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

Primary Purpose

HIV/AIDS

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PlusCare
Sponsored by
Dimagi Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring youth, young adults, digital health, mobile application, case management

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PlusCare

Arm 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.

Outcomes

Primary Outcome Measures

CD4 cell count
Change in CD4 cell count (cells/mm^3)
viral load
Change in viral load (copies/mL)
HIV medical visit frequency and gaps in medical visits
(Observed number of visits) / (Expected number of visits)

Secondary Outcome Measures

Proximal outcomes (monthly medication adherence item)
Self-reported levels of adherence reported on a monthly basis
Patient-centered outcomes (quality of life): Self-reported responses to survey
Self-reported responses to survey assessments at 3 timepoints
Patient-centered outcomes (self-efficacy): Self-reported responses to survey
Self-reported responses to survey assessments at 3 timepoints
System usability (user satisfaction): System Usability Scale
Self-reported score on the System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability.

Full Information

First Posted
November 9, 2018
Last Updated
January 8, 2019
Sponsor
Dimagi Inc.
Collaborators
Boston Children's Hospital, Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03758066
Brief Title
PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
Official Title
PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dimagi Inc.
Collaborators
Boston Children's Hospital, Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
youth, young adults, digital health, mobile application, case management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post quasi-experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PlusCare
Arm Type
Other
Arm 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(s)
PlusCare
Intervention Description
PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
Primary Outcome Measure Information:
Title
CD4 cell count
Description
Change in CD4 cell count (cells/mm^3)
Time Frame
1 year
Title
viral load
Description
Change in viral load (copies/mL)
Time Frame
1 year
Title
HIV medical visit frequency and gaps in medical visits
Description
(Observed number of visits) / (Expected number of visits)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proximal outcomes (monthly medication adherence item)
Description
Self-reported levels of adherence reported on a monthly basis
Time Frame
1 year
Title
Patient-centered outcomes (quality of life): Self-reported responses to survey
Description
Self-reported responses to survey assessments at 3 timepoints
Time Frame
1 year (Baseline, 6-month, 12-month)
Title
Patient-centered outcomes (self-efficacy): Self-reported responses to survey
Description
Self-reported responses to survey assessments at 3 timepoints
Time Frame
1 year (Baseline, 6-month, 12-month)
Title
System usability (user satisfaction): System Usability Scale
Description
Self-reported score on the System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Fuller, BA
Phone
617-649-2214
Email
pluscare@dimagi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meryn Robinson, MPH
Phone
617-649-2214
Email
pluscare@dimagi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan L Jackson, MEng
Organizational Affiliation
Dimagi Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vikram S Kumar, MD
Organizational Affiliation
Dimagi Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Dumont, BA
Phone
617-355-2509
First Name & Middle Initial & Last Name & Degree
Carly Guss, MD
Phone
617-355-7181

12. IPD Sharing Statement

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

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