Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01970293
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2013-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AA Linkage for Alcohol Abusing Women Leaving Jail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of alcohol use days from baseline to 6 months', 'timeFrame': 'Baseline, 1, 3, and 6 months', 'description': 'Timeline Followback (TLFB) participant recall of alcohol use days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alcohol use', 'STI', 'Incarcerated women', 'AA'], 'conditions': ['Alcohol Use', 'AA Attendance', 'Sexual Risk Behavior']}, 'referencesModule': {'references': [{'pmid': '32876998', 'type': 'DERIVED', 'citation': 'Timko C, Chatav Schonbrun Y, Anderson B, Johnson JE, Stein M. Perceived Substance Use Norms Among Jailed Women with Alcohol Use Disorders. Alcohol Clin Exp Res. 2020 Sep;44(9):1834-1841. doi: 10.1111/acer.14403. Epub 2020 Sep 2.'}, {'pmid': '30311822', 'type': 'DERIVED', 'citation': 'Schonbrun YC, Kurth M, Johnson J, Timko C, Stein M. Participant Evaluation of Twelve-Step Group Linkage for Jailed Women With Alcohol Use Disorder. Int J Offender Ther Comp Criminol. 2019 Mar;63(4):610-623. doi: 10.1177/0306624X18805598. Epub 2018 Oct 12.'}, {'pmid': '30238292', 'type': 'DERIVED', 'citation': 'Timko C, Johnson JE, Kurth M, Schonbrun YC, Anderson BJ, Stein MD. Health Services Use Among Jailed Women with Alcohol Use Disorders. J Behav Health Serv Res. 2019 Jan;46(1):116-128. doi: 10.1007/s11414-018-9634-7.'}, {'pmid': '29996829', 'type': 'DERIVED', 'citation': 'Hailemariam M, Stein M, Anderson B, Schonbrun YC, Moore K, Kurth M, Richie F, Johnson JE. Correlates of alcoholics anonymous affiliation among justice-involved women. BMC Womens Health. 2018 Jul 11;18(1):125. doi: 10.1186/s12905-018-0614-0.'}]}, 'descriptionModule': {'briefSummary': 'The primary aims of this study are to test the hypotheses that among alcohol abusing and dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA) linkage intervention will result in less alcohol use at follow-up, increased AA attendance once released, and decreased HIV/STI sexual risk behavior. Additionally, this study seeks to test the hypotheses that increased AA attendance will mediate the effect of the AA linkage intervention on alcohol use and that percent days abstinent will mediate the effect of the intervention on HIV/STI sexual risk-taking outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible for the study participants must:\n\n1. Be 18 years or older\n2. Live in RI or MA within 20 miles of Providence and plan to remain in the area for the next 6 months\n3. Meet DSM-IV criteria for alcohol abuse or dependence in the last six months\n4. Do not expect to attend residential alcohol or drug treatment upon release\n5. Report STI/HIV sexual risk defined as unprotected heterosexual sex at least three times in the three months prior to incarceration\n6. Speak English.\n7. Be currently held at the Rhode Island Adult Correctional Institutions Jail facility\n\nWomen will be excluded from participation if they:\n\n1\\. Cannot provide the name of at least two locator persons who will know where they can be found.'}, 'identificationModule': {'nctId': 'NCT01970293', 'briefTitle': 'AA Linkage for Alcohol Abusing Women Leaving Jail', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'AA Linkage for Alcohol Abusing Women Leaving Jail', 'orgStudyIdInfo': {'id': '1R01AA021732-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA021732-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Introduction to AA volunteer', 'interventionNames': ['Other: Introduction to AA volunteer']}, {'type': 'NO_INTERVENTION', 'label': 'AA materials offered'}], 'interventions': [{'name': 'Introduction to AA volunteer', 'type': 'OTHER', 'description': 'In-person, in jail introduction to an AA volunteer, who will offer assistance in attending 2 AA meetings.', 'armGroupLabels': ['Introduction to AA volunteer']}]}, 'contactsLocationsModule': {'locations': [{'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': 'SPONSOR'}}}}