<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/NCT03772327</url>
  </required_header>
  <id_info>
    <org_study_id>1308014206</org_study_id>
    <nct_id>NCT03772327</nct_id>
  </id_info>
  <brief_title>HIV Adherence Bottle Intervention Trial</brief_title>
  <acronym>HABIT</acronym>
  <official_title>HIV Adherence Bottle Intervention Trial (HABIT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AdhereTech</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</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>
      This is a randomized study for participants treated with tenofovir-based antiretroviral drug&#xD;
      regimens with a history of suboptimal adherence (detectable HIV RNA twice over the last&#xD;
      year). Eligible participants are enrolled, receive routine adherence counseling and are&#xD;
      randomized to receive an AdhereTech &quot;smart pill bottle&quot; or not (open label). The &quot;smart pill&#xD;
      bottle&quot; quantitates the number of tenofovir-containing pills taken and sends this to a&#xD;
      centralized server; if a dose is missed, the participant is contacted by either phone or&#xD;
      text. Participants are assessed at baseline and weeks 4, 8, and 12 for tenofovir diphosphate&#xD;
      (TFV-DP) levels (by plasma and dried red blood cell spots), HIV RNA level, and adherence&#xD;
      using a standardized questionnaire. Primary outcome is change in TFV-DP levels from baseline&#xD;
      in the 2 groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 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 Tenofovir Diphosphate (TFV-DP) Drug Levels</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Using dried blood spots from red blood cells, TFV-DP levels will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.</measure>
    <time_frame>Week 12</time_frame>
    <description>Feasibility of using the AdhereTech &quot;Smart Pill Bottles&quot; in individuals living with HIV as measured by the proportion of participants that complete the study compared between arms. A statistically lower proportion in the AdhereTech bottle arm compared to the routine counseling arm would suggest use of the bottle is not feasible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quantitative HIV Viral Load</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to &lt; 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>This is a measure of qualitative HIV RNA outcome. The number of participants &quot;converting&quot; from &quot;detectable&quot; (HIV RNA ≥ 20 copies/mL) at baseline to &quot;undetectable&quot; (HIV RNA &lt; 20 copies/mL) at week 12 in the AdhereTech bottle arm versus the routine counseling only arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TFV-DP Plasma Levels</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Assess TFV-DP plasma levels to compare to dried blood spot levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.</measure>
    <time_frame>Week 12</time_frame>
    <description>Analyze participant's self-reported adherence using National Institutes of Health AIDS Clinical Trials Group (ACTG) standardized and validated questionnaire of number of days with no missed doses of medication over prior 4 days (minimum 0, maximum 4). Number of days with missed doses was dichotomized to &quot;no missed doses&quot; (100% adherence) and &quot;≥ 1 missed dose.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>HIV-1-infection</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Routine counseling + AdhereTech bottle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive routine medication adherence counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adheretech &quot;smart bottle&quot;</intervention_name>
    <description>A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.</description>
    <arm_group_label>Routine counseling + AdhereTech bottle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine adherence counseling</intervention_name>
    <description>Participants will be provided with routine adherence counseling</description>
    <arm_group_label>Routine counseling</arm_group_label>
    <arm_group_label>Routine counseling + AdhereTech bottle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected&#xD;
&#xD;
          -  Taking a tenofovir-containing antiretroviral regimen for HIV treatment&#xD;
&#xD;
          -  Documented suboptimal adherence (2 HIV RNA levels documented above the level of&#xD;
             detection, i.e. not suppressed, on 2 occasions over the prior 52 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plans to change the current HIV drug regimen&#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>Roy M Gulick, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <results_first_submitted>July 29, 2019</results_first_submitted>
  <results_first_submitted_qc>September 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2019</results_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>September 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03772327/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment occurred primarily from the clinic population receiving care for HIV at New York Presbyterian Hospital Center for Special Studies located in New York City. A total of 24 and 42 participants were recruited from the Upper East Side and Chelsea locations respectively from May 2015 to August 2018.</recruitment_details>
      <pre_assignment_details>67 were screened for the study and 4 did not enroll because: 1 elected not to participate given excellent adherence to medications, 1 was ineligible after a switch off a tenofovir containing regimen, 1 did not come to the enrollment appointment, and 1 did not provide consent.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Routine Counseling + AdhereTech Bottle</title>
          <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
        </group>
        <group group_id="P2">
          <title>Routine Counseling</title>
          <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 0 Visit</title>
              <participants_list>
                <participants group_id="P1" count="28">2 participants were lost to follow up after randomization prior to any study interventions.</participants>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Routine Counseling + AdhereTech Bottle</title>
          <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
        </group>
        <group group_id="B2">
          <title>Routine Counseling</title>
          <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</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="30"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="63"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="48" upper_limit="56"/>
                    <measurement group_id="B2" value="49" lower_limit="42" upper_limit="52"/>
                    <measurement group_id="B3" value="51" lower_limit="43" upper_limit="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transgender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV RNA &lt;= 20 copies/mL</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4</title>
          <units>cells/μL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="380" lower_limit="227" upper_limit="580"/>
                    <measurement group_id="B2" value="428" lower_limit="306" upper_limit="616"/>
                    <measurement group_id="B3" value="409" lower_limit="242" upper_limit="612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of daily antiretroviral pills</title>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.</population>
          <units>pills per day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B2" value="3" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B3" value="3" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants reporting days of no missed doses in prior 4 days</title>
          <description>In the four days prior to baseline visit the number of days on which participants reported missing no doses of antiretroviral medication</description>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the adherence could be collected at the baseline visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>4 days</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 days</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>2 days</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 day</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No days</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants prescribed a tenofovir containing regimen</title>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants prescribed a NRTI containing regimen</title>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants prescribed a NNRTI containing regimen</title>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants prescribed a Protease inhibitor containing regimen</title>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants prescribed an Integrase inhibitor containing regimen</title>
          <population>2 participants in the Routine counseling + AdhereTech bottle group were lost to follow up before the medication data could be collected at the baseline visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <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>Change in Tenofovir Diphosphate (TFV-DP) Drug Levels</title>
        <description>Using dried blood spots from red blood cells, TFV-DP levels will be assessed.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Of the 5 in AdhereTech bottle group missing baseline TFV-DP levels 2 were lost to follow up prior to the visit and 3 are missing levels. 3 participants in AdhereTech group left the study before Week 12. 4 participants in the routine counseling group are missing TFV-DP levels from baseline visit and then 7 left the study prior to Week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Counseling + AdhereTech Bottle</title>
            <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
          <group group_id="O2">
            <title>Routine Counseling</title>
            <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tenofovir Diphosphate (TFV-DP) Drug Levels</title>
          <description>Using dried blood spots from red blood cells, TFV-DP levels will be assessed.</description>
          <population>Of the 5 in AdhereTech bottle group missing baseline TFV-DP levels 2 were lost to follow up prior to the visit and 3 are missing levels. 3 participants in AdhereTech group left the study before Week 12. 4 participants in the routine counseling group are missing TFV-DP levels from baseline visit and then 7 left the study prior to Week 12.</population>
          <units>fmol/punch</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1230" lower_limit="923" upper_limit="2066"/>
                    <measurement group_id="O2" value="1108" lower_limit="418" upper_limit="1886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1887" lower_limit="797" upper_limit="2794"/>
                    <measurement group_id="O2" value="1084" lower_limit="504" upper_limit="1175"/>
                  </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>The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.070</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.333</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.028</ci_lower_limit>
            <ci_upper_limit>0.694</ci_upper_limit>
            <estimate_desc>The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.</title>
        <description>Feasibility of using the AdhereTech &quot;Smart Pill Bottles&quot; in individuals living with HIV as measured by the proportion of participants that complete the study compared between arms. A statistically lower proportion in the AdhereTech bottle arm compared to the routine counseling arm would suggest use of the bottle is not feasible.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Routine Counseling + AdhereTech Bottle</title>
            <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
          <group group_id="O2">
            <title>Routine Counseling</title>
            <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.</title>
          <description>Feasibility of using the AdhereTech &quot;Smart Pill Bottles&quot; in individuals living with HIV as measured by the proportion of participants that complete the study compared between arms. A statistically lower proportion in the AdhereTech bottle arm compared to the routine counseling arm would suggest use of the bottle is not feasible.</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="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                  </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>The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p &gt; 0.05.</non_inferiority_desc>
