<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/NCT01722552</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DA032423-01A1</org_study_id>
    <nct_id>NCT01722552</nct_id>
  </id_info>
  <brief_title>China Adherence Through Technology Study</brief_title>
  <acronym>CATS</acronym>
  <official_title>China Adherence Through Technology Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangxi Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dimagi Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The CATS project is designed to increase understanding of interventions that are feasible and&#xD;
      effective in helping injection drug users (IDU) or other patients at high risk of poor&#xD;
      medication adherence who are HIV-positive to maintain a high ART adherence. The study will&#xD;
      involve: assessing the feasibility and acceptability of using real-time feedback, a wireless&#xD;
      technology-updated adaptation of an approach the investigators found to be feasible and&#xD;
      effective in China, to promote ART adherence among Chinese patients, including IDU;&#xD;
      generating preliminary effectiveness data of real-time feedback on adherence, CD4 count, and&#xD;
      HIV viral load; and identifying the factors that explain how real-time feedback influences&#xD;
      intervention success or failure.&#xD;
&#xD;
      The specific aims of the study are:&#xD;
&#xD;
      SA1: Determine the feasibility and acceptability of using real-time feedback, a wireless&#xD;
      technology-updated adaptation of an approach we found to be feasible and effective in China,&#xD;
      to promote ART adherence among Chinese patients. The investigators will conduct a pilot RCT&#xD;
      of the real-time feedback intervention among Chinese patients in order to assess its&#xD;
      feasibility and acceptability in this population.&#xD;
&#xD;
      SA2: Generate preliminary effectiveness data of real-time feedback on adherence, CD4 count,&#xD;
      and HIV viral load. The RCT will allow the researchers to generate rigorous estimates of&#xD;
      effect sizes on these important endpoints.&#xD;
&#xD;
      SA3: Describe the factors that explain how real-time feedback influences intervention success&#xD;
      or failure. The investigators will use a quantitative-qualitative mixed-methods research&#xD;
      approach to explore how the intervention influences the experience of adherence support in&#xD;
      this patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will implement CATS over 2.5 years by implementing a randomized controlled&#xD;
      trial to assess real-time feedback, an intervention that utilizes wireless technology via an&#xD;
      electronic pill container device ('Wisepill'), and investigating the mechanisms by which the&#xD;
      intervention operates using quantitative and qualitative research methods. 120 patients will&#xD;
      be enrolled in a HIV clinic in Nanning, capital of Guangxi province, a border province with&#xD;
      high rates of HIV and IDU. Enrolled patients will be randomized to intervention vs.&#xD;
      comparison group for the 6-month intervention. The study will follow all patients for an&#xD;
      additional 3 months to determine sustainability of intervention impact. In addition to&#xD;
      adherence and clinical data, quantitative and qualitative data will be collected using survey&#xD;
      instruments, focus groups, and in-depth interviews. Analysis of these data will enable&#xD;
      achievement of the specific aims and contribute to the scientific evidence base on effective&#xD;
      approaches to promoting ART adherence among IDU and other patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Proportion of Subjects Who Achieve &gt;/= 95% Adherence</measure>
    <time_frame>Measured at 6 months after start of intervention</time_frame>
    <description>Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Who Achieve &gt;/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period</measure>
    <time_frame>6 months</time_frame>
    <description>Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>adherence feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was &lt;95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>adherence feedback</intervention_name>
    <arm_group_label>adherence feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standard of care</intervention_name>
    <arm_group_label>standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are 18 years of age and above, currently on ART or about to begin ART at&#xD;
             the Guangxi CDC clinic, deemed at risk for poor adherence either by patients or&#xD;
             medical staff, own a cell phone, and provide written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons who do not speak Mandarin Chinese or who have mental health issues such that&#xD;
             they cannot provide written informed consent will not be allowed to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lora Sabin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University Center for Global Health and Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University Center for Global Health and Development</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangxi CDC ART Clinic</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>March 11, 2017</results_first_submitted>
  <results_first_submitted_qc>March 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2017</results_first_posted>
  <last_update_submitted>March 11, 2017</last_update_submitted>
  <last_update_submitted_qc>March 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Lora Sabin</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>AIDS</keyword>
  <keyword>antiretroviral therapy</keyword>
  <keyword>adherence</keyword>
  <keyword>China</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We have no IPD sharing plan.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We recruited subjects from December 2012-April 2013. They were recruited at the Guangxi Provincial ART clinic in Nanning, China. Patients were eligible if they were receiving or initiating antiretroviral therapy (ART), aged 18 years or above, deemed at risk for poor adherence by clinic staff or patients themselves, and owned a mobile phone.</recruitment_details>
      <pre_assignment_details>After enrollment, each subject was given a Wisepill electronic adherence monitoring container for use with his/her ART medications. Subjects selected one or more ART medications to be monitored within the device. All subjects underwent baseline adherence monitoring using Wisepill for 3 months before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adherence Feedback</title>
          <description>Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was &lt;95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.&#xD;
adherence feedback</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120">Number of subjects enrolled</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116">Number of subjects who completed the intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intervention arm baseline information</population>
      <group_list>
        <group group_id="B1">
          <title>Adherence Feedback</title>
          <description>Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was &lt;95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.&#xD;
adherence feedback</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="63"/>
          </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="36.9" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference in Proportion of Subjects Who Achieve &gt;/= 95% Adherence</title>
        <description>Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.</description>
        <time_frame>Measured at 6 months after start of intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adherence Feedback</title>
            <description>Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was &lt;95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.&#xD;
adherence feedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Proportion of Subjects Who Achieve &gt;/= 95% Adherence</title>
          <description>Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.</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="63"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Who Achieve &gt;/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period</title>
        <description>Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adherence Feedback</title>
            <description>Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was &lt;95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.&#xD;
adherence feedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Achieve &gt;/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period</title>
          <description>Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.</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="63"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="29"/>
                  </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 primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The margin for non-equivalence was 25 percentage points.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.21</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data collection took place from December 2012 and April 2014.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Adherence Feedback</title>
          <description>Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was &lt;95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.&#xD;
adherence feedback</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </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="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Lora Sabin</name_or_title>
      <organization>Boston University School of Public Health</organization>
      <phone>617-414-1272 ext 617</phone>
      <email>lsabin@bu.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/NCT01722552
org study id: 1R34DA032423-01A1
nct id: NCT01722552
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The CATS project is designed to increase understanding of interventions that are feasible and
      effective in helping injection drug users (IDU) or other patients at high risk of poor
      medication adherence who are HIV-positive to maintain a high ART adherence. The study will
      involve: assessing the feasibility and acceptability of using real-time feedback, a wireless
      technology-updated adaptation of an approach the investigators found to be feasible and
      effective in China, to promote ART adherence among Chinese patients, including IDU;
      generating preliminary effectiveness data of real-time feedback on adherence, CD4 count, and
      HIV viral load; and identifying the factors that explain how real-time feedback influences
      intervention success or failure.

