<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/NCT01707030</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 12-009</org_study_id>
    <nct_id>NCT01707030</nct_id>
  </id_info>
  <brief_title>Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C</brief_title>
  <official_title>Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous&#xD;
      for them than it is for a non-infected person. In this VA study, such individuals will be&#xD;
      screened and given feedback on their drinking using an Internet-based program which has been&#xD;
      shown to reduce drinking in other populations. The research team will evaluate whether the&#xD;
      program helps Veterans drink less over time and thereby improve their health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As many as 80% of Veterans with the hepatitis C virus (HCV) engage in harmful drinking. This&#xD;
      is a major health challenge given that even light and moderate alcohol consumption can worsen&#xD;
      the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In&#xD;
      response, the VA Uniform Mental Health Services Package has made it a priority that HCV and&#xD;
      other ambulatory clinics provide evidence-based mental health services to all Veterans&#xD;
      engaging in harmful drinking within two week (but preferably the same day as the clinic&#xD;
      visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA&#xD;
      Operations (10N), and the VA Office of Public Health, are strongly committed to achieving&#xD;
      this standard throughout the Veterans Health Administration (VHA). However, the cost and&#xD;
      organizational challenges to meeting this mandate in HCV clinics are enormous, but may be&#xD;
      surmountable through the use of self-directed technology that minimizes demands on scarce&#xD;
      staff time.&#xD;
&#xD;
      The primary objective of this study is to implement and evaluate a web-based brief alcohol&#xD;
      intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics -&#xD;
      Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs&#xD;
      Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators&#xD;
      plan to assess patient, provider, and system factors that may impact the initial adoption of&#xD;
      this intervention in two VA HCV clinics. These data will result in the development of a&#xD;
      protocol for the initial implementation of the web-based BAI at the investigators' two study&#xD;
      sites. A secondary aim will involve obtaining patient and provider feedback on an existing&#xD;
      web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use&#xD;
      with this population. Second (Aim 2), the investigators will implement and examine the&#xD;
      effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans&#xD;
      with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will&#xD;
      conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and&#xD;
      diffusion of the web-based BAI and the trajectory of health care spending for study&#xD;
      participants.&#xD;
&#xD;
      This mixed-methods study will utilize qualitative and quantitative methods to achieve its&#xD;
      three primary aims. To address aim 1, qualitative interviews will be used to collect data&#xD;
      that will inform the initial implementation and re-versioning of a web-based BAI for use in&#xD;
      two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the&#xD;
      investigators will use a randomized, hybrid (type 1) design with patient level clinical&#xD;
      outcome data and formative evaluation data collected to examine the effectiveness of the&#xD;
      web-based BAI. &quot;Hybrid&quot; designs also integrate formative evaluation into experimental designs&#xD;
      to identify factors that impact the effectiveness of implementation efforts. Formative&#xD;
      evaluation (e.g., site visits, clinic observation, and interviews with staff and patients)&#xD;
      will be used to improve the adoption of the web-based BAI at both sites and to provide&#xD;
      evidence-based guidance to the investigators' CREATE operational partners for nationwide&#xD;
      implementation. To address aim 3, the investigators will conduct a budget impact analysis to&#xD;
      estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and&#xD;
      the trajectory of health care spending for study participants. The investigators plan to&#xD;
      collect several types of utilization data, including outpatient, inpatient, and pharmacy&#xD;
      utilization, and calculate total dollars.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">June 29, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Days of Unhealthy Alcohol Consumption</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Drinking Days</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>The number of days on which alcohol was consumed at any level in the last 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Drinks Per Drinking Day</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptoms of Psychological Distress (PHQ-9)</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 Physical Health Composite</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Additional Care</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in SF-12 Mental Health Composite</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>BAI Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving a web-based brief intervention for alcohol problems</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Web-Based Brief Alcohol Intervention</intervention_name>
    <description>Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.</description>
    <arm_group_label>BAI Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
    <arm_group_label>BAI Arm</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a US military veteran.&#xD;
&#xD;
          -  Over the age of 17 with liver disease.&#xD;
&#xD;
          -  Must be receiving care at a VA liver clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with no current or historical use of alcohol.&#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>Keith N. Humphreys, PhD MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Palo Alto Health Care System, Palo Alto, CA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael A Cucciare, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System, Palo Alto, CA</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304-1290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco VA Medical Center, San Francisco, CA</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.</citation>
    <PMID>26467975</PMID>
  </reference>
  <results_reference>
    <citation>Cucciare MA, Timko C. Bridging the gap between medical settings and specialty addiction treatment. Addiction. 2015 Sep;110(9):1417-9. doi: 10.1111/add.12977. No abstract available.</citation>
    <PMID>26223170</PMID>
  </results_reference>
  <results_reference>
    <citation>Cucciare MA, Cheung RC, Rongey C. Treating substance use disorders in patients with hepatitis C. Addiction. 2015 Jul;110(7):1057-9. doi: 10.1111/add.12893. Epub 2015 Mar 27. No abstract available.</citation>
