<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/NCT03031197</url>
  </required_header>
  <id_info>
    <org_study_id>1R21MH109381-01</org_study_id>
    <nct_id>NCT03031197</nct_id>
  </id_info>
  <brief_title>Supporting Adolescent Adherence in Vietnam (SAAV)</brief_title>
  <acronym>SAAV</acronym>
  <official_title>The Supporting Adolescent Adherence in Vietnam (SAAV) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New England</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Population, Health and Development, Vietnam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New England</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The small RCT will assess feasibility, acceptability, and impact of a real-time intervention&#xD;
      on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a&#xD;
      wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a&#xD;
      personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when&#xD;
      they miss a dose, and engage in monthly counseling sessions informed by their adherence data.&#xD;
      Comparison subjects will receive usual care and an offer of counseling at monthly clinic&#xD;
      visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A major priority in HIV care and treatment is identifying effective interventions for&#xD;
      adolescent patients, including those that make use of new technologies, to help them achieve&#xD;
      and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they&#xD;
      take responsibility for their own medication-taking in the transition to adult care. The&#xD;
      research planned here will contribute to the scientific evidence base on approaches to&#xD;
      support ART adherence effectively among youth by 1) conducting formative research on&#xD;
      adherence challenges among adolescents and refining options for a personalized adherence&#xD;
      intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess&#xD;
      the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that&#xD;
      permits adolescent patients to tailor intervention features to suit their individual&#xD;
      preferences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">May 25, 2018</completion_date>
  <primary_completion_date type="Actual">May 25, 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>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal on-time adherence</measure>
    <time_frame>End of intervention period (month 7)</time_frame>
    <description>Proportion of patients with ≥95% on-time adherence at end of 6-month intervention period in each study arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CD4 count</measure>
    <time_frame>Pre-intervention month (month 1) vs. last intervention month (month 7)</time_frame>
    <description>Mean change in CD4 count in each study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load</measure>
    <time_frame>End of intervention period (month 7)</time_frame>
    <description>Percent of patients with undetectable viral load (UDVL) in each study arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Adolescents</condition>
  <condition>HIV/AIDS</condition>
  <condition>Patient Adherence</condition>
  <arm_group>
    <arm_group_label>Tailored realtime triggered reminder pkg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The core intervention will utilize innovative wireless technology to provide patients with 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. The core intervention will be personalized by each intervention arm patient, who may choose features to suit their preferences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Tailored realtime triggered reminder pkg</intervention_name>
    <description>Core intervention: 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. Personalized features of the intervention will be selected by each patient and may include 1) reminders sent to the WPC (light or chimes) or to patient's or caregiver's cell phone if dose is late; 2) content of text messages from a menu of options; 3) use of &quot;youth-friendly&quot; WPC adherence reports for interactive counseling sessions; 4) additional counseling by clinic staff; 5) a &quot;buddy&quot; system, by choosing someone to review the adherence report with him/her; and 6) a &quot;reward message&quot; after a pre-selected time period of excellent adherence.</description>
    <arm_group_label>Tailored realtime triggered reminder pkg</arm_group_label>
    <other_name>wireless monitoring/feedback, counseling, dose histories</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently a patient at the Infectious Disease (ID) clinic at National Hospital for&#xD;
             Pediatrics (NHP) in Hanoi, Vietnam&#xD;
&#xD;
          -  between 12 and 17 years old of age AND&#xD;
&#xD;
          -  expected to remain in care at the NHP for 7 months minimum&#xD;
&#xD;
          -  currently on ART&#xD;
&#xD;
          -  live in the clinic catchment area&#xD;
&#xD;
          -  willing to provide informed assent, caregiver willing to provide consent&#xD;
&#xD;
          -  identified ás having adherence challenges (CD4, detectable VL, and/or clinician&#xD;
             suggestion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below the age of 12 years or above the age of 18&#xD;
&#xD;
          -  not currently on ART&#xD;
&#xD;
          -  live outside the clinic catchment area&#xD;
&#xD;
          -  not willing to provide informed assent, caregiver not willing to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary DeSilva, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New England</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Population Health and Development</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <disposition_first_submitted>April 2, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>April 2, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 8, 2020</disposition_first_posted>
  <last_update_submitted>April 2, 2020</last_update_submitted>
  <last_update_submitted_qc>April 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New England</investigator_affiliation>
    <investigator_full_name>Mary DeSilva</investigator_full_name>
    <investigator_title>Assistant Research Professor</investigator_title>
  </responsible_party>
  <keyword>adherence</keyword>
  <keyword>adolescent</keyword>
  <keyword>HIV/AIDS</keyword>
  <keyword>Vietnam</keyword>
  <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>Undecided</sharing_ipd>
    <ipd_description>Undecided.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03031197
org study id: 1R21MH109381-01
nct id: NCT03031197
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The small RCT will assess feasibility, acceptability, and impact of a real-time intervention
      on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a
      wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a
      personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when
      they miss a dose, and engage in monthly counseling sessions informed by their adherence data.
      Comparison subjects will receive usual care and an offer of counseling at monthly clinic
      visits.
A major priority in HIV care and treatment is identifying effective interventions for
      adolescent patients, including those that make use of new technologies, to help them achieve
      and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they
      take responsibility for their own medication-taking in the transition to adult care. The
      research planned here will contribute to the scientific evidence base on approaches to
      support ART adherence effectively among youth by 1) conducting formative research on
      adherence challenges among adolescents and refining options for a personalized adherence
      intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess
      the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that
      permits adolescent patients to tailor intervention features to suit their individual
      preferences.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Open Label
measure: Optimal on-time adherence
time frame: End of intervention period (month 7)
description: Proportion of patients with ≥95% on-time adherence at end of 6-month intervention period in each study arm
measure: CD4 count
time frame: Pre-intervention month (month 1) vs. last intervention month (month 7)
description: Mean change in CD4 count in each study arm
measure: Viral load
time frame: End of intervention period (month 7)
description: Percent of patients with undetectable viral load (UDVL) in each study arm
arm group label: Tailored realtime triggered reminder pkg
arm group type: Experimental
description: The core intervention will utilize innovative wireless technology to provide patients with 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. The core intervention will be personalized by each intervention arm patient, who may choose features to suit their preferences.
arm group label: Control
arm group type: No Intervention
description: Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.
intervention type: Combination Product
intervention name: Tailored realtime triggered reminder pkg
description: Core intervention: 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. Personalized features of the intervention will be selected by each patient and may include 1) reminders sent to the WPC (light or chimes) or to patient's or caregiver's cell phone if dose is late; 2) content of text messages from a menu of options; 3) use of "youth-friendly" WPC adherence reports for interactive counseling sessions; 4) additional counseling by clinic staff; 5) a "buddy" system, by choosing someone to review the adherence report with him/her; and 6) a "reward message" after a pre-selected time period of excellent adherence.
arm group label: Tailored realtime triggered reminder pkg
other name: wireless monitoring/feedback, counseling, dose histories
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Mary DeSilva, ScD
role: Principal Investigator
affiliation: University of New England
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: University of New England
investigator full name: Mary DeSilva
investigator title: Assistant Research Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Undecided
ipd description: Undecided.