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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: PlusCare
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
1 year prior to baseline (pre), 1 year post-baseline (post)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Monthly
Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey
Time Frame: 1 year (Baseline, 6-month, 12-month)
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)
Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey
Time Frame: 1 year (Baseline, 6-month, 12-month)
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)
System Usability (User Satisfaction): System Usability Scale
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dimagi Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Children's Hospital
Boston Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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