    <PMID>25816843</PMID>
  </results_reference>
  <results_reference>
    <citation>Timko C, Kong C, Vittorio L, Cucciare MA. Screening and brief intervention for unhealthy substance use in patients with chronic medical conditions: a systematic review. J Clin Nurs. 2016 Nov;25(21-22):3131-3143. doi: 10.1111/jocn.13244. Epub 2016 May 3.</citation>
    <PMID>27140392</PMID>
  </results_reference>
  <results_reference>
    <citation>Cucciare MA, Jamison AL, Combs AS, Joshi G, Cheung RC, Rongey C, Huggins J, Humphreys K. Adapting a computer-delivered brief alcohol intervention for veterans with Hepatitis C. Inform Health Soc Care. 2017 Dec;42(4):378-392. doi: 10.1080/17538157.2016.1255628. Epub 2017 Jan 9.</citation>
    <PMID>28068154</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>August 27, 2019</results_first_submitted>
  <results_first_submitted_qc>August 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2019</results_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clinical trial</keyword>
  <keyword>veteran</keyword>
  <keyword>substance use disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT01707030/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Web-Based BAI Arm</title>
          <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care Arm</title>
          <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention: Computer-Based Brief Alcohol Intervention</title>
          <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Intervention participants will also receive usual care.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
        </group>
        <group group_id="B2">
          <title>Control: Treatment as Usual</title>
          <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="67"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="138"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" spread="8.682"/>
                    <measurement group_id="B2" value="63" spread="7.212"/>
                    <measurement group_id="B3" value="63.5" spread="8.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="133"/>
                  </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>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Asian and/or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African Amerian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White/Caucasion, not of Hispanic origin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Declined to State/Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Days of Unhealthy Alcohol Consumption</title>
        <description>The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.</description>
        <time_frame>Baseline, 3 months, and 6 months</time_frame>
        <population>Not all participants were able to complete all follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
        <group_list>
          <group group_id="O1">
            <title>BAI Arm</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Days of Unhealthy Alcohol Consumption</title>
          <description>The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.</description>
          <population>Not all participants were able to complete all follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
          <units>Unhealthy drinking days in last 30</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Days of Unhealthy Alcohol Consumption</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.46" spread="9.24"/>
                    <measurement group_id="O2" value="7.16" spread="10.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-mo Days of Unhealthy Alcohol Consumption</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.72" spread="6.69"/>
                    <measurement group_id="O2" value="5.56" spread="10.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-mo Days of Unhealthy Alcohol Consumption</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="6.37"/>
                    <measurement group_id="O2" value="4.78" spread="9.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Drinking Days</title>
        <description>The number of days on which alcohol was consumed at any level in the last 30 days.</description>
        <time_frame>Baseline, 3 months, and 6 months</time_frame>
        <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention: Web Based BAI</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
          <group group_id="O2">
            <title>Control: Usual Care</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Drinking Days</title>
          <description>The number of days on which alcohol was consumed at any level in the last 30 days.</description>
          <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
          <units>Number of drinking days in last 30</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline drinking days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.39" spread="10.44"/>
                    <measurement group_id="O2" value="12.41" spread="11.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-mo drinking days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.20" spread="8.09"/>
                    <measurement group_id="O2" value="7.77" spread="10.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-mo drinking days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.61" spread="7.66"/>
                    <measurement group_id="O2" value="8.26" spread="10.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Drinks Per Drinking Day</title>
        <description>The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.</description>
        <time_frame>Baseline, 3 months, and 6 months</time_frame>
        <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention: Web Based BAI</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
          <group group_id="O2">
            <title>Control: Usual Care</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Drinks Per Drinking Day</title>
          <description>The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.</description>
          <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
          <units>Drinks per Drinking Day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Drinks per Drinking Day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="3.90"/>
                    <measurement group_id="O2" value="3.72" spread="3.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-mo Drinks per Drinking Day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="2.47"/>
                    <measurement group_id="O2" value="2.17" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-mo Drinks per Drinking Day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" spread="2.85"/>
                    <measurement group_id="O2" value="1.87" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Symptoms of Psychological Distress (PHQ-9)</title>
        <description>Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.</description>
        <time_frame>Baseline, 3 months, and 6 months</time_frame>
