Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT01362634
Status:
COMPLETED
Last Update Posted:
2017-12-07
First Post:
2011-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2011-05-26', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'unprotected sexual intercourse events outside of primary relationships', 'timeFrame': '3 months'}, {'measure': 'unprotected sexual intercourse events outside of primary relationship', 'timeFrame': '6 months'}, {'measure': 'unprotected sexual intercourse events outside of primary relationship', 'timeFrame': '12 months'}, {'measure': 'Days drug use in the past 90 days', 'timeFrame': '3 months'}, {'measure': 'Days drug use in the past 90 days', 'timeFrame': '6 months'}, {'measure': 'Days drug use in the past 90 days', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'substance use', 'club drugs', 'sexual risk'], 'conditions': ['HIV Infection', 'Substance Abuse']}, 'descriptionModule': {'briefSummary': 'The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.', 'detailedDescription': "The specific aims of the 5-year study are to:\n\n1. identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.\n2. evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:\n\n * Arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (CAPI Intervention) similar to the baseline instrument used in the parent grant;\n * Arm 2, an identical self-administered comprehensive assessment intervention (ACASI Intervention); and\n * Arm 3, a waitlist control condition (Control). Outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups.\n3. conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heterosexually active\n* ongoing club and prescription drug use\n* between 18-39 years of age\n* must go to local clubs at least two times per month\n\nExclusion Criteria:\n\n* no current working phone number or e-mail address\n* no intention to remain in South Florida for the next 12 months\n* new HIV diagnosis in the past 90 days\n* currently participating in a drug treatment program (excluding 12-step programs such as Alcoholics Anonymous)'}, 'identificationModule': {'nctId': 'NCT01362634', 'briefTitle': 'A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV', 'orgStudyIdInfo': {'id': '7R01DA019048', 'link': 'https://reporter.nih.gov/quickSearch/7R01DA019048', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAPI Intervention', 'description': 'an interviewer-administered comprehensive health and social risk assessment intervention', 'interventionNames': ['Behavioral: Trans-theoretical Process of Change Model - interviewer']}, {'type': 'EXPERIMENTAL', 'label': 'ACASI Intervention', 'description': 'self-administered comprehensive health and social risk assessment intervention', 'interventionNames': ['Behavioral: Trans-theoretical Process of Change Model-self']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'waitlist control condition'}], 'interventions': [{'name': 'Trans-theoretical Process of Change Model-self', 'type': 'BEHAVIORAL', 'description': 'self-administered, computer-based intervention', 'armGroupLabels': ['ACASI Intervention']}, {'name': 'Trans-theoretical Process of Change Model - interviewer', 'type': 'BEHAVIORAL', 'description': 'interviewer-administered intervention', 'armGroupLabels': ['CAPI Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'NSU Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven Kurtz, Ph.D.', 'investigatorAffiliation': 'Nova Southeastern University'}}}}