AzTrials
AzTrials

HIV/AIDSNCT03758066

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

A study testing PlusCare in people with HIV/AIDS, run by Dimagi Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 13 to 25 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
PlusCare
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
2 Jan 2019to 31 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
  • Actively employed at a participating study site
  • Performs case management duties with HIV-positive patients aged 13-25 years.

Who cannot join

  • Non-English speaker or
  • Visually/hearing impaired
  • CASE MANAGERS:
  • (None)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the 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.

Conditions
HIV/AIDS
Being tested
PlusCare
Keywords
youth, young adults, digital health, mobile application, case management
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlusCareDevice

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

Study groups in NCT03758066
Study groupRoleWhat they receive
PlusCareOtherPatients 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.
Receives: Device: PlusCare

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD4 Cell Count

    Comparison of average CD4 cell count (cells/mm^3) between pre and post time points

    Measured: 1 year prior to baseline (pre), 1 year post-baseline (post)

  2. Viral Load

    Comparison of average viral load (copies/mL) between pre and post time points

    Measured: 1 year prior to baseline (pre), 1 year post-baseline (post)

  3. 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

    Measured: 1 year prior to baseline (pre), 1 year post-baseline (post)

Secondary outcomes (4)

  1. 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.

    Measured: Monthly

  2. 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").

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

  3. 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.

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

  4. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2018
  2. Study start2 Jan 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Pre-post quasi-experimental design
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03758066
Sponsor's protocol ID
9R44MH117956-02
Status last verified
Oct 2023
First submitted
9 Nov 2018
Last updated
26 Oct 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 36409541

Questions about this trial

What is this clinical trial studying?

A study testing PlusCare in people with HIV/AIDS, run by Dimagi Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4 Cell Count (time frame: 1 year prior to baseline (pre), 1 year post-baseline (post)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03758066, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in