        <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention: Web Based BAI</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
          <group group_id="O2">
            <title>Control: Usual Care</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Symptoms of Psychological Distress (PHQ-9)</title>
          <description>Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.</description>
          <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline PHQ-9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" spread="5.70"/>
                    <measurement group_id="O2" value="6.68" spread="5.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-mo PHQ-9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.03" spread="5.65"/>
                    <measurement group_id="O2" value="6.91" spread="6.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-mo PHQ-9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.57" spread="5.07"/>
                    <measurement group_id="O2" value="7.44" spread="7.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 Physical Health Composite</title>
        <description>The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.</description>
        <time_frame>Baseline, 3 months, and 6 months</time_frame>
        <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention: Web Based BAI</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
          <group group_id="O2">
            <title>Control: Usual Care</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 Physical Health Composite</title>
          <description>The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.</description>
          <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SF-12 Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.43" spread="12.20"/>
                    <measurement group_id="O2" value="40.49" spread="11.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3mo SF-12 Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.92" spread="12.25"/>
                    <measurement group_id="O2" value="41.59" spread="12.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6mo SF-12 Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.21" spread="10.43"/>
                    <measurement group_id="O2" value="40.75" spread="12.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Additional Care</title>
        <description>Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>These are the same individuals enrolled in the clinical trial from whom the primary outcomes were assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Web-Based BAI Arm</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Arm</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Additional Care</title>
          <description>Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.</description>
          <population>These are the same individuals enrolled in the clinical trial from whom the primary outcomes were assessed.</population>
          <units>US Dollars</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42412" spread="5381"/>
                    <measurement group_id="O2" value="51667" spread="8611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in SF-12 Mental Health Composite</title>
        <description>The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.</description>
        <time_frame>Baseline, 3 months, and 6 months</time_frame>
        <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention: Web Based BAI</title>
            <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
          <group group_id="O2">
            <title>Control: Usual Care</title>
            <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 Mental Health Composite</title>
          <description>The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.</description>
          <population>Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SF-12 Mental Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.10" spread="12.72"/>
                    <measurement group_id="O2" value="48.91" spread="11.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3mo SF-12 Mental Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.83" spread="9.94"/>
                    <measurement group_id="O2" value="49.25" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 mo SF-12 Mental Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.63" spread="10.59"/>
                    <measurement group_id="O2" value="48.51" spread="12.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected for 4 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention: Web-Based BAI Arm</title>
          <description>Receiving a web-based brief intervention for alcohol problems&#xD;
Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.</description>
        </group>
        <group group_id="E2">
          <title>Control: Usual Care Arm</title>
          <description>In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls&#xD;
Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Intervention: Unable to pinpoint cause of death at time of entry as participant had multiple disorders which could have caused death. Control: Renal Disease</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
              </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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Micheal Cucciare</name_or_title>
      <organization>Department of Veterans Affairs</organization>
      <phone>501-257-1068</phone>
      <email>Michael.Cucciare@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01707030
org study id: CRE 12-009
nct id: NCT01707030
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous
      for them than it is for a non-infected person. In this VA study, such individuals will be
      screened and given feedback on their drinking using an Internet-based program which has been
      shown to reduce drinking in other populations. The research team will evaluate whether the
      program helps Veterans drink less over time and thereby improve their health.
As many as 80% of Veterans with the hepatitis C virus (HCV) engage in harmful drinking. This
      is a major health challenge given that even light and moderate alcohol consumption can worsen
      the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In
      response, the VA Uniform Mental Health Services Package has made it a priority that HCV and
      other ambulatory clinics provide evidence-based mental health services to all Veterans
      engaging in harmful drinking within two week (but preferably the same day as the clinic
      visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA
      Operations (10N), and the VA Office of Public Health, are strongly committed to achieving
      this standard throughout the Veterans Health Administration (VHA). However, the cost and
      organizational challenges to meeting this mandate in HCV clinics are enormous, but may be
      surmountable through the use of self-directed technology that minimizes demands on scarce
      staff time.

