<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/NCT01721226</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA030747-01</org_study_id>
    <nct_id>NCT01721226</nct_id>
  </id_info>
  <brief_title>CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)</brief_title>
  <acronym>CARE+</acronym>
  <official_title>CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether an intervention (CARE+ Corrections)&#xD;
      delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and&#xD;
      recently -released ex-detainees in the community can improve linkage to community HIV care&#xD;
      and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral&#xD;
      suppression following community re-entry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention is modeled after CARE, a technology based HIV-counseling tool used in other&#xD;
      settings. The investigators have adapted CARE to create CARE+ Corrections, a tool designed&#xD;
      specifically for incarcerated and recently-released populations. New and innovative&#xD;
      information communication tools (ICT), including a cell phone/text messaging component&#xD;
      delivered in the community after release from jail, will be included in the intervention.&#xD;
&#xD;
      The study is a randomized controlled trial. One half of the participants will receive the&#xD;
      intervention either inside the jail, in addition to standard discharge planning services, or&#xD;
      in the community right after release. The other half of the participants will view an&#xD;
      educational video related to the prevention of drug overdose following release, in addition&#xD;
      to standard discharge planning services, or in the community right after release. The&#xD;
      investigators will follow all participants for 6 months post release/study enrollment and&#xD;
      determine if the linkage to community care and adherence to HIV medications was higher in the&#xD;
      intervention arm.&#xD;
&#xD;
      The study also has an evaluation component to it. The evaluation component consists in a&#xD;
      series of qualitative interviews with the goal of gaining a better understanding of the&#xD;
      barriers and facilitators involved in implementing the CARE+ Corrections intervention and to&#xD;
      better assess the usability and participants' experiences with the CARE+ Corrections&#xD;
      intervention. The semi-structured interviews are being conducted among the following groups:&#xD;
      1) managers and staff at local correctional facilities and agencies which have interaction&#xD;
      with HIV+ individuals transitioning to the community; 2) leadership and selected staff at&#xD;
      relevant and targeted community-based organizations; and 3) selected study participants from&#xD;
      the intervention group of the RCT. the interviews elicit perspectives on the foreseen&#xD;
      facilitators and challenges in implementing the CARE+ Corrections tool at their respective&#xD;
      organizations as well as their perception on the acceptability of the tool. We also ask their&#xD;
      views about the intervention and the post-release experiences of HIV-positive individuals who&#xD;
      complete the CARE+ Corrections Tool and receive the text message plan.&#xD;
&#xD;
      No prisoners will be involved in this subsection of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Plasma Viral Load Suppression</measure>
    <time_frame>24 weeks</time_frame>
    <description>Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Linkage to Community Care</measure>
    <time_frame>24 weeks</time_frame>
    <description>At least 1 visit to health care provider in past 24 weeks/6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CARE tool and cell phone/text messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention Arm (computer-based CARE+ Corrections tool)</intervention_name>
    <description>Study participants in the intervention arm will complete the computer-based CARE+ Corrections tool at baseline. The CARE tool provides tailored feedback based on the participants' responses to a series of questions included in the counseling session. Participants in this arm of the study recruited inside the DC DOC will receive typical discharge planning services as conducted by the correctional facility. Participants will be followed for six months after release/study enrollment. At the post-release baseline visit, participants in the intervention arm will receive a cell phone/SMS text messaging intervention consisting of using cell phone-delivered SMS text messages with the intent of improving linkage to community HIV care and adherence to ART (if prescribed.)</description>
    <arm_group_label>CARE tool and cell phone/text messaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational video on opiate overdose prevention</intervention_name>
    <description>Participants in the Control Arm will view an educational video on opiate overdose prevention in jail prior to release. Control arm participants will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently detained in jail or released from the jail/prison 6 months ago or less&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Able to provide informed consent for research participation&#xD;
&#xD;
          -  Anticipated release from the DOC to the community (or living in the community if&#xD;
             recently released ex-detainee)&#xD;
&#xD;
          -  Confirmed to be HIV-infected by self-report&#xD;
&#xD;
          -  Live in metropolitan Washington, DC area&#xD;
&#xD;
          -  Able to read at 8th grade level as assessed by brief literacy screen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expected release to restricted setting (or currently living in a restricted setting if&#xD;
             recruited in the community), including residential drug treatment, sober house,&#xD;
             half-way house, or similar&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Kuo, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Washington University School of Public Health and Health Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Family and Medical Counseling Services</name>
      <address>
        <city>Washington DC</city>
        <state>District of Columbia</state>
        <zip>20020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>September 14, 2016</results_first_submitted>
  <results_first_submitted_qc>December 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2017</results_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Linkage to HIV care following release from prison</keyword>
  <keyword>Anti-retroviral therapy adherence after release from prison</keyword>
  <keyword>HIV loads after release from prison</keyword>
  <keyword>information technology and ART adherence</keyword>
  <keyword>information technology and linkage to HIV care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opiate Alkaloids</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Arm</title>
          <description>Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
        </group>
        <group group_id="P2">
          <title>CARE Tool and Cell Phone/Text Messaging</title>
          <description>The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Baseline</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 12</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 24</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Arm</title>
          <description>Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
        </group>
        <group group_id="B2">
          <title>CARE Tool and Cell Phone/Text Messaging</title>
          <description>The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
            <count group_id="B2" value="57"/>
            <count group_id="B3" value="112"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39" lower_limit="30" upper_limit="57"/>
                    <measurement group_id="B2" value="42" lower_limit="30" upper_limit="50"/>
                    <measurement group_id="B3" value="41.5" lower_limit="30" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transgender</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Viral Suppression</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Virally suppressed (PVL&lt;100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not virally suppressed (PVL &gt;=100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasma Viral Load Suppression</title>
        <description>Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction</description>
        <time_frame>24 weeks</time_frame>
        <population>All study participants with available PVL data</population>
        <group_list>
          <group group_id="O1">
            <title>Control Arm</title>
            <description>Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
          </group>
          <group group_id="O2">
            <title>CARE Tool and Cell Phone/Text Messaging</title>
            <description>The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Viral Load Suppression</title>
          <description>Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction</description>
          <population>All study participants with available PVL data</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Virally suppressed (PVL&lt;100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not virally suppressed (PVL &gt;=100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Linkage to Community Care</title>
        <description>At least 1 visit to health care provider in past 24 weeks/6 months</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Arm</title>
            <description>Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
          </group>
          <group group_id="O2">
            <title>CARE Tool and Cell Phone/Text Messaging</title>
            <description>The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Linkage to Community Care</title>
          <description>At least 1 visit to health care provider in past 24 weeks/6 months</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes-achieved outcome</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No-did not achieve outcome</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Enrollment and follow-up period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control Arm</title>
          <description>Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
        </group>
        <group group_id="E2">
          <title>CARE Tool and Cell Phone/Text Messaging</title>
          <description>The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Irene Kuo</name_or_title>
      <organization>George Washington University</organization>
      <phone>202-994-0367</phone>
      <email>ikuo@gwu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01721226
org study id: R01DA030747-01
nct id: NCT01721226
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether an intervention (CARE+ Corrections)
      delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and
      recently -released ex-detainees in the community can improve linkage to community HIV care
      and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral
      suppression following community re-entry.
The intervention is modeled after CARE, a technology based HIV-counseling tool used in other
      settings. The investigators have adapted CARE to create CARE+ Corrections, a tool designed
      specifically for incarcerated and recently-released populations. New and innovative
      information communication tools (ICT), including a cell phone/text messaging component
      delivered in the community after release from jail, will be included in the intervention.

