<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/NCT03275350</url>
  </required_header>
  <id_info>
    <org_study_id>Clinical Trials Network-0067</org_study_id>
    <nct_id>NCT03275350</nct_id>
  </id_info>
  <brief_title>Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up</brief_title>
  <official_title>Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jackson Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tarzana Treatment Centers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruth M. Rothstein CORE Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The Primary Objective of this study is to compare the effectiveness of HIV clinic-based&#xD;
      extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral&#xD;
      suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in&#xD;
      this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone&#xD;
      (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES&#xD;
      scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework&#xD;
      for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care&#xD;
      clinics. The study is an open-label, randomized, comparative effectiveness trial of&#xD;
      office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in&#xD;
      HIV-infected participants with untreated opioid use disorder. Each participant will be&#xD;
      engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and&#xD;
      enrollment procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2018</start_date>
  <completion_date type="Actual">November 8, 2019</completion_date>
  <primary_completion_date type="Actual">November 8, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
    <description>HIV-1 RNA &lt;200 copies/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With HIV Viral Suppression, Complete Case</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
    <description>HIV-1 RNA &lt;200 copies/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With HIV Viral Suppression, Per-protocol</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
    <description>HIV-1 RNA &lt;200 copies/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Veterans Aging Cohort Study (VACS) Index</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Absolute value of participant VACS Index at baseline and 24 weeks&#xD;
Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 Count</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Cluster of Differentiation 4&#xD;
Absolute value of CD4 count at baseline and 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in HIV Care: Antiretroviral Therapy Prescribed</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in HIV Care: 100% Antiretroviral Therapy Adherence</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>At least 1 HIV care visit in past 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Had Unprotected Sex in Past 30 Days</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Multiple Sex Partners in Past 30 Days</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in HIV Care: Quality of Life</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.&#xD;
Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Self-Reported Days of Opioid Use in Last 30 Days</measure>
    <time_frame>Between baseline and 24 weeks</time_frame>
    <description>Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Test Positive for Opioids at 24 Weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number and percent of participants with UDS positive for opioids at 24 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Hiv</condition>
  <arm_group>
    <arm_group_label>XR-NTX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Extended-release naltrexone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naltrexone Injectable Suspension</intervention_name>
    <description>Six monthly injections of extended-release naltrexone</description>
    <arm_group_label>XR-NTX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Standard treatment for opioid use disorder provided at each HIV clinic</description>
    <arm_group_label>TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is at least 18 years old&#xD;
&#xD;
          -  Participant has provided written informed consent and HIPAA for medical record&#xD;
             abstraction&#xD;
&#xD;
          -  Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe&#xD;
             opioid use disorder&#xD;
&#xD;
          -  Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid&#xD;
             use disorder&#xD;
&#xD;
          -  Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)&#xD;
&#xD;
          -  Willing to establish ongoing HIV care at the site if not already receiving ongoing&#xD;
             care&#xD;
&#xD;
          -  If female, willing to take at least one evidence-based measure to avoid becoming&#xD;
             pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a serious medical, psychiatric, or substance use disorder that, in the&#xD;
             opinion of the study physician, would make participation hazardous to the participant,&#xD;
             compromise study findings, or prevent participant from completing the study. Examples&#xD;
             include:&#xD;
&#xD;
          -  Acutely life-threatening medical illnesses (e.g., active opportunistic infection,&#xD;
             uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to&#xD;
             severe renal impairment) as assessed by medical history, review of symptoms, physical&#xD;
             exam and/or laboratory assessments&#xD;
&#xD;
          -  Severe, inadequately treated mental health disorder (e.g., active psychosis,&#xD;
             uncontrolled manic-depressive illness) as assessed by history and/or clinical&#xD;
             interview&#xD;
&#xD;
          -  Suicidal or homicidal ideation requiring immediate attention&#xD;
&#xD;
          -  Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT)&#xD;
             liver enzymes greater than five times the upper limit of normal on screening&#xD;
             phlebotomy&#xD;
&#xD;
          -  Participant has an international normalized ratio (INR) &gt; 1.5 or platelet count &lt;100k&#xD;
&#xD;
          -  Participant has a known allergy or sensitivity to naloxone, naltrexone,&#xD;
             polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol&#xD;
             diluent&#xD;
&#xD;
          -  Anticipate undergoing surgery during study participation&#xD;
&#xD;
          -  Have chronic pain requiring ongoing pain management with opioid analgesics&#xD;
&#xD;
          -  If female, currently (at time of consent) pregnant or breastfeeding or planning on&#xD;
             conceiving in the coming months&#xD;
&#xD;
          -  Body habitus that, in the judgment of the study physician, precludes safe&#xD;
             intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)&#xD;
&#xD;
          -  Received methadone of buprenorphine maintenance therapy for treatment of opioid&#xD;
             dependence in the 4 weeks prior to screening&#xD;
&#xD;
          -  Have taken an investigational drug in another study within 30 days of study consent&#xD;
&#xD;
          -  Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior&#xD;
             to consent&#xD;
&#xD;
          -  Are currently in jail, prison or have a pending legal action which may prevent an&#xD;
             individual from completing the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tarzana Treatment Centers</name>
      <address>
        <city>Tarzana</city>
        <state>California</state>
        <zip>91356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruth M. Rothstein CORE Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Bluegrass Care Clinic</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University, Bartlett Specialty Clinic</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>April 28, 2021</results_first_submitted>
  <results_first_submitted_qc>April 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2022</results_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>P. Todd Korthuis, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</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>January 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03275350/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Extended-release Naltrexone (XR-NTX)</title>
          <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
        </group>
        <group group_id="P2">
          <title>Treatment as Usual (TAU)</title>
          <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</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="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Incarcerated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Extended-release Naltrexone (XR-NTX)</title>
          <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
        </group>
        <group group_id="B2">
          <title>Treatment as Usual (TAU)</title>
          <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</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="59"/>
            <count group_id="B3" value="114"/>
          </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="48" spread="10.8"/>
                    <measurement group_id="B2" value="46" spread="11.5"/>
                    <measurement group_id="B3" value="47" spread="11.1"/>
                  </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="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="71"/>
                  </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="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="100"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="30"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="42"/>
                  </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="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV Viral Load</title>
          <units>log10 copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.0" spread="0.9"/>
                    <measurement group_id="B2" value="4.0" spread="1.1"/>
                    <measurement group_id="B3" value="4.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed</title>
        <description>HIV-1 RNA &lt;200 copies/ml</description>
        <time_frame>12 weeks and 24 weeks</time_frame>
        <population>Non-inferiority analyses of HIV viral suppression by treatment arm Intent to Treat Group Missing imputed as unsuppressed</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed</title>
          <description>HIV-1 RNA &lt;200 copies/ml</description>
          <population>Non-inferiority analyses of HIV viral suppression by treatment arm Intent to Treat Group Missing imputed as unsuppressed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HIV Viral Suppression, Complete Case</title>
        <description>HIV-1 RNA &lt;200 copies/ml</description>
        <time_frame>12 weeks and 24 weeks</time_frame>
        <population>Non-inferiority analyses of HIV viral suppression by treatment arm Complete case: Includes 81 participants with non-missing viral load data at 12 and 24 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HIV Viral Suppression, Complete Case</title>
          <description>HIV-1 RNA &lt;200 copies/ml</description>
          <population>Non-inferiority analyses of HIV viral suppression by treatment arm Complete case: Includes 81 participants with non-missing viral load data at 12 and 24 weeks</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HIV Viral Suppression, Per-protocol</title>
        <description>HIV-1 RNA &lt;200 copies/ml</description>
        <time_frame>12 weeks and 24 weeks</time_frame>
        <population>Non-inferiority analyses of HIV viral suppression by treatment arm Missing as unsuppressed Per-protocol population includes 69 participants who received at least one dose of their assigned study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HIV Viral Suppression, Per-protocol</title>
          <description>HIV-1 RNA &lt;200 copies/ml</description>
          <population>Non-inferiority analyses of HIV viral suppression by treatment arm Missing as unsuppressed Per-protocol population includes 69 participants who received at least one dose of their assigned study medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veterans Aging Cohort Study (VACS) Index</title>
        <description>Absolute value of participant VACS Index at baseline and 24 weeks&#xD;
Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Veterans Aging Cohort Study (VACS) Index</title>
          <description>Absolute value of participant VACS Index at baseline and 24 weeks&#xD;
Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.1" spread="18.1"/>
                    <measurement group_id="O2" value="68.4" spread="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4" spread="20.7"/>
                    <measurement group_id="O2" value="63.5" spread="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD4 Count</title>
        <description>Cluster of Differentiation 4&#xD;
Absolute value of CD4 count at baseline and 24 weeks.</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>CD4 Count</title>
          <description>Cluster of Differentiation 4&#xD;
Absolute value of CD4 count at baseline and 24 weeks.</description>
          <units>cells/mm3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="380.7" spread="248.2"/>
                    <measurement group_id="O2" value="439.8" spread="336.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="459.1" spread="249.1"/>
                    <measurement group_id="O2" value="505.1" spread="349.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Engagement in HIV Care: Antiretroviral Therapy Prescribed</title>
        <description>Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <population>Number analyzed at 24 weeks lower than baseline due to study retention and availability of data.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Engagement in HIV Care: Antiretroviral Therapy Prescribed</title>
          <description>Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.</description>
          <population>Number analyzed at 24 weeks lower than baseline due to study retention and availability of data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Engagement in HIV Care: 100% Antiretroviral Therapy Adherence</title>
        <description>Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.</description>
        <time_frame>24 weeks</time_frame>
        <population>This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Engagement in HIV Care: 100% Antiretroviral Therapy Adherence</title>
          <description>Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.</description>
          <population>This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks</title>
        <description>At least 1 HIV care visit in past 12 weeks</description>
        <time_frame>24 weeks</time_frame>
        <population>This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks</title>
          <description>At least 1 HIV care visit in past 12 weeks</description>
          <population>This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Had Unprotected Sex in Past 30 Days</title>
        <description>Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <population>Those reporting no sex are excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had Unprotected Sex in Past 30 Days</title>
          <description>Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).</description>
          <population>Those reporting no sex are excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Multiple Sex Partners in Past 30 Days</title>
