Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-17 @ 10:01 PM
Study NCT ID:
NCT01686750
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006716', 'term': 'Homosexuality'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'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'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'glucas@jhmi.edu', 'phone': '410-614-0560', 'title': 'Dr. Gregory M.Lucas', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'This study was based on cross-sectional surveys. Therefore adverse events were only documented at the time of the survey visit (1 day).', 'eventGroups': [{'id': 'EG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach', 'otherNumAtRisk': 11001, 'deathsNumAtRisk': 11001, 'otherNumAffected': 0, 'seriousNumAtRisk': 11001, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.', 'otherNumAtRisk': 10725, 'deathsNumAtRisk': 10725, 'otherNumAffected': 0, 'seriousNumAtRisk': 10725, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion Reporting HIV Testing in the Prior 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}, {'value': '10725', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '53.3'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '37.3'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.81', 'estimateComment': 'Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.', 'groupDescription': 'We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.', 'statisticalMethod': 'Prevalence ratio', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters'}, {'type': 'SECONDARY', 'title': 'Proportion of HIV-infected Participants Aware of Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1974', 'groupId': 'OG000'}, {'value': '2306', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '86.5'}, {'value': '59.4', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '97.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.50', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Proportion of HIV-positive participants that were aware of their status at the time of the visit', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'Participants who tested HIV-positive at the survey visit'}, {'type': 'SECONDARY', 'title': 'Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1974', 'groupId': 'OG000'}, {'value': '2306', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach\n\nIntegrated care centers'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '73.9'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '88.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.81', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'HIV-positive survey participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1647', 'groupId': 'OG000'}, {'value': '1749', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '87'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '95.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.77', 'ciUpperLimit': '2.41', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study'}, {'type': 'SECONDARY', 'title': 'Community Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'timeFrame': '2 years', 'description': 'Average log(10) HIV RNA concentration among HIV-infected participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were not collected therefore there is no data to report.'}, {'type': 'SECONDARY', 'title': 'Proportion of HIV-infected Participants With Suppressed HIV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1647', 'groupId': 'OG000'}, {'value': '1749', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '78.6'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '82.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.28', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Proportion of HIV-positive participants meeting criteria for antiretroviral therapy \\[cluster of differentiation 4 (CD4) count \\<350 cells/mm3 or current or past use of antiretroviral therapy)\\] who have a suppressed viral load (HIV RNA \\<150 copies/mL)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'HIV-positive participants who meet criteria for antiretroviral therapy'}, {'type': 'SECONDARY', 'title': 'Prevalence of Recent HIV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were not collected therefore there is no data to report.'}, {'type': 'SECONDARY', 'title': 'Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6000', 'groupId': 'OG000'}, {'value': '5721', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '30.8'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '56.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.42', 'ciUpperLimit': '4.93', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'Participants from the PWID sites'}, {'type': 'SECONDARY', 'title': 'Proportion of IDU Reporting Drug Abstinence in Prior 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6000', 'groupId': 'OG000'}, {'value': '5721', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '72.9'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '42.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '0.49', 'ciUpperLimit': '7.16', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'Participants at PWID sites'}, {'type': 'SECONDARY', 'title': 'Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5001', 'groupId': 'OG000'}, {'value': '5004', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '78.9'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '41.7', 'upperLimit': '84'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.56', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'Participants at MSM sites'}, {'type': 'SECONDARY', 'title': 'Number of Non-main Male Partners in Prior 6 Months in MSM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5001', 'groupId': 'OG000'}, {'value': '5004', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '6.4'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '8.