<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/NCT04418076</url>
  </required_header>
  <id_info>
    <org_study_id>1508016342</org_study_id>
    <secondary_id>1R21DA039842-01A1</secondary_id>
    <nct_id>NCT04418076</nct_id>
  </id_info>
  <brief_title>Project SMART Automated Pillbox Study</brief_title>
  <acronym>SMART</acronym>
  <official_title>Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University at Albany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART)&#xD;
      adherence and persistence among HIV-infected individuals with co-occurring cocaine use&#xD;
      disorders (CUDs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use&#xD;
      cocaine and healthcare providers that will assess the acceptability, feasibility,&#xD;
      facilitators and barriers of implementing mHealth interventions; and will aid in developing&#xD;
      the final design and content of both automated and clinician feedback in preparation for&#xD;
      designing a pilot feasibility study.&#xD;
&#xD;
      To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine&#xD;
      the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback&#xD;
      (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART&#xD;
      adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use,&#xD;
      retention in HIV care).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2017</start_date>
  <completion_date type="Actual">August 18, 2020</completion_date>
  <primary_completion_date type="Actual">August 18, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period</measure>
    <time_frame>Week 12</time_frame>
    <description>Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)</measure>
    <time_frame>Week 16</time_frame>
    <description>This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in HIV 1 RNA, QN PCR (Copies/ML)</measure>
    <time_frame>End of intervention (Week 12)</time_frame>
    <description>HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in CD4 Count From Baseline to Week 12</measure>
    <time_frame>Baseline and End of intervention (Week 12)</time_frame>
    <description>CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention in Care</measure>
    <time_frame>up to End of the study (week 16)</time_frame>
    <description>Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Cocaine Use</condition>
  <arm_group>
    <arm_group_label>No feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automated feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automated feedback + Clinician feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automated feedback + Social Network feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group A_No feedback</intervention_name>
    <description>In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
    <arm_group_label>No feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group B_Automated feedback</intervention_name>
    <description>For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
    <arm_group_label>Automated feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group C_Automated feedback + Clinician feedback</intervention_name>
    <description>For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
    <arm_group_label>Automated feedback + Clinician feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group D_Automated feedback + Social Network feedback</intervention_name>
    <description>For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
    <arm_group_label>Automated feedback + Social Network feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal to or greater than 18 years&#xD;
&#xD;
          -  Clinic-confirmed HIV diagnosis&#xD;
&#xD;
          -  Currently prescribed or eligible for ART&#xD;
&#xD;
          -  Currently has insurance&#xD;
&#xD;
          -  Self-reported cocaine use in the past 30 days&#xD;
&#xD;
          -  Willing and able to use a cell phone and electronic pill box for the 12-week&#xD;
             intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Verbally or physically threatening to research staff&#xD;
&#xD;
          -  Unable to communicate in either English or Spanish&#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>Frederick Altice, M.D., M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Clinical Research</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>March 16, 2018</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <results_first_submitted>May 13, 2021</results_first_submitted>
  <results_first_submitted_qc>April 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 15, 2023</results_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data will be kept confidential.</ipd_description>
  </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 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04418076/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04418076/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from two sites--New Haven and Hartford, CT. Recruitment started in June 2017 and concluded in January 1st 2020.</recruitment_details>
      <pre_assignment_details>This study required participants to change their pharmacy for delivery of HIV medication , so that the medication blister pack could be inserted into the TowerView smart pillbox. In some cases, participants who had severe opioid use disorder were prevented by their provider from participating in this study; they prefer close monitoring. Other factors preventing participants from continuing included co-morbidities (cancer, severe SUD), incarceration, and difficulty with transportation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>No Feedback</title>
          <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
        </group>
        <group group_id="P2">
          <title>Automated Feedback</title>
          <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
        </group>
        <group group_id="P3">
          <title>Automated Feedback + Clinician Feedback</title>
          <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
        </group>
        <group group_id="P4">
          <title>Automated Feedback + Social Network Feedback</title>
          <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>9 Participants Had Complete Lab Results at 16 Weeks</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>57 Participants Completed 12 Weeks</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Dropped out after receiving pillbox and phone</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Feedback</title>
          <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
        </group>
        <group group_id="B2">
          <title>Automated Feedback</title>
          <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
        </group>
        <group group_id="B3">
          <title>Automated Feedback + Clinician Feedback</title>
          <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
        </group>
        <group group_id="B4">
          <title>Automated Feedback + Social Network Feedback</title>
          <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
        </group>
        <group group_id="B5">
          <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="19"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="23"/>
            <count group_id="B5" 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="55.91" spread="7.70"/>
                    <measurement group_id="B2" value="54.78" spread="6.81"/>
                    <measurement group_id="B3" value="51.45" spread="6.45"/>
                    <measurement group_id="B4" value="55.94" spread="6.35"/>
