<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/NCT01662336</url>
  </required_header>
  <id_info>
    <org_study_id>P13-566</org_study_id>
    <nct_id>NCT01662336</nct_id>
  </id_info>
  <brief_title>Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program</brief_title>
  <official_title>Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of the study was to describe the real-life adherence, effectiveness and&#xD;
      safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency&#xD;
      virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r;&#xD;
      Kaletra®) in Canada.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that&#xD;
      has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA&#xD;
      offers individual counseling with an HIV experienced nurse who assists patients with various&#xD;
      aspects of their therapy including life-style changes, emotional stress, and adverse events.&#xD;
      Patients enrolled in KASA may also have access to various healthcare professionals&#xD;
      (dietician, social worker, psychologist, etc.) or may be offered other types of support&#xD;
      (transportation, exercise, etc.), which may help improve their quality of life as well as&#xD;
      adherence or compliance while taking LPV/r.&#xD;
&#xD;
      This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a&#xD;
      prospective single cohort design. All treatments including participation in the KASA program&#xD;
      were according to the decision of the treating physician and the patients and were not&#xD;
      affected in any way by their decision to participate in the study. Follow-up was for 12&#xD;
      months at an interval of every six months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Adherent to Treatment at Month 6</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Adherence Summative Score at Months 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).&#xD;
The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Adherent to Treatment at Month 12</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life General Health Perception Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Role Functioning Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Social Functioning Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Pain Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Mental Health Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Perception of Stress</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psychological Well-being</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Coping Self-Efficacy</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Resource Utilization</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load at Each Visit</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Provider Satisfaction</measure>
    <time_frame>Month 6 and Month 12</time_frame>
    <description>For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">173</enrollment>
  <condition>Human Immunodeficiency Virus Infection</condition>
  <arm_group>
    <arm_group_label>Lopinavir/Ritonavir + KASA</arm_group_label>
    <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lopinavir / ritonavir</intervention_name>
    <description>Prescribed according to the product monograph and physician's discretion.</description>
    <arm_group_label>Lopinavir/Ritonavir + KASA</arm_group_label>
    <other_name>Kaletra®</other_name>
    <other_name>LPV/r</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Kaletra Adherence Support Assistance Program</intervention_name>
    <description>A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.</description>
    <arm_group_label>Lopinavir/Ritonavir + KASA</arm_group_label>
    <other_name>KASA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were enrolled from the offices (at clinic or hospital) of primary care physicians&#xD;
        across Canada treating HIV-positive patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is HIV-positive&#xD;
&#xD;
          -  On treatment with LPV/r or currently initiated on treatment with LPV/r.&#xD;
&#xD;
          -  Has provided written informed consent allowing the use of their data for the study and&#xD;
             providing permission for contact by the study personnel.&#xD;
&#xD;
          -  Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.&#xD;
&#xD;
          -  Prescribed LPV/r as part of his/her treatment by the treating physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to sign an informed consent.&#xD;
&#xD;
          -  In the opinion of the treating physician is unlikely to be available for the 12-month&#xD;
             follow-up duration of the study.&#xD;
&#xD;
          -  Is currently participating in a clinical trial of an investigational product.&#xD;
&#xD;
          -  Not willing to participate in the KASA program.&#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>Christina Pelizon, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie Corporation</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>June 19, 2017</results_first_submitted>
  <results_first_submitted_qc>June 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2018</results_first_posted>
  <last_update_submitted>June 19, 2017</last_update_submitted>
  <last_update_submitted_qc>June 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited from the practices of 8 physicians in Canada between 29 June 2012 and 06 August 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Lopinavir/Ritonavir + KASA</title>
          <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with lopinavir / ritonavir (LPV/r; Kaletra®) and participation in the Kaletra Adherence Support Assistance (KASA) program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Month 6 Visit</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Month 12 Visit</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer on LPV/r</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lopinavir/Ritonavir + KASA</title>
          <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="173"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.7" spread="10.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian/ Alaska</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Adherence Self-Efficacy Scale (ASES) Scores</title>
          <description>The ASES is a 12 item tool that measures patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranges from 0 to 120, with higher scores indicating higher treatment self-efficacy. The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90 and the adherence perseverance subscale score ranges from 0 to 30.</description>
          <population>Intent-to-treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; data are reported for participants with non-missing data at baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Adherence Summative Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102.5" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adherence Integration Subscale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.1" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adherence Perseverance Subscale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.0" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health Status Assessment (HSA)</title>
          <description>Quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA), a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The survey includes 21 items assessing 8 domains of health-related QoL including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>General Health Perception</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.2" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.8" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.3" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.8" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.0" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.4" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.3" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy/ Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.8" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Perception of Stress</title>