      The specific aims of the study are:

      SA1: Determine the feasibility and acceptability of using real-time feedback, a wireless
      technology-updated adaptation of an approach we found to be feasible and effective in China,
      to promote ART adherence among Chinese patients. The investigators will conduct a pilot RCT
      of the real-time feedback intervention among Chinese patients in order to assess its
      feasibility and acceptability in this population.

      SA2: Generate preliminary effectiveness data of real-time feedback on adherence, CD4 count,
      and HIV viral load. The RCT will allow the researchers to generate rigorous estimates of
      effect sizes on these important endpoints.

      SA3: Describe the factors that explain how real-time feedback influences intervention success
      or failure. The investigators will use a quantitative-qualitative mixed-methods research
      approach to explore how the intervention influences the experience of adherence support in
      this patient population.
The investigators will implement CATS over 2.5 years by implementing a randomized controlled
      trial to assess real-time feedback, an intervention that utilizes wireless technology via an
      electronic pill container device ('Wisepill'), and investigating the mechanisms by which the
      intervention operates using quantitative and qualitative research methods. 120 patients will
      be enrolled in a HIV clinic in Nanning, capital of Guangxi province, a border province with
      high rates of HIV and IDU. Enrolled patients will be randomized to intervention vs.
      comparison group for the 6-month intervention. The study will follow all patients for an
      additional 3 months to determine sustainability of intervention impact. In addition to
      adherence and clinical data, quantitative and qualitative data will be collected using survey
      instruments, focus groups, and in-depth interviews. Analysis of these data will enable
      achievement of the specific aims and contribute to the scientific evidence base on effective
      approaches to promoting ART adherence among IDU and other patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Difference in Proportion of Subjects Who Achieve >/= 95% Adherence
time frame: Measured at 6 months after start of intervention
description: Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.
measure: Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period
time frame: 6 months
description: Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.
arm group label: adherence feedback
arm group type: Experimental
description: Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.
arm group label: standard of care
arm group type: Active Comparator
description: Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
intervention type: Behavioral
intervention name: adherence feedback
arm group label: adherence feedback
intervention type: Behavioral
intervention name: standard of care
arm group label: standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lora Sabin, PhD
role: Principal Investigator
affiliation: Boston University Center for Global Health and Development
facility: 
facility: 
country: China
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Lora Sabin
investigator title: Associate Professor
sharing ipd: No
ipd description: We have no IPD sharing plan.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 