<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/NCT03758066</url>
  </required_header>
  <id_info>
    <org_study_id>9R44MH117956-02</org_study_id>
    <nct_id>NCT03758066</nct_id>
  </id_info>
  <brief_title>PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS</brief_title>
  <official_title>PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dimagi Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dimagi Inc.</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>
      While major advancements in medical technology over the past decade have significantly&#xD;
      improved the life expectancy of persons infected with human immunodeficiency virus (HIV),&#xD;
      HIV-positive youth today face new barriers to the treatment of HIV as a chronic, manageable&#xD;
      illness. The mobile system proposed will help improve linkage to care through mobile&#xD;
      technology support for the case management of youth living with HIV. Results of this project&#xD;
      will determine the impact of this system on case management processes and outcomes and have&#xD;
      implications for the care of youth living with other chronic, complex illnesses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the advancement of medical treatments, which has contributed to the overall decrease in&#xD;
      opportunistic infections and deaths related to human immunodeficiency virus (HIV) in youth,&#xD;
      there is a need to ensure that youth living with HIV (YLH) are linked to and engaged in care&#xD;
      to successfully achieve viral suppression. While an increasing number of mobile health&#xD;
      (mHealth) technologies have been designed to address HIV prevention and care, a critical gap&#xD;
      in innovation remains in tools designed to address the specific needs of YLH. In a Phase I&#xD;
      project, investigators demonstrated the acceptability and feasibility of a user-centered&#xD;
      prototype design of PlusCare, an mHealth application that can be used by YLH and their case&#xD;
      managers (CMs) to support HIV care. Results of Phase I suggest that PlusCare could facilitate&#xD;
      multi-disciplinary, team-based case management of YLH by supporting the sharing and signing&#xD;
      of documents remotely, automation of adherence reminders, sharing of lab results, alerts CMs&#xD;
      about program requirements related to age and developmental milestones, streamlining of&#xD;
      communication between multiple members of a patient's case management team and the patient,&#xD;
      and offering accessibility to data from multiple modalities. In this Phase II project,&#xD;
      investigators will conduct a mixed methods, non-randomized pre-post study with CMs (N=20) and&#xD;
      YLH patients (N=70) to examine the use of PlusCare on case management processes and health&#xD;
      outcomes (i.e., HIV viral load, medical visit frequency and gaps) in 3 different case&#xD;
      management programs at 2 different clinical study site settings. An initial cost analysis&#xD;
      will be performed to assess potential cost effectiveness. Results of these Phase I and II&#xD;
      projects will inform the development of a product that can be used in multiple case&#xD;
      management settings and prepare PlusCare for future commercialization. Results have&#xD;
      implications for future development of PlusCare to serve the broader HIV population (YLH aged&#xD;
      25-34 years old and at-risk individuals) as well as youth living with other chronic health&#xD;
      conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre-post quasi-experimental design</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD4 cell count</measure>
    <time_frame>1 year</time_frame>
    <description>Change in CD4 cell count (cells/mm^3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>viral load</measure>
    <time_frame>1 year</time_frame>
    <description>Change in viral load (copies/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV medical visit frequency and gaps in medical visits</measure>
    <time_frame>1 year</time_frame>
    <description>(Observed number of visits) / (Expected number of visits)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proximal outcomes (monthly medication adherence item)</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported levels of adherence reported on a monthly basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-centered outcomes (quality of life): Self-reported responses to survey</measure>
    <time_frame>1 year (Baseline, 6-month, 12-month)</time_frame>
    <description>Self-reported responses to survey assessments at 3 timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-centered outcomes (self-efficacy): Self-reported responses to survey</measure>
    <time_frame>1 year (Baseline, 6-month, 12-month)</time_frame>
    <description>Self-reported responses to survey assessments at 3 timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System usability (user satisfaction): System Usability Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported score on the System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>PlusCare</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients and case managers who work with them will be given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PlusCare</intervention_name>
    <description>PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.</description>
    <arm_group_label>PlusCare</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PATIENTS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  between 13-25 years old&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  enrolled in treatment at a participating study site&#xD;
&#xD;
          -  owns or has ability to access a smartphone (e.g., iPhone, Android) for one year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaker or&#xD;
&#xD;
          -  Visually/hearing impaired&#xD;
&#xD;
        CASE MANAGERS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Actively employed at a participating study site&#xD;
&#xD;
          -  Performs case management duties with HIV-positive patients aged 13-25 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (None)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan L Jackson, MEng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dimagi Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vikram S Kumar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dimagi Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julia Fuller, BA</last_name>
    <phone>617-649-2214</phone>
    <email>pluscare@dimagi.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meryn Robinson, MPH</last_name>
    <phone>617-649-2214</phone>
    <email>pluscare@dimagi.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia Dumont, BA</last_name>
      <phone>617-355-2509</phone>
    </contact>
    <contact_backup>
      <last_name>Carly Guss, MD</last_name>
      <phone>617-355-7181</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>youth</keyword>
  <keyword>young adults</keyword>
  <keyword>digital health</keyword>
  <keyword>mobile application</keyword>
  <keyword>case management</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>
  <pending_results>
    <submitted>March 27, 2022</submitted>
    <returned>April 22, 2022</returned>
    <submitted>February 26, 2023</submitted>
    <returned>March 22, 2023</returned>
    <submitted>September 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03758066
org study id: 9R44MH117956-02
nct id: NCT03758066
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While major advancements in medical technology over the past decade have significantly
      improved the life expectancy of persons infected with human immunodeficiency virus (HIV),
      HIV-positive youth today face new barriers to the treatment of HIV as a chronic, manageable
      illness. The mobile system proposed will help improve linkage to care through mobile
      technology support for the case management of youth living with HIV. Results of this project
      will determine the impact of this system on case management processes and outcomes and have
      implications for the care of youth living with other chronic, complex illnesses.