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '4.2', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'partners', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'Participants at MSM sites'}, {'type': 'SECONDARY', 'title': 'Proportion Reporting Substance Abuse Among MSM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were not collected therefore there is no data to report.'}, {'type': 'SECONDARY', 'title': 'Proportion With Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}, {'value': '10725', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '26.9'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '35.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.52', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Participants with Score \\>=10 on Patient Health Questionnaire-9', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters'}, {'type': 'SECONDARY', 'title': 'Number of Unprotected Sexual Acts Reported by MSM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were not collected therefore there is no data to report.'}, {'type': 'SECONDARY', 'title': 'Vicarious Stigma as Assessed by 6-item Stigma Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'OG000'}, {'value': '10725', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.2'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '7.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-0.6', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters'}, {'type': 'SECONDARY', 'title': 'Proportion Reporting Spouse Ever Tested for HIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5550', 'groupId': 'OG000'}, {'value': '4439', 'groupId': 'OG001'}]}, {'units': 'clusters', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'OG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '74.3'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '79.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.36', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clusters', 'denomUnitsSelected': 'clusters', 'populationDescription': 'Participants with a spouse (opposite sex)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'FG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11001'}, {'groupId': 'FG001', 'numUnits': '11', 'numSubjects': '10725'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11001'}, {'groupId': 'FG001', 'numUnits': '11', 'numSubjects': '10725'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Clusters', 'recruitmentDetails': 'Recruited by respondent-driven sampling in 22 sites in India.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11001', 'groupId': 'BG000'}, {'value': '10725', 'groupId': 'BG001'}, {'value': '21726', 'groupId': 'BG002'}]}, {'units': 'Clusters', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Integrated Care Centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach'}, {'id': 'BG001', 'title': 'Standard Services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '34'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '35'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Clusters'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10780', 'groupId': 'BG000'}, {'value': '10453', 'groupId': 'BG001'}, {'value': '21233', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11001', 'groupId': 'BG000'}, {'value': '10725', 'groupId': 'BG001'}, {'value': '21726', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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', 'denomUnitsSelected': 'Participants'}, {'title': 'At least secondary school education', 'classes': [{'categories': [{'measurements': [{'value': '8729', 'groupId': 'BG000'}, {'value': '7455', 'groupId': 'BG001'}, {'value': '16184', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who have had at least a secondary school education.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Clusters'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-14', 'size': 972423, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-26T13:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2012-09-13', 'resultsFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2012-09-13', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-26', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion Reporting HIV Testing in the Prior 12 Months', 'timeFrame': '2 years', 'description': 'Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.'}], 'secondaryOutcomes': [{'measure': 'Proportion of HIV-infected Participants Aware of Status', 'timeFrame': '2 years', 'description': 'Proportion of HIV-positive participants that were aware of their status at the time of the visit'}, {'measure': 'Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months', 'timeFrame': '2 years'}, {'measure': 'Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy', 'timeFrame': '2 years'}, {'measure': 'Community Viral Load', 'timeFrame': '2 years', 'description': 'Average log(10) HIV RNA concentration among HIV-infected participants'}, {'measure': 'Proportion of HIV-infected Participants With Suppressed HIV RNA', 'timeFrame': '2 years', 'description': 'Proportion of HIV-positive participants meeting criteria for antiretroviral therapy \\[cluster of differentiation 4 (CD4) count \\<350 cells/mm3 or current or past use of antiretroviral therapy)\\] who have a suppressed viral load (HIV RNA \\<150 copies/mL)'}, {'measure': 'Prevalence of Recent HIV Infection', 