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PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS

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ClinicalTrials.gov Identifier: NCT03758066
Recruitment Status : Unknown
Verified January 2019 by Dimagi Inc..
Recruitment status was:  Recruiting
First Posted : November 29, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Boston Children's Hospital
Boston Medical Center
Information provided by (Responsible Party):
Dimagi Inc.

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 29, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE January 8, 2018
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • CD4 cell count [ Time Frame: 1 year ]
    Change in CD4 cell count (cells/mm^3)
  • viral load [ Time Frame: 1 year ]
    Change in viral load (copies/mL)
  • HIV medical visit frequency and gaps in medical visits [ Time Frame: 1 year ]
    (Observed number of visits) / (Expected number of visits)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • Proximal outcomes (monthly medication adherence item) [ Time Frame: 1 year ]
    Self-reported levels of adherence reported on a monthly basis
  • Patient-centered outcomes (quality of life): Self-reported responses to survey [ Time Frame: 1 year (Baseline, 6-month, 12-month) ]
    Self-reported responses to survey assessments at 3 timepoints
  • Patient-centered outcomes (self-efficacy): Self-reported responses to survey [ Time Frame: 1 year (Baseline, 6-month, 12-month) ]
    Self-reported responses to survey assessments at 3 timepoints
  • System usability (user satisfaction): System Usability Scale [ Time Frame: 1 year ]
    Self-reported score on the System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
Official Title  ICMJE PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Pre-post quasi-experimental design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Device: PlusCare
PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
Study Arms  ICMJE PlusCare
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: Device: PlusCare
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 28, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

PATIENTS:

Inclusion Criteria:

  • between 13-25 years old
  • HIV positive
  • enrolled in treatment at a participating study site
  • owns or has ability to access a smartphone (e.g., iPhone, Android) for one year

Exclusion Criteria:

  • Non-English speaker or
  • Visually/hearing impaired

CASE MANAGERS:

Inclusion Criteria:

  • Actively employed at a participating study site
  • Performs case management duties with HIV-positive patients aged 13-25 years.

Exclusion Criteria:

  • (None)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03758066
Other Study ID Numbers  ICMJE 9R44MH117956-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dimagi Inc.
Study Sponsor  ICMJE Dimagi Inc.
Collaborators  ICMJE
  • Boston Children's Hospital
  • Boston Medical Center
Investigators  ICMJE
Principal Investigator: Jonathan L Jackson, MEng Dimagi Inc.
Principal Investigator: Vikram S Kumar, MD Dimagi Inc.
PRS Account Dimagi Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP