<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/NCT03779997</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00005069</org_study_id>
    <secondary_id>4R44DA044053-02</secondary_id>
    <nct_id>NCT03779997</nct_id>
  </id_info>
  <brief_title>Trial of Adherence App for Buprenorphine Treatment (TAAB) Study</brief_title>
  <official_title>Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders With Buprenorphine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>emocha Mobile Health, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to pilot test a smartphone application that allows video-based&#xD;
      directly observed therapy for participants receiving buprenorphine treatment for opioid use&#xD;
      disorder in office-based settings. This application may help participants take their&#xD;
      medication more regularly so that they are successful in treatment. Participants will be&#xD;
      randomly assigned to either using a smartphone application that allows them to take daily&#xD;
      videos confirming their buprenorphine medication ingestion or they will continue with their&#xD;
      care as usual (treatment-as-usual or TAU). The primary study outcome will be the percentage&#xD;
      of weekly study urine drug tests that are negative for opiates between baseline and 12 weeks&#xD;
      post-randomization. The secondary outcome will be engagement in treatment at week 12.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to compare an innovative mobile health (mHealth) platform to&#xD;
      support participants being treated for opioid use disorder (OUD) with buprenorphine to&#xD;
      treatment-as-usual (TAU). The application will provide video-based directly observed therapy&#xD;
      (VDOT) which may result in better health outcomes for participants and less public health&#xD;
      risk for diversion. This study is a randomized controlled trial with two arms: TAU and&#xD;
      mHealth intervention. Randomization to the two study arms will be completed using computer&#xD;
      randomization procedures. Participants in the intervention group will learn how to use the&#xD;
      mHealth application on their personal smartphones or tablets. If a participant does not have&#xD;
      access to a personal device or prefers to not use a personal device then a study-provided&#xD;
      smartphone will be offered for the duration of the study. Intervention participants are asked&#xD;
      to record one daily video of themselves taking buprenorphine. Buprenorphine clinical staff&#xD;
      (i.e., physicians, nurses and medical assistants) of patients enrolled in the intervention&#xD;
      group will be trained and have the opportunity to review the videos. Adherence for the&#xD;
      intervention group will be measured through participation in VDOT, namely the percentage of&#xD;
      daily medication doses that are observed through submitted videos. The TAU group will not be&#xD;
      given access to the intervention and therefore will not have the opportunity to be exposed to&#xD;
      the intervention.&#xD;
&#xD;
      All participants will follow the same visit schedule. Interviews will occur at baseline (Week&#xD;
      0) and the final visit (Week 12) to assess current and prior substance use, treatment&#xD;
      history, medication adherence, drug diversion, general physical and mental health and&#xD;
      treatment satisfaction. A point of care urine drug test will also be administered which will&#xD;
      assess for opiates and other substances. In between the baseline and final visits,&#xD;
      participants will meet with research staff weekly to conduct a urine drug test and assess&#xD;
      self-reported adherence to buprenorphine. Research staff will review the electronic medical&#xD;
      record at baseline and week 12 to assess engagement in treatment. Additionally, at 24 weeks&#xD;
      post-enrollment the research staff will complete a review of the electronic medical record&#xD;
      and record engagement in clinic treatment, changes in buprenorphine treatment during the&#xD;
      study period and the results of any clinical urine drug testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">July 29, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</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>Percentage Opioid Negative Urine Tests</measure>
    <time_frame>Baseline to 12 weeks post-randomization</time_frame>
    <description>Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Engaged in Treatment at Week 12</measure>
    <time_frame>Week 12 post-randomization</time_frame>
    <description>The percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants Engaged in Treatment at Week 24</measure>
    <time_frame>Week 24 post-randomization</time_frame>
    <description>The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.</description>
  </other_outcome>
  <other_outcome>
    <measure>Consecutive Weeks Opioid Negative Urine Tests</measure>
    <time_frame>Baseline to 12 weeks post-randomization</time_frame>
    <description>The number of consecutive weeks with urine drug test negative for opioids.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Self-report of Opioid Use</measure>
    <time_frame>Week 12 post-randomization</time_frame>
    <description>Self-reported use of illicit opioids in past 30 days at week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Buprenorphine Adherence Self-Report</measure>
    <time_frame>Baseline to 12 weeks post-randomization</time_frame>
    <description>Mean number of days adherent to buprenorphine by self-report over the 12-week study period, using a 7-day timeline-follow-back (TLFB) survey procedure each week. Days with missing data were excluded from analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Discharge</measure>
    <time_frame>Baseline to 24 weeks post-randomization</time_frame>
    <description>Time to discharge from treatment, measured by EHR review.</description>
  </other_outcome>
  <other_outcome>
    <measure>Buprenorphine Non-use: One or More UDT Negative for Buprenorphine</measure>
    <time_frame>Baseline to 12 weeks post-randomization</time_frame>