'timeFrame': '2 years'}, {'measure': 'Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months', 'timeFrame': '2 years'}, {'measure': 'Proportion of IDU Reporting Drug Abstinence in Prior 6 Months', 'timeFrame': '2 years'}, {'measure': 'Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months', 'timeFrame': '2 years'}, {'measure': 'Number of Non-main Male Partners in Prior 6 Months in MSM', 'timeFrame': '2 years'}, {'measure': 'Proportion Reporting Substance Abuse Among MSM', 'timeFrame': '2 years'}, {'measure': 'Proportion With Depressive Symptoms', 'timeFrame': '2 years', 'description': 'Participants with Score \\>=10 on Patient Health Questionnaire-9'}, {'measure': 'Number of Unprotected Sexual Acts Reported by MSM', 'timeFrame': '2 years'}, {'measure': 'Vicarious Stigma as Assessed by 6-item Stigma Scale', 'timeFrame': '2 years', 'description': 'Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma'}, {'measure': 'Proportion Reporting Spouse Ever Tested for HIV', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'injection drug use', 'men who have sex with men', 'voluntary counselling and testing', 'risk reduction', 'sexually transmitted infections', 'community viral load', 'antiretroviral therapy'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '25849835', 'type': 'BACKGROUND', 'citation': 'Solomon SS, Mehta SH, Srikrishnan AK, Vasudevan CK, Mcfall AM, Balakrishnan P, Anand S, Nandagopal P, Ogburn EL, Laeyendecker O, Lucas GM, Solomon S, Celentano DD. High HIV prevalence and incidence among MSM across 12 cities in India. AIDS. 2015 Mar 27;29(6):723-31. doi: 10.1097/QAD.0000000000000602.'}, {'pmid': '25715105', 'type': 'BACKGROUND', 'citation': 'Lucas GM, Solomon SS, Srikrishnan AK, Agrawal A, Iqbal S, Laeyendecker O, McFall AM, Kumar MS, Ogburn EL, Celentano DD, Solomon S, Mehta SH. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015 Mar 13;29(5):619-28. doi: 10.1097/QAD.0000000000000592.'}, {'pmid': '25486851', 'type': 'BACKGROUND', 'citation': 'Solomon SS, Mehta SH, Srikrishnan AK, Solomon S, McFall AM, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Lucas GM, Kumar MS, Sulkowski MS, Quinn TC. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study. Lancet Infect Dis. 2015 Jan;15(1):36-45. doi: 10.1016/S1473-3099(14)71045-X. Epub 2014 Dec 3.'}, {'pmid': '23801014', 'type': 'BACKGROUND', 'citation': 'Solomon SS, Lucas GM, Celentano DD, Sifakis F, Mehta SH. Beyond surveillance: a role for respondent-driven sampling in implementation science. Am J Epidemiol. 2013 Jul 15;178(2):260-7. doi: 10.1093/aje/kws432. Epub 2013 Jun 25.'}, {'pmid': '27842543', 'type': 'BACKGROUND', 'citation': 'Solomon SS, Lucas GM, Celentano DD, McFall AM, Ogburn E, Moulton LH, Srikrishnan AK, Kumar MS, Anand S, Solomon S, Mehta SH. Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India. BMC Health Serv Res. 2016 Nov 14;16(1):652. doi: 10.1186/s12913-016-1905-5.'}, {'pmid': '26251048', 'type': 'BACKGROUND', 'citation': 'Mehta SH, Lucas GM, Solomon S, Srikrishnan AK, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement. Clin Infect Dis. 2015 Dec 1;61(11):1732-41. doi: 10.1093/cid/civ669. Epub 2015 Aug 6.'}, {'pmid': '30952565', 'type': 'RESULT', 'citation': 'Solomon SS, Solomon S, McFall AM, Srikrishnan AK, Anand S, Verma V, Vasudevan CK, Balakrishnan P, Ogburn EL, Moulton LH, Kumar MS, Sachdeva KS, Laeyendecker O, Celentano DD, Lucas GM, Mehta SH; Indian National Collaboration on AIDS Study. Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial. Lancet HIV. 2019 May;6(5):e283-e296. doi: 10.1016/S2352-3018(19)30034-7. Epub 2019 Apr 2.'}, {'pmid': '35410326', 'type': 'DERIVED', 'citation': 'Prabhu S, Mehta SH, McFall AM, Srikrishnan AK, Vasudevan CK, Lucas GM, Celentano DD, Solomon SS. Substance use is associated with condomless anal intercourse among men who have sex with men in India: a partner-level analysis. BMC Public Health. 2022 Apr 11;22(1):722. doi: 10.1186/s12889-022-13192-y.'}, {'pmid': '31604081', 'type': 'DERIVED', 'citation': 'Solomon SS, Quinn TC, Solomon S, McFall AM, Srikrishnan AK, Verma V, Kumar MS, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Thomas DL, Sachdeva KS, Lucas GM, Mehta SH. Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial. J Hepatol. 2020 Jan;72(1):67-74. doi: 10.1016/j.jhep.2019.09.022. Epub 2019 Oct 8.'}, {'pmid': '27036994', 'type': 'DERIVED', 'citation': 'Solomon SS, Mehta SH, McFall AM, Srikrishnan AK, Saravanan S, Laeyendecker O, Balakrishnan P, Celentano DD, Solomon S, Lucas GM. Community viral load, antiretroviral therapy coverage, and HIV incidence in India: a cross-sectional, comparative study. Lancet HIV. 2016 Apr;3(4):e183-90. doi: 10.1016/S2352-3018(16)00019-9. Epub 2016 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a cluster randomized trial to evaluate the effectiveness of integrated care centers (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to stratify sites according to key baseline characteristics. We will perform stratified randomization to assign sites to either the ICC intervention or to standard services. ICCs, which will be either IDU or MSM-focused, will provide an accepting atmosphere in which members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be scaled-up from existing governmental or non-governmental organizations and services provided at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After providing services in communities for two years, we will conduct an evaluation survey (with biological and behavioral measures) of approximately 1000 subjects in the target populations in each of the 22 study sites. Integrated care centers have the potential to improve access to HIV prevention and treatment services among vulnerable, high-risk populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nKey Informant Interviews:\n\nPersons may be included in the key informant interviews if they meet all of the following criteria:\n\n1. 