Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04521920
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2020-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Providing Suboxone and PrEP Using Telemedicine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'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': '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': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}, {'id': 'D065129', 'term': 'Pre-Exposure Prophylaxis'}], 'ancestors': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mehri.mckellar@duke.edu', 'phone': '(919) 613-6129', 'title': 'Dr. Mehri McKellar', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Defined as self-reported opioid use in prior month', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 8 participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Defined as self-reported opioid use in prior month.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 11 participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Remain HIV Negative at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Measured via negative HIV test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Received labs to confirm HIV status from 8 participants at month 3.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Remain HIV Negative at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Measured via negative HIV test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Received labs to confirm HIV status from 3 participants at month 6'}, {'type': 'PRIMARY', 'title': 'Persistence in Care at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Defined as the number of participants who remain on treatment (MOUD or PrEP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Persistence in Care at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Defined as the number of participants who remain on treatment (MOUD or PrEP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Motivators and Barriers Affecting Medication Adherence and Persistence', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Motivators and Barriers Affecting Program Persistence', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Perceived Usefulness of the Program', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Perceived Usefulness of the Program', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Satisfaction With the Program', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Satisfaction With the Program', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceptions of Medical Care Quality Via a Telemedicine Video Platform', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ease/Difficulty of Accessing the Telemedicine Video Platform', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Month 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruited people who inject drugs, who access services at syringe services programs in Wilmington and Charlotte, North Carolina.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Medication and Telemedicine Follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine\n\nSuboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.\n\nPrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', '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': '1', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Some high school', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'High school or GED', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Any college', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Education completed measured via self-report', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance status', 'classes': [{'categories': [{'title': 'Private', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Public', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'No insurance', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Insurance coverage measured via self-report', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship status', 'classes': [{'categories': [{'title': 'Single/ Separated', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Married/ Partnered', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Relationship status measured via self-report', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'categories': [{'title': 'Working full-time', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Working part-time', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Student', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Disabled, unable to work', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unemployed', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Stay at home parent', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Employment status measured via self-report', 'unitOfMeasure': 'Participants'}, {'title': 'Ever taken Suboxone', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Whether the participant has ever taken Suboxone prior to the study measured via self-report', 'unitOfMeasure': 'Participants'}, {'title': 'Ever Overdosed', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Whether the participant has ever overdosed on heroin, fentanyl, or prescription pain medication measured via self-report', 'unitOfMeasure': 'Participants'}, {'title': 'Access to technology', 'classes': [{'title': 'Computer with video camera', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Computer without video camera', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Smartphone', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Tablet', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Basic telephone (without internet capabilities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Technology participants have access to measured via self-report', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-19', 