<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/NCT01726712</url>
  </required_header>
  <id_info>
    <org_study_id>11-0654</org_study_id>
    <secondary_id>1R34MH097622-01</secondary_id>
    <nct_id>NCT01726712</nct_id>
  </id_info>
  <brief_title>Network Supported Engagement In HIV Care</brief_title>
  <acronym>NSEC</acronym>
  <official_title>Network Supported Engagement In HIV Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>ACCESS Community Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and&#xD;
      culturally sensitive intervention designed to capitalize on organic yet underutilized social&#xD;
      support networks in the lives of young black men who have sex with men (YBMSM) who have been&#xD;
      recently diagnosed with HIV. The intervention has been developed with input from clients and&#xD;
      their support network members, case managers, social workers, HIV primary care providers and&#xD;
      pastoral care at a Federally Qualified Health Center. The goal of the intervention is to&#xD;
      improve retention in care for newly diagnosed YBMSM who present for their first HIV primary&#xD;
      care clinic appointment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Missed Visit Proportion (MVP)</measure>
    <time_frame>12 months</time_frame>
    <description>The primary aim is to test for differences in MVP by treatment group across the study time period of 12 months</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>HIV</condition>
  <condition>Patient Acceptance of Health Care</condition>
  <arm_group>
    <arm_group_label>Routine Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive Contact</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive Care</intervention_name>
    <description>Provide emotional support. Provide practical support. Support friend/family by helping him find information or help for those with HIV in the community</description>
    <arm_group_label>Supportive Contact</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Index subjects&#xD;
&#xD;
          -  Self-identify as African-American and male;&#xD;
&#xD;
          -  same gender anal/oral sex in the past 2 years;&#xD;
&#xD;
          -  English speaking;&#xD;
&#xD;
          -  have at least one SC in their network;&#xD;
&#xD;
          -  own a cell phone not shared with other persons;&#xD;
&#xD;
          -  agreeable to text-message mini-booster sessions; and&#xD;
&#xD;
          -  between the ages of 16-29 years old.&#xD;
&#xD;
        Supportive Contact:&#xD;
&#xD;
          -  Index participant has agreed to including the supportive contact;&#xD;
&#xD;
          -  Supportive contact is willing to attend face to face and telephone mini-booster&#xD;
             sessions;&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  English speaking; and&#xD;
&#xD;
          -  owns a cell phone that is not shared with other persons.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Index Subject:&#xD;
&#xD;
          -  unable to provide assent/consent;&#xD;
&#xD;
          -  plan to move out of the area within the next 12 months;&#xD;
&#xD;
          -  are not willing to attend intervention sessions; or&#xD;
&#xD;
          -  not willing to return for assessments&#xD;
&#xD;
        Supportive Contact:&#xD;
&#xD;
          -  unable to provide informed consent; or&#xD;
&#xD;
          -  not willing to return for 3 and 12 month assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John A Schneider, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Care Management</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>HIV</keyword>
  <keyword>Patient Acceptance of Health Care</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/NCT01726712
org study id: 11-0654
secondary id: 1R34MH097622-01
nct id: NCT01726712
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and
      culturally sensitive intervention designed to capitalize on organic yet underutilized social
      support networks in the lives of young black men who have sex with men (YBMSM) who have been
      recently diagnosed with HIV. The intervention has been developed with input from clients and
      their support network members, case managers, social workers, HIV primary care providers and
      pastoral care at a Federally Qualified Health Center. The goal of the intervention is to
      improve retention in care for newly diagnosed YBMSM who present for their first HIV primary
      care clinic appointment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Missed Visit Proportion (MVP)
time frame: 12 months
description: The primary aim is to test for differences in MVP by treatment group across the study time period of 12 months
arm group label: Routine Care
arm group type: No Intervention
arm group label: Supportive Contact
arm group type: Active Comparator
intervention type: Other
intervention name: Supportive Care
description: Provide emotional support. Provide practical support. Support friend/family by helping him find information or help for those with HIV in the community
arm group label: Supportive Contact
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John A Schneider, MD, PhD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor