Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-27 @ 10:28 PM
Study NCT ID:
NCT04546061
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-03', 'size': 199182, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-28T08:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in substance use from baseline to 6-month follow-up', 'timeFrame': 'Baseline and 6-months', 'description': 'Addiction Severity Index collected via a computer assisted self-interviewing survey'}, {'measure': 'Change in mental health status from baseline to 6-month follow-up', 'timeFrame': 'Baseline and 6-months', 'description': 'Brief Symptom Inventory collected via a computer assisted self-interviewing survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual and Gender Minorities', 'Substance Use and Mental Health Treatment', 'Mental Health', 'Substance Use', 'Minority Stress', 'Young Adults', 'Intensive Case Management', 'Peer Support'], 'conditions': ['Substance Use', 'Mental Health']}, 'descriptionModule': {'briefSummary': 'This study provides substance use and mental health treatment for young sexual and gender minority adults in Durham and Charlotte, NC and seeks to provide intensive wraparound services that address factors that influence substance use and mental health among this population such as minority stressors and lack of social support, housing instability, lack of access to affirmative health care, and limited job opportunities.', 'detailedDescription': 'Project Uplift provides evidenced-based substance use and mental health treatment, intensive case management, and peer support services for sexual and gender minorities, ages 18-35. The program is based in two metropolitan areas in North Carolina, Durham and Charlotte, and will offer services for approximately 80 sexual and gender minority young adults. Survey data collected from participants at baseline and at the end of the 6-month program will be used to evaluate the effectiveness the comprehensive care program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 1) age 18-35; 2) substance use in the last 90 days; 3) self-identify as a sexual and/or gender minority; 4) reside in the Durham or Charlotte geographic areas including neighboring counties\n\nExclusion Criteria: 1) inability to speak and read English'}, 'identificationModule': {'nctId': 'NCT04546061', 'briefTitle': 'Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities', 'orgStudyIdInfo': {'id': 'Pro00103883'}, 'secondaryIdInfos': [{'id': '1H79TI081999', 'type': 'OTHER_GRANT', 'domain': 'SAMHSA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project Uplift Intervention', 'description': 'A 6-month long intervention for young adult sexual and gender minorities, ages 18-35.', 'interventionNames': ['Behavioral: Project Uplift']}], 'interventions': [{'name': 'Project Uplift', 'type': 'BEHAVIORAL', 'description': 'Substance use and mental health treatment for young sexual and gender minorities in Durham and Charlotte, NC in conjunction with intensive wraparound services that address factors that influence substance use and mental health among this population.', 'armGroupLabels': ['Project Uplift Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mecklenburg County Community Support Services', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sara H LeGrand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Susan Reif, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}