    <description>Having one or more study urine drug tests negative for buprenorphine</description>
  </other_outcome>
  <other_outcome>
    <measure>UDT Positive for Stimulants at Week 12</measure>
    <time_frame>Week 12 post-randomization</time_frame>
    <description>Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>Week 12 post-randomization</time_frame>
    <description>Likert scale survey question of participant's satisfaction with clinic's treatment of opioid use disorder (OUD); on a scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Opioid-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Video-based DOT Application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video-based DOT Application</intervention_name>
    <description>Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
    <arm_group_label>Video-based DOT Application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Receiving buprenorphine treatment at an office-based buprenorphine program for ≤4&#xD;
             weeks&#xD;
&#xD;
          -  Willing to be randomized to either VDOT or TAU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to use smart phone&#xD;
&#xD;
          -  Cognitive impairment resulting in inability to provide informed consent&#xD;
&#xD;
          -  Researcher's discretion that participant will not be appropriate for participation in&#xD;
             the study (e.g. participant is planning on moving away, is knowledgeable of future&#xD;
             incarceration during the study, or has behavioral issues that may pose safety concerns&#xD;
             for clinic and research staff)&#xD;
&#xD;
          -  Inability to read and understand English as needed for following app instructions&#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>Judith I. Tsui, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Schramm ZA, Leroux BG, Radick AC, Ventura AS, Klein JW, Samet JH, Saxon AJ, Kim TW, Tsui JI. Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2020 Jul 31;15(1):30. doi: 10.1186/s13722-020-00203-9.</citation>
    <PMID>32736660</PMID>
  </reference>
  <results_reference>
    <citation>Tsui JI, Leroux BG, Radick AC, Schramm ZA, Blalock K, Labelle C, Heerema M, Klein JW, Merrill JO, Saxon AJ, Samet JH, Kim TW. Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial. Drug Alcohol Depend. 2021 Oct 1;227:108917. doi: 10.1016/j.drugalcdep.2021.108917. Epub 2021 Jul 28.</citation>
    <PMID>34399136</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>May 5, 2021</results_first_submitted>
  <results_first_submitted_qc>June 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 1, 2021</results_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Judith I. Tsui</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Buprenorphine</keyword>
  <keyword>Directly Observed Therapy</keyword>
  <keyword>mHealth</keyword>
  <keyword>Opioid Abuse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</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>April 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03779997/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Video-based DOT Application</title>
          <description>Video-based directly observed therapy (DOT) Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
        </group>
        <group group_id="P2">
          <title>Treatment as Usual (TAU)</title>
          <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed at Least One Visit</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Video-based DOT Application</title>
          <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
        </group>
        <group group_id="B2">
          <title>Treatment as Usual (TAU)</title>
          <description>Office-based buprenorphine treatment</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="39"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="78"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.7" spread="11.9"/>
                    <measurement group_id="B2" value="40.7" spread="12.0"/>
                    <measurement group_id="B3" value="41.7" spread="11.9"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Study Site</title>
          <description>Site of enrollment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seattle</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Boston</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <description>Self-reported participant education level</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than a high school diploma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school diploma/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some post-high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Postgraduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Buprenorphine Treatment</title>
          <description>Self-report at baseline of receiving prior buprenorphine treatment prescribed by a doctor (No/Yes).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Homelessness</title>
          <description>Self-reported baseline homelessness within the past 3 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not homeless</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Homeless</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Opioid Negative Urine Tests</title>
        <description>Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.</description>
        <time_frame>Baseline to 12 weeks post-randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Opioid Negative Urine Tests</title>
          <description>Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.</description>
          <units>urine drug tests</units>
          <param>Count of Units</param>
          <units_analyzed>urine drug tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>urine drug tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="468"/>
                <count group_id="O2" value="468"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="234"/>
                    <measurement group_id="O2" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>Log-linear GEE regression</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.78</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Engaged in Treatment at Week 12</title>
