Creating Access to Resources and Economic Support (CARES)

March 24, 2026 updated by: Duke University

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?

Researchers will compare mental health outcomes among three groups of participants:

A. 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.

C. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University (online recruitment)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • inability to provide informed consent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Monthly financial education videos and one-time microgrant
Behavioral: Financial education videos
Brief videos providing structured information on managing one's money
Other: Microgrant
$150 stipend
Active Comparator: Monthly microgrants
Monthly financial education videos and monthly microgrants
Behavioral: Financial education videos
Brief videos providing structured information on managing one's money
Other: Microgrant
$150 stipend
Active Comparator: Monthly microgrants plus peer mentoring
Monthly financial education videos, monthly microgrants, and peer mentoring support
Behavioral: Financial education videos
Brief videos providing structured information on managing one's money
Other: Microgrant
$150 stipend
Behavioral: Peer mentoring
One-on-one structured mentoring sessions with a trained peer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in psychological distress, as measured by Kessler 6
Time Frame: Baseline, 6 months, 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)
Time Frame: Baseline, 6 months, 12 months
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
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Tonia C. Poteat, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Actual)

March 21, 2026

Study Completion (Actual)

March 21, 2026

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00113319
  • R01MD016755 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

Data will become available 12 months after publication of primary study findings.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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