          <description>Perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.</description>
          <population>Intent-to-treat population with non-missing data at baseline</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.3" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psychological Well-being</title>
          <description>Psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.</description>
          <population>Intent-to-treat population with non-missing data at baseline</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.4" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coping Self-Efficacy Scale</title>
          <description>Coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.</description>
          <population>Intent-to-treat population with non-missing data at baseline</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="187.0" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Adherent to Treatment at Month 6</title>
        <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>The intent-to treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Adherent to Treatment at Month 6</title>
          <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.</description>
          <population>The intent-to treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3" lower_limit="35.9" upper_limit="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Adherence Summative Score at Months 6 and 12</title>
        <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Adherence Summative Score at Months 6 and 12</title>
          <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
          <units>units 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="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12</title>
        <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).&#xD;
The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12</title>
          <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).&#xD;
The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
          <units>units 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="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12</title>
        <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12</title>
          <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
          <units>units 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="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Adherent to Treatment at Month 12</title>
        <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>The intent-to treat population; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Adherent to Treatment at Month 12</title>
          <description>Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.</description>
          <population>The intent-to treat population; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2" lower_limit="23.3" upper_limit="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life General Health Perception Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life General Health Perception Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Role Functioning Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Role Functioning Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Social Functioning Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Social Functioning Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Pain Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Pain Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Mental Health Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Mental Health Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score</title>
        <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score</title>
          <description>Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Perception of Stress</title>
        <description>Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Perception of Stress</title>
          <description>Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psychological Well-being</title>
        <description>Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psychological Well-being</title>
          <description>Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Coping Self-Efficacy</title>
        <description>Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Coping Self-Efficacy</title>
          <description>Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.</description>
          <population>Intent-to-treat population with non-missing data at baseline and each time point.</population>
          <units>units 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="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="64.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="54.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Resource Utilization</title>
        <description>Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
          </group>
          <group group_id="O2">
            <title>Month 6</title>
          </group>
          <group group_id="O3">
            <title>Month 12</title>
          </group>
        </group_list>
        <measure>
          <title>Health Resource Utilization</title>
          <description>Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.</description>
          <population>Intent-to-treat population with non-missing data at each time point.</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="173"/>
                <count group_id="O2" value="142"/>
                <count group_id="O3" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Emergency Room</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1"/>
                    <measurement group_id="O2" value="8.5"/>
                    <measurement group_id="O3" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Admitted to Hospital</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="2.8"/>
                    <measurement group_id="O3" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Admitted to a Long-Term Care Facility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit to a Doctor's Office/ Clinic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5"/>
                    <measurement group_id="O2" value="50.7"/>
                    <measurement group_id="O3" value="50.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ambulance Service</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="1.4"/>
                    <measurement group_id="O3" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physiotherapist/ Rehabilitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="7.7"/>
                    <measurement group_id="O3" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatrist/ Psychologist/ Counselor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2"/>
                    <measurement group_id="O2" value="12.0"/>
                    <measurement group_id="O3" value="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nursing Services</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7"/>
                    <measurement group_id="O2" value="14.8"/>
                    <measurement group_id="O3" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2"/>
                    <measurement group_id="O2" value="12.7"/>
                    <measurement group_id="O3" value="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Load at Each Visit</title>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Load at Each Visit</title>
