Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-29 @ 7:42 AM
Study NCT ID:
NCT01976702
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Level HIV Prevention for Pregnant Drug Abusers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Service utilization, social support, and individual cognitive-behavioral factors', 'timeFrame': '6 months post intervention'}], 'primaryOutcomes': [{'measure': 'Sexual risk behavior', 'timeFrame': '6 months post intervention', 'description': 'Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers'}], 'secondaryOutcomes': [{'measure': 'Drug use risk behavior', 'timeFrame': '6 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV risk behaviors', 'Pregnant drug abusers'], 'conditions': ['Substance Related Disorders']}, 'descriptionModule': {'briefSummary': 'This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen relationship-based social competency skills of the original BST that were crucial in sustaining adherence to protective behavior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* a recent history (within the past year) of using illicit substances\n* 12-32 weeks pregnant and not planning to terminate the pregnancy\n* able to read English Informed Consent form; understand and provided written informed consent\n* have competency in conversational English which is required to complete assessments and to participate in the intervention groups\n* have a stable living arrangement and provide contact information\n* currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention\n* currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality\n* report at least one episode of unprotected vaginal/anal sex since becoming pregnant\n* answer "Yes" to this question: "Do you plan to be in the area for the next 12 months?"\n* agree to a urine test at the time of each interview to detect the presence of drugs\n\nExclusion Criteria:\n\n* under age 18 years'}, 'identificationModule': {'nctId': 'NCT01976702', 'acronym': 'PDA', 'briefTitle': 'Multi-Level HIV Prevention for Pregnant Drug Abusers', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Multi-Level HIV Prevention for Pregnant Drug Abusers', 'orgStudyIdInfo': {'id': 'DESPR DA021521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Behavioral Skills Training', 'description': 'The Enhanced Behavioral Skills Training (E-BST) will include four 90-minute group sessions and two 60-minute individual sessions regarding HIV prevention and diminishing risk behavior, enhancing communication skills, improving the use of support services, and enhancing the use of resources in their community.', 'interventionNames': ['Behavioral: Enhanced Behavioral Skills Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Promotion Comparison', 'description': 'The Health Promotion Comparison (HPC)condition will receive one video-based HIV prevention session, 3 video-based 90-minute group sessions and an additional 2 60-minute sessions with discussions on relevant topics unrelated to HIV.', 'interventionNames': ['Behavioral: Enhanced Behavioral Skills Training']}], 'interventions': [{'name': 'Enhanced Behavioral Skills Training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Enhanced Behavioral Skills Training', 'Health Promotion Comparison']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}