            <p_value>0.89</p_value>
            <method>Chi-squared, Corrected</method>
            <method_desc>degrees of freedom = 1</method_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>0.045</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.179</ci_lower_limit>
            <ci_upper_limit>0.270</ci_upper_limit>
            <estimate_desc>This is the proportion of those completing a week 12 visit less those completing a week 0 visit.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quantitative HIV Viral Load</title>
        <description>Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. And additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Counseling + AdhereTech Bottle</title>
            <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
          <group group_id="O2">
            <title>Routine Counseling</title>
            <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quantitative HIV Viral Load</title>
          <description>Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.</description>
          <population>5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. And additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.</population>
          <units>copies/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" lower_limit="19" upper_limit="71"/>
                    <measurement group_id="O2" value="28" lower_limit="19" upper_limit="275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" lower_limit="19" upper_limit="49"/>
                    <measurement group_id="O2" value="26" lower_limit="19" upper_limit="406"/>
                  </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: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.328</p_value>
            <method>Kruskal-Wallis</method>
            <method_desc>Log transformation of viral load</method_desc>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.07</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Difference of log viral load at Week 12 less the log viral load at baseline</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to &lt; 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.</title>
        <description>This is a measure of qualitative HIV RNA outcome. The number of participants &quot;converting&quot; from &quot;detectable&quot; (HIV RNA ≥ 20 copies/mL) at baseline to &quot;undetectable&quot; (HIV RNA &lt; 20 copies/mL) at week 12 in the AdhereTech bottle arm versus the routine counseling only arm.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. An additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Counseling + AdhereTech Bottle</title>
            <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
          <group group_id="O2">
            <title>Routine Counseling</title>
            <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to &lt; 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.</title>
          <description>This is a measure of qualitative HIV RNA outcome. The number of participants &quot;converting&quot; from &quot;detectable&quot; (HIV RNA ≥ 20 copies/mL) at baseline to &quot;undetectable&quot; (HIV RNA &lt; 20 copies/mL) at week 12 in the AdhereTech bottle arm versus the routine counseling only arm.</description>
          <population>5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. An additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <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: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA &lt; 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.294</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.395</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.058</ci_lower_limit>
            <ci_upper_limit>2.044</ci_upper_limit>
            <estimate_desc>Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA &lt; 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TFV-DP Plasma Levels</title>
        <description>Assess TFV-DP plasma levels to compare to dried blood spot levels</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Funding was not obtained to obtain TFV-DP plasma levels in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Counseling + AdhereTech Bottle</title>
            <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
          <group group_id="O2">
            <title>Routine Counseling</title>
            <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
        </group_list>
        <measure>
          <title>TFV-DP Plasma Levels</title>
          <description>Assess TFV-DP plasma levels to compare to dried blood spot levels</description>
          <population>Funding was not obtained to obtain TFV-DP plasma levels in the study</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.</title>
        <description>Analyze participant's self-reported adherence using National Institutes of Health AIDS Clinical Trials Group (ACTG) standardized and validated questionnaire of number of days with no missed doses of medication over prior 4 days (minimum 0, maximum 4). Number of days with missed doses was dichotomized to &quot;no missed doses&quot; (100% adherence) and &quot;≥ 1 missed dose.&quot;</description>
        <time_frame>Week 12</time_frame>
        <population>5 and 7 participants dropped out between baseline and week 12 in the AdhereTech bottle arm and routine counseling only arms respectively. One participant in the AdhereTech bottle arm did not fully complete the adherence questionnaire at week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Counseling + AdhereTech Bottle</title>
            <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
          <group group_id="O2">
            <title>Routine Counseling</title>
            <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.</title>
          <description>Analyze participant's self-reported adherence using National Institutes of Health AIDS Clinical Trials Group (ACTG) standardized and validated questionnaire of number of days with no missed doses of medication over prior 4 days (minimum 0, maximum 4). Number of days with missed doses was dichotomized to &quot;no missed doses&quot; (100% adherence) and &quot;≥ 1 missed dose.&quot;</description>
          <population>5 and 7 participants dropped out between baseline and week 12 in the AdhereTech bottle arm and routine counseling only arms respectively. One participant in the AdhereTech bottle arm did not fully complete the adherence questionnaire at week 12.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="20"/>
                  </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: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1</p_value>
            <method>Chi-squared, Corrected</method>
            <param_type>Difference in proportions</param_type>
            <param_value>0.019</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.237</ci_lower_limit>
            <ci_upper_limit>0.276</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Routine Counseling + AdhereTech Bottle</title>
          <description>Participants will receive routine medication adherence counseling and be given the AdhereTech &quot;smart bottle&quot; with reminders.&#xD;
Adheretech &quot;smart bottle&quot;: A &quot;smart pill bottle&quot; that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
        </group>
        <group group_id="E2">
          <title>Routine Counseling</title>
          <description>Participants will receive routine medication adherence counseling.&#xD;
Routine adherence counseling: Participants will be provided with routine adherence counseling</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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>
    <limitations_and_caveats>Unmet recruitment goals. Unexpectedly high TFV-DP dried blood spot levels in 3 participants due to unexpected drug-drug interactions. 2 participants were switched from tenofovir disproxil fumarate to tenofovir alefenamide during study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Grant Ellsworth</name_or_title>
      <organization>Weill Cornell Medicine</organization>
      <phone>212-746-7204</phone>
      <email>gre9006@med.cornell.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/NCT03772327
org study id: 1308014206
nct id: NCT03772327
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized study for participants treated with tenofovir-based antiretroviral drug
      regimens with a history of suboptimal adherence (detectable HIV RNA twice over the last
      year). Eligible participants are enrolled, receive routine adherence counseling and are
      randomized to receive an AdhereTech "smart pill bottle" or not (open label). The "smart pill
      bottle" quantitates the number of tenofovir-containing pills taken and sends this to a
      centralized server; if a dose is missed, the participant is contacted by either phone or
      text. Participants are assessed at baseline and weeks 4, 8, and 12 for tenofovir diphosphate
      (TFV-DP) levels (by plasma and dried red blood cell spots), HIV RNA level, and adherence
      using a standardized questionnaire. Primary outcome is change in TFV-DP levels from baseline
      in the 2 groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Tenofovir Diphosphate (TFV-DP) Drug Levels
time frame: Baseline and Week 12
description: Using dried blood spots from red blood cells, TFV-DP levels will be assessed.
measure: Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.
time frame: Week 12
description: Feasibility of using the AdhereTech "Smart Pill Bottles" in individuals living with HIV as measured by the proportion of participants that complete the study compared between arms. A statistically lower proportion in the AdhereTech bottle arm compared to the routine counseling arm would suggest use of the bottle is not feasible.
measure: Change in Quantitative HIV Viral Load
time frame: Baseline and Week 12
description: Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.
measure: Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to < 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.
time frame: Baseline and Week 12
description: This is a measure of qualitative HIV RNA outcome. The number of participants "converting" from "detectable" (HIV RNA ≥ 20 copies/mL) at baseline to "undetectable" (HIV RNA < 20 copies/mL) at week 12 in the AdhereTech bottle arm versus the routine counseling only arm.
measure: TFV-DP Plasma Levels
time frame: Baseline and Week 12
description: Assess TFV-DP plasma levels to compare to dried blood spot levels
measure: Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.
time frame: Week 12
description: Analyze participant's self-reported adherence using National Institutes of Health AIDS Clinical Trials Group (ACTG) standardized and validated questionnaire of number of days with no missed doses of medication over prior 4 days (minimum 0, maximum 4). Number of days with missed doses was dichotomized to "no missed doses" (100% adherence) and "≥ 1 missed dose."
arm group label: Routine counseling + AdhereTech bottle
arm group type: Experimental
description: Participants will receive routine medication adherence counseling and be given the AdhereTech "smart bottle" with reminders.
arm group label: Routine counseling
arm group type: Active Comparator
description: Participants will receive routine medication adherence counseling.
intervention type: Device
intervention name: Adheretech "smart bottle"
description: A "smart pill bottle" that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message.
arm group label: Routine counseling + AdhereTech bottle
intervention type: Behavioral
intervention name: Routine adherence counseling
description: Participants will be provided with routine adherence counseling
arm group label: Routine counseling
arm group label: Routine counseling + AdhereTech bottle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roy M Gulick, MD, MPH
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Unmet recruitment goals. Unexpectedly high TFV-DP dried blood spot levels in 3 participants due to unexpected drug-drug interactions. 2 participants were switched from tenofovir disproxil fumarate to tenofovir alefenamide during study.
point of contact: 