Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04650269
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040261', 'term': 'Harm Reduction'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hetookes@miami.edu', 'phone': '3056897030', 'title': 'Hansel Tookes', 'organization': 'University of Miami Miller School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Rapid ART Group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.\n\nBiktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months\n\nHIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV Viral Load Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid ART Group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.\n\nBiktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months\n\nHIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "HIV viral load suppression is defined as \\<200 copies/ml in participants' blood", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for those participants that were lost to follow-up or death due to COVID pandemic'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV Viral Load Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid ART Group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.\n\nBiktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months\n\nHIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': "HIV viral load suppression is defined as \\<200 copies/ml in participants' blood", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV Viral Load Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid ART Group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.\n\nBiktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months\n\nHIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': "HIV viral load suppression is defined as \\<200 copies/ml in participants' blood", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rapid ART Group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.\n\nBiktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months\n\nHIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rapid ART Group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.\n\nBiktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months\n\nHIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-25', 'size': 342047, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-13T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2020-11-24', 'resultsFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-16', 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV Viral Load Suppression', 'timeFrame': '6 months', 'description': "HIV viral load suppression is defined as \\<200 copies/ml in participants' blood"}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV Viral Load Suppression', 'timeFrame': '1 month', 'description': "HIV viral load suppression is defined as \\<200 copies/ml in participants' blood"}, {'measure': 'Percentage of Participants With HIV Viral Load Suppression', 'timeFrame': '12 months', 'description': "HIV viral load suppression is defined as \\<200 copies/ml in participants' blood"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Harm Reduction', 'HIV Infections', 'Drug Use']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'self-representation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (age\\>18 years);\n2. positive rapid HIV test;\n3. ability to provide informed consent;\n4. HIV RNA \\> 200 copies/ml;\n5. creatinine clearance \\> 30 mg/dl as measured by serum creatinine;\n6. no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies.\n\nExclusion Criteria:\n\n1\\) Any other comorbidities at the discretion of the investigator'}, 'identificationModule': {'nctId': 'NCT04650269', 'briefTitle': 'Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program', 'orgStudyIdInfo': {'id': '20200793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid ART group', 'description': 'Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.', 'interventionNames': ['Drug: Biktarvy 50Mg-200Mg-25Mg Tablet', 'Other: HIV care']}], 'interventions': [{'name': 'Biktarvy 50Mg-200Mg-25Mg Tablet', 'type': 'DRUG', 'description': 'Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months', 'armGroupLabels': ['Rapid ART group']}, {'name': 'HIV care', 'type': 'OTHER', 'description': 'HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.', 'armGroupLabels': ['Rapid ART group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Hansel Tookes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hansel Tookes', 'investigatorAffiliation': 'University of Miami'}}}}