18 years of age or older\n2. Knowledge of the local HIV risk group of interest (IDU or MSM)\n3. Psychologically fit to participate in the study and to understand the consent\n4. Ability to comprehend one of the consent translation languages\n5. Provide informed consent\n\nFocus groups:\n\nPersons may be included in the focus groups if they meet all of the following criteria:\n\n1. 18 years of age or older\n2. Member of a target HIV risk group, meeting criterion 2a or 2b\n\n 1. IDU: self-reported injection drug use in prior 12 months\n 2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months\n3. Psychologically fit to participate in the study and to understand the consent\n4. Ability to comprehend one of the consent translation languages\n5. Provide informed consent\n\nBaseline or evaluation respondent-driven sampling (RDS) survey\n\nPersons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria:\n\n1. 18 years of age or older\n2. Member of a target HIV risk group, meeting criterion 2a or 2b\n\n 1. IDU: self-reported injection drug use in prior 24 months\n 2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months\n3. Psychologically fit to participate in the study and to understand the consent\n4. Ability to comprehend one of the consent translation languages\n5. Present a valid RDS referral coupon (unless a seed)\n6. Provide informed consent\n\nExclusion Criteria:\n\nKey Informant Interviews:\n\nPersons will be excluded from the key informant interviews if they meet any of the following criteria:\n\n1. Younger than 18 years\n2. Do not have knowledge of the local HIV risk group of interest (IDU or MSM)\n3. Are not psychologically fit to participate in the study or to understand the consent\n4. Do not have ability to comprehend one of the consent translation languages\n5. Do not provide informed consent\n\nFocus groups:\n\nPersons will be excluded from the focus groups if they meet any of the following criteria:\n\n1. Younger than 18 years\n2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b\n\n 1. IDU: self-reported injection drug use in prior 12 months\n 2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months\n3. Are not psychologically fit to participate in the study or to understand the consent\n4. Do not have ability to comprehend one of the consent translation languages\n5. Do not provide informed consent\n\nBaseline or evaluation RDS survey\n\nPersons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria:\n\n1. Younger than 18 years\n2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b\n\n 1. IDU: self-reported injection drug use in prior 24 months\n 2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months\n3. Are not psychologically fit to participate in the study or to understand the consent\n4. Do not have ability to comprehend one of the consent translation languages\n5. Do not present a valid RDS referral coupon and are not a seed\n6. Do not provide informed consent'}, 'identificationModule': {'nctId': 'NCT01686750', 'briefTitle': 'Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Cluster Randomized Trial of Integrated Care Centers to Improve Access to HIV Prevention, Testing, and Treatment Services Among High-Risk Vulnerable Populations in India', 'orgStudyIdInfo': {'id': 'NA_00047702'}, 'secondaryIdInfos': [{'id': 'R01DA032059', 'link': 'https://reporter.nih.gov/quickSearch/R01DA032059', 'type': 'NIH'}, {'id': 'R01MH089266', 'link': 'https://reporter.nih.gov/quickSearch/R01MH089266', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated care centers', 'description': 'Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.\n\n* HIV voluntary counseling and testing \\& staging\n* Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy\n* Substance abuse counseling\n* Sexually transmitted infection screening and treatment\n* Access to free antiretroviral therapy and adherence support\n* Peer community outreach', 'interventionNames': ['Behavioral: Integrated care centers']}, {'type': 'NO_INTERVENTION', 'label': 'Standard services', 'description': 'In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.'}], 'interventions': [{'name': 'Integrated care centers', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Integrated care centers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600113', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'YR Gaitonde Center for AIDS Research and Education', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}], 'overallOfficials': [{'name': 'Gregory M Lucas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Shruti Mehta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'David D Celentano, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Suniti Solomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'YR Gaitonde Centre for AIDS Research and Education'}, {'name': 'Aylur Srikrishnan, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'YR Gaitonde Centre for AIDS Research and Education'}, {'name': 'Suresh Kumar, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'YR Gaitonde Centre for AIDS Research and Education'}, {'name': 'Sunil S Solomon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'YR Gaitonde Centre for AIDS Research and Education', 'class': 'OTHER'}, {'name': 'Elton John AIDS Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}