<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/NCT03836625</url>
  </required_header>
  <id_info>
    <org_study_id>181640</org_study_id>
    <secondary_id>R34MH118028</secondary_id>
    <nct_id>NCT03836625</nct_id>
  </id_info>
  <brief_title>CareConekta: A Smartphone App to Improve Engagement in HIV Care</brief_title>
  <official_title>CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Population mobility is common in South Africa, but important research gaps exist describing&#xD;
      this mobility and its impact on engagement in HIV care, particularly among pregnant and&#xD;
      postpartum women. Through this study, the investigators propose to test a smartphone&#xD;
      application - CareConekta - to conduct essential formative work on mobility and evaluate this&#xD;
      app as an intervention to facilitate engagement in HIV care during times of mobility. This&#xD;
      work is critical to adapting CareConekta for widespread use, providing critical information&#xD;
      about mobility during the peripartum period and the impact on engagement in HIV care, and&#xD;
      piloting this intervention to improve engagement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      South Africa is home to the world's largest antiretroviral therapy (ART) program, but&#xD;
      sustaining high retention along the HIV care continuum has proven challenging in the country&#xD;
      and throughout the wider region. Population mobility is common in South Africa, but important&#xD;
      research gaps exist describing this mobility and its impact on engagement in HIV care.&#xD;
      Postpartum women and their infants in South Africa are known to be at high risk of dropping&#xD;
      out of HIV care after delivery and are frequently mobile. The investigators recently&#xD;
      developed a beta version of a smartphone application (app) - CareConekta - that detects a&#xD;
      user's smartphone location to allow for prospective characterization of mobility. Through&#xD;
      this three-year study, the investigators propose to test CareConekta to conduct essential&#xD;
      formative work on mobility and evaluate an intervention - the CareConekta app plus text&#xD;
      notifications and optional staff phone calls and/or WhatsApp messages - to facilitate&#xD;
      engagement in HIV care during times of mobility. After first adapting CareConekta to use&#xD;
      appropriate smartphone technology for the local population, the investigators will&#xD;
      characterize mobility among South African women during the peripartum period and its impact&#xD;
      on engagement in HIV care. The investigators also will evaluate the acceptability,&#xD;
      feasibility, and initial efficacy of using CareConekta as an intervention to improve&#xD;
      engagement in HIV care. The investigators will work with a South African technology company&#xD;
      with a strong connection to the South African Department of Health to adapt the app prior to&#xD;
      enrolling study participants. The study will observe mobility within an observational cohort&#xD;
      and will then assess the impact of the intervention among participants who travel during the&#xD;
      study period. This work is critical to adapting an existing app for widespread use, providing&#xD;
      critical information about mobility during the peripartum period and the impact on engagement&#xD;
      in HIV care, and piloting an intervention to improve engagement. This study will lay the&#xD;
      necessary groundwork for a larger efficacy trial of the intervention within different&#xD;
      geographic settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 9, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</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>Mobility Prevalence</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Median Number of Trips Per Person</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CareConekta Feasibility: Same Phone at Follow-up</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The number of participants who report using the same phone from enrollment at follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timing of Travel</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Permanent Move</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>Was the move permanent (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CareConekta Feasibility: GPS Disabled During the Study Period</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The number of participants who disabled GPS during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CareConekta Feasibility -- Participant Reported Sharing Phone</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The number of participants who reported sharing their phone with another person during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CareConekta Feasibility -- Participant Ever Opened App</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The number of participants who reported opening the CareConekta app at least once after enrollment visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities</measure>
    <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
    <description>The number of participants who reported using the CareConekta app to locate a new health facility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CareConekta Initial Efficacy -- Maternal Engagement in HIV Care</measure>
    <time_frame>6 months after delivery</time_frame>
    <description>The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and maternal retention in care and viral suppression 6 months after delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CareConekta Initial Efficacy -- Infant Outcomes</measure>
    <time_frame>10 weeks after delivery, study end</time_frame>
    <description>The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and vertical HIV transmission and completion of 10-week infant HIV PCR test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Mobility -- Maternal Engagement in HIV Care</measure>
    <time_frame>6 months after delivery</time_frame>
    <description>In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and engagement in HIV care for the mother (defined as retention in care and viral suppression six months after delivery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Mobility -- Infant Outcomes</measure>
    <time_frame>10 weeks after delivery, study end</time_frame>
    <description>In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and completion of routine early infant diagnosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CareConekta</intervention_name>
    <description>CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. We will only enroll participants attending the Gugulethu Community Health Centre, near&#xD;
