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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758066
• Other study ID #: 9R44MH117956-02
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2023
• Source: Dimagi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dimagi Inc.	Boston Children's Hospital, Boston Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Adult — View 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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 Cell Count	Comparison of average CD4 cell count (cells/mm^3) between pre and post time points	1 year prior to baseline (pre), 1 year post-baseline (post)
Primary	Viral Load	Comparison of average viral load (copies/mL) between pre and post time points	1 year prior to baseline (pre), 1 year post-baseline (post)
Primary	Appointment Adherence Rate	Comparison of median appointment adherence ratio between pre and post time points, i.e., (Actual completed appointments) / (Expected appointments) where expected appointments includes completed appointments, no shows, and cancellations	1 year prior to baseline (pre), 1 year post-baseline (post)
Secondary	Proximal Outcomes (Monthly Medication Adherence Item)	Self-reported levels of medication adherence were reported on a monthly basis, where AYA living with HIV rated their adherence to their prescribed medication using the self-rating scale item (SRSI) single-item adherence measure. Patients reported medication adherence for the past month on a 6-point Likert scale ranging from 1 ("very poor") to 6 ("excellent"). Patients received monthly SMS text messages alerting them to report adherence via survey forms created in the PlusCare app. Mean self-reported monthly medication adherence ratings across 12 months is reported.	Monthly
Secondary	Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey	Self-reported scores to the General Health item of the CDC "Health Days Measure" Core Module (CDC HRQOL-4) item were compared between 3 timepoints, with scores ranging from 1 ("Poor") to 5 ("Excellent").	1 year (Baseline, 6-month, 12-month)
Secondary	Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey	Self-reported average scores to the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD6) were compared between 3 timepoints. SEMCD6 scores range from 1 to 10, with higher numbers indicating higher self-efficacy.	1 year (Baseline, 6-month, 12-month)
Secondary	System Usability (User Satisfaction): System Usability Scale	Self-reported ratings of perceived system usability on the 10-point Likert-scaled System Usability Scale (SUS) scored in a range of 0 of 100, with higher scores indicating higher usability, were collected at end of study.	1 year