Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-25 @ 11:32 AM
Study NCT ID:
NCT01790633
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}, {'id': 'D000092025', 'term': 'Rapid Diagnostic Tests'}], 'ancestors': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000067716', 'term': 'Point-of-Care Testing'}, {'id': 'D019095', 'term': 'Point-of-Care Systems'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julie.bottero@aphp.fr', 'phone': '+33 1 49 28 04 24', 'title': 'Dr. Julie Bottero', 'organization': 'Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Single-center pilot study, possibly reducing generalizability; small number of participants and infected individuals may have decreased power to detect differences in linkage-to-care; not all rapid tests were approved for routine use in France.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Testing With ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).\n\nELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rapid Testing', 'description': "HBV, HCV, and HIV infection status determined by a rapid test\n\nRapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day.", 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accessibility of Testing Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Testing With ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).\n\nELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).'}, {'id': 'OG001', 'title': 'Rapid Testing', 'description': "HBV, HCV, and HIV infection status determined by a rapid test\n\nRapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."}], 'classes': [{'categories': [{'measurements': [{'value': '0.642', 'groupId': 'OG000'}, {'value': '0.981', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \\< 0.05', 'groupDescription': 'We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated once, up to 4 months after testing', 'description': 'The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Access to Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Testing With ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).\n\nELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).'}, {'id': 'OG001', 'title': 'Rapid Testing', 'description': "HBV, HCV, and HIV infection status determined by a rapid test\n\nRapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."}], 'classes': [{'categories': [{'measurements': [{'value': '0.938', 'groupId': 'OG000'}, {'value': '0.900', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \\< 0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluated once, up to 4 months after testing', 'description': 'The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes only participants with positive HIV, HBV, and/or HCV results.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion Participating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened for Eligibility', 'description': 'Individuals who were screened for eligibility, prior to being considered for randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.890', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At testing', 'description': 'The number of individuals accepting to participate in the study divided by the total number of individuals proposed.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Rapid Test Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Testing With ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).\n\nELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).'}, {'id': 'OG001', 'title': 'Rapid Testing', 'description': "HBV, HCV, and HIV infection status determined by a rapid test\n\nRapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."}], 'classes': [{'categories': [{'measurements': [{'value': '0.074', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At testing', 'description': 'The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to the rapid testing arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Testing With ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).\n\nELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).'}, {'id': 'FG001', 'title': 'Rapid Testing', 'description': "HBV, HCV, and HIV infection status determined by a rapid test\n\nRapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did not have serology performed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'RT failure and no follow-up ELISA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Volunteers were recruited from an innercity clinic for persons without healthcare coverage ("Médecins du Monde", Paris, France). From February 25, 2013 to June 21, 2013, individuals seeking care at the center were asked to participate.', 'preAssignmentDetails': '554 participants were initially screened for eligibility. 150 did not meet inclusion criteria, 16 had a medical condition requiring immediate referral to a specialist, and 61 declined to participate. A total of 327 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Testing With ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).\n\nELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).'}, {'id': 'BG001', 'title': 'Rapid Testing', 'description': "HBV, HCV, and HIV infection status determined by a rapid test\n\nRapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HBV prevalence of birth country', 'classes': [{'title': 'Low (<2.0%)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Intermediate (2.0%-8.0%)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'High (>8.0%)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'No health insurance plan', 'classes': [{'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2013-02-07', 'resultsFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2013-02-11', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-19', 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion Participating', 'timeFrame': 'At testing', 'description': 'The number of individuals accepting to participate in the study divided by the total number of individuals proposed.'}, {'measure': 'Proportion of Rapid Test Failures', 'timeFrame': 'At testing', 'description': 'The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).'}], 'primaryOutcomes': [{'measure': 'Accessibility of Testing Results', 'timeFrame': 'Evaluated once, up to 4 months after testing', 'description': 'The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.'}], 'secondaryOutcomes': [{'measure': 'Access to Care', 'timeFrame': 'Evaluated once, up to 4 months after testing', 'description': 'The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rapid test', 'screening', 'ELISA', 'hepatitis B virus', 'hepatitis C virus', 'human immunodeficiency virus', 'access to care'], 'conditions': ['HIV', 'Hepatitis B', 'Hepatitis C', 'Carcinoma, Hepatocellular', 'AIDS']}, 'referencesModule': {'references': [{'pmid': '23183527', 'type': 'BACKGROUND', 'citation': 'Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, Boo N, Dhotte P, Varsat B, Muller G, Cha O, Picard O, Nau J, Campa P, Silbermann B, Bary M, Girard PM, Lacombe K. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol. 2013 Mar;58(3):473-8. doi: 10.1016/j.jhep.2012.11.016. Epub 2012 Nov 23.'}, {'pmid': '26668814', 'type': 'RESULT', 'citation': 'Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.'}]}, 'descriptionModule': {'briefSummary': "This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).\n\nInfection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.\n\nThe overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years of age\n* Seeking care at the CASO MDM health care center\n* Accept to be followed at Saint-Antoine Hospital in the event of a positive test.\n\nExclusion Criteria:\n\n* Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV\n* Already has been tested (must give any of the following as evidence):\n\n * results from HBV and HCV and HIV tests dating at least 3 months back\n * results from HCV and HIV tests dating at least 3 months back and HBV serology indicating that the participant is immunized against HBV."}, 'identificationModule': {'nctId': 'NCT01790633', 'acronym': 'OPTISCREEN-III', 'briefTitle': 'Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests', 'organization': {'class': 'OTHER', 'fullName': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba"}, 'officialTitle': 'Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests As a Tool for Screening and Access to Care Among At-Risk Populations', 'orgStudyIdInfo': {'id': 'IMEA 38B'}, 'secondaryIdInfos': [{'id': '2012-A01681-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard testing with ELISA', 'description': 'HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).', 'interventionNames': ['Other: ELISA']}, {'type': 'EXPERIMENTAL', 'label': 'Rapid testing', 'description': 'HBV, HCV, and HIV infection status determined by a rapid test', 'interventionNames': ['Other: Rapid Test']}], 'interventions': [{'name': 'ELISA', 'type': 'OTHER', 'description': 'Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).', 'armGroupLabels': ['Standard testing with ELISA']}, {'name': 'Rapid Test', 'type': 'OTHER', 'otherNames': ["VIKIA®, Biomerieux, Marcy-l'Étoile, France", 'OraQuick® HCV Rapid Antibody Test, OraSure Technologies, Inc., Bethlehem, PA, USA'], 'description': "A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day.", 'armGroupLabels': ['Rapid testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75011', 'city': 'Paris', 'country': 'France', 'facility': "Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Julie Bottero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Saint-Antoine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared under the following conditions: (1) interested parties must submit a request for data access to the principal investigator and (2) the request is approved by the Scientific Committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba", 'class': 'OTHER'}, 'collaborators': [{'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'Mairie de Paris', 'class': 'UNKNOWN'}, {'name': 'BioMérieux', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}