        <description>Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <population>Two or more sex partners during past month, those reporting no sex partners are excluded</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Multiple Sex Partners in Past 30 Days</title>
          <description>Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).</description>
          <population>Two or more sex partners during past month, those reporting no sex partners are excluded</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Engagement in HIV Care: Quality of Life</title>
        <description>Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.&#xD;
Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Engagement in HIV Care: Quality of Life</title>
          <description>Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.&#xD;
Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="19.1"/>
                    <measurement group_id="O2" value="64.3" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" spread="21.2"/>
                    <measurement group_id="O2" value="71.2" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Self-Reported Days of Opioid Use in Last 30 Days</title>
        <description>Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).</description>
        <time_frame>Between baseline and 24 weeks</time_frame>
        <population>Per-protocol population includes participants who received at least one dose of their assigned study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Self-Reported Days of Opioid Use in Last 30 Days</title>
          <description>Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).</description>
          <population>Per-protocol population includes participants who received at least one dose of their assigned study medication.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intent-to-treat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.73" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O2" value="14.81" lower_limit="0" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Per-protocol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.02" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O2" value="13.58" lower_limit="0" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Test Positive for Opioids at 24 Weeks</title>
        <description>Number and percent of participants with UDS positive for opioids at 24 weeks.</description>
        <time_frame>24 weeks</time_frame>
        <population>Per-protocol population includes participants who received at least one dose of their assigned study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended-release Naltrexone (XR-NTX)</title>
            <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Test Positive for Opioids at 24 Weeks</title>
          <description>Number and percent of participants with UDS positive for opioids at 24 weeks.</description>
          <population>Per-protocol population includes participants who received at least one dose of their assigned study medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intent-to-treat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Per-protocol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Extended-release Naltrexone (XR-NTX)</title>
          <description>Extended-release naltrexone&#xD;
Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone</description>
        </group>
        <group group_id="E2">
          <title>Treatment as Usual (TAU)</title>
          <description>Treatment as usual&#xD;
Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning and procedural complications</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Non-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="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </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>Dr. Todd Korthuis</name_or_title>
      <organization>Oregon Health &amp; Science University</organization>
      <phone>503-494-8044</phone>
      <email>korthuis@ohsu.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/NCT03275350
org study id: Clinical Trials Network-0067
nct id: NCT03275350
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The Primary Objective of this study is to compare the effectiveness of HIV clinic-based
      extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral
      suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in
      this population.
The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone
      (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES
      scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework
      for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care
      clinics. The study is an open-label, randomized, comparative effectiveness trial of
      office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in
      HIV-infected participants with untreated opioid use disorder. Each participant will be
      engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and
      enrollment procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
time frame: 12 weeks and 24 weeks
description: HIV-1 RNA <200 copies/ml
measure: Number of Participants With HIV Viral Suppression, Complete Case
time frame: 12 weeks and 24 weeks
description: HIV-1 RNA <200 copies/ml
measure: Number of Participants With HIV Viral Suppression, Per-protocol
time frame: 12 weeks and 24 weeks
description: HIV-1 RNA <200 copies/ml
measure: Veterans Aging Cohort Study (VACS) Index
time frame: Baseline and 24 weeks
description: Absolute value of participant VACS Index at baseline and 24 weeks
Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.
measure: CD4 Count
time frame: Baseline and 24 weeks
description: Cluster of Differentiation 4
Absolute value of CD4 count at baseline and 24 weeks.
measure: Engagement in HIV Care: Antiretroviral Therapy Prescribed
time frame: Baseline and 24 weeks
description: Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.
measure: Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
time frame: 24 weeks
description: Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.
measure: Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
time frame: 24 weeks
description: At least 1 HIV care visit in past 12 weeks
measure: Number of Participants Who Had Unprotected Sex in Past 30 Days
time frame: Baseline and 24 weeks
description: Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
measure: Number of Participants With Multiple Sex Partners in Past 30 Days
time frame: Baseline and 24 weeks
description: Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
measure: Engagement in HIV Care: Quality of Life
time frame: Baseline and 24 weeks
description: Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.
Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome
measure: Average Number of Self-Reported Days of Opioid Use in Last 30 Days
time frame: Between baseline and 24 weeks
description: Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).
measure: Number of Participants Who Test Positive for Opioids at 24 Weeks
time frame: 24 weeks
description: Number and percent of participants with UDS positive for opioids at 24 weeks.
arm group label: XR-NTX
arm group type: Active Comparator
description: Extended-release naltrexone
arm group label: TAU
arm group type: Active Comparator
description: Treatment as usual
intervention type: Drug
intervention name: Naltrexone Injectable Suspension
description: Six monthly injections of extended-release naltrexone
arm group label: XR-NTX
intervention type: Other
intervention name: Treatment as usual
description: Standard treatment for opioid use disorder provided at each HIV clinic
arm group label: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: P. Todd Korthuis, MD
investigator title: Professor of Medicine
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 