With the advancement of medical treatments, which has contributed to the overall decrease in
      opportunistic infections and deaths related to human immunodeficiency virus (HIV) in youth,
      there is a need to ensure that youth living with HIV (YLH) are linked to and engaged in care
      to successfully achieve viral suppression. While an increasing number of mobile health
      (mHealth) technologies have been designed to address HIV prevention and care, a critical gap
      in innovation remains in tools designed to address the specific needs of YLH. In a Phase I
      project, investigators demonstrated the acceptability and feasibility of a user-centered
      prototype design of PlusCare, an mHealth application that can be used by YLH and their case
      managers (CMs) to support HIV care. Results of Phase I suggest that PlusCare could facilitate
      multi-disciplinary, team-based case management of YLH by supporting the sharing and signing
      of documents remotely, automation of adherence reminders, sharing of lab results, alerts CMs
      about program requirements related to age and developmental milestones, streamlining of
      communication between multiple members of a patient's case management team and the patient,
      and offering accessibility to data from multiple modalities. In this Phase II project,
      investigators will conduct a mixed methods, non-randomized pre-post study with CMs (N=20) and
      YLH patients (N=70) to examine the use of PlusCare on case management processes and health
      outcomes (i.e., HIV viral load, medical visit frequency and gaps) in 3 different case
      management programs at 2 different clinical study site settings. An initial cost analysis
      will be performed to assess potential cost effectiveness. Results of these Phase I and II
      projects will inform the development of a product that can be used in multiple case
      management settings and prepare PlusCare for future commercialization. Results have
      implications for future development of PlusCare to serve the broader HIV population (YLH aged
      25-34 years old and at-risk individuals) as well as youth living with other chronic health
      conditions.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre-post quasi-experimental design
primary purpose: Health Services Research
masking: None (Open Label)
measure: CD4 cell count
time frame: 1 year
description: Change in CD4 cell count (cells/mm^3)
measure: viral load
time frame: 1 year
description: Change in viral load (copies/mL)
measure: HIV medical visit frequency and gaps in medical visits
time frame: 1 year
description: (Observed number of visits) / (Expected number of visits)
measure: Proximal outcomes (monthly medication adherence item)
time frame: 1 year
description: Self-reported levels of adherence reported on a monthly basis
measure: Patient-centered outcomes (quality of life): Self-reported responses to survey
time frame: 1 year (Baseline, 6-month, 12-month)
description: Self-reported responses to survey assessments at 3 timepoints
measure: Patient-centered outcomes (self-efficacy): Self-reported responses to survey
time frame: 1 year (Baseline, 6-month, 12-month)
description: Self-reported responses to survey assessments at 3 timepoints
measure: System usability (user satisfaction): System Usability Scale
time frame: 1 year
description: Self-reported score on the System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability.
arm group label: PlusCare
arm group type: Other
description: Patients and case managers who work with them will be given access to a web-/mobile-based application, PlusCare, to support various case management activities for one year.
intervention type: Device
intervention name: PlusCare
description: PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
arm group label: PlusCare
criteria: 
gender: All
minimum age: 13 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan L Jackson, MEng
role: Principal Investigator
affiliation: Dimagi Inc.
last name: Vikram S Kumar, MD
role: Principal Investigator
affiliation: Dimagi Inc.
last name: Julia Fuller, BA
phone: 617-649-2214
email: pluscare@dimagi.com
last name: Meryn Robinson, MPH
phone: 617-649-2214
email: pluscare@dimagi.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
submitted: March 27, 2022
returned: April 22, 2022
submitted: February 26, 2023
returned: March 22, 2023
submitted: September 10, 2023