xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05971160</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113319</org_study_id>
      <secondary_id>R01MD016755</secondary_id>
      <nct_id>NCT05971160</nct_id>
    </id_info>
    <brief_title>Creating Access to Resources and Economic Support</brief_title>
    <acronym>CARES</acronym>
    <official_title>Creating Access to Resources and Economic Support</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to test the ability of small grants and/or peer support to improve&#xD;
        mental health among transgender people experiencing material hardship. The main questions the&#xD;
        study will answer are:&#xD;
  &#xD;
          1. Do microgrants with or without peer mentoring improve mental health?&#xD;
  &#xD;
          2. Do microgrants with or without peer mentoring improve mental health by reducing material&#xD;
             hardship and/or increasing a sense of community connection?&#xD;
  &#xD;
        Researchers will compare mental health outcomes among three groups of participants:&#xD;
  &#xD;
        A. Participants who receive one small grant and monthly financial education videos B.&#xD;
        Participants who receive a small grant every month and monthly financial education videos for&#xD;
        a total of 6 months.&#xD;
  &#xD;
        C. Participants who receive a small grant every month, peer mentoring support, and monthly&#xD;
        financial education videos for a total of 6 months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in psychological distress, as measured by Kessler 6</measure>
      <time_frame>Baseline, 6 months, 12 months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)</measure>
      <time_frame>Baseline, 6 months, 12 months</time_frame>
      <description>DAST-10 is a 10-item scale with with one one point for each &quot;yes&quot; response for a total score range from 0-10, with higher scores indicating more problematic substance use</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Psychological Distress</condition>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Monthly financial education videos and one-time microgrant</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Monthly microgrants</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Monthly financial education videos and monthly microgrants</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Monthly microgrants plus peer mentoring</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Monthly financial education videos, monthly microgrants, and peer mentoring support</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Financial education videos</intervention_name>
      <description>Brief videos providing structured information on managing one's money</description>
      <arm_group_label>Monthly microgrants</arm_group_label>
      <arm_group_label>Monthly microgrants plus peer mentoring</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Microgrant</intervention_name>
      <description>$150 stipend</description>
      <arm_group_label>Monthly microgrants</arm_group_label>
      <arm_group_label>Monthly microgrants plus peer mentoring</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer mentoring</intervention_name>
      <description>One-on-one structured mentoring sessions with a trained peer</description>
      <arm_group_label>Monthly microgrants plus peer mentoring</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18 years or older&#xD;
  &#xD;
            -  gender identity different from sex assigned on original birth certificate&#xD;
  &#xD;
            -  access to a mobile phone or email&#xD;
  &#xD;
            -  score &gt; 0 on the material hardship index&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  inability to provide informed consent in English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Gender different from sex assigned at birth</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tonia C. Poteat, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jennifer Williams, PhD</last_name>
      <phone>919-660-1693</phone>
      <email>jennifer.williams@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tonia C Poteat, PhD</last_name>
      <phone>919-684-9303</phone>
      <email>tonia.poteat@duke.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data will become available 12 months after publication of primary study findings.</ipd_time_frame>
      <ipd_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_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05971160
  org study id: Pro00113319
  secondary id: R01MD016755
  nct id: NCT05971160
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Change in psychological distress, as measured by Kessler 6
  time frame: 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.
  measure: Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)
  time frame: 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
  arm group label: Usual Care
  arm group type: Active Comparator
  description: Monthly financial education videos and one-time microgrant
  arm group label: Monthly microgrants
  arm group type: Active Comparator
  description: Monthly financial education videos and monthly microgrants
  arm group label: Monthly microgrants plus peer mentoring
  arm group type: Active Comparator
  description: Monthly financial education videos, monthly microgrants, and peer mentoring support
  intervention type: Behavioral
  intervention name: Financial education videos
  description: Brief videos providing structured information on managing one's money
  arm group label: Monthly microgrants
  arm group label: Monthly microgrants plus peer mentoring
  arm group label: Usual Care
  intervention type: Other
  intervention name: Microgrant
  description: $150 stipend
  arm group label: Monthly microgrants
  arm group label: Monthly microgrants plus peer mentoring
  arm group label: Usual Care
  intervention type: Behavioral
  intervention name: Peer mentoring
  description: One-on-one structured mentoring sessions with a trained peer
  arm group label: Monthly microgrants plus peer mentoring
  criteria: 
  gender: All
  gender based: Yes
  gender description: Gender different from sex assigned at birth
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tonia C. Poteat, PhD
  role: Principal Investigator
  affiliation: Duke University
  last name: Jennifer Williams, PhD
  phone: 919-660-1693
  email: jennifer.williams@duke.edu
  last name: Tonia C Poteat, PhD
  phone: 919-684-9303
  email: tonia.poteat@duke.edu
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data will become available 12 months after publication of primary study findings.
  ipd 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.