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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 : 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.

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Device: PlusCare Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-post quasi-experimental design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Device: PlusCare
PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.




Primary Outcome Measures :
  1. CD4 cell count [ Time Frame: 1 year ]
    Change in CD4 cell count (cells/mm^3)

  2. viral load [ Time Frame: 1 year ]
    Change in viral load (copies/mL)

  3. HIV medical visit frequency and gaps in medical visits [ Time Frame: 1 year ]
    (Observed number of visits) / (Expected number of visits)


Secondary Outcome Measures :
  1. Proximal outcomes (monthly medication adherence item) [ Time Frame: 1 year ]
    Self-reported levels of adherence reported on a monthly basis

  2. 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

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758066


Contacts
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Contact: Julia Fuller, BA 617-649-2214 pluscare@dimagi.com
Contact: Meryn Robinson, MPH 617-649-2214 pluscare@dimagi.com

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Olivia Dumont, BA    617-355-2509      
Contact: Carly Guss, MD    617-355-7181      
Sponsors and Collaborators
Dimagi Inc.
Boston Children’s Hospital
Boston Medical Center
Investigators
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Principal Investigator: Jonathan L Jackson, MEng Dimagi Inc.
Principal Investigator: Vikram S Kumar, MD Dimagi Inc.

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Responsible Party: Dimagi Inc.
ClinicalTrials.gov Identifier: NCT03758066     History of Changes
Other Study ID Numbers: 9R44MH117956-02 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dimagi Inc.:
youth
young adults
digital health
mobile application
case management