Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-04-11 @ 8:53 PM
Study NCT ID:
NCT01366495
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2011-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgordon@friendsresearch.org', 'phone': '410-837-3977', 'title': 'Dr. Michael S. Gordon, Senior Research Scientist', 'phoneExt': '251', 'organization': 'Friends Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '18-months', 'eventGroups': [{'id': 'EG000', 'title': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Treatment As Usual', 'description': 'Passive referral to HIV community treatment provider.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'On-site Testing', 'description': 'HIV testing on-site at probation/parole office.', 'otherNumAtRisk': 349, 'deathsNumAtRisk': 349, 'otherNumAffected': 0, 'seriousNumAtRisk': 349, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Off-site Testing', 'description': 'HIV testing at a community health center or HIV clinic.', 'otherNumAtRisk': 348, 'deathsNumAtRisk': 348, 'otherNumAffected': 0, 'seriousNumAtRisk': 348, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death', 'notes': 'overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 349}, {'groupId': 'EG003', 'numAtRisk': 348}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Willing to Undergo Rapid HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'On-site Rapid HIV Testing', 'description': 'On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.'}, {'id': 'OG001', 'title': 'Off-site Referral for HIV Testing', 'description': 'Off-site referral for rapid HIV testing at a community health center or HIV testing clinic'}], 'classes': [{'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek).\n\nAim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Entered Community HIV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.'}, {'id': 'OG001', 'title': 'Treatment As Usual', 'description': 'Passive referral to HIV community treatment provider.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-months', 'description': 'Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retention in Community HIV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.'}, {'id': 'OG001', 'title': 'Treatment As Usual', 'description': 'Passive referral to HIV community treatment provider.'}], 'classes': [{'categories': [{'measurements': [{'value': '377.04', 'spread': '187.44', 'groupId': 'OG000'}, {'value': '318.82', 'spread': '208.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Number of Days with Retention in Community HIV Treatment', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.'}, {'id': 'OG001', 'title': 'Treatment As Usual', 'description': 'Passive referral to HIV community treatment provider.'}], 'timeFrame': '6,12,18-months', 'description': 'To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.', 'reportingStatus': 'POSTED', 'populationDescription': 'We were unable to obtain official medical records from treatment clinics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.'}, {'id': 'FG001', 'title': 'Treatment As Usual', 'description': 'Passive referral to HIV community treatment provider.'}, {'id': 'FG002', 'title': 'On-site Testing', 'description': 'HIV testing on-site at probation/parole office'}, {'id': 'FG003', 'title': 'Off-Site Testing', 'description': 'Off-site HIV testing at a community health center or HIV clinic.'}], 'periods': [{'title': 'Testing Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '349'}, {'groupId': 'FG003', 'numSubjects': '348'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '349'}, {'groupId': 'FG003', 'numSubjects': '348'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'HIV Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}, {'value': '797', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.\n\nProject Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': 'Passive referral to HIV community treatment provider'}, {'id': 'BG002', 'title': 'On-site Testing', 'description': 'Rapid oral swab HIV testing on-site at a community supervision office.'}, {'id': 'BG003', 'title': 'Off-Site Testing', 'description': 'HIV testing at a community treatment clinic.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'HIV Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '46.8', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '45.1', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '45.9', 'spread': '7.6', 'groupId': 'BG004'}]}]}, {'title': 'HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}, {'value': '697', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '38.3', 'spread': '11.1', 'groupId': 'BG003'}, {'value': '38.7', 'spread': '11.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Allows for reporting of two RCT baseline measures.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'HIV Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG004'}]}]}, {'title': 'HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}, {'value': '697', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '284', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}, {'value': '567', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Allows for reporting of two RCT baseline measures'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'HIV Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}, {'value': '697', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '305', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}, {'value': '602', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Allows for reporting of two RCT baseline measures'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'HIV Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}, {'value': '697', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '184', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '79', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '145', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Allows for reporting of two RCT baseline measures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 797}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2011-06-01', 'resultsFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-09', 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Willing to Undergo Rapid HIV Testing', 'timeFrame': 'Baseline', 'description': 'Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek).\n\nAim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test).'}, {'measure': 'Number of Participants That Entered Community HIV Treatment', 'timeFrame': '3-months', 'description': 'Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Retention in Community HIV Treatment', 'timeFrame': '18 months', 'description': 'Number of Days with Retention in Community HIV Treatment'}, {'measure': 'Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable', 'timeFrame': '6,12,18-months', 'description': 'To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Seek', 'Test', 'Treat'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '33492021', 'type': 'DERIVED', 'citation': 'Crable EL, Blue TR, McKenzie M, Rich JD, Gordon MS. Effect of Case Management on HIV Outcomes for Community Corrections Population: Results of an 18-Month Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2021 May 1;87(1):755-762. doi: 10.1097/QAI.0000000000002624.'}, {'pmid': '23536140', 'type': 'DERIVED', 'citation': 'Gordon MS, Kinlock TW, McKenzie M, Wilson ME, Rich JD. Rapid HIV testing for individuals on probation/parole: outcomes of an intervention trial. AIDS Behav. 2013 Jul;17(6):2022-30. doi: 10.1007/s10461-013-0456-6.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to conduct both a randomized trial of HIV testing in community corrections, and a randomized trial of linkage to HIV care for people with HIV recruited through community corrections (probation and parole).', 'detailedDescription': 'The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. Inclusion criteria will be: 1) Adult probationer/parolee; 2) not known to be HIV positive, and 3) resident of greater Baltimore or Providence throughout the study period. Exclusion criteria will be: 1) unable to give informed consent. The second study is a randomized trial, whereby all individuals identified at community corrections with HIV will be offered enrollment in a one-year intervention study to examine the ability to improve linkage into HIV care. Participants will be randomized to receive one of two conditions: 1) Project Bridge for one year, or 2) Treatment as Usual-referral to standard level of care. Moreover, those randomized to TAU will be given an opportunity to "crossover" to PB if they have failed to engage in treatment during the first three months. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction that is associated with multiple HIV-related risk behaviors in these two cities and a high likelihood of being on probation and/or parole. Furthermore, Maryland ranks 10th and Rhode Island ranks 4th in the nation in the number of probationers per 100,000 adult residents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Probation or Parole;\n2. Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV'}, 'identificationModule': {'nctId': 'NCT01366495', 'briefTitle': 'A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections', 'organization': {'class': 'OTHER', 'fullName': 'Friends Research Institute, Inc.'}, 'officialTitle': 'A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections', 'orgStudyIdInfo': {'id': 'R01DA030771-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DA030771-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'On-site Rapid HIV Testing', 'description': 'On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.', 'interventionNames': ['Behavioral: Project Bridge']}, {'type': 'NO_INTERVENTION', 'label': 'Off-site Referral for HIV Testing', 'description': 'Off-site referral for rapid HIV testing at a community health center or HIV testing clinic'}, {'type': 'EXPERIMENTAL', 'label': 'Project Bridge', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.', 'interventionNames': ['Behavioral: Project Bridge']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'Passive referral to HIV community treatment provider.'}], 'interventions': [{'name': 'Project Bridge', 'type': 'BEHAVIORAL', 'description': 'Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.', 'armGroupLabels': ['On-site Rapid HIV Testing', 'Project Bridge']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Michael S Gordon, D.P.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friends Research Institute, Inc.'}, {'name': 'Josiah D Rich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friends Research Institute, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}