Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-20 @ 12:30 PM
Study NCT ID:
NCT05320835
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Setting Focus Overdose Prevention Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'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'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069078', 'term': 'Seroconversion'}], 'ancestors': [{'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Equal attention'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial (RCT)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 285}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overdose prevention', 'timeFrame': '6 months', 'description': 'Frequency of carrying naloxone'}, {'measure': 'HIV/HCV prevention', 'timeFrame': '6 months', 'description': 'Frequency of using used cookers'}], 'secondaryOutcomes': [{'measure': 'Overdose behaviors', 'timeFrame': '6 months', 'description': 'Frequency of testing drugs before using'}, {'measure': 'Overdose behaviors 2', 'timeFrame': '6 months', 'description': 'Frequency of talking about overdose prevention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'HCV', 'Drug Overdose']}, 'descriptionModule': {'briefSummary': 'A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).', 'detailedDescription': 'This is a pilot of an injection setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors. Participants will be randomized to conditions: 1) Peer education and stocking of semi-public injection settings (SPIS) with risk reduction materials, and the standard of care. Based on their SPIS use, 120 index PWID participants will be selected.\n\nA conceptual model for the intervention: The conceptual model is based on social influence, social network, and social cognitive theory. The prior work delineated social influence mechanisms. It is expected that training and modeling of effective communication skills will increase the occurrence of conversations on HIV/HCV and overdose prevention. These conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. The prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. It has been found that PWID are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. It is hypothesized that peer outreach and supply of materials to SPIS will lead to reduced sharing of injection equipment and increased naloxone availability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current drug user (opioid use in the prior two weeks)\n\nExclusion Criteria:\n\n* Any mental or physical health impairment that impedes ability to participate'}, 'identificationModule': {'nctId': 'NCT05320835', 'acronym': 'Oasis', 'briefTitle': 'A Setting Focus Overdose Prevention Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland', 'orgStudyIdInfo': {'id': 'R01DA050470', 'link': 'https://reporter.nih.gov/quickSearch/R01DA050470', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'IRB00019139', 'type': 'OTHER', 'domain': 'JHSPH IRB'}, {'id': 'R01DA050470', 'link': 'https://reporter.nih.gov/quickSearch/R01DA050470', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'behavioral training with 6 sessions', 'interventionNames': ['Behavioral: HIV, HCV and overdose prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comparison', 'description': 'Attention control', 'interventionNames': ['Behavioral: HIV, HCV and overdose prevention']}], 'interventions': [{'name': 'HIV, HCV and overdose prevention', 'type': 'BEHAVIORAL', 'description': 'HIV, HCV and overdose prevention', 'armGroupLabels': ['Experimental', 'comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carl Latkin, PhD', 'role': 'CONTACT', 'email': 'carl.latkin@jhu.edu', 'phone': '410-502-5368'}, {'name': 'Melissa Davey-Rothwell, PhD', 'role': 'CONTACT', 'email': 'mdavey1@jhu.edu', 'phone': '410-614-5854'}, {'name': 'Carl Latkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lighthouse Studies at Peer Point', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Carl Latkin, PhD', 'role': 'CONTACT', 'email': 'carl.latkin@jhu.edu', 'phone': '410-955-3972'}, {'name': 'Lauren Dayton, PhD', 'role': 'CONTACT', 'email': 'ldayton2@jhu.edu', 'phone': '4105025368'}], 'overallOfficials': [{'name': 'Carl Latkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}