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

NCT03758066 | Completed Results

• 1 other identifier: 9R44MH117956-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

youth; young adults; digital health; mobile application; case management

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (4)

• Proximal Outcomes (Monthly Medication Adherence Item)

  Monthly

• Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey

  1 year (Baseline, 6-month, 12-month)

• Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey

  1 year (Baseline, 6-month, 12-month)

• System Usability (User Satisfaction): System Usability Scale

  1 year

Study Arms (1)

PlusCare

OTHER

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

Interventions

PlusCare DEVICE

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

PlusCare

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaker or
• Visually/hearing impaired
• CASE MANAGERS:
• Actively employed at a participating study site
• Performs case management duties with HIV-positive patients aged 13-25 years.
• (None)

Sponsors & Collaborators

• Dimagi Inc.: lead
• Boston Children's Hospital: collaborator
• Boston Medical Center: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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)

  BACKGROUND

• 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.

  PMID: 36409541 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Y. Xian Ho
• Organization: Dimagi, Inc.

yho@dimagi.com

617-649-2214

Study Officials

• Jonathan L Jackson, MEng

  Dimagi Inc.

  PRINCIPAL INVESTIGATOR

• Vikram S Kumar, MD

  Dimagi Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pre-post quasi-experimental design

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 29, 2018
• Study Start: January 2, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)