Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT02318732
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-27
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of California's Armed and Prohibited Persons System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Community level rates of violence', 'timeFrame': 'Up to 3 years', 'description': 'Community-level rates of violent and firearm-related crimes'}, {'measure': 'Cost benefit analysis', 'timeFrame': 'Up to 3 years', 'description': 'Assess benefits of APPS relative to costs.'}], 'primaryOutcomes': [{'measure': 'Incidence of arrest for violent and firearm-related crimes', 'timeFrame': 'Up to 3 years', 'description': 'Arrests for violent and firearm-related crimes among persons eligible for the APPS intervention'}], 'secondaryOutcomes': [{'measure': 'Incidence of arrest for non-violent, non firearms-related crimes', 'timeFrame': 'Up to 3 years', 'description': 'Arrests for crimes not involving violence or firearms among persons eligible for the APPS intervention'}, {'measure': 'Incidence of emergency mental health hospitalizations', 'timeFrame': 'Up to 3 years', 'description': 'Emergency mental health hospitalizations following a determination of dangerousness to self or others or grave disability among persons eligible for the APPS intervention'}, {'measure': 'Incidence of domestic violence restraining orders', 'timeFrame': 'Up to 3 years', 'description': 'Domestic violence restraining orders among persons eligible for the APPS intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['violence'], 'conditions': ['Violence']}, 'referencesModule': {'references': [{'pmid': '27729440', 'type': 'BACKGROUND', 'citation': "Wintemute GJ, Beckett L, Kass PH, Tancredi D, Studdert D, Pierce G, Braga AA, Wright MA, Cerda M. Evaluation of California's Armed and Prohibited Persons System: study protocol for a cluster-randomised trial. Inj Prev. 2017 Oct;23(5):358. doi: 10.1136/injuryprev-2016-042194. Epub 2016 Oct 11."}, {'pmid': '39358039', 'type': 'DERIVED', 'citation': 'Wintemute GJ, Tancredi D, Pear VA, Li Y, McCort CD, Pierce G, Braga AA, Wright MA, Laqueur H, Kravitz-Wirtz N, Studdert D, Beckett L. Population-level effects on crime of recovering firearms from armed prohibited persons: intention-to-treat analysis of a pragmatic cluster-randomised trial in California cities. Inj Prev. 2024 Oct 2:ip-2024-045234. doi: 10.1136/ip-2024-045234. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "This study evaluates exposure to California's Armed and Prohibited Persons System (APPS) and risk of future violence and other important outcome events among individuals who legally purchased firearms in the past but have since become prohibited from owning them. The main hypothesis is that APPS will be associated with a significant reduction in risk for future violence among individuals who are directly affected.", 'detailedDescription': 'Violence remains an important public safety and public health problem. Prior research has shown that denying firearm purchases by individuals who are at high risk for committing violent crimes, thereby restricting their access to firearms, is an effective violence prevention strategy. The Armed and Prohibited Persons System (APPS) is a new violence prevention initiative undertaken by the California Department of Justice (CalDOJ). APPS is used by law enforcement to systematically identify persons who, having legally purchased firearms in the past, have become prohibited persons in the present-usually as the result of a criminal conviction. Such individuals are at increased risk for future violence.\n\nAPPS uses existing data to identify firearm owners among persons who have become prohibited from owning or possessing firearms under California or federal law. CalDOJ then uses this information to contact and attempt recovery of firearms in the possession of prohibited individuals.\n\nThis controlled prospective longitudinal evaluation of APPS relies principally on data collected by CalDOJ in the course of APPS operations or on data in the public domain, such as community characteristics published by the U.S. Census Bureau.\n\nTo maximize fairness during the implementation of APPS, approximately 1,000 California communities will be stratified by region, population, and violent crime rate and randomized into two groups that will be exposed to APPS at different times during the study period. Hierarchical analysis will examine outcomes for individuals clustered at the community level. The principal analysis will be on an intent to treat basis. A secondary per protocol analysis will also be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with records of firearms ownership who have experienced a prohibiting event. Prohibiting events are based in Federal and California state law. Among others, they include criminal convictions for felonies and selected violent misdemeanors; emergency hospitalization for dangerousness associated with severe mental illness, as specified in statute; and status as respondent to a domestic violence restraining order.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT02318732', 'acronym': 'APPS', 'briefTitle': "Evaluation of California's Armed and Prohibited Persons System", 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': "Prospective Evaluation of California's Armed and Prohibited Persons System", 'orgStudyIdInfo': {'id': '553213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'APPS intervention will be implemented in Group 1 communities prior to implementation in Group 2 communities.', 'interventionNames': ['Behavioral: APPS intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'APPS intervention will be implemented in Group 2 communities following implementation in Group 1 communities.', 'interventionNames': ['Behavioral: APPS intervention']}], 'interventions': [{'name': 'APPS intervention', 'type': 'BEHAVIORAL', 'description': 'Contact with and recovery of firearms from individuals who are prohibited from possessing them', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95618', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Garen J Wintemute, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rutgers University', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Northeastern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}