<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/NCT03290391</url>
  </required_header>
  <id_info>
    <org_study_id>H-36706</org_study_id>
    <secondary_id>R01DA045547</secondary_id>
    <nct_id>NCT03290391</nct_id>
  </id_info>
  <brief_title>Linking Infectious and Narcology Care-Part II</brief_title>
  <acronym>LINC-II</acronym>
  <official_title>Linking Infectious and Narcology Care-Part II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</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>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study, &quot;Linking Infectious and Narcology Care - Part II (LINC-II),&quot; will implement and&#xD;
      evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial&#xD;
      among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy&#xD;
      (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months&#xD;
      of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load&#xD;
      suppression), impact on care systems and cost-effectiveness of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the&#xD;
      world, with highest transmission risks among people who inject drugs (PWID) and their sexual&#xD;
      partners. While routine HIV testing within addiction treatment systems in Russia (i.e.,&#xD;
      narcology hospitals) is the norm, links between the narcology and HIV care systems are&#xD;
      limited and ineffective. In St. Petersburg 50-60% of PWID are HIV-infected, yet among this&#xD;
      population less than 10% are on antiretroviral therapy (ART). For Russia to make progress&#xD;
      toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed&#xD;
      on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is&#xD;
      required. The objective of this study, &quot;Linking Infectious and Narcology Care - Part II&#xD;
      (LINC-II),&quot; is to implement and evaluate, via a two-armed randomized controlled trial among&#xD;
      240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e.,&#xD;
      rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of&#xD;
      strengths-based case management.&#xD;
&#xD;
      The central hypothesis is that LINC-II will lead to marked progress toward the achievement of&#xD;
      the 90-90-90 HIV cascade of care targets among HIV-infected PWID, relative to current&#xD;
      standard of care, and that LINC-II will facilitate health system coordination of narcology&#xD;
      and HIV care. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL&#xD;
      at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in&#xD;
      CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care&#xD;
      in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact&#xD;
      of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed&#xD;
      methods data from health care providers, administrators, and patients; and 3) evaluate the&#xD;
      cost-effectiveness of the intervention to inform policy makers on scaling up the LINC-II&#xD;
      approach both within Russia and other countries with HIV epidemics driven by injection drug&#xD;
      use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2018</start_date>
  <completion_date type="Actual">April 6, 2022</completion_date>
  <primary_completion_date type="Actual">April 6, 2022</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Undetectable HIV Viral Load at 12 Months</measure>
    <time_frame>12 months post randomization</time_frame>
    <description>Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (&lt;40 copies per milliliter)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Initiation of Antiretroviral Therapy (ART)</measure>
    <time_frame>Within 28 days of randomization</time_frame>
    <description>Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean CD4 Count From Baseline to 12 Months</measure>
    <time_frame>Change from baseline to 12 months</time_frame>
    <description>The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention in HIV Care</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Undetectable HIV Viral Load at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (&lt;40 copies per milliliter).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>HIV Infection</condition>
  <condition>Drug Use</condition>
  <arm_group>
    <arm_group_label>LINC-II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rapid ART initiation</intervention_name>
    <description>The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.</description>
    <arm_group_label>LINC-II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharmacotherapy for opioid use disorder</intervention_name>
    <description>Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).</description>
    <arm_group_label>LINC-II</arm_group_label>
    <other_name>Naltrexone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strengths-based HIV case management</intervention_name>
    <description>Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
    <arm_group_label>LINC-II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  HIV infected&#xD;
&#xD;
          -  Hospitalized at narcology hospital&#xD;
&#xD;
          -  History of injection drug use&#xD;
&#xD;
          -  Current diagnosis of opioid use disorder&#xD;
&#xD;
          -  Provision of information for 2 contacts to assist with follow-up&#xD;
&#xD;
          -  Address within 100 kilometers of St. Petersburg&#xD;
&#xD;
          -  Possession of a telephone (home or cell)&#xD;
&#xD;
          -  Able and willing to comply with all study protocols and procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not fluent in Russian&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Pregnancy, planning to become pregnant, or breastfeeding&#xD;
&#xD;
          -  ART use in past 30 days prior to hospitalization&#xD;
&#xD;
          -  Known hypersensitivity to naltrexone&#xD;
&#xD;
          -  Acute severe psychiatric illness (i.e. ,answered yes to any of the following: past&#xD;
             three month active hallucinations; mental health symptoms prompting a visit to the ED&#xD;
             or hospital; mental health medication changes due to worsening symptoms; presence of&#xD;
             suicidal ideations)&#xD;
&#xD;
          -  Known history of liver failure&#xD;
&#xD;
