Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 5:59 PM
Study NCT ID:
NCT01781806
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rlandovitz@mednet.ucla.edu', 'phone': '(310) 825-6689', 'title': 'Dr. Raphael J. Landovitz', 'organization': 'UCLA CARE Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STI diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.', 'otherNumAtRisk': 297, 'otherNumAffected': 195, 'seriousNumAtRisk': 297, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort LM (PEP)', 'description': 'Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 80, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Oropharyngeal gonococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 68, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Proctitis chlamydial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 109, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Proctitis gonococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 61, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urethritis chlamydial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Grade 2 or Higher Adverse Event by Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STI diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}, {'id': 'OG001', 'title': 'Cohort LM (PEP)', 'description': 'Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}], 'classes': [{'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort H PrEP Engagement by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STI diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort H (PrEP) and Cohort LM (PEP)', 'description': 'Participants enrolled in Cohort H (PrEP) and Cohort LM (PEP)'}], 'classes': [{'categories': [{'title': 'High risk reported at baseline and remained high', 'measurements': [{'value': '278', 'groupId': 'OG000'}]}, {'title': 'Risk increased from low (baseline) to high', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Low risk reported at baseline and remained low', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of HIV Seroconversions by Cohort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STI diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}, {'id': 'OG001', 'title': 'Cohort LM (PEP)', 'description': 'Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 48 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STI diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}, {'id': 'FG001', 'title': 'Cohort LM (PEP)', 'description': 'Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Week 0', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Week 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Week 8', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Week 12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Week 36', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Week 48', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Of the 328 participants who enrolled in the study, 27 screen failed for various reasons and were not assigned to a cohort.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STI diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}, {'id': 'BG001', 'title': 'Cohort LM (PEP)', 'description': 'Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.\n\nemtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min, Truvada will be discontinued.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '42'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '39'}, {'value': '34', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'title': 'Male', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Transfemale', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander/Alaskan Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race/Other', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'High school or less', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'College graduate', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Any postgraduate', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance', 'classes': [{'categories': [{'title': 'Uninsured', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Insured', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Married/civil union/legal partnership', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Living with primary or main partner', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Have primary or main partner, not living together', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Single/divorced/widowed', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family Income', 'classes': [{'title': '$20,000 or less', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': '$20,001 - $50,000', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': '$50,001 or more', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2013-01-29', 'resultsFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-24', 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.'}, {'measure': 'Number of HIV Seroconversions by Cohort.', 'timeFrame': 'Baseline to 48 weeks'}], 'primaryOutcomes': [{'measure': 'Number of Participants With a Grade 2 or Higher Adverse Event by Cohort', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.'}], 'secondaryOutcomes': [{'measure': 'Cohort H PrEP Engagement by Study Visit', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Prevention']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM and transgender women.', 'detailedDescription': 'Two community-based sites (LALGBT Center and The OASIS Clinic) will serve as facilities at which participants may present for screening for prevention services. At the sites, eligibility criteria will be assessed, HIV, Sexually Transmitted Disease (STD) and laboratory testing will be performed, and HIV prevention service referrals will be initiated. Follow-up will be on a monthly basis for the first three months, and then de-escalated to an every-3-month interval.\n\nThe program stratifies participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H). Participants in the LM cohort will be provided a customized prevention package (CPP) including access to PEP for emergency HIV prevention in the event of unanticipated HIV exposure. Participants in the H cohort will be provided a CPP including daily Truvada-based PrEP. All participants will be followed for 48 weeks. Participants in the LM cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the H-cohort will be transitioned to the H-cohort.\n\nAt each follow-up visit, a careful safety assessment will be made, including signs/symptoms and laboratory assessments. STD testing will be performed at 3 month intervals. An escalating-intensity adherence intervention will be implemented based on real-time plasma tenofovir levels. A computer-assisted self-interview (CASI) will be used to capture detailed sexual risk, adherence, and substance use behavior.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years of age\n* Able to understand and provide consent in English or Spanish\n* Self identified MSM, MSM/W, or Transfemale\n* At least one male sex partner for anal intercourse in the prior 12 months\n* HIV negative by enzyme immunoassay (EIA) and viral load (VL)\n* CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)\n* No signs or symptoms suggestive of primary HIV infection (PHI).\n\nExclusion Criteria:\n\n* Participants \\<18 years of age\n* Unable to understand and provide consent in English or Spanish\n* Known or found on testing to be HIV positive\n* Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing\n* Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry\n* Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.\n* Signs or symptoms suspicious for PHI."}, 'identificationModule': {'nctId': 'NCT01781806', 'acronym': 'PATH-PrEP', 'briefTitle': 'A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among Men Who Have Sex With Men (MSM) and Transgender Women in Los Angeles County', 'orgStudyIdInfo': {'id': 'EI11-LA-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort H (PrEP)', 'description': 'Participants in the H cohort will be provided with a CPP, including daily oral emtricitabine/tenofovir-based PrEP.\n\nHigh Risk Cohort Criteria (one or more of the following has to be met):\n\n1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.\n2. STD diagnosis during the last 12 months.\n3. Previous PEP use during the last 12 months (\\* see exclusion criteria)\n4. Has at least one HIV infected sexual partner for ≥4 weeks.', 'interventionNames': ['Drug: emtricitabine 200mg/tenofovir 300mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort LM (PEP)', 'description': 'Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.', 'interventionNames': ['Drug: emtricitabine 200mg/tenofovir 300mg']}], 'interventions': [{'name': 'emtricitabine 200mg/tenofovir 300mg', 'type': 'DRUG', 'otherNames': ['Truvada'], 'description': 'The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in creatinine clearance (CrCl) to \\<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl \\<30 mL/min, Truvada will be discontinued.', 'armGroupLabels': ['Cohort H (PrEP)', 'Cohort LM (PEP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'L.A. Gay and Lesbian Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The OASIS Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Raphael Landovitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Los Angeles County Department of Public Health', 'class': 'OTHER_GOV'}, {'name': 'Los Angeles LGBT Center', 'class': 'OTHER'}, {'name': 'The OASIS Clinic', 'class': 'UNKNOWN'}, {'name': 'AIDS Project Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Raphael Landovitz', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}