        <description>The percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.</description>
        <time_frame>Week 12 post-randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Engaged in Treatment at Week 12</title>
          <description>The percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>Poisson regression with robust SEs</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.84</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants Engaged in Treatment at Week 24</title>
        <description>The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.</description>
        <time_frame>Week 24 post-randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Engaged in Treatment at Week 24</title>
          <description>The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>Poisson regression with robust SEs</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.73</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Consecutive Weeks Opioid Negative Urine Tests</title>
        <description>The number of consecutive weeks with urine drug test negative for opioids.</description>
        <time_frame>Baseline to 12 weeks post-randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Consecutive Weeks Opioid Negative Urine Tests</title>
          <description>The number of consecutive weeks with urine drug test negative for opioids.</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Weeks</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Weeks</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="4.2"/>
                    <measurement group_id="O2" value="5.7" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.31</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.9</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>TAU is the reference group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Self-report of Opioid Use</title>
        <description>Self-reported use of illicit opioids in past 30 days at week 12.</description>
        <time_frame>Week 12 post-randomization</time_frame>
        <population>There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Self-report of Opioid Use</title>
          <description>Self-reported use of illicit opioids in past 30 days at week 12.</description>
          <population>There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.57</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>Poisson regression with robust SEs</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.71</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
            <estimate_desc>TAU is the reference group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Buprenorphine Adherence Self-Report</title>
        <description>Mean number of days adherent to buprenorphine by self-report over the 12-week study period, using a 7-day timeline-follow-back (TLFB) survey procedure each week. Days with missing data were excluded from analysis.</description>
        <time_frame>Baseline to 12 weeks post-randomization</time_frame>
        <population>Missing days are excluded from analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Buprenorphine Adherence Self-Report</title>
          <description>Mean number of days adherent to buprenorphine by self-report over the 12-week study period, using a 7-day timeline-follow-back (TLFB) survey procedure each week. Days with missing data were excluded from analysis.</description>
          <population>Missing days are excluded from analysis.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Days</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Days</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="378"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.99" spread="2.18"/>
                    <measurement group_id="O2" value="5.93" spread="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.88</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>GEE Poisson regression</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.01</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.066</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>TAU is the reference group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Discharge</title>
        <description>Time to discharge from treatment, measured by EHR review.</description>
        <time_frame>Baseline to 24 weeks post-randomization</time_frame>
        <population>Data was not avaiable on video-based DOT application participants. Therefore, data analysis is not possible.</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Discharge</title>
          <description>Time to discharge from treatment, measured by EHR review.</description>
          <population>Data was not avaiable on video-based DOT application participants. Therefore, data analysis is not possible.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="NA" spread="NA">Data collected on only 4 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Buprenorphine Non-use: One or More UDT Negative for Buprenorphine</title>
        <description>Having one or more study urine drug tests negative for buprenorphine</description>
        <time_frame>Baseline to 12 weeks post-randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Buprenorphine Non-use: One or More UDT Negative for Buprenorphine</title>
          <description>Having one or more study urine drug tests negative for buprenorphine</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.77</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>Poisson regression with robust SEs</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.17</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.60</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>3.24</ci_upper_limit>
            <estimate_desc>TAU is the reference group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>UDT Positive for Stimulants at Week 12</title>
        <description>Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).</description>
        <time_frame>Week 12 post-randomization</time_frame>
        <population>There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>UDT Positive for Stimulants at Week 12</title>
          <description>Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).</description>
