<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/NCT01722838</url>
  </required_header>
  <id_info>
    <org_study_id>5U01PS001574</org_study_id>
    <secondary_id>PS09-007</secondary_id>
    <nct_id>NCT01722838</nct_id>
  </id_info>
  <brief_title>Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM</brief_title>
  <acronym>B-ME</acronym>
  <official_title>An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loyola University Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      B-ME is a research intervention study designed to address the needs of African American men&#xD;
      who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is&#xD;
      to decrease HIV risk behaviors among African American MSM using an intervention developed by&#xD;
      and for African American MSM.&#xD;
&#xD;
      The hypothesis guiding this study is: that participants who complete B-ME intervention will&#xD;
      report greater reductions in sexual risk behaviors than the standard of care comparison&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Specific Aims of this study are 1) to further explicate and develop the intervention, 2)&#xD;
      to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of&#xD;
      research on HIV prevention/risk reduction practices for African American men who have sex&#xD;
      with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving&#xD;
      B-ME intervention to receiving basic men's health and wellness messaging (standard of care),&#xD;
      hypothesizing: hypothesizing: that participants who complete B-ME intervention will report&#xD;
      greater reductions in sexual risk behaviors than the standard of care comparison group. The&#xD;
      study will utilize a pre-test/post-test design with participants randomized to intervention&#xD;
      and comparison groups; have a strategy to retain at least 80% of participants through study&#xD;
      completion; collect data at baseline, at 3 months post-intervention, and at 6 months&#xD;
      post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will&#xD;
      be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes&#xD;
      that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex&#xD;
      events; (2) number of unprotected sex events with persons of unknown HIV status; (3)&#xD;
      frequency of HIV testing, and (4) increased communication between partners about sex and&#xD;
      strategies for reducing the risk of HIV infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 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>
    <intervention_model_description>Assignment to behavioral intervention or comparison group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reductions in sexual risk behaviors</measure>
    <time_frame>baseline, 3-month, 6-month</time_frame>
    <description>Unprotected anal or vaginal sex and condom use during</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">438</enrollment>
  <condition>HIV CDC Category A1</condition>
  <arm_group>
    <arm_group_label>B-ME intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men will receive behavioral HIV prevention intervention, B-ME.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Men in this arm will receive monthly text or telephone voice messages relaying general health messages.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>B-ME Intervention</intervention_name>
    <description>B-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format.</description>
    <arm_group_label>B-ME intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a) Be 18 to 55 years old b) Self identify as African American (Black national) c) Self&#xD;
             identify as a male (because this is a study of an intervention to impact change among&#xD;
             Black MSM, only self identified males will be included, therefore no females or&#xD;
             transgendered identified persons will be included).&#xD;
&#xD;
             d) Report being sexually active in the past 30 days (ie., one or more instances of&#xD;
             vaginal or anal sex with a male or female) e) Report at least one instance of&#xD;
             unprotected anal or oral sex with a male identified partner in the past year f) Have&#xD;
             not previously participated in the CTCA intervention. g) Have not received an&#xD;
             evidence-based HIV prevention intervention in the past 180 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men are ineligible to participate in the trial if they:&#xD;
&#xD;
               1. Identify as a transgender woman; OR&#xD;
&#xD;
               2. Plan to move before the end of the study; OR&#xD;
&#xD;
               3. Have participated in any HIV or substance use prevention studies in the last 180&#xD;
                  days.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darrell P Wheeler, PHD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola University Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loyola University Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Black MSM</keyword>
  <keyword>HIV Prevention</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/NCT01722838
org study id: 5U01PS001574
secondary id: PS09-007
nct id: NCT01722838
lead sponsor: 
has dmc: Yes
B-ME is a research intervention study designed to address the needs of African American men
      who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is
      to decrease HIV risk behaviors among African American MSM using an intervention developed by
      and for African American MSM.

      The hypothesis guiding this study is: that participants who complete B-ME intervention will
      report greater reductions in sexual risk behaviors than the standard of care comparison
      group.
The Specific Aims of this study are 1) to further explicate and develop the intervention, 2)
      to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of
      research on HIV prevention/risk reduction practices for African American men who have sex
      with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving
      B-ME intervention to receiving basic men's health and wellness messaging (standard of care),
      hypothesizing: hypothesizing: that participants who complete B-ME intervention will report
      greater reductions in sexual risk behaviors than the standard of care comparison group. The
      study will utilize a pre-test/post-test design with participants randomized to intervention
      and comparison groups; have a strategy to retain at least 80% of participants through study
      completion; collect data at baseline, at 3 months post-intervention, and at 6 months
      post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will
      be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes
      that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex
      events; (2) number of unprotected sex events with persons of unknown HIV status; (3)
      frequency of HIV testing, and (4) increased communication between partners about sex and
      strategies for reducing the risk of HIV infection.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Assignment to behavioral intervention or comparison group
primary purpose: Prevention
masking: None (Open Label)
measure: reductions in sexual risk behaviors
time frame: baseline, 3-month, 6-month
description: Unprotected anal or vaginal sex and condom use during
arm group label: B-ME intervention
arm group type: Experimental
description: Men will receive behavioral HIV prevention intervention, B-ME.
arm group label: Control Arm
arm group type: No Intervention
description: Men in this arm will receive monthly text or telephone voice messages relaying general health messages.
intervention type: Behavioral
intervention name: B-ME Intervention
description: B-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format.
arm group label: B-ME intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Darrell P Wheeler, PHD MPH
role: Principal Investigator
affiliation: Loyola University Chicago
facility: 
country: United States
responsible party type: Sponsor