'size': 455345, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-19T13:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2020-08-18', 'resultsFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-19', 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Motivators and Barriers Affecting Medication Adherence and Persistence', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)'}, {'measure': 'Motivators and Barriers Affecting Program Persistence', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)'}, {'measure': 'Participant Perceived Usefulness of the Program', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)'}, {'measure': 'Participant Perceived Usefulness of the Program', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)'}, {'measure': 'Participant Satisfaction With the Program', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)'}, {'measure': 'Participant Satisfaction With the Program', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)'}, {'measure': 'Perceptions of Medical Care Quality Via a Telemedicine Video Platform', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)'}, {'measure': 'Ease/Difficulty of Accessing the Telemedicine Video Platform', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)'}, {'measure': 'Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine', 'timeFrame': '6 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method)'}, {'measure': 'Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine', 'timeFrame': '1 month', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months', 'timeFrame': '3 months', 'description': 'Defined as self-reported opioid use in prior month'}, {'measure': 'Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months', 'timeFrame': '6 months', 'description': 'Defined as self-reported opioid use in prior month.'}, {'measure': 'Number of Participants Who Remain HIV Negative at 3 Months', 'timeFrame': '3 months', 'description': 'Measured via negative HIV test.'}, {'measure': 'Number of Participants Who Remain HIV Negative at 6 Months', 'timeFrame': '6 months', 'description': 'Measured via negative HIV test.'}, {'measure': 'Persistence in Care at 3 Months', 'timeFrame': '3 months', 'description': 'Defined as the number of participants who remain on treatment (MOUD or PrEP).'}, {'measure': 'Persistence in Care at 6 Months', 'timeFrame': '6 months', 'description': 'Defined as the number of participants who remain on treatment (MOUD or PrEP).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid', 'medication for opioid use disorder', 'syringe services program', 'telemedicine', 'PrEP', 'HIV prevention', 'retention in care', 'suboxone', 'buprenorphine', 'feasibility', 'acceptability'], 'conditions': ['Opioid Use', 'Opioid-use Disorder', 'Risk Reduction', 'Hiv']}, 'referencesModule': {'references': [{'pmid': '24238956', 'type': 'BACKGROUND', 'citation': 'Mars SG, Bourgois P, Karandinos G, Montero F, Ciccarone D. "Every \'never\' I ever said came true": transitions from opioid pills to heroin injecting. Int J Drug Policy. 2014 Mar;25(2):257-66. doi: 10.1016/j.drugpo.2013.10.004. Epub 2013 Oct 19.'}, {'pmid': '21689917', 'type': 'BACKGROUND', 'citation': 'Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20.'}, {'pmid': '21883604', 'type': 'BACKGROUND', 'citation': 'Young AM, Havens JR. Transition from first illicit drug use to first injection drug use among rural Appalachian drug users: a cross-sectional comparison and retrospective survival analysis. Addiction. 2012 Mar;107(3):587-96. doi: 10.1111/j.1360-0443.2011.03635.x. Epub 2011 Oct 26.'}, {'pmid': '24300900', 'type': 'BACKGROUND', 'citation': 'Al-Tayyib AA, Rice E, Rhoades H, Riggs P. Association between prescription drug misuse and injection among runaway and homeless youth. Drug Alcohol Depend. 2014 Jan 1;134:406-409. doi: 10.1016/j.drugalcdep.2013.10.027. Epub 2013 Nov 7.'}, {'pmid': '18192204', 'type': 'BACKGROUND', 'citation': 'Valdez A, Neaigus A, Cepeda A. Potential risk factors for injecting among Mexican American non-injecting heroin users. J Ethn Subst Abuse. 2007;6(2):49-73. doi: 10.1300/J233v06n02_05.'}, {'pmid': '23769234', 'type': 'BACKGROUND', 'citation': 'Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.'}, {'pmid': '29559865', 'type': 'BACKGROUND', 'citation': 'Velander JR. Suboxone: Rationale, Science, Misconceptions. Ochsner J. 2018 Spring;18(1):23-29. No abstract available.'}, {'pmid': '17933486', 'type': 'BACKGROUND', 'citation': "Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15."}, {'pmid': '30311777', 'type': 'BACKGROUND', 'citation': 'Bazzi AR, Biancarelli DL, Childs E, Drainoni ML, Edeza A, Salhaney P, Mimiaga MJ, Biello KB. Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. AIDS Patient Care STDS. 2018 Dec;32(12):529-537. doi: 10.1089/apc.2018.0126. Epub 2018 Oct 11.'}, {'pmid': '27896552', 'type': 'BACKGROUND', 'citation': "Edelman EJ, Moore BA, Calabrese SK, Berkenblit G, Cunningham C, Patel V, Phillips K, Tetrault JM, Shah M, Fiellin DA, Blackstock O. Primary Care Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs. AIDS Behav. 2017 Apr;21(4):1025-1033. doi: 10.1007/s10461-016-1612-6."}, {'pmid': '30732542', 'type': 'BACKGROUND', 'citation': 'Molfenter T, Fitzgerald M, Jacobson N, McCarty D, Quanbeck A, Zehner M. Barriers to Buprenorphine Expansion in Ohio: A Time-Elapsed Qualitative Study. J Psychoactive Drugs. 2019 Jul-Aug;51(3):272-279. doi: 10.1080/02791072.2019.1566583. Epub 2019 Feb 7.'}, {'pmid': '31251376', 'type': 'BACKGROUND', 'citation': 'Haffajee RL, Lin LA, Bohnert ASB, Goldstick JE. Characteristics of US Counties With High Opioid Overdose Mortality and Low Capacity to Deliver Medications for Opioid Use Disorder. JAMA Netw Open. 2019 Jun 5;2(6):e196373. doi: 10.1001/jamanetworkopen.2019.6373.'