Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 10:02 AM
Study NCT ID:
NCT05108935
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2021-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}, {'id': 'D006526', 'term': 'Hepatitis C'}], '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'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D065129', 'term': 'Pre-Exposure Prophylaxis'}, {'id': 'C000654128', 'term': 'glecaprevir and pibrentasvir'}], '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': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'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': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-23', 'size': 630504, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-09T09:39', 'hasProtocol': False}]}}, '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': '2022-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion who demonstrate no or minimal opioid use.', 'timeFrame': '3 months', 'description': 'Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.'}, {'measure': 'Proportion who demonstrate no or minimal opioid use.', 'timeFrame': '6 months', 'description': 'Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.'}, {'measure': 'Proportion who remain HIV negative.', 'timeFrame': '3 months', 'description': 'Measured via negative HIV test.'}, {'measure': 'Proportion who remain HIV negative.', 'timeFrame': '6 months', 'description': 'Measured via negative HIV test.'}, {'measure': 'Among participants who undergo hepatitis C treatment, the hepatitis C cure rate', 'timeFrame': '6 months', 'description': 'Measured via negative hepatitis C test.'}, {'measure': 'Persistence in care', 'timeFrame': '3 months', 'description': 'Defined as the proportion who remain on treatment.'}, {'measure': 'Persistence in care', 'timeFrame': '6 months', 'description': 'Defined as the proportion who remain on treatment.'}, {'measure': 'Ease/difficulty of visiting a SSP to meet with a provider via telemedicine', 'timeFrame': 'month 1', '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': 'month 6', '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': 'month 1', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)'}, {'measure': 'Acceptability of medical care 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': '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': 'Participant satisfaction with the program', 'timeFrame': 'month 6', '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': 'month 1', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)'}, {'measure': 'Participant perceived usefulness of the program', 'timeFrame': 'month 6', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)'}, {'measure': 'Motivators and barriers affecting program persistence', 'timeFrame': 'month 6', '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 medication adherence and persistence', 'timeFrame': '6 months', 'description': 'Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid', 'medication for opioid use disorder', 'Drug user health hub', 'syringe services program', 'syringe exchange', 'PrEP', 'HIV prevention', 'retention in care', 'Suboxone', 'Hepatitis C treatment', 'hepatitis C', 'Opioid use disorder', 'feasibility', 'acceptability'], 'conditions': ['Opioid Use', 'Opioid Use Disorder', 'Risk Reduction', 'Hiv', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment 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 site in Greensboro, 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, pre-exposure prophylaxis (PrEP) for HIV prevention and/or hepatitis C treatment 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\nTo assess uptake and persistence to bup/nx, PrEP, and hepatitis C treatment as part of a comprehensive telemedicine-based harm reduction program among people who inject drugs using SSPs.\n\nTo assess feasibility and acceptability of implementing a telemedicine-based care harm reduction program among program implementers To assess feasibility and acceptability of participating in a telemedicine-based harm reduction program among users\n\nThe study population is people who inject drugs, specifically opioids, and who access services at an SSP in Greensboro, NC. The study team will enroll 30 people who inject drugs accessing the participating SSP. 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 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 SSP.\n\nParticipants on any combination of treatment including MOUD:\n\nFor the first month (Month 1), telemedicine visits will be weekly with each to ensure that participants are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly.\n\nFor participants on any combination of treatment NOT including MOUD:\n\nParticipants will attend telemedicine follow up visits at month 3 and month 6 to check in and provide labs.\n\nAll 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. All participants will also be asked to participate in qualitative interviews on their experiences with the program at month 1 and month 6.\n\nBy the end of the study, we hope to determine the following:\n\n1. The proportion of persons who demonstrate no or minimal opioid use 1a. Defined as completing Month 3 and Month 6 visits with self-reported opioid use on ≤4 days in the past month and/or 2\n2. The proportion of persons who remain HIV negative. 2a.Measured via negative HIV test at Month 3 and Month 6\n3. Among participants who undergo hepatitis C treatment, the hepatitis C cure rate\n4. Retention or persistence in care 4a. Defined as the proportion who remain on treatment (all or any combination of MOUD, PrEP, and hepatitis C treatment) at Month 3 and Month 6 4b. We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.\n5. Organizational facilitators and barriers to establishing a telehealth program in an SSP 5a. We will iteratively collect programmatic data and document challenges and problem-solving that occurs throughout the implementation period of providing bup/nx, PrEP, and/or hepatitis C treatment. We will identify and describe organizational factors using the framework of the Implementation Research Logic Model.\n6. Patient perspectives on telehealth delivery of PrEP, MOUD, and/or hepatitis C treatment via SSP 6a. Analysis of interview data at Month 1 and Month 6 to measure attitudes toward PrEP, MOUD, and hepatitis C treatment in general, and on delivery of treatment via telehealth and at the SSP 6b. Analysis of questionnaire data at baseline, Month 3, and Month 6'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Participant in SSP\n* History of self-report injection opioid use in the past 6 months\n* Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months\n* Not currently taking PrEP\n* HIV negative\n* Not pregnant\n* Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV\\* in the past 6 months\n\n \\*Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you?\n* Traded sex for money or drugs\n* Had a sexual partner who is HIV positive\n* Did not consistently use condoms when having sex\n* Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis)\n* No medical contraindications for these medications such as history of renal failure or bone diseases\n\nExclusion Criteria:\n\n* Have altered mental status in which participant cannot sign a consent form\n* Receive a positive pregnancy test (will be checked at screening visit)\n* Receive a positive HIV test at enrollment (will be checked at screening visit)\n* Have evidence of renal failure (will be checked at screening visit)\n* Have a history of hepatitis B (will be checked at screening visit)\n* Becoming incarcerated during the study\n\nAdditional considerations:\n\nThe following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive:\n\n* Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment\n* Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD'}, 'identificationModule': {'nctId': 'NCT05108935', 'acronym': 'PARTNERUP', 'briefTitle': 'Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro', 'orgStudyIdInfo': {'id': 'Pro00104147_1'}, 'secondaryIdInfos': [{'id': '5P30AI064518-17', 'link': 'https://reporter.nih.gov/quickSearch/5P30AI064518-17', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication and telemedicine follow up', 'description': 'Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.', 'interventionNames': ['Drug: Suboxone', 'Drug: Truvada', 'Drug: Mavyret']}], 'interventions': [{'name': 'Suboxone', 'type': 'DRUG', 'otherNames': ['Buprenorphine Naloxone'], 'description': 'Enrolled participants will be prescribed PrEP Mavyret 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': 'Truvada', 'type': 'DRUG', 'otherNames': ['Pre-Exposure Prophylaxis (PrEP)'], 'description': 'Enrolled participants will be prescribed PrEP Mavyret 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': 'Mavyret', 'type': 'DRUG', 'otherNames': ['Hepatitis C treatment'], 'description': 'Enrolled participants will be prescribed PrEP Mavyret 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': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Department of Population Health Sciences', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Survivors Union', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}], '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'}, 'collaborators': [{'name': 'Center for AIDS Research (CFAR)', 'class': 'UNKNOWN'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}