          -  ALT or AST &gt;5 times the upper limit of normal&#xD;
&#xD;
          -  Known severe thrombocytopenia (&lt;50k)&#xD;
&#xD;
          -  Known coagulation disorder/taking anticoagulation medications&#xD;
&#xD;
          -  Body habitus that precludes intramuscular injection&#xD;
&#xD;
          -  Known hypersensitivity to naloxone&#xD;
&#xD;
          -  Known history of Raynaud's disease&#xD;
&#xD;
          -  Known history of Itsenko-Cushing syndrome&#xD;
&#xD;
          -  Known history of generalized mycoses&#xD;
&#xD;
          -  Known history of glaucoma&#xD;
&#xD;
          -  Known history of osteoporosis.&#xD;
&#xD;
          -  Planned surgeries in the next 12 months&#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>Jeffrey Samet, MD MA MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First St. Petersburg Pavlov State Medical University</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Addiction Hospital</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>February 9, 2023</results_first_submitted>
  <results_first_submitted_qc>March 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 18, 2023</results_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Russia</keyword>
  <keyword>Substance use</keyword>
  <keyword>Peer case managers</keyword>
  <keyword>ART</keyword>
  <keyword>HIV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03290391/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03290391/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>953 potential participants were assessed for eligibility via medical record pre-screen. 642 were ineligible and 75 did not proceed with in-person screener due to being previously enrolled or discharged early.&#xD;
236 potential eligible participants completed the in-person screener; 7 did not meet the inclusion criteria and 4 declined to participate. 225 completed the baseline interview and were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LINC-II</title>
          <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Allocation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Completed 6 Month Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Completed 12 Month Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LINC-II</title>
          <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</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="111"/>
            <count group_id="B2" value="114"/>
            <count group_id="B3" value="225"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37" spread="5"/>
                    <measurement group_id="B2" value="37" spread="5"/>
                    <measurement group_id="B3" value="37" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Undetectable HIV Viral Load at 12 Months</title>
        <description>Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (&lt;40 copies per milliliter)</description>
        <time_frame>12 months post randomization</time_frame>
        <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
        <group_list>
          <group group_id="O1">
            <title>LINC-II</title>
            <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
          </group>
        </group_list>
        <measure>
          <title>Undetectable HIV Viral Load at 12 Months</title>
          <description>Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (&lt;40 copies per milliliter)</description>
          <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9"/>
                    <measurement group_id="O2" value="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Initiation of Antiretroviral Therapy (ART)</title>
        <description>Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.</description>
        <time_frame>Within 28 days of randomization</time_frame>
        <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
        <group_list>
          <group group_id="O1">
            <title>LINC-II</title>
            <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
          </group>
        </group_list>
        <measure>
          <title>Initiation of Antiretroviral Therapy (ART)</title>
          <description>Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.</description>
          <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9"/>
                    <measurement group_id="O2" value="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean CD4 Count From Baseline to 12 Months</title>
        <description>The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results</description>
        <time_frame>Change from baseline to 12 months</time_frame>
        <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
        <group_list>
          <group group_id="O1">
            <title>LINC-II</title>
            <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean CD4 Count From Baseline to 12 Months</title>
          <description>The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results</description>
          <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
          <units>cells per cubic millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" spread="171"/>
                    <measurement group_id="O2" value="-8" spread="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retention in HIV Care</title>
        <description>Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.</description>
        <time_frame>12 months</time_frame>
        <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
        <group_list>
          <group group_id="O1">
            <title>LINC-II</title>
            <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention in HIV Care</title>
          <description>Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.</description>
          <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4"/>
                    <measurement group_id="O2" value="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Undetectable HIV Viral Load at 6 Months</title>
        <description>Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (&lt;40 copies per milliliter).</description>
        <time_frame>6 months</time_frame>
        <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
        <group_list>
          <group group_id="O1">
