<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/NCT02185742</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00064852</org_study_id>
    <secondary_id>1R34DA035728-01A1</secondary_id>
    <nct_id>NCT02185742</nct_id>
  </id_info>
  <brief_title>Planning for SUCCESS</brief_title>
  <acronym>SUCCESS</acronym>
  <official_title>Planning for Sustained, Unbroken Connections to Care, Entry Services, and Suppression (SUCCESS)-- A Project to Improve the Connection to Community Care for HIV Infected Persons Leaving Jail in Atlanta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and&#xD;
      Suppression) is a project to improve the connection to community care for HIV infected&#xD;
      persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.&#xD;
&#xD;
      Hypothesis: Participants who receive the intervention will be more likely to link to medical&#xD;
      care after jail release than similar participants who do not receive the intervention.&#xD;
&#xD;
      Rationale and objective: This project aims to make sure HIV positive persons leaving jail&#xD;
      maintain medical care. Case managers will use strength based case management and phone&#xD;
      texting technology to improve release's connections to care in the community.&#xD;
&#xD;
      This study will have extensive tracking of outcomes. The key outcome will be whether HIV&#xD;
      infected participants receiving an intervention experience suppression of their viral load&#xD;
      after release from jail . The investigators wish to demonstrate the ability to recruit&#xD;
      participants into the SUCCESS intervention and repeatedly check community medical records to&#xD;
      see how well their infection is being controlled after they linked to care. Investigators&#xD;
      also want to conduct a survey at baseline, 3 months and 12 months.&#xD;
&#xD;
      Investigators will compare the viral load of participants receiving the intervention to&#xD;
      participants passing through the jail who do not receive the outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV viral load</measure>
    <time_frame>12 months after release from jail</time_frame>
    <description>HIV viral load can be drawn; obtaining it shows that the person is in care. Ideally, it should be suppressed 12 months out of jail.&#xD;
One measurement of viral load within three months after release will demonstrate linkage; two clinical visits occurring within 12 months post release, with at least 2 clinical visits spaced a minimum of 3 months apart, will indicate retention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Show feasibility of conducting protocol</measure>
    <time_frame>Four months</time_frame>
    <description>Demonstrate that 14 persons can be recruited per month and that delivery of the intervention is feasible.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Strength Based Case Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength Based Case Management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contemporary, HIV+ Jail Detainees</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strength Based Case Management</intervention_name>
    <arm_group_label>Strength Based Case Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV infected (HIV+); age of or over 18 years;&#xD;
&#xD;
          -  Mentally able to give consent; understand spoken English;&#xD;
&#xD;
          -  Detained or sentenced in either the Fulton County Jail or the Atlanta City Detention&#xD;
             Center; and&#xD;
&#xD;
          -  Likely to leave within 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give consent because of mental illness or inebriation;&#xD;
&#xD;
          -  A recent participant in a randomized trial conducted by the investigators of an&#xD;
             intervention to increase retention in HIV care (e.g., ARTAS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne C Spaulding, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fulton County Jail</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</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>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</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 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Anne C Spaulding</investigator_full_name>
    <investigator_title>Assoc Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>jail</keyword>
  <keyword>detainee</keyword>
  <keyword>Linkage and Retention</keyword>
  <keyword>Treatment as Prevention</keyword>
  <keyword>Strength Based Case Management</keyword>
  <keyword>releases</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/NCT02185742
org study id: IRB00064852
secondary id: 1R34DA035728-01A1
nct id: NCT02185742
lead sponsor: 
collaborator: 
has dmc: No
Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and
      Suppression) is a project to improve the connection to community care for HIV infected
      persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.

      Hypothesis: Participants who receive the intervention will be more likely to link to medical
      care after jail release than similar participants who do not receive the intervention.

      Rationale and objective: This project aims to make sure HIV positive persons leaving jail
      maintain medical care. Case managers will use strength based case management and phone
      texting technology to improve release's connections to care in the community.

      This study will have extensive tracking of outcomes. The key outcome will be whether HIV
      infected participants receiving an intervention experience suppression of their viral load
      after release from jail . The investigators wish to demonstrate the ability to recruit
      participants into the SUCCESS intervention and repeatedly check community medical records to
      see how well their infection is being controlled after they linked to care. Investigators
      also want to conduct a survey at baseline, 3 months and 12 months.

      Investigators will compare the viral load of participants receiving the intervention to
      participants passing through the jail who do not receive the outcome.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: HIV viral load
time frame: 12 months after release from jail
description: HIV viral load can be drawn; obtaining it shows that the person is in care. Ideally, it should be suppressed 12 months out of jail.
One measurement of viral load within three months after release will demonstrate linkage; two clinical visits occurring within 12 months post release, with at least 2 clinical visits spaced a minimum of 3 months apart, will indicate retention.
measure: Show feasibility of conducting protocol
time frame: Four months
description: Demonstrate that 14 persons can be recruited per month and that delivery of the intervention is feasible.
arm group label: Strength Based Case Management
arm group type: Experimental
description: Strength Based Case Management
arm group label: Contemporary, HIV+ Jail Detainees
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Strength Based Case Management
arm group label: Strength Based Case Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Anne C Spaulding, MD MPH
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Anne C Spaulding
investigator title: Assoc Professor