<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/NCT02223130</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00002878</org_study_id>
    <secondary_id>R34MH096544-03</secondary_id>
    <nct_id>NCT02223130</nct_id>
  </id_info>
  <brief_title>Addressing Discrimination and Mistrust Among Black Men: Phase III</brief_title>
  <official_title>Addressing Discrimination and Mistrust Among Black Men: Phase III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fenway Community Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to test a group program aimed at improving the quality&#xD;
      of life of HIV+ Black men who have sex with men. The group will address ways to cope with&#xD;
      discrimination and will help men examine mistrust that they may have about healthcare,&#xD;
      including doctors and other healthcare providers and HIV medications. The aim is to provide a&#xD;
      supportive community for HIV+ Black men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to examine whether the pilot intervention can reduce mistrust and&#xD;
      improve coping responses to discrimination among HIV positive Black men who have sex with men&#xD;
      (MSM). We will conduct a small randomized pilot trial to test the feasibility of evaluation&#xD;
      methods. All participants will attend a baseline, a first follow-up visit, and a final&#xD;
      follow-up visit (each 3 months apart) at which they will take computer assessments.&#xD;
      Participants who are assigned to the intervention will attend 9 weekly intervention sessions&#xD;
      after baseline and before the first follow-up. Using a wait-list control design, control&#xD;
      group participants from the first two cohorts will be offered the intervention after they&#xD;
      complete the final follow-up visit. Control group participants from the third cohort will be&#xD;
      offered the intervention after they complete the first final-up visit and before they&#xD;
      complete their final follow-up due to timing and budgetary restraints. We will hold three&#xD;
      consecutive groups for our small randomized control trial. This means that we will be&#xD;
      recruiting continuously; once we finish recruiting for the first group, we will start&#xD;
      recruiting for the second group, and so on. Each group has about 12 or 13 intervention and&#xD;
      7-11 control participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coping</measure>
    <time_frame>3 months post-baseline</time_frame>
    <description>Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mistrust</measure>
    <time_frame>3 months post-baseline</time_frame>
    <description>Reduced mistrust scores on Medical Mistrust scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will attend the baseline, first follow-up, and final follow-up study visits, at which they take computer surveys. After their baseline interview and before their first follow-up interview, participants attend the Intervention Group, which consist of 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who uses Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions, and behaviors in response to stressful/discrimination experiences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are not given the Intervention Group while they are enrolled in the study. Instead, they only attend the baseline, first follow-up, and final follow-up study visits, at which they take computer surveys.&#xD;
After they have completed the study, participants from the first two cohorts are offered the option of attending an intervention group that is identical in content to the intervention group being studied.The third cohort is offered the intervention group after they have completed the first follow-up but before they complete the final follow-up due to timing and budgetary restraints. No data is collected and no incentives are given during these intervention groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy techniques</intervention_name>
    <description>Participants attend 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who use Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions and behaviors in response to stressful/discrimination experiences.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years-old or older&#xD;
&#xD;
          -  Biologically male at birth&#xD;
&#xD;
          -  Currently self-identifies as male&#xD;
&#xD;
          -  Self-identifies as Black or African American (mixed-race individuals will be eligible&#xD;
             if they primarily identify as Black or African American)&#xD;
&#xD;
          -  HIV-positive&#xD;
&#xD;
          -  Reported having sex with men in lifetime&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet all of the inclusion criteria (e.g., if they are unable to provide proof&#xD;
             of their HIV-positive status)&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Reports or presents evidence of severe mental health problems that require immediate&#xD;
             treatment (e.g., psychotic symptoms, active suicidality at time of enrollment) or&#xD;
             diagnosed mental disorder that would limit the ability to participate (e.g., dementia)&#xD;
&#xD;
          -  Reports or presents evidence of cognitive impairments that limit the ability to&#xD;
             comprehend the informed consent or to fully participate in the various parts of the&#xD;
             study (assessments, intervention, homework).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura M Bogart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fenway Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>January 26, 2016</last_update_submitted>
  <last_update_submitted_qc>January 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Laura Bogart</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Discrimination</keyword>
  <keyword>Coping</keyword>
  <keyword>Medical Mistrust</keyword>
  <keyword>HIV Outcomes</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02223130
org study id: IRB-P00002878
secondary id: R34MH096544-03
nct id: NCT02223130
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research study is to test a group program aimed at improving the quality
      of life of HIV+ Black men who have sex with men. The group will address ways to cope with
      discrimination and will help men examine mistrust that they may have about healthcare,
      including doctors and other healthcare providers and HIV medications. The aim is to provide a
      supportive community for HIV+ Black men.
The aim of the study is to examine whether the pilot intervention can reduce mistrust and
      improve coping responses to discrimination among HIV positive Black men who have sex with men
      (MSM). We will conduct a small randomized pilot trial to test the feasibility of evaluation
      methods. All participants will attend a baseline, a first follow-up visit, and a final
      follow-up visit (each 3 months apart) at which they will take computer assessments.
      Participants who are assigned to the intervention will attend 9 weekly intervention sessions
      after baseline and before the first follow-up. Using a wait-list control design, control
      group participants from the first two cohorts will be offered the intervention after they
      complete the final follow-up visit. Control group participants from the third cohort will be
      offered the intervention after they complete the first final-up visit and before they
      complete their final follow-up due to timing and budgetary restraints. We will hold three
      consecutive groups for our small randomized control trial. This means that we will be
      recruiting continuously; once we finish recruiting for the first group, we will start
      recruiting for the second group, and so on. Each group has about 12 or 13 intervention and
      7-11 control participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Coping
time frame: 3 months post-baseline
description: Improved coping scores on Brief Cope, Emotional and Behavioral Coping, and Africultural Coping scales
measure: Mistrust
time frame: 3 months post-baseline
description: Reduced mistrust scores on Medical Mistrust scale
arm group label: Intervention Group
arm group type: Experimental
description: Participants will attend the baseline, first follow-up, and final follow-up study visits, at which they take computer surveys. After their baseline interview and before their first follow-up interview, participants attend the Intervention Group, which consist of 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who uses Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions, and behaviors in response to stressful/discrimination experiences.
arm group label: Waitlist Control
arm group type: No Intervention
description: Participants are not given the Intervention Group while they are enrolled in the study. Instead, they only attend the baseline, first follow-up, and final follow-up study visits, at which they take computer surveys.
After they have completed the study, participants from the first two cohorts are offered the option of attending an intervention group that is identical in content to the intervention group being studied.The third cohort is offered the intervention group after they have completed the first follow-up but before they complete the final follow-up due to timing and budgetary restraints. No data is collected and no incentives are given during these intervention groups.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy techniques
description: Participants attend 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who use Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions and behaviors in response to stressful/discrimination experiences.
arm group label: Intervention Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laura M Bogart, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Laura Bogart
investigator title: Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital