Clinical trial NCT03758066: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: youth
young adults
digital health
mobile application
case management
Lead sponsor: Dimagi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boston Children's Hospital
name: Boston Medical Center
First posted: 2018-11-29
Enrollment: 65
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post quasi-experimental design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: CD4 Cell Count
timeFrame: 1 year prior to baseline (pre), 1 year post-baseline (post)
measure: Viral Load
timeFrame: 1 year prior to baseline (pre), 1 year post-baseline (post)
measure: Appointment Adherence Rate
timeFrame: 1 year prior to baseline (pre), 1 year post-baseline (post)
Secondary outcomes:
measure: Proximal Outcomes (Monthly Medication Adherence Item)
timeFrame: Monthly
measure: Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey
timeFrame: 1 year (Baseline, 6-month, 12-month)
measure: Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey
timeFrame: 1 year (Baseline, 6-month, 12-month)
measure: System Usability (User Satisfaction): System Usability Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Dimagi Inc.
name: Jonathan L Jackson, MEng
role: PRINCIPAL_INVESTIGATOR
affiliation: Dimagi Inc.
name: Vikram S Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guss, CE, Woods, ER, Cooper, ER, Burchett, S, Fuller, JM, Dumont, O, Ho, YX, Robinson, M, Swendeman, D, Haberer, J, Mulvaney, S, & Kumar, V. (2020). PlusCare: A Mobile Platform Designed to Increase Linkage to Care for Youth Living with HIV/AIDS. J Adol Health, 66(2),127-128. doi:https://doi.org/10.1016/j.jadohealth.2019.11.255 (Abstract)
citation: Fee C, Fuller J, Guss CE, Woods ER, Cooper ER, Bhaumik U, Graham D, Burchett SK, Dumont O, Martey EB, Narvaez M, Haberer JE, Swendeman D, Mulvaney SA, Kumar VS, Jackson JL, Ho YX. A Digital Platform to Support HIV Case Management for Youth and Young Adults: Mixed Methods Feasibility Study. JMIR Form Res. 2022 Nov 21;6(11):e39357. doi: 10.2196/39357.