                    <measurement group_id="B5" value="54.65" spread="6.95"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transgender (male to female)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transgender (female to male)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Puerto Rican</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health literacy</title>
          <description>It includes three Likert scale questions on a scale of 1 to 5. The scores of each question were averaged to obtain an average score. Higher score indicates higher level of health literacy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.04" spread=".99"/>
                    <measurement group_id="B2" value="3.92" spread=".92"/>
                    <measurement group_id="B3" value="3.92" spread=".85"/>
                    <measurement group_id="B4" value="3.86" spread="1.02"/>
                    <measurement group_id="B5" value="3.93" spread=".94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mental health (CESD-D10)</title>
          <description>The CES-D Scale: A self-report depression scale for research in the general population. It includes 10 questions, measured from 0 to 3, where higher score indicates higher level of depression. All of the questions are totaled, thus minimal is 0 and maximum is 30.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.89" spread="6.67"/>
                    <measurement group_id="B2" value="9.80" spread="7.13"/>
                    <measurement group_id="B3" value="9.56" spread="6.18"/>
                    <measurement group_id="B4" value="11.43" spread="7.20"/>
                    <measurement group_id="B5" value="10.50" spread="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol screening AUDIT C</title>
          <description>Scales measure substance use using multiple choices. Questions were coded as 0, 1 to 4. The results were summed up for each participant. If the sum &gt;=2, then presence of substance use, else no substance use. Answers are summed up, 0 is the minimal and 12 is the maximum.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.50" spread="3.09"/>
                    <measurement group_id="B2" value="3.46" spread="3.13"/>
                    <measurement group_id="B3" value="5.10" spread="3.64"/>
                    <measurement group_id="B4" value="4.00" spread="2.88"/>
                    <measurement group_id="B5" value="4.45" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Presence of cocaine use disorder</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period</title>
        <description>Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Feedback</title>
            <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
          </group>
          <group group_id="O2">
            <title>Automated Feedback</title>
            <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
          </group>
          <group group_id="O3">
            <title>Automated Feedback + Clinician Feedback</title>
            <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
          </group>
          <group group_id="O4">
            <title>Automated Feedback + Social Network Feedback</title>
            <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period</title>
          <description>Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.</description>
          <units>percentage of times pills taken</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.07" spread="25.58"/>
                    <measurement group_id="O2" value="96.00" spread="12.98"/>
                    <measurement group_id="O3" value="99.82" spread=".60"/>
                    <measurement group_id="O4" value="94.81" spread="13.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)</title>
        <description>This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.</description>
        <time_frame>Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Feedback</title>
            <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
          </group>
          <group group_id="O2">
            <title>Automated Feedback</title>
            <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
          </group>
          <group group_id="O3">
            <title>Automated Feedback + Clinician Feedback</title>
            <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
          </group>
          <group group_id="O4">
            <title>Automated Feedback + Social Network Feedback</title>
            <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)</title>
          <description>This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.</description>
          <units>percentage of times pills taken</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.31" spread="7.49"/>
                    <measurement group_id="O2" value="93.00" spread="25.76"/>
                    <measurement group_id="O3" value="92.75" spread="21.53"/>
                    <measurement group_id="O4" value="93.24" spread="24.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in HIV 1 RNA, QN PCR (Copies/ML)</title>
        <description>HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.</description>
        <time_frame>End of intervention (Week 12)</time_frame>
        <population>If there is a change from viral suppression or not viral suppression to maximum viral suppression between baseline and intervention end date. Maximum viral suppression is &lt;20, viral suppression is &lt;200, not viral suppression is &gt;200 copies/ML. Only 26 participants whose labs are complete. Thus we were only able to analyze this outcome on 26 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>No Feedback</title>
            <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
          </group>
          <group group_id="O2">
            <title>Automated Feedback</title>
            <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
          </group>
          <group group_id="O3">
            <title>Automated Feedback + Clinician Feedback</title>
            <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
          </group>
          <group group_id="O4">
            <title>Automated Feedback + Social Network Feedback</title>
            <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in HIV 1 RNA, QN PCR (Copies/ML)</title>
          <description>HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.</description>
          <population>If there is a change from viral suppression or not viral suppression to maximum viral suppression between baseline and intervention end date. Maximum viral suppression is &lt;20, viral suppression is &lt;200, not viral suppression is &gt;200 copies/ML. Only 26 participants whose labs are complete. Thus we were only able to analyze this outcome on 26 participants.</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="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Changed to maximum viral suppression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral load decreased but not achieve max viral suppression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral load increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change and remained max suppression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change and remained viral suppression or no viral suppression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in CD4 Count From Baseline to Week 12</title>
        <description>CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.</description>
        <time_frame>Baseline and End of intervention (Week 12)</time_frame>
