Creating Access to Resources and Economic Support
CARES
2 other identifiers
interventional
360
1 country
1
Brief Summary
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:
- 1.Do microgrants with or without peer mentoring improve mental health?
- 2.Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedStudy Start
First participant enrolled
December 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2026
CompletedMarch 27, 2026
March 1, 2026
2.3 years
July 24, 2023
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in psychological distress, as measured by Kessler 6
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.
Baseline, 6 months, 12 months
Secondary Outcomes (1)
Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)
Baseline, 6 months, 12 months
Study Arms (3)
Usual Care
ACTIVE COMPARATORMonthly financial education videos and one-time microgrant
Monthly microgrants
ACTIVE COMPARATORMonthly financial education videos and monthly microgrants
Monthly microgrants plus peer mentoring
ACTIVE COMPARATORMonthly financial education videos, monthly microgrants, and peer mentoring support
Interventions
One-on-one structured mentoring sessions with a trained peer
Brief videos providing structured information on managing one's money
Eligibility Criteria
You may qualify if:
- age 18 years or older
- gender identity different from sex assigned on original birth certificate
- access to a mobile phone or email
- score \> 0 on the material hardship index
You may not qualify if:
- inability to provide informed consent in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University (online recruitment)
Durham, North Carolina, 27710, United States
Related Publications (1)
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.
PMID: 39186770DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Tonia C. Poteat, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 2, 2023
Study Start
December 12, 2023
Primary Completion
March 21, 2026
Study Completion
March 21, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will become available 12 months after publication of primary study findings.
- Access Criteria
- 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.
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.