             Cape Town, South Africa&#xD;
&#xD;
          2. HIV-positive&#xD;
&#xD;
          3. adult (≥18 years)&#xD;
&#xD;
          4. pregnant (≥28 weeks)&#xD;
&#xD;
          5. own a smartphone that meets the technical requirements&#xD;
&#xD;
          6. willing to opt-in to installation of CareConekta on her personal phone and to mobility&#xD;
             tracking&#xD;
&#xD;
          7. demonstrate the ability to read simple text language&#xD;
&#xD;
          8. willing to be randomized&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If an interested participant meets all of the inclusion criteria, there are no&#xD;
             additional exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>We will enroll only pregnant women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate Clouse, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gugulethu Community Health Centre</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <results_first_submitted>October 28, 2022</results_first_submitted>
  <results_first_submitted_qc>January 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2023</results_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Kate Clouse</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>Yes</sharing_ipd>
    <ipd_description>De-identified datasets will be made available by request, subject to agreement to (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Anytime, by request</ipd_time_frame>
  </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>October 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03836625/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
        </group>
        <group group_id="P2">
          <title>Intervention</title>
          <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator withdrawn at/near time of enrollment</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Total excludes 7 participants withdrawn by investigators at/soon after enrollment. Data were not included in analyses.</population>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="93"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="193"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" lower_limit="28" upper_limit="36"/>
                    <measurement group_id="B2" value="31" lower_limit="28" upper_limit="35"/>
                    <measurement group_id="B3" value="32" lower_limit="28" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age 18-24 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 25-29 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 30-34 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 35 years and older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="58"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Never completed primary school</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Primary school only</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some high school</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completed high school</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any tertiary education</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Currently employed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not currently employed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>On antiretroviral therapy prior to first antenatal visit</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birthplace</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Western Cape Province, South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In South Africa, but not Western Cape Province</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Outside of South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mobility Prevalence</title>
        <description>The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>The number of participants who reported travel during the study period (defined as 3 or more nights away from home)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>Mobility Prevalence</title>
          <description>The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.</description>
          <population>The number of participants who reported travel during the study period (defined as 3 or more nights away from home)</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="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Traveled yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Traveled no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Median Number of Trips Per Person</title>
        <description>Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>Participants who reported travel (n=54)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Number of Trips Per Person</title>
          <description>Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.</description>
          <population>Participants who reported travel (n=54)</population>
          <units>trip</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CareConekta Feasibility: Same Phone at Follow-up</title>
        <description>The number of participants who report using the same phone from enrollment at follow-up</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>CareConekta Feasibility: Same Phone at Follow-up</title>
          <description>The number of participants who report using the same phone from enrollment at follow-up</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="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timing of Travel</title>
        <description>The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>Number of trips reported (n=60)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>Timing of Travel</title>
          <description>The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.</description>
          <population>Number of trips reported (n=60)</population>
          <units>Trips</units>
          <param>Count of Units</param>
          <units_analyzed>Trips</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Trips</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Traveled before delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Traveled after delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Permanent Move</title>
        <description>Was the move permanent (yes/no)</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>Total number of trips per person, by study arm</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>Permanent Move</title>
          <description>Was the move permanent (yes/no)</description>
          <population>Total number of trips per person, by study arm</population>
          <units>Trips</units>
          <param>Count of Units</param>
