- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758066
PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
October 2, 2023 updated by: Dimagi Inc.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CD4 Cell Count
Time Frame: 1 year prior to baseline (pre), 1 year post-baseline (post)
|
Comparison of average CD4 cell count (cells/mm^3) between pre and post time points
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1 year prior to baseline (pre), 1 year post-baseline (post)
|
Viral Load
Time Frame: 1 year prior to baseline (pre), 1 year post-baseline (post)
|
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
Time Frame: 1 year prior to baseline (pre), 1 year post-baseline (post)
|
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
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1 year prior to baseline (pre), 1 year post-baseline (post)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proximal Outcomes (Monthly Medication Adherence Item)
Time Frame: Monthly
|
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.
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Monthly
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Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey
Time Frame: 1 year (Baseline, 6-month, 12-month)
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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").
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1 year (Baseline, 6-month, 12-month)
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Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey
Time Frame: 1 year (Baseline, 6-month, 12-month)
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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.
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1 year (Baseline, 6-month, 12-month)
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System Usability (User Satisfaction): System Usability Scale
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan L Jackson, MEng, Dimagi Inc.
- Principal Investigator: Vikram S Kumar, MD, Dimagi Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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)
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2019
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 28, 2018
First Posted (Actual)
November 29, 2018
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 9R44MH117956-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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