          <population>There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.30</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance.</p_value_desc>
            <method>Poisson regression with robust SEs</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.67</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
            <estimate_desc>TAU is the reference group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Satisfaction</title>
        <description>Likert scale survey question of participant's satisfaction with clinic's treatment of opioid use disorder (OUD); on a scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied.</description>
        <time_frame>Week 12 post-randomization</time_frame>
        <population>There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Video-based DOT Application</title>
            <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual (TAU)</title>
            <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction</title>
          <description>Likert scale survey question of participant's satisfaction with clinic's treatment of opioid use disorder (OUD); on a scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied.</description>
          <population>There were 15 missing survey responses among the video DOT application arm and 9 missing from the TAU arm, these participants were excluded from the analysis.</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="24"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="0.6"/>
                    <measurement group_id="O2" value="4.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: No difference between arms in mean treatment satisfaction scores</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.91</p_value>
            <p_value_desc>0.05 a priori threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
            <estimate_desc>TAU is the reference group</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Video-based DOT Application</title>
          <description>Video-based DOT Application: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.</description>
        </group>
        <group group_id="E2">
          <title>Treatment as Usual (TAU)</title>
          <description>Treatment-as-usual administered at office-based buprenorphine treatment clinics.</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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>In-patient hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>In-patient hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>In-patient hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>In-patient hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>In-patient hospitalization</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>In-patient hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea from medicine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Generall Illness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain - lower extremities</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations of the study included a small sample size and limited power for detecting small but clinically meaningful differences in outcomes. The study did not provide participants with incentives for using the intervention, which may have resulted in low rates of use. Limited provider and clinic staff involvement in the intervention is another limitation that may have affected the uptake of video DOT.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Judith I. Tsui</name_or_title>
      <organization>University of Washington</organization>
      <phone>206-744-1835</phone>
      <email>tsuij@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779997
org study id: STUDY00005069
secondary id: 4R44DA044053-02
nct id: NCT03779997
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to pilot test a smartphone application that allows video-based
      directly observed therapy for participants receiving buprenorphine treatment for opioid use
      disorder in office-based settings. This application may help participants take their
      medication more regularly so that they are successful in treatment. Participants will be
      randomly assigned to either using a smartphone application that allows them to take daily
      videos confirming their buprenorphine medication ingestion or they will continue with their
      care as usual (treatment-as-usual or TAU). The primary study outcome will be the percentage
      of weekly study urine drug tests that are negative for opiates between baseline and 12 weeks
      post-randomization. The secondary outcome will be engagement in treatment at week 12.
The objective of this study is to compare an innovative mobile health (mHealth) platform to
      support participants being treated for opioid use disorder (OUD) with buprenorphine to
      treatment-as-usual (TAU). The application will provide video-based directly observed therapy
      (VDOT) which may result in better health outcomes for participants and less public health
      risk for diversion. This study is a randomized controlled trial with two arms: TAU and
      mHealth intervention. Randomization to the two study arms will be completed using computer
      randomization procedures. Participants in the intervention group will learn how to use the
      mHealth application on their personal smartphones or tablets. If a participant does not have
      access to a personal device or prefers to not use a personal device then a study-provided
      smartphone will be offered for the duration of the study. Intervention participants are asked
      to record one daily video of themselves taking buprenorphine. Buprenorphine clinical staff
      (i.e., physicians, nurses and medical assistants) of patients enrolled in the intervention
      group will be trained and have the opportunity to review the videos. Adherence for the
      intervention group will be measured through participation in VDOT, namely the percentage of
      daily medication doses that are observed through submitted videos. The TAU group will not be
      given access to the intervention and therefore will not have the opportunity to be exposed to
      the intervention.

