Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT05971160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creating Access to Resources and Economic Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-13', 'size': 270275, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-30T16:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in psychological distress, as measured by Kessler 6', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Kessler 6 is a 6-item scale with each item scored from 0-4 for a total score range from 0-24, with higher scores indicating greater psychological distress.'}], 'secondaryOutcomes': [{'measure': 'Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'DAST-10 is a 10-item scale with with one one point for each "yes" response for a total score range from 0-10, with higher scores indicating more problematic substance use'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Distress']}, 'referencesModule': {'references': [{'pmid': '39186770', 'type': 'DERIVED', 'citation': 'Poteat TC, Reisner SL, Wirtz AL, Mayo-Wilson LJ, Brown C, Kornbluh W, Humphrey A, Perrin N. A Microfinance Intervention With or Without Peer Support to Improve Mental Health Among Transgender and Nonbinary Adults (the Creating Access to Resources and Economic Support Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 26;13:e63656. doi: 10.2196/63656.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are:\n\n1. Do microgrants with or without peer mentoring improve mental health?\n2. Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection?\n\nResearchers will compare mental health outcomes among three groups of participants:\n\nA. Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months.\n\nC. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Gender different from sex assigned at birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* gender identity different from sex assigned on original birth certificate\n* access to a mobile phone or email\n* score \\> 0 on the material hardship index\n\nExclusion Criteria:\n\n* inability to provide informed consent in English'}, 'identificationModule': {'nctId': 'NCT05971160', 'acronym': 'CARES', 'briefTitle': 'Creating Access to Resources and Economic Support', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Creating Access to Resources and Economic Support', 'orgStudyIdInfo': {'id': 'Pro00113319'}, 'secondaryIdInfos': [{'id': 'R01MD016755', 'link': 'https://reporter.nih.gov/quickSearch/R01MD016755', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Monthly financial education videos and one-time microgrant', 'interventionNames': ['Behavioral: Financial education videos', 'Other: Microgrant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monthly microgrants', 'description': 'Monthly financial education videos and monthly microgrants', 'interventionNames': ['Behavioral: Financial education videos', 'Other: Microgrant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monthly microgrants plus peer mentoring', 'description': 'Monthly financial education videos, monthly microgrants, and peer mentoring support', 'interventionNames': ['Behavioral: Financial education videos', 'Other: Microgrant', 'Behavioral: Peer mentoring']}], 'interventions': [{'name': 'Financial education videos', 'type': 'BEHAVIORAL', 'description': "Brief videos providing structured information on managing one's money", 'armGroupLabels': ['Monthly microgrants', 'Monthly microgrants plus peer mentoring', 'Usual Care']}, {'name': 'Microgrant', 'type': 'OTHER', 'description': '$150 stipend', 'armGroupLabels': ['Monthly microgrants', 'Monthly microgrants plus peer mentoring', 'Usual Care']}, {'name': 'Peer mentoring', 'type': 'BEHAVIORAL', 'description': 'One-on-one structured mentoring sessions with a trained peer', 'armGroupLabels': ['Monthly microgrants plus peer mentoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University (online recruitment)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Tonia C. Poteat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will become available 12 months after publication of primary study findings.', 'ipdSharing': 'YES', 'description': 'The investigators plan to share data via one of the NIH repositories listed by the Trans-NIH BioMedical Informatics Coordinating Committee (BMIC). The final available dataset from this proposed research will include self-reported demographic, psychosocial, and behavioral data from quantitative surveys. No personal identifiers will be included with the final available dataset.', 'accessCriteria': 'In accordance with the NIH Data Sharing Policy and Implementation Guidance, the investigators will make the data and supporting information available to users under a data-sharing agreement that provides for: (1) complete protection of human subjects training and a commitment to research ethics; (2) a commitment to using the data only for research purposes and not to identify an individual participant; (3) a commitment to securing the data using appropriate technology, and (4) a commitment to destroying or returning the data after analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}