}, {'pmid': '28107210', 'type': 'BACKGROUND', 'citation': 'Zheng W, Nickasch M, Lander L, Wen S, Xiao M, Marshalek P, Dix E, Sullivan C. Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. J Addict Med. 2017 Mar/Apr;11(2):138-144. doi: 10.1097/ADM.0000000000000287.'}, {'pmid': '30265425', 'type': 'BACKGROUND', 'citation': 'Weintraub E, Greenblatt AD, Chang J, Himelhoch S, Welsh C. Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. Am J Addict. 2018 Dec;27(8):612-617. doi: 10.1111/ajad.12805. Epub 2018 Sep 28.'}, {'pmid': '11718472', 'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):1-57; quiz CE1-19a1-CE6-19a1.'}, {'pmid': '38532395', 'type': 'DERIVED', 'citation': 'McKellar MS, Des Marais AC, Chen H, Choi Y, Lilly R, Ayers D, Bennett J, Kestner L, Perry B, Poley S, Corneli A, Meade CS, Sachdeva N. Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study. Harm Reduct J. 2024 Mar 26;21(1):69. doi: 10.1186/s12954-024-00983-2.'}, {'pmid': '36463214', 'type': 'DERIVED', 'citation': 'Corneli A, Perry B, Des Marais A, Choi Y, Chen H, Lilly R, Ayers D, Bennett J, Kestner L, Meade CS, Sachdeva N, McKellar MS. Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation. Harm Reduct J. 2022 Dec 3;19(1):132. doi: 10.1186/s12954-022-00718-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.\n\nThe initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.', 'detailedDescription': "The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.\n\nThe study objectives are the following:\n\n1. To assess uptake and persistence to bup/nx and PrEP as part of a comprehensive harm reduction program among people who inject drugs using SSPs.\n2. To assess feasibility and acceptability of implementing a telemedicine-based MOUD and PrEP program\n\nThe study population is people who inject drugs, specifically opioids, and who access services at SSPs in Charlotte and Wilmington, NC. The study team will enroll 20 PWID accessing the participating SSPs in Charlotte and Wilmington, NC (10 from each site). Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.\n\nData collection\n\nEnrollment visit:\n\nThe study coordinator will administer the SOCRATES 8D and a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.\n\nFollow up visits:\n\nFollow-up visits will be conducted via telemedicine at the SSPs. For the first month (Month 1), telemedicine visits will be weekly with each study participant to ensure that they are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly. Participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation for both bup/nx and PrEP.\n\nBy the end of the study, we hope to determine the following:\n\n* The proportion of persons who demonstrate no or minimal opioid use\n* The proportion of persons who remain HIV negative.\n* Retention or persistence in care\n\nWe will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.\n\nUnder the secondary ID, IRB Pro00104148, we will conduct an ancillary study to contribute to the overall feasibility purpose of the primary study (Pro00104147) by collecting qualitative data from program users. The ancillary study will include conducting in-depth interviews (IDIs) with 10 to 20 participants in the primary study at the end of their month 1 telemedicine visit and at the end of their month 6 telemedicine visit (completion of the primary study). We will use applied thematic analysis to analyze participants' narratives. We chose to position this assessment within an ancillary protocol rather that embed it within the primary study in order to reduce the potential for socially desirable responses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of self-report injection opioid use in the past 6 months\n* Participate in SSPs,\n* HIV negative\n* Willing to take bup/nx and PrEP for 6 months\n* No medical contraindications for these medications\n* Not pregnant\n* 18 years or older\n* Not currently taking PrEP\n* Not currently taking any form of MOUD\n* History of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV (such as engaging in sex work or men who have sex with men) in the past 6 months\n\nExclusion Criteria:\n\n* Positive pregnancy test including during the course of the study\n* Positive HIV test at enrollment\n* Altered mental status in which participant cannot sign a consent form\n* Renal insufficiency/failure\n* Hepatitis B surface antigen positive\n* Becoming incarcerated during the study'}, 'identificationModule': {'nctId': 'NCT04521920', 'briefTitle': 'Providing Suboxone and PrEP Using Telemedicine', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study', 'orgStudyIdInfo': {'id': 'Pro00104147'}, 'secondaryIdInfos': [{'id': 'Pro00104148', 'type': 'OTHER', 'domain': 'Duke University Health System'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication and telemedicine follow up', 'description': 'All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine', 'interventionNames': ['Drug: Suboxone', 'Drug: PrEP']}], 'interventions': [{'name': 'Suboxone', 'type': 'DRUG', 'description': 'Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.', 'armGroupLabels': ['Medication and telemedicine follow up']}, {'name': 'PrEP', 'type': 'DRUG', 'otherNames': ['Pre-Exposure Prophylaxis (PrEP)'], 'description': 'Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.', 'armGroupLabels': ['Medication and telemedicine follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28215', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Queen City Needle Exchnge', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Department of Population Health Sciences', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28403', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Harm Reduction Coalition', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'Mehri McKellar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not share IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}