            <title>LINC-II</title>
            <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
          </group>
        </group_list>
        <measure>
          <title>Undetectable HIV Viral Load at 6 Months</title>
          <description>Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (&lt;40 copies per milliliter).</description>
          <population>Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4"/>
                    <measurement group_id="O2" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over the course of the 12-month study period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LINC-II</title>
          <description>LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.&#xD;
Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.&#xD;
Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).&#xD;
Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Death due to heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Death due to sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Death due to COVID</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Death due to overdose</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Death due to suicide</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Death due to acute alcohol intoxication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>COVID</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Elevated AST</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Elevated ALT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Muscle pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Jeffrey Samet, MD MA MPH</name_or_title>
      <organization>Boston Medical Center and BU Chobanian &amp; Avedisian School of Medicine</organization>
      <phone>(617) 414-7288</phone>
      <email>jsamet@bu.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/NCT03290391
org study id: H-36706
secondary id: R01DA045547
nct id: NCT03290391
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study, "Linking Infectious and Narcology Care - Part II (LINC-II)," will implement and
      evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial
      among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy
      (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months
      of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load
      suppression), impact on care systems and cost-effectiveness of the intervention.
Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the
      world, with highest transmission risks among people who inject drugs (PWID) and their sexual
      partners. While routine HIV testing within addiction treatment systems in Russia (i.e.,
      narcology hospitals) is the norm, links between the narcology and HIV care systems are
      limited and ineffective. In St. Petersburg 50-60% of PWID are HIV-infected, yet among this
      population less than 10% are on antiretroviral therapy (ART). For Russia to make progress
      toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed
      on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is
      required. The objective of this study, "Linking Infectious and Narcology Care - Part II
      (LINC-II)," is to implement and evaluate, via a two-armed randomized controlled trial among
      240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e.,
      rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of
      strengths-based case management.

      The central hypothesis is that LINC-II will lead to marked progress toward the achievement of
      the 90-90-90 HIV cascade of care targets among HIV-infected PWID, relative to current
      standard of care, and that LINC-II will facilitate health system coordination of narcology
      and HIV care. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL
      at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in
      CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care
      in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact
      of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed
      methods data from health care providers, administrators, and patients; and 3) evaluate the
      cost-effectiveness of the intervention to inform policy makers on scaling up the LINC-II
      approach both within Russia and other countries with HIV epidemics driven by injection drug
      use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Undetectable HIV Viral Load at 12 Months
time frame: 12 months post randomization
description: Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (<40 copies per milliliter)
measure: Initiation of Antiretroviral Therapy (ART)
time frame: Within 28 days of randomization
description: Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
measure: Change in Mean CD4 Count From Baseline to 12 Months
time frame: Change from baseline to 12 months
description: The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results
measure: Retention in HIV Care
time frame: 12 months
description: Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.
measure: Undetectable HIV Viral Load at 6 Months
time frame: 6 months
description: Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (<40 copies per milliliter).
arm group label: LINC-II
arm group type: Experimental
description: LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.
arm group label: Standard of Care
arm group type: No Intervention
description: Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.
intervention type: Other
intervention name: Rapid ART initiation
description: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.
arm group label: LINC-II
intervention type: Drug
intervention name: Pharmacotherapy for opioid use disorder
description: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).
arm group label: LINC-II
other name: Naltrexone
intervention type: Behavioral
intervention name: Strengths-based HIV case management
description: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.
arm group label: LINC-II
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Samet, MD MA MPH
role: Principal Investigator
affiliation: Boston University
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Naltrexone
sharing ipd: No
provided document: 
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point of contact: 