Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-05 @ 6:40 PM
Study NCT ID:
NCT02234167
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Swedish Prison Program is an Intervention Prevention Program Targeting Injecting Drug Users Risk Behaviours and Infectious Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with injection risk behaviour', 'timeFrame': '2002-2012', 'description': 'Have you received already used injection equipment from someone last 12 months Have you lent (away) already used injection equipment to someone last 12 months Have you shared solution and/or filter with someone last 12 months Number of people shared needles with last month Number of injections last month Number of Hepatitis C positive Number of HIV positive Number of Hepatitis B positive Number of respondenst positive for sexually transmitted infections'}], 'secondaryOutcomes': [{'measure': 'Number of participants with infectious diseases', 'timeFrame': '2002-2012', 'description': 'HIV, HCV, HBV and STI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Having Ever Injected Drugs']}, 'referencesModule': {'references': [{'pmid': '28814336', 'type': 'DERIVED', 'citation': 'Karlsson N, Santacatterina M, Kall K, Hagerstrand M, Wallin S, Berglund T, Ekstrom AM. Risk behaviour determinants among people who inject drugs in Stockholm, Sweden over a 10-year period, from 2002 to 2012. Harm Reduct J. 2017 Aug 16;14(1):57. doi: 10.1186/s12954-017-0184-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU) with primary and secondary health interventions with regards to injecting and sexual risk behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted infections (STI).\n\nThe overall aim is to assess the effect of different prevention efforts on HIV/HCV risk behaviour and disease outcome among IDUs over time.', 'detailedDescription': 'Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Defined as an injecting drug user, in the prison and probation service and agree to anonymously participate\n\nExclusion Criteria:\n\n* Being defined as a non-drug user, non-injecting drug user'}, 'identificationModule': {'nctId': 'NCT02234167', 'acronym': 'SHP', 'briefTitle': 'The Swedish Prison Program is an Intervention Prevention Program Targeting Injecting Drug Users Risk Behaviours and Infectious Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Svenska Häktesprogrammet, Prevention, Risk Behaviour and Infectious Diseases Among IDU.', 'orgStudyIdInfo': {'id': 'Swedish Prison Program'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Risk behaviour and infectious diseases', 'description': '.(among IDU)', 'interventionNames': ['Behavioral: Risk behaviour and infectious diseases']}], 'interventions': [{'name': 'Risk behaviour and infectious diseases', 'type': 'BEHAVIORAL', 'otherNames': ['biological and behavioural'], 'description': 'through counselling, testing vaccination', 'armGroupLabels': ['Risk behaviour and infectious diseases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'SHP', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Agency of Sweden', 'class': 'OTHER_GOV'}, {'name': 'Swedish Prison and Probation Service', 'class': 'UNKNOWN'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Niklas Karlsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}