      The study is a randomized controlled trial. One half of the participants will receive the
      intervention either inside the jail, in addition to standard discharge planning services, or
      in the community right after release. The other half of the participants will view an
      educational video related to the prevention of drug overdose following release, in addition
      to standard discharge planning services, or in the community right after release. The
      investigators will follow all participants for 6 months post release/study enrollment and
      determine if the linkage to community care and adherence to HIV medications was higher in the
      intervention arm.

      The study also has an evaluation component to it. The evaluation component consists in a
      series of qualitative interviews with the goal of gaining a better understanding of the
      barriers and facilitators involved in implementing the CARE+ Corrections intervention and to
      better assess the usability and participants' experiences with the CARE+ Corrections
      intervention. The semi-structured interviews are being conducted among the following groups:
      1) managers and staff at local correctional facilities and agencies which have interaction
      with HIV+ individuals transitioning to the community; 2) leadership and selected staff at
      relevant and targeted community-based organizations; and 3) selected study participants from
      the intervention group of the RCT. the interviews elicit perspectives on the foreseen
      facilitators and challenges in implementing the CARE+ Corrections tool at their respective
      organizations as well as their perception on the acceptability of the tool. We also ask their
      views about the intervention and the post-release experiences of HIV-positive individuals who
      complete the CARE+ Corrections Tool and receive the text message plan.

      No prisoners will be involved in this subsection of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Plasma Viral Load Suppression
time frame: 24 weeks
description: Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
measure: Linkage to Community Care
time frame: 24 weeks
description: At least 1 visit to health care provider in past 24 weeks/6 months
arm group label: Control Arm
arm group type: Sham Comparator
description: Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
arm group label: CARE tool and cell phone/text messaging
arm group type: Experimental
description: The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
intervention type: Device
intervention name: Intervention Arm (computer-based CARE+ Corrections tool)
description: Study participants in the intervention arm will complete the computer-based CARE+ Corrections tool at baseline. The CARE tool provides tailored feedback based on the participants' responses to a series of questions included in the counseling session. Participants in this arm of the study recruited inside the DC DOC will receive typical discharge planning services as conducted by the correctional facility. Participants will be followed for six months after release/study enrollment. At the post-release baseline visit, participants in the intervention arm will receive a cell phone/SMS text messaging intervention consisting of using cell phone-delivered SMS text messages with the intent of improving linkage to community HIV care and adherence to ART (if prescribed.)
arm group label: CARE tool and cell phone/text messaging
intervention type: Other
intervention name: Educational video on opiate overdose prevention
description: Participants in the Control Arm will view an educational video on opiate overdose prevention in jail prior to release. Control arm participants will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
arm group label: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Irene Kuo, PhD, MPH
role: Principal Investigator
affiliation: George Washington University School of Public Health and Health Services
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Opiate Alkaloids
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 