Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 1:56 AM
Study NCT ID:
NCT01372605
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2011-06-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Collaborative Depression Care Management for HIV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bpence@unc.edu', 'phone': '9199667446', 'title': 'Dr. Brian Pence', 'organization': 'University of North Carolina-Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse events were collected without classification by specific Adverse Event Terms.\n\nPer protocol, hospitalizations were considered other adverse events in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications', 'otherNumAtRisk': 149, 'otherNumAffected': 37, 'seriousNumAtRisk': 149, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.', 'otherNumAtRisk': 155, 'otherNumAffected': 37, 'seriousNumAtRisk': 155, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Medical hospitalization', 'notes': 'This is hospitalizations from all non-psychiatric causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 63, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 51, 'numAffected': 33}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Death by all causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antiretroviral Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.2', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '87.6', 'spread': '22.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months post-enrollment', 'description': 'Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor', 'unitOfMeasure': 'observed pills taken as % of expected', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All those completing a 6-month pill count which resulted in a valid adherence measure'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All those completing a 6-month outcomes interview which resulted in a valid HAMD measure'}, {'type': 'SECONDARY', 'title': 'Antiretroviral Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.3', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '94.5', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor', 'unitOfMeasure': 'Percentage of expected pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data.'}, {'type': 'SECONDARY', 'title': 'Health Care Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '4611', 'spread': '151', 'groupId': 'OG000'}, {'value': '4535', 'spread': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Total health care costs over 12 months', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed using all available time points, with multiple imputation used to address missing data.'}, {'type': 'SECONDARY', 'title': 'Appointment Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '26.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment', 'unitOfMeasure': 'Percent of appts that were kept', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Viral Load Below Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'HIV RNA viral load below the limit of detection at 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data.'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data.'}, {'type': 'SECONDARY', 'title': 'Self Reported Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.7', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '93.9', 'spread': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data.'}, {'type': 'SECONDARY', 'title': 'Self-reported Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.6', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '94.1', 'spread': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data.'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Psychiatric hospitalizations', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '136', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least one depression measure contributed to this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'FG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Changed medical home', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Collaborative Depression Care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.\n\nMeasurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications'}, {'id': 'BG001', 'title': 'Enhanced Usual Care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Transgender', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '291', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2011-06-12', 'resultsFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2011-06-12', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-25', 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiretroviral Medication Adherence', 'timeFrame': 'Six months post-enrollment', 'description': 'Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': 'Six months', 'description': 'Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.'}, {'measure': 'Antiretroviral Medication Adherence', 'timeFrame': '12 months', 'description': 'Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor'}, {'measure': 'Health Care Costs', 'timeFrame': '12 months', 'description': 'Total health care costs over 12 months'}, {'measure': 'Appointment Adherence', 'timeFrame': '12 months', 'description': 'Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment'}, {'measure': 'Number of Participants With Viral Load Below Detection', 'timeFrame': '6 months', 'description': 'HIV RNA viral load below the limit of detection at 6 months'}, {'measure': 'Quality of Life', 'timeFrame': '6 months', 'description': 'Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.'}, {'measure': 'Self Reported Adherence', 'timeFrame': '6 months', 'description': 'Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).'}, {'measure': 'Self-reported Adherence', 'timeFrame': '12 months', 'description': 'Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).'}, {'measure': 'Safety Endpoint', 'timeFrame': '12 months', 'description': 'Psychiatric hospitalizations'}, {'measure': 'Depression-free Days', 'timeFrame': '12 months', 'description': 'Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'HIV', 'Adherence', 'Collaborative care', 'Measurement-Based Care'], 'conditions': ['Depression', 'HIV']}, 'referencesModule': {'references': [{'pmid': '22542960', 'type': 'BACKGROUND', 'citation': 'Pence BW, Gaynes BN, Williams Q, Modi R, Adams J, Quinlivan EB, Heine A, Thielman N, Mugavero MJ. Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: rationale and design of the SLAM DUNC Study. Contemp Clin Trials. 2012 Jul;33(4):828-38. doi: 10.1016/j.cct.2012.04.002. Epub 2012 Apr 20.'