          <units_analyzed>Trips</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Trips</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CareConekta Feasibility: GPS Disabled During the Study Period</title>
        <description>The number of participants who disabled GPS during the study period</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>The total number of participants who completed follow-up (n=173)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>CareConekta Feasibility: GPS Disabled During the Study Period</title>
          <description>The number of participants who disabled GPS during the study period</description>
          <population>The total number of participants who completed follow-up (n=173)</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="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I don't know</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CareConekta Feasibility -- Participant Reported Sharing Phone</title>
        <description>The number of participants who reported sharing their phone with another person during the study period</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>Total number of participants who completed follow-up (n=173)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>CareConekta Feasibility -- Participant Reported Sharing Phone</title>
          <description>The number of participants who reported sharing their phone with another person during the study period</description>
          <population>Total number of participants who completed follow-up (n=173)</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="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CareConekta Feasibility -- Participant Ever Opened App</title>
        <description>The number of participants who reported opening the CareConekta app at least once after enrollment visit</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>All participants who completed follow-up (n=173)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>CareConekta Feasibility -- Participant Ever Opened App</title>
          <description>The number of participants who reported opening the CareConekta app at least once after enrollment visit</description>
          <population>All participants who completed follow-up (n=173)</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="84"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities</title>
        <description>The number of participants who reported using the CareConekta app to locate a new health facility.</description>
        <time_frame>Baseline to End of Study (up to 2 years)</time_frame>
        <population>Number of participants who reported opening app during study period (n=157)</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
          </group>
        </group_list>
        <measure>
          <title>CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities</title>
          <description>The number of participants who reported using the CareConekta app to locate a new health facility.</description>
          <population>Number of participants who reported opening app during study period (n=157)</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="80"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CareConekta Initial Efficacy -- Maternal Engagement in HIV Care</title>
        <description>The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and maternal retention in care and viral suppression 6 months after delivery.</description>
        <time_frame>6 months after delivery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CareConekta Initial Efficacy -- Infant Outcomes</title>
        <description>The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and vertical HIV transmission and completion of 10-week infant HIV PCR test.</description>
        <time_frame>10 weeks after delivery, study end</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Impact of Mobility -- Maternal Engagement in HIV Care</title>
        <description>In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and engagement in HIV care for the mother (defined as retention in care and viral suppression six months after delivery).</description>
        <time_frame>6 months after delivery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Impact of Mobility -- Infant Outcomes</title>
        <description>In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and completion of routine early infant diagnosis.</description>
        <time_frame>10 weeks after delivery, study end</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout study period, median duration = 7.4 months</time_frame>
      <desc>Adverse events were reported per IRB and sponsor guidelines.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>The control arm will receive standard CareConekta, which will track their mobility with no additional features.</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled &gt;50 km from the study site for &gt;7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.&#xD;
CareConekta: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </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="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>We found that several key challenges impeded our study feasibility. The primary challenge is that during the study period, no participant's smartphone recorded at least one heartbeat per day.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kate Clouse</name_or_title>
      <organization>Vanderbilt University</organization>
      <phone>(615) 343-5351</phone>
      <email>kate.clouse@vanderbilt.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/NCT03836625
org study id: 181640
secondary id: R34MH118028
nct id: NCT03836625
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Population mobility is common in South Africa, but important research gaps exist describing
      this mobility and its impact on engagement in HIV care, particularly among pregnant and
      postpartum women. Through this study, the investigators propose to test a smartphone
      application - CareConekta - to conduct essential formative work on mobility and evaluate this
      app as an intervention to facilitate engagement in HIV care during times of mobility. This
      work is critical to adapting CareConekta for widespread use, providing critical information
      about mobility during the peripartum period and the impact on engagement in HIV care, and
      piloting this intervention to improve engagement.
South Africa is home to the world's largest antiretroviral therapy (ART) program, but
      sustaining high retention along the HIV care continuum has proven challenging in the country
      and throughout the wider region. Population mobility is common in South Africa, but important
      research gaps exist describing this mobility and its impact on engagement in HIV care.
