Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:47 AM
Study NCT ID:
NCT07409350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 398}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with PrEP Uptake', 'timeFrame': 'Month 6', 'description': 'Measured via filled PrEP prescription.'}, {'measure': 'Percentage of Participants with PrEP Uptake', 'timeFrame': 'Month 12', 'description': 'Measured via filled PrEP prescription.'}, {'measure': 'Percentage of Participants with MOUD Uptake', 'timeFrame': 'Month 6', 'description': 'Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.'}, {'measure': 'Percentage of Participants with MOUD Uptake', 'timeFrame': 'Month 12', 'description': 'Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.'}, {'measure': 'Percentage of Participants with PrEP Adherence', 'timeFrame': 'Month 6', 'description': 'Measured via urine immunoassays to test for oral PrEP.'}, {'measure': 'Percentage of Participants with PrEP Adherence', 'timeFrame': 'Month 12', 'description': 'Measured via urine immunoassays to test for oral PrEP.'}, {'measure': 'Percentage of Participants with MOUD Adherence', 'timeFrame': 'Month 6', 'description': 'Measured via urinalysis to test for metabolites for MOUD.'}, {'measure': 'Percentage of Participants with MOUD Adherence', 'timeFrame': 'Month 12', 'description': 'Measured via urinalysis to test for metabolites for MOUD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use', 'HIV Prevention']}, 'descriptionModule': {'briefSummary': 'This study includes finalization of the LINKED social network intervention to improve PrEP and MOUD uptake among people who inject drugs (PWID) in collaboration with an Expert Advisory Board and staff (N=16) at The Sidewalk Project (TSP), followed by a Hybrid Type II cluster randomized trial of the LINKED intervention (versus an equal-attention control) among N=372 people who inject drugs, with 6- and 12-month follow-up assessment of PrEP and MOUD uptake. The investigators will also evaluate implementation outcomes to inform future sustainable implementation of LINKED in harm reduction organizations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAim 1 - Virtual Focus Group\n\n* Is 18 years or older\n* Is a current TSP staff\n* Is capable and willing to provide consent\n\nAim 2 - Intervention\n\n* 18 years or older\n* Spend majority of their time in the Los Angeles, CA area where recruited\n* Able to complete surveys and group sessions in English\n* Self-report to have injected drugs in the past 3 months\n* Self-reported HIV negative serostatus\n* Not currently on PrEP or MOUD\n* Not pregnant\n* If a network recruit: presents a valid recruitment coupon\n* Is capable and willing to provide consent\n\nAim 3 - Virtual Focus Group/Surveys\n\n* Is 18 years or older\n* Is a current TSP staff\n* Is capable and willing to provide consent\n\nExclusion Criteria:\n\nAims 1 and 3:\n\n• Individuals who are not current TSP staff members will be excluded from participation.\n\nAim 2:\n\n* Under age 18;\n* Does not spend majority of time in the Los Angeles, CA area where recruited;\n* Unable to complete surveys and groups sessions in English;\n* Does not self-report injecting drugs in past 3 months;\n* Self-reported HIV positive serostatus\n* Currently on PrEP or MOUD\n* Currently pregnant\n* If a network recruit: does not present a valid recruitment coupon'}, 'identificationModule': {'nctId': 'NCT07409350', 'briefTitle': 'A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs', 'orgStudyIdInfo': {'id': '25-01629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LINKED Intervention', 'description': 'Participants randomized to the LINKED arm will receive a peer change agent intervention consisting of a 3-hour workshop divided into four learning and practice modules.', 'interventionNames': ['Behavioral: LINKED']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Equal-Attention Control', 'description': 'Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff.', 'interventionNames': ['Behavioral: Group Intervention']}], 'interventions': [{'name': 'LINKED', 'type': 'BEHAVIORAL', 'description': 'LINKED is a theory-driven social network intervention (SNI) that leverages peer influence within the social networks of people who inject drugs (PWID) to disseminate information, encourage communication, and increase pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD) uptake and persistence in harm reduction organization (HRO) settings.', 'armGroupLabels': ['LINKED Intervention']}, {'name': 'Group Intervention', 'type': 'BEHAVIORAL', 'description': 'Group intervention facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose.', 'armGroupLabels': ['Equal-Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Ricky Bluthenthal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Alida Bouris, PhD, MSW', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Suzan Walters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Suzan Walters, PhD', 'role': 'CONTACT', 'email': 'Suzan.Walters@nyulangone.org', 'phone': '951-443-6351'}], 'overallOfficials': [{'name': 'Suzan Walters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': "The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Suzan.Walters@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.", 'accessCriteria': "The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Suzan.Walters@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}