}, {'pmid': '23134559', 'type': 'BACKGROUND', 'citation': 'Adams JL, Gaynes BN, McGuinness T, Modi R, Willig J, Pence BW. Treating depression within the HIV "medical home": a guided algorithm for antidepressant management by HIV clinicians. AIDS Patient Care STDS. 2012 Nov;26(11):647-54. doi: 10.1089/apc.2012.0113.'}, {'pmid': '23442030', 'type': 'BACKGROUND', 'citation': "Bess KD, Adams J, Watt MH, O'Donnell JK, Gaynes BN, Thielman NM, Heine A, Zinski A, Raper JL, Pence BW. Providers' attitudes towards treating depression and self-reported depression treatment practices in HIV outpatient care. AIDS Patient Care STDS. 2013 Mar;27(3):171-80. doi: 10.1089/apc.2012.0406. Epub 2013 Feb 26."}, {'pmid': '24103743', 'type': 'BACKGROUND', 'citation': 'Edwards M, Quinlivan EB, Bess K, Gaynes BN, Heine A, Zinski A, Modi R, Pence BW. Implementation of PHQ-9 depression screening for HIV-infected patients in a real-world setting. J Assoc Nurses AIDS Care. 2014 May-Jun;25(3):243-52. doi: 10.1016/j.jana.2013.05.004. Epub 2013 Oct 5.'}, {'pmid': '25105320', 'type': 'BACKGROUND', 'citation': "Bengtson AM, Pence BW, O'Donnell J, Thielman N, Heine A, Zinski A, Modi R, McGuinness T, Gaynes B. Improvements in depression and changes in quality of life among HIV-infected adults. AIDS Care. 2015;27(1):47-53. doi: 10.1080/09540121.2014.946386. Epub 2014 Aug 8."}, {'pmid': '25727123', 'type': 'BACKGROUND', 'citation': 'Pence BW, Quinlivan EB, Heine A, Edwards M, Thielman NM, Gaynes BN. When "need plus supply" does not equal demand: challenges in uptake of depression treatment in HIV clinical care. Psychiatr Serv. 2015 Mar 1;66(3):321-3. doi: 10.1176/appi.ps.201400132. Epub 2014 Dec 1.'}], 'seeAlsoLinks': [{'url': 'http://slamdunc.web.unc.edu/', 'label': 'SLAM DUNC study website'}]}, 'descriptionModule': {'briefSummary': 'This project will integrate a depression treatment and brief medication adherence counseling intervention into clinical care at three HIV clinics and will use a randomized controlled trial to assess whether, relative to usual care, the intervention leads to improved HIV medication adherence. The depression treatment intervention uses a model known as Measurement-Based Care which equips Depression Care Managers with systematic measurement tools, a decision algorithm, and psychiatric backup and trains them to provide decision support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.', 'detailedDescription': 'Our goal in this project is to conduct a randomized controlled trial of an evidence-based depression treatment intervention known as Measurement-Based Care (MBC), combined with brief Motivational Interviewing (MI) adherence counseling, in depressed people living with HIV/AIDS to assess its impact on ART adherence and clinical outcomes. MBC employs Depression Care Managers with expertise in depression management to screen for depression and help non-psychiatric physicians implement guideline-concordant, algorithm-driven antidepressant treatment. The Depression Care Manager use standardized metrics (depressive symptoms, side effects) and an algorithm to monitor treatment response and recommend changes. Weekly supervision from a psychiatrist ensures quality care. Biweekly contact between patients and the Depression Care Manager will include brief MI adherence counseling.\n\nWe will recruit 390 people living with HIV/AIDS on antiretroviral therapy (ART) with confirmed depression, and will conduct a randomized trial of the MBC intervention versus enhanced usual care. Our aims are: (1) to test whether MBC improves ART adherence and HIV clinical outcomes, (2) to assess the cost-effectiveness of MBC, and (3) to collect process measures concerning MBC implementation to inform replication at other sites. Since the Depression Care Manager role can be effectively filled by a behavioral health provider or nurse given appropriate training and supervision and the intervention has limited time requirements, this model is potentially replicable to a wide range of resource-constrained HIV treatment settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65\n* HIV-positive\n* Patient Health Questionnaire-9 (PHQ-9) total score \\>= 10\n* Confirmed current major depressive episode\n* English-speaking\n\nExclusion Criteria:\n\n* History of bipolar disorder\n* History of psychotic disorder\n* Failure of adequate trials of two different antidepressants at effective doses in the current depressive episode\n* Current substance dependence requiring inpatient hospitalization\n* Not mentally competent\n* Acute suicidality or other psychiatric presentation requiring immediate hospitalization'}, 'identificationModule': {'nctId': 'NCT01372605', 'acronym': 'SLAM DUNC', 'briefTitle': 'Trial of Collaborative Depression Care Management for HIV Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'SLAM DUNC: Strategies to Link Antidepressant and Antiretroviral Management at Duke University, University of Alabama at Birmingham, Northern Outreach Clinic (Henderson, NC), and University of North Carolina', 'orgStudyIdInfo': {'id': 'Pro00019233'}, 'secondaryIdInfos': [{'id': 'R01MH086362', 'link': 'https://reporter.nih.gov/quickSearch/R01MH086362', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collaborative depression care', 'description': 'Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.', 'interventionNames': ['Other: Measurement-Based Care collaborative depression management']}, {'type': 'OTHER', 'label': 'Enhanced usual care', 'description': 'Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.', 'interventionNames': ['Other: Enhanced Usual Care']}], 'interventions': [{'name': 'Measurement-Based Care collaborative depression management', 'type': 'OTHER', 'description': 'Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications', 'armGroupLabels': ['Collaborative depression care']}, {'name': 'Enhanced Usual Care', 'type': 'OTHER', 'armGroupLabels': ['Enhanced usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham 1917 Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals Infectious Diseases Clinic', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Clinic 2J', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27536', 'city': 'Henderson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Northern Outreach Clinic', 'geoPoint': {'lat': 36.32959, 'lon': -78.39916}}], 'overallOfficials': [{'name': 'Brian W Pence, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Bradley N Gaynes, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}