      Postpartum women and their infants in South Africa are known to be at high risk of dropping
      out of HIV care after delivery and are frequently mobile. The investigators recently
      developed a beta version of a smartphone application (app) - CareConekta - that detects a
      user's smartphone location to allow for prospective characterization of mobility. Through
      this three-year study, the investigators propose to test CareConekta to conduct essential
      formative work on mobility and evaluate an intervention - the CareConekta app plus text
      notifications and optional staff phone calls and/or WhatsApp messages - to facilitate
      engagement in HIV care during times of mobility. After first adapting CareConekta to use
      appropriate smartphone technology for the local population, the investigators will
      characterize mobility among South African women during the peripartum period and its impact
      on engagement in HIV care. The investigators also will evaluate the acceptability,
      feasibility, and initial efficacy of using CareConekta as an intervention to improve
      engagement in HIV care. The investigators will work with a South African technology company
      with a strong connection to the South African Department of Health to adapt the app prior to
      enrolling study participants. The study will observe mobility within an observational cohort
      and will then assess the impact of the intervention among participants who travel during the
      study period. This work is critical to adapting an existing app for widespread use, providing
      critical information about mobility during the peripartum period and the impact on engagement
      in HIV care, and piloting an intervention to improve engagement. This study will lay the
      necessary groundwork for a larger efficacy trial of the intervention within different
      geographic settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Mobility Prevalence
time frame: Baseline to End of Study (up to 2 years)
description: The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.
measure: Median Number of Trips Per Person
time frame: Baseline to End of Study (up to 2 years)
description: Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
measure: CareConekta Feasibility: Same Phone at Follow-up
time frame: Baseline to End of Study (up to 2 years)
description: The number of participants who report using the same phone from enrollment at follow-up
measure: Timing of Travel
time frame: Baseline to End of Study (up to 2 years)
description: The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.
measure: Permanent Move
time frame: Baseline to End of Study (up to 2 years)
description: Was the move permanent (yes/no)
measure: CareConekta Feasibility: GPS Disabled During the Study Period
time frame: Baseline to End of Study (up to 2 years)
description: The number of participants who disabled GPS during the study period
measure: CareConekta Feasibility -- Participant Reported Sharing Phone
time frame: Baseline to End of Study (up to 2 years)
description: The number of participants who reported sharing their phone with another person during the study period
measure: CareConekta Feasibility -- Participant Ever Opened App
time frame: Baseline to End of Study (up to 2 years)
description: The number of participants who reported opening the CareConekta app at least once after enrollment visit
measure: CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities
time frame: Baseline to End of Study (up to 2 years)
description: The number of participants who reported using the CareConekta app to locate a new health facility.
measure: CareConekta Initial Efficacy -- Maternal Engagement in HIV Care
time frame: 6 months after delivery
description: The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and maternal retention in care and viral suppression 6 months after delivery.
measure: CareConekta Initial Efficacy -- Infant Outcomes
time frame: 10 weeks after delivery, study end
description: The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and vertical HIV transmission and completion of 10-week infant HIV PCR test.
measure: Impact of Mobility -- Maternal Engagement in HIV Care
time frame: 6 months after delivery
description: In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and engagement in HIV care for the mother (defined as retention in care and viral suppression six months after delivery).
measure: Impact of Mobility -- Infant Outcomes
time frame: 10 weeks after delivery, study end
description: In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and completion of routine early infant diagnosis.
arm group label: Control
arm group type: No Intervention
description: The control arm will receive standard CareConekta, which will track their mobility with no additional features.
arm group label: Intervention
arm group type: Experimental
description: The intervention arm will receive standard CareConekta, plus text notifications of nearby ART facilities when they have traveled >50 km from the study site for >7 days. At enrollment, participants in the intervention arm also will be able to opt-in to phone call(s) and/or WhatsApp message(s) from study staff to when they have met this travel threshold. The study staff calls and messages will ask about medication supply and will provide assistance with nearby facilities, if requested.
intervention type: Other
intervention name: CareConekta
description: CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
gender description: We will enroll only pregnant women.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kate Clouse, PhD, MPH
role: Principal Investigator
affiliation: Vanderbilt University School of Nursing
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Kate Clouse
investigator title: Assistant Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Yes
ipd description: De-identified datasets will be made available by request, subject to agreement to (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Anytime, by request
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: We found that several key challenges impeded our study feasibility. The primary challenge is that during the study period, no participant's smartphone recorded at least one heartbeat per day.
point of contact: 