      All participants will follow the same visit schedule. Interviews will occur at baseline (Week
      0) and the final visit (Week 12) to assess current and prior substance use, treatment
      history, medication adherence, drug diversion, general physical and mental health and
      treatment satisfaction. A point of care urine drug test will also be administered which will
      assess for opiates and other substances. In between the baseline and final visits,
      participants will meet with research staff weekly to conduct a urine drug test and assess
      self-reported adherence to buprenorphine. Research staff will review the electronic medical
      record at baseline and week 12 to assess engagement in treatment. Additionally, at 24 weeks
      post-enrollment the research staff will complete a review of the electronic medical record
      and record engagement in clinic treatment, changes in buprenorphine treatment during the
      study period and the results of any clinical urine drug testing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage Opioid Negative Urine Tests
time frame: Baseline to 12 weeks post-randomization
description: Percentage of weekly study urine drug tests that are negative for opioids, missing assumed to be positive.
measure: Percentage of Participants Engaged in Treatment at Week 12
time frame: Week 12 post-randomization
description: The percentage of participants with an active script for buprenorphine at week 12 (engaged in treatment), measured by electronic health record (EHR) review.
measure: Percentage of Participants Engaged in Treatment at Week 24
time frame: Week 24 post-randomization
description: The percentage of participants engaged in treatment at 24 weeks post-randomization, measured by EHR review.
measure: Consecutive Weeks Opioid Negative Urine Tests
time frame: Baseline to 12 weeks post-randomization
description: The number of consecutive weeks with urine drug test negative for opioids.
measure: Number of Participants With Self-report of Opioid Use
time frame: Week 12 post-randomization
description: Self-reported use of illicit opioids in past 30 days at week 12.
measure: Buprenorphine Adherence Self-Report
time frame: Baseline to 12 weeks post-randomization
description: Mean number of days adherent to buprenorphine by self-report over the 12-week study period, using a 7-day timeline-follow-back (TLFB) survey procedure each week. Days with missing data were excluded from analysis.
measure: Treatment Discharge
time frame: Baseline to 24 weeks post-randomization
description: Time to discharge from treatment, measured by EHR review.
measure: Buprenorphine Non-use: One or More UDT Negative for Buprenorphine
time frame: Baseline to 12 weeks post-randomization
description: Having one or more study urine drug tests negative for buprenorphine
measure: UDT Positive for Stimulants at Week 12
time frame: Week 12 post-randomization
description: Number of participants having a study urine drug test positive for stimulants (cocaine, amphetamines or methamphetamines).
measure: Treatment Satisfaction
time frame: Week 12 post-randomization
description: Likert scale survey question of participant's satisfaction with clinic's treatment of opioid use disorder (OUD); on a scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied.
arm group label: Video-based DOT Application
arm group type: Experimental
arm group label: Treatment as Usual (TAU)
arm group type: No Intervention
intervention type: Behavioral
intervention name: Video-based DOT Application
description: Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
arm group label: Video-based DOT Application
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith I. Tsui, MD, MPH
role: Principal Investigator
affiliation: University of Washington
facility: 
facility: 
country: United States
citation: Schramm ZA, Leroux BG, Radick AC, Ventura AS, Klein JW, Samet JH, Saxon AJ, Kim TW, Tsui JI. Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2020 Jul 31;15(1):30. doi: 10.1186/s13722-020-00203-9.
PMID: 32736660
citation: Tsui JI, Leroux BG, Radick AC, Schramm ZA, Blalock K, Labelle C, Heerema M, Klein JW, Merrill JO, Saxon AJ, Samet JH, Kim TW. Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial. Drug Alcohol Depend. 2021 Oct 1;227:108917. doi: 10.1016/j.drugalcdep.2021.108917. Epub 2021 Jul 28.
PMID: 34399136
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Judith I. Tsui
investigator title: Associate Professor of Medicine
mesh term: Opioid-Related Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations of the study included a small sample size and limited power for detecting small but clinically meaningful differences in outcomes. The study did not provide participants with incentives for using the intervention, which may have resulted in low rates of use. Limited provider and clinic staff involvement in the intervention is another limitation that may have affected the uptake of video DOT.
point of contact: 