<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/NCT03794648</url>
  </required_header>
  <id_info>
    <org_study_id>2017/00150</org_study_id>
    <nct_id>NCT03794648</nct_id>
  </id_info>
  <brief_title>The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication</brief_title>
  <official_title>The Feasibility and Preliminary Efficacy of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Medication Adherence of Patients With HIV Infection: a Pilot Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 40 HIV infected patients will be randomly assigned into intervention or control&#xD;
      group. Participants in the intervention group will use an smart phone application for two&#xD;
      months. Participants will receive reminder notifications and use the app to take and send&#xD;
      videos of themselves taking the pill(s), uploaded videos will be centrally reviewed by a&#xD;
      study nurse . Control group participants will receive standard care. Antiretroviral Therapy&#xD;
      adherence will be measured by self-report, pill count, and smart bottle as well as the App.&#xD;
      Participants' perceptions of app using experience will be recorded via face to face&#xD;
      interview.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from one month percentage ART adherence at two months (by MEMScap)</measure>
    <time_frame>one-month follow-up and two-month follow-up visits</time_frame>
    <description>Change percentage ART adherence over the 2 month study period, as measured by MEMScaps, collected at the 1 and 2 month visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage ART adherence (self-reported)</measure>
    <time_frame>Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit)</time_frame>
    <description>Percentage self-reported adherence over a 21 day period (summation of the 7 days preceding each study visit) as measured by a standardised questionnaire at each study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage ART adherence (by pill count)</measure>
    <time_frame>One-month follow-up visit, two-month follow-up visit(end of study visit)</time_frame>
    <description>Percentage adherence over the 2 month study period, as measured by pill count, collected at month 1 and 2 follow-up visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variability in time (minutes) between prescribed pill time and actual dose taken</measure>
    <time_frame>One-month follow-up visit, two-month follow-up visit(end of study visit)</time_frame>
    <description>Variability in time (minutes) between prescribed pill time and actual dose taken, as measured by MEMScaps, collected at the 1 and 2 month visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' perceptions on using MIST intervention</measure>
    <time_frame>two-month follow-up visit (end of the study visit)</time_frame>
    <description>Participants' perception of MIST intervention , assessed at the 2 month visit by a sei-structured interview. The interview mainly addressed five areas namely: perception of overall MIST app use experience, perceived usefulness of each feature, strengths and weakness of MIST, interest in continued to use MIST for future and recommendations for further improvements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>HIV-infection/Aids</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Interactive Supervised Therapy (MIST)</intervention_name>
    <description>MIST system will send a reminder notification (via push or SMS) to participants 10 to 15 minutes before the scheduled time for taking their medication. Participants will then activate the recording function of the MIST app on their phone, and record themselves taking their medication.Participants will be asked to go through a series of steps for recording the video.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 21&#xD;
&#xD;
          -  HIV infection diagnosis confirmed by western blot&#xD;
&#xD;
          -  Taking a once daily regimen of HIV medications&#xD;
&#xD;
          -  Able to take pills orally&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to operate a smart phone&#xD;
&#xD;
          -  Active Tuberculosis infection requiring treatment during study (due to additional&#xD;
             challenge posed to adherence that may confound the assessment of HIV adherence)&#xD;
&#xD;
          -  Substance use&#xD;
&#xD;
          -  Visual or hearing impairment&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mobile app</keyword>
  <keyword>HIV-infections</keyword>
  <keyword>medication adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03794648
org study id: 2017/00150
nct id: NCT03794648
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A total of 40 HIV infected patients will be randomly assigned into intervention or control
      group. Participants in the intervention group will use an smart phone application for two
      months. Participants will receive reminder notifications and use the app to take and send
      videos of themselves taking the pill(s), uploaded videos will be centrally reviewed by a
      study nurse . Control group participants will receive standard care. Antiretroviral Therapy
      adherence will be measured by self-report, pill count, and smart bottle as well as the App.
      Participants' perceptions of app using experience will be recorded via face to face
      interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from one month percentage ART adherence at two months (by MEMScap)
time frame: one-month follow-up and two-month follow-up visits
description: Change percentage ART adherence over the 2 month study period, as measured by MEMScaps, collected at the 1 and 2 month visits.
measure: Percentage ART adherence (self-reported)
time frame: Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit)
description: Percentage self-reported adherence over a 21 day period (summation of the 7 days preceding each study visit) as measured by a standardised questionnaire at each study visit
measure: Percentage ART adherence (by pill count)
time frame: One-month follow-up visit, two-month follow-up visit(end of study visit)
description: Percentage adherence over the 2 month study period, as measured by pill count, collected at month 1 and 2 follow-up visits
measure: Variability in time (minutes) between prescribed pill time and actual dose taken
time frame: One-month follow-up visit, two-month follow-up visit(end of study visit)
description: Variability in time (minutes) between prescribed pill time and actual dose taken, as measured by MEMScaps, collected at the 1 and 2 month visits.
measure: Participants' perceptions on using MIST intervention
time frame: two-month follow-up visit (end of the study visit)
description: Participants' perception of MIST intervention , assessed at the 2 month visit by a sei-structured interview. The interview mainly addressed five areas namely: perception of overall MIST app use experience, perceived usefulness of each feature, strengths and weakness of MIST, interest in continued to use MIST for future and recommendations for further improvements.
arm group label: Intervention Group
arm group type: Experimental
arm group label: Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Mobile Interactive Supervised Therapy (MIST)
description: MIST system will send a reminder notification (via push or SMS) to participants 10 to 15 minutes before the scheduled time for taking their medication. Participants will then activate the recording function of the MIST app on their phone, and record themselves taking their medication.Participants will be asked to go through a series of steps for recording the video.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Infections
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
sharing ipd: Undecided