'Proportion of evidence-based care components received', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.22', 'groupId': 'BG000'}, {'value': '0.60', 'spread': '0.22', 'groupId': 'BG001'}, {'value': '0.60', 'spread': '0.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For each individual, this measure is the number of components that were received divided by the number of components they were eligible for, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual.', 'unitOfMeasure': 'proportion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Adaptive coping (social support seeking)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.91', 'groupId': 'BG000'}, {'value': '2.57', 'spread': '0.92', 'groupId': 'BG001'}, {'value': '2.61', 'spread': '0.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a 4-point scale (range 1-4)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This outcome was missing for n=4 (1.1%), participants who did not respond to any of the 4 survey items included in this scale'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-13', 'size': 355628, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-28T19:08', 'hasProtocol': True}, {'date': '2023-04-04', 'size': 206150, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-28T19:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor does not randomize participant until after the baseline assessment'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'whyStopped': 'NIH terminated the study due to shifted policy priorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2020-10-01', 'resultsFirstSubmitDate': '2025-10-07', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-31', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inadequate Healthcare Utilization', 'timeFrame': 'baseline to 12-month post-baseline', 'description': 'Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization) or at least 1 hospitalization in the past 4 months at any of the 3 follow-up assessments (4, 8, and 12 months post-baseline)'}, {'measure': 'Proportion of Evidence-based Care Components Received Across Follow-up Assessments', 'timeFrame': 'baseline to 12 months post-baseline', 'description': 'For each individual, this measure is the number of components that were received at any time across the 3 follow-up assessments divided by the number of components they were eligible for at any time across the 3 follow-up assessments, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual and follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Adaptive Coping Strategies (Social Support Seeking)', 'timeFrame': '4-, 8-, and 12-months post-baseline', 'description': 'Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Black/African American sexual minority men'], 'conditions': ['Discrimination, Social', 'Health Care Utilization']}, 'descriptionModule': {'briefSummary': 'This study consists of a randomized controlled trial of a multi-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Primary intervention objectives include increasing health care engagement and receipt of evidence-based preventive care, as well as better coping and reduced anticipated and internalized stigma, and medical mistrust among intervention participants.', 'detailedDescription': "This study is a randomized controlled trial of Still Climbin', an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Designed to be flexible for use in community settings, this intervention was developed in partnership with community stakeholders who emphasized the need for a community-based program outside of the health care system, and without a specific disease focus. It intends to give Black SMM a safe space to receive support for the whole of their identity and to openly discuss barriers to health care. Participants will be followed for 12 months. The effectiveness of the Still Climbin' intervention will be assessed on health care engagement and receipt of evidence-based preventive care, through surveys administered at multiple points throughout the intervention period. These outcomes will be confirmed with information from medical records. A total of 370 Black participants will be recruited and randomly assign 185 to receive the coping intervention and 185 to a no-treatment control. There will be about 10 groups of about 15 participants each for both intervention and control. Participants will be randomized to an intervention or control group after they complete the baseline survey. Participants will complete four surveys, starting with the baseline survey, and followed by 4-, 8-, and 12-month post-baseline follow-up surveys to assess health care engagement and receipt of evidence-based preventive care (e.g., cancer and diabetes screening, cardiovascular disease prevention, influenza vaccination, HIV prevention), and other topics such as coping strategies, stigma, and discrimination. The intervention is hypothesized to show increased health care engagement and receipt of evidence-based preventive care, in addition to better coping and reduced medical mistrust than the control group."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Biologically male at birth; Identify as male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Biologically male at birth\n* Identify as male\n* Self-identify as a Black/African American\n* Report having sex with men in the past 24 months\n* Anticipate being available for the next 12 months to attend study visits\n* Able to interact and communicate in written and spoken English.\n\nExclusion Criteria:\n\n* Unwilling/Unable to provide informed consent\n* Cisgender women\n* Transgender women\n* Transgender men'}, 'identificationModule': {'nctId': 'NCT04587869', 'briefTitle': "Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men", 'organization': {'class': 'OTHER', 'fullName': 'RAND'}, 'officialTitle': "Still Climbin': A Randomized Controlled Trial to Improve Coping, Medical Mistrust, and Healthcare Engagement Among Black Sexual Minority Men", 'orgStudyIdInfo': {'id': 'R01MD014722', 'link': 'https://reporter.nih.gov/quickSearch/R01MD014722', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).', 'interventionNames': ['Behavioral: CBT Coping Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No-treatment control', 'description': 'Participants who are assigned to the control group will not receive the intervention.'}], 'interventions': [{'name': 'CBT Coping Intervention', 'type': 'BEHAVIORAL', 'description': 'A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90016', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'APLA Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Laura Bogart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAND'}]}, 'ipdSharingStatementModule': {'timeFrame': 'For three years, following publication of the main study papers.', 'ipdSharing': 'YES', 'description': 'Following publication of the main study papers, de-identified survey data will be made publicly available to researchers who successfully complete a registration process after requesting to use the data. The data made available will not contain any direct or indirect identifiers. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.', 'accessCriteria': 'Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Users must notify the institutional review board of their institution of their intention to use the data and their procedures for data management and security. Users must submit proposals regarding intended use of the data; the RAND study team and the RAND Human Subjects Protections Committee (HSPC) will determine the scientific soundness of the proposal as part of the decision for the researcher to be able to access the dataset.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAND', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'APLA Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}