          <population>Intent-to-treat population with non-missing data at baseline and each time point</population>
          <units>copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </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="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.3" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.7" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.2" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit</title>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lopinavir/Ritonavir + KASA</title>
            <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit</title>
          <population>Intent-to-treat population with non-missing data at each time point</population>
          <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="171"/>
              </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="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="547.0" spread="294.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="620.8" spread="294.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="620.2" spread="301.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Provider Satisfaction</title>
        <description>For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.</description>
        <time_frame>Month 6 and Month 12</time_frame>
        <population>Intent-to-treat population with non-missing data at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Month 6</title>
          </group>
          <group group_id="O2">
            <title>Month 12</title>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Provider Satisfaction</title>
          <description>For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.</description>
          <population>Intent-to-treat population with non-missing data at each time point</population>
          <units>units 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="142"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Satisfaction with KASA Program</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.1" spread="22.10"/>
                    <measurement group_id="O2" value="73.3" spread="22.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Benefits in Maintaining Treatment Adherence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="26.38"/>
                    <measurement group_id="O2" value="62.7" spread="25.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Likelihood to Recommend KASA Program in Future</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.7" spread="21.99"/>
                    <measurement group_id="O2" value="70.0" spread="23.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lopinavir/Ritonavir + KASA</title>
          <description>Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie (prior Sponsor Abbott)</organization>
      <phone>800-633-9110</phone>
    </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/NCT01662336
org study id: P13-566
nct id: NCT01662336
lead sponsor: 
has dmc: No
The overall purpose of the study was to describe the real-life adherence, effectiveness and
      safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency
      virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r;
      Kaletra®) in Canada.
The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that
      has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA
      offers individual counseling with an HIV experienced nurse who assists patients with various
      aspects of their therapy including life-style changes, emotional stress, and adverse events.
      Patients enrolled in KASA may also have access to various healthcare professionals
      (dietician, social worker, psychologist, etc.) or may be offered other types of support
      (transportation, exercise, etc.), which may help improve their quality of life as well as
      adherence or compliance while taking LPV/r.

      This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a
      prospective single cohort design. All treatments including participation in the KASA program
      were according to the decision of the treating physician and the patients and were not
      affected in any way by their decision to participate in the study. Follow-up was for 12
      months at an interval of every six months.
observational model: Case-Only
time perspective: Prospective
measure: Percentage of Participants Adherent to Treatment at Month 6
time frame: Baseline and 6 months
description: Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
measure: Change From Baseline in Adherence Summative Score at Months 6 and 12
time frame: Baseline, Month 6 and Month 12
description: Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.
measure: Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12
time frame: Baseline, Month 6 and Month 12
description: Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).
The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.
measure: Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12
time frame: Baseline, Month 6 and Month 12
description: Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.
measure: Percentage of Participants Adherent to Treatment at Month 12
time frame: Baseline and 12 months
description: Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
measure: Change From Baseline in Health-related Quality of Life General Health Perception Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Role Functioning Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Social Functioning Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Pain Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Mental Health Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score
time frame: Baseline, Month 6 and Month 12
description: Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
measure: Change From Baseline in Patient Perception of Stress
time frame: Baseline, Month 6 and Month 12
description: Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.
measure: Change From Baseline in Psychological Well-being
time frame: Baseline, Month 6 and Month 12
description: Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.
measure: Change From Baseline in Coping Self-Efficacy
time frame: Baseline, Month 6 and Month 12
description: Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.
measure: Health Resource Utilization
time frame: Baseline, Month 6 and Month 12
description: Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.
measure: Viral Load at Each Visit
time frame: Baseline, Month 6 and Month 12
measure: Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit
time frame: Baseline, Month 6 and Month 12
measure: Healthcare Provider Satisfaction
time frame: Month 6 and Month 12
description: For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.
arm group label: Lopinavir/Ritonavir + KASA
description: Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
intervention type: Drug
intervention name: Lopinavir / ritonavir
description: Prescribed according to the product monograph and physician's discretion.
arm group label: Lopinavir/Ritonavir + KASA
other name: Kaletra®
other name: LPV/r
intervention type: Behavioral
intervention name: Kaletra Adherence Support Assistance Program
description: A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
arm group label: Lopinavir/Ritonavir + KASA
other name: KASA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Pelizon, MD
role: Study Director
affiliation: AbbVie Corporation
country: Canada
url: http://rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Virus Diseases
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes
mesh term: Ritonavir
mesh term: Lopinavir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 