Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-12 @ 1:20 PM
Study NCT ID:
NCT03143205
Status:
COMPLETED
Last Update Posted:
2024-10-22
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gene expression', 'timeFrame': 'Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up', 'description': 'Gene expression related to inflammation measured in blood'}], 'secondaryOutcomes': [{'measure': 'Change in Substance Use', 'timeFrame': 'Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up', 'description': 'Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus Infection', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '39992775', 'type': 'DERIVED', 'citation': 'Flentje A, Sunder G, Carrico AW, Asam K, Neilands TB, Lisha NE, Dilley J, Flowers E, Kober K, Aouizerat B. Differential gene expression in response to AWARENESS: A randomized controlled trial of an intersectional minority stress intervention. Health Psychol. 2025 Mar;44(3):291-296. doi: 10.1037/hea0001451.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participant must self-identify as male at the time of screening into the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide evidence or documentation of HIV positive status (e.g. a letter of diagnosis or medication bottles with matched photo ID)\n* Be English speaking\n* Be able to consent\n* Sexual activity with a man in the 3 years prior to initial contact or identification as gay or bisexual\n* Not currently be enrolled in formal substance abuse treatment\n* Report at least one occasion of drinking 5 or more drinks or of using an illicit substance in the previous 3 months, but not meet criteria for a severe substance use disorder.\n\nExclusion Criteria:\n\n* Presence of a severe substance use disorder\n* Presence of current symptoms consistent with schizophrenia or bipolar disorder, which would indicate that an intervention targeting these symptoms would be more appropriate.'}, 'identificationModule': {'nctId': 'NCT03143205', 'briefTitle': 'Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men', 'orgStudyIdInfo': {'id': 'K23DA039800', 'link': 'https://reporter.nih.gov/quickSearch/K23DA039800', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23DA039800', 'link': 'https://reporter.nih.gov/quickSearch/K23DA039800', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AWARENESS for sexual minorities', 'description': 'Group receives new CBT-based intervention', 'interventionNames': ['Behavioral: AWARENESS for Sexual Minorities']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Writing tasks', 'description': 'Group receives writing-based sessions', 'interventionNames': ['Behavioral: Writing tasks']}], 'interventions': [{'name': 'AWARENESS for Sexual Minorities', 'type': 'BEHAVIORAL', 'description': '9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.', 'armGroupLabels': ['AWARENESS for sexual minorities']}, {'name': 'Writing tasks', 'type': 'BEHAVIORAL', 'description': 'Writing sessions to explore daily activities.', 'armGroupLabels': ['Writing tasks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}