        <population>18 lab results were missing or lost and not available. 60 participants submitted their CD4 data (summarized here) vs. 57 participants completed all data measures at week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>No Feedback</title>
            <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
          </group>
          <group group_id="O2">
            <title>Automated Feedback</title>
            <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
          </group>
          <group group_id="O3">
            <title>Automated Feedback + Clinician Feedback</title>
            <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
          </group>
          <group group_id="O4">
            <title>Automated Feedback + Social Network Feedback</title>
            <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in CD4 Count From Baseline to Week 12</title>
          <description>CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.</description>
          <population>18 lab results were missing or lost and not available. 60 participants submitted their CD4 data (summarized here) vs. 57 participants completed all data measures at week 12.</population>
          <units>percentage of CD4 (helper cells)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.00" spread="13.33"/>
                    <measurement group_id="O2" value="26.09" spread="12.75"/>
                    <measurement group_id="O3" value="28.8" spread="9.96"/>
                    <measurement group_id="O4" value="30.81" spread="6.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retention in Care</title>
        <description>Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).</description>
        <time_frame>up to End of the study (week 16)</time_frame>
        <population>These data were not collected due to changes in the research plan.</population>
        <group_list>
          <group group_id="O1">
            <title>No Feedback</title>
            <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
          </group>
          <group group_id="O2">
            <title>Automated Feedback</title>
            <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
          </group>
          <group group_id="O3">
            <title>Automated Feedback + Clinician Feedback</title>
            <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
          </group>
          <group group_id="O4">
            <title>Automated Feedback + Social Network Feedback</title>
            <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention in Care</title>
          <description>Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).</description>
          <population>These data were not collected due to changes in the research plan.</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 group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>No Feedback</title>
          <description>For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.&#xD;
Group A_No feedback: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.</description>
        </group>
        <group group_id="E2">
          <title>Automated Feedback</title>
          <description>For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.&#xD;
Group B_Automated feedback: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.</description>
        </group>
        <group group_id="E3">
          <title>Automated Feedback + Clinician Feedback</title>
          <description>For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.&#xD;
Group C_Automated feedback + Clinician feedback: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.</description>
        </group>
        <group group_id="E4">
          <title>Automated Feedback + Social Network Feedback</title>
          <description>For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.&#xD;
Group D_Automated feedback + Social Network feedback: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.</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="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </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>
    <point_of_contact>
      <name_or_title>Natalie Kil</name_or_title>
      <organization>Associate Director Domestic Projects</organization>
      <phone>203.737.2883</phone>
      <email>natalie.kil@yale.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/NCT04418076
org study id: 1508016342
secondary id: 1R21DA039842-01A1
nct id: NCT04418076
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART)
      adherence and persistence among HIV-infected individuals with co-occurring cocaine use
      disorders (CUDs).
To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use
      cocaine and healthcare providers that will assess the acceptability, feasibility,
      facilitators and barriers of implementing mHealth interventions; and will aid in developing
      the final design and content of both automated and clinician feedback in preparation for
      designing a pilot feasibility study.

      To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine
      the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback
      (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART
      adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use,
      retention in HIV care).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
time frame: Week 12
description: Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
measure: Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)
time frame: Week 16
description: This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.
measure: Changes in HIV 1 RNA, QN PCR (Copies/ML)
time frame: End of intervention (Week 12)
description: HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.
measure: Percent Change in CD4 Count From Baseline to Week 12
time frame: Baseline and End of intervention (Week 12)
description: CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.
measure: Retention in Care
time frame: up to End of the study (week 16)
description: Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).
arm group label: No feedback
arm group type: Experimental
description: For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
arm group label: Automated feedback
arm group type: Experimental
description: For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
arm group label: Automated feedback + Clinician feedback
arm group type: Experimental
description: For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
arm group label: Automated feedback + Social Network feedback
arm group type: Experimental
description: For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
intervention type: Device
intervention name: Group A_No feedback
description: In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
arm group label: No feedback
intervention type: Device
intervention name: Group B_Automated feedback
description: For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
arm group label: Automated feedback
intervention type: Device
intervention name: Group C_Automated feedback + Clinician feedback
description: For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
arm group label: Automated feedback + Clinician feedback
intervention type: Device
intervention name: Group D_Automated feedback + Social Network feedback
description: For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
arm group label: Automated feedback + Social Network feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederick Altice, M.D., M.A.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No
ipd description: All data will be kept confidential.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 