Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 5:11 AM
Study NCT ID:
NCT01892358
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Bacterial and Viral Infections Among Injection Drug Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacterial infections', 'timeFrame': 'one year'}, {'measure': 'high-risk behavior', 'timeFrame': 'one year'}, {'measure': 'health service use', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['injection drug use'], 'conditions': ['Bacterial Infection', 'HIV']}, 'referencesModule': {'references': [{'pmid': '33813580', 'type': 'DERIVED', 'citation': 'Freibott CE, Phillips KT, Anderson BJ, Stewart C, Liebschutz JM, Stein MD. Under the Skin: The Relationship Between Subcutaneous Injection and Skin Infections Among People Who Inject Drugs. J Addict Med. 2022 Mar-Apr 01;16(2):164-168. doi: 10.1097/ADM.0000000000000844.'}, {'pmid': '32830383', 'type': 'DERIVED', 'citation': 'Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission\n* have injected heroin, cocaine, or meth for at least three months\n* positive urine screen for heroin, cocaine, or meth\n\nExclusion Criteria:\n\n* currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal\n* cannot provide informed consent\n* not able to complete interviews in English (expected to exclude \\<5% of IDUs)\n* in police custody, expecting incarceration\n* unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes\n* plan to move out of the Boston area in the next 12 months.'}, 'identificationModule': {'nctId': 'NCT01892358', 'briefTitle': 'Preventing Bacterial and Viral Infections Among Injection Drug Users', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Preventing Bacterial and Viral Infections Among Injection Drug Users', 'orgStudyIdInfo': {'id': 'DA034957'}, 'secondaryIdInfos': [{'id': '1210-003', 'type': 'OTHER', 'domain': 'Butler Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SKIN Intervention', 'description': 'Participants will receive the SKIN intervention at Baseline and 1-mo interviews.', 'interventionNames': ['Behavioral: SKIN Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Assessment-Only', 'description': 'Participants in this arm will receive treatment-as-usual', 'interventionNames': ['Other: Treatment as Usual']}], 'interventions': [{'name': 'SKIN Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['SKIN Intervention']}, {'name': 'Treatment as Usual', 'type': 'OTHER', 'armGroupLabels': ['Assessment-Only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Stein, MD', 'investigatorAffiliation': 'Butler Hospital'}}}}