      The primary objective of this study is to implement and evaluate a web-based brief alcohol
      intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics -
      Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs
      Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators
      plan to assess patient, provider, and system factors that may impact the initial adoption of
      this intervention in two VA HCV clinics. These data will result in the development of a
      protocol for the initial implementation of the web-based BAI at the investigators' two study
      sites. A secondary aim will involve obtaining patient and provider feedback on an existing
      web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use
      with this population. Second (Aim 2), the investigators will implement and examine the
      effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans
      with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will
      conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and
      diffusion of the web-based BAI and the trajectory of health care spending for study
      participants.

      This mixed-methods study will utilize qualitative and quantitative methods to achieve its
      three primary aims. To address aim 1, qualitative interviews will be used to collect data
      that will inform the initial implementation and re-versioning of a web-based BAI for use in
      two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the
      investigators will use a randomized, hybrid (type 1) design with patient level clinical
      outcome data and formative evaluation data collected to examine the effectiveness of the
      web-based BAI. "Hybrid" designs also integrate formative evaluation into experimental designs
      to identify factors that impact the effectiveness of implementation efforts. Formative
      evaluation (e.g., site visits, clinic observation, and interviews with staff and patients)
      will be used to improve the adoption of the web-based BAI at both sites and to provide
      evidence-based guidance to the investigators' CREATE operational partners for nationwide
      implementation. To address aim 3, the investigators will conduct a budget impact analysis to
      estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and
      the trajectory of health care spending for study participants. The investigators plan to
      collect several types of utilization data, including outpatient, inpatient, and pharmacy
      utilization, and calculate total dollars.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Days of Unhealthy Alcohol Consumption
time frame: Baseline, 3 months, and 6 months
description: The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.
measure: Change in Drinking Days
time frame: Baseline, 3 months, and 6 months
description: The number of days on which alcohol was consumed at any level in the last 30 days.
measure: Change in Drinks Per Drinking Day
time frame: Baseline, 3 months, and 6 months
description: The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.
measure: Change in Symptoms of Psychological Distress (PHQ-9)
time frame: Baseline, 3 months, and 6 months
description: Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.
measure: Change in SF-12 Physical Health Composite
time frame: Baseline, 3 months, and 6 months
description: The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.
measure: Change in Additional Care
time frame: Baseline and 12 months
description: Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.
measure: Change in SF-12 Mental Health Composite
time frame: Baseline, 3 months, and 6 months
description: The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.
arm group label: BAI Arm
arm group type: Experimental
description: Receiving a web-based brief intervention for alcohol problems
arm group label: Usual Care
arm group type: Active Comparator
description: In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls
intervention type: Other
intervention name: Web-Based Brief Alcohol Intervention
description: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.
arm group label: BAI Arm
intervention type: Other
intervention name: Usual Care
description: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
arm group label: BAI Arm
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Keith N. Humphreys, PhD MA
role: Principal Investigator
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
last name: Michael A Cucciare, PhD
role: Principal Investigator
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
facility: 
facility: 
country: United States
citation: Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.
PMID: 26467975
citation: Cucciare MA, Timko C. Bridging the gap between medical settings and specialty addiction treatment. Addiction. 2015 Sep;110(9):1417-9. doi: 10.1111/add.12977. No abstract available.
PMID: 26223170
citation: Cucciare MA, Cheung RC, Rongey C. Treating substance use disorders in patients with hepatitis C. Addiction. 2015 Jul;110(7):1057-9. doi: 10.1111/add.12893. Epub 2015 Mar 27. No abstract available.
PMID: 25816843
citation: Timko C, Kong C, Vittorio L, Cucciare MA. Screening and brief intervention for unhealthy substance use in patients with chronic medical conditions: a systematic review. J Clin Nurs. 2016 Nov;25(21-22):3131-3143. doi: 10.1111/jocn.13244. Epub 2016 May 3.
PMID: 27140392
citation: Cucciare MA, Jamison AL, Combs AS, Joshi G, Cheung RC, Rongey C, Huggins J, Humphreys K. Adapting a computer-delivered brief alcohol intervention for veterans with Hepatitis C. Inform Health Soc Care. 2017 Dec;42(4):378-392. doi: 10.1080/17538157.2016.1255628. Epub 2017 Jan 9.
PMID: 28068154
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Alcoholism
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 