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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
| Boston Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PlusCare | Device | PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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PATIENTS:
Inclusion Criteria:
Exclusion Criteria:
CASE MANAGERS:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan L Jackson, MEng | Dimagi Inc. | Principal Investigator |
| Vikram S Kumar, MD | Dimagi Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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) | ||
| 36409541 | Result | 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. |
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There were no significant effects that occurred after participant enrollment that affected enrolled participants receiving the intervention. This was a one-armed prospective study where participants were enrolled into the study and then enrolled into the PlusCare system in-person in one session.
Study participants were recruited and enrolled into the study between January 2019 to June 2019 from 3 HIV/AIDS programs at two large, private, not-for-profit academic hospitals in the metro Boston area. Participants were case management program team members (CMs) and adolescents and young adults (AYA) living with HIV. CMs were enrolled and trained on the system first. Patients were then enrolled on a rolling basis. An RA at each site assessed eligibility, consented and enrolled participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | PlusCare | AYA living with HIV and CMs 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 web/mobile application designed to be used by youth and young adults with HIV and case managers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were members of HIV case management care team members (CMs) in 3 different programs and adolescent and young adult (AYA) patients living with HIV who they work with in the programs.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CD4 Cell Count | Comparison of average CD4 cell count (cells/mm^3) between pre and post time points | Posted | Mean | 95% Confidence Interval | cells/mm^3 | 1 year prior to baseline (pre), 1 year post-baseline (post) |
|
|
Approximately 1 year from enrollment
Adverse events (AE) in this study will be any breach of confidentiality. A serious AE will be considered to have occurred if a subject's identity or personal health information becomes known to someone who is not supposed to have (and previously did not have) access to the information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PlusCare | AYA living with HIV and CMs 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 web/mobile application designed to be used by youth and young adults with HIV and case managers. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Y. Xian Ho | Dimagi, Inc. | 617-649-2214 | 63 | yho@dimagi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 | Jul 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Pre-post quasi-experimental design
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| Monthly |
| 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) |
| 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) |
| 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 |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) | Count of Participants | Participants |
|
| Education | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) | Count of Participants | Participants |
|
| Smartphone ownership | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) | Count of Participants | Participants |
|
| Hours on the phone per day | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) | Count of Participants | Participants |
|
| Tech savvy | Survey item: How tech savvy would you rate yourself, from 1 to 10? (1=not savvy, 10=very savvy) | Demographics are reported for each of the 2 participant types (CM and AYA living with HIV) | Mean | Standard Deviation | units on a scale |
|
|
| Primary | Viral Load | Comparison of average viral load (copies/mL) between pre and post time points | Posted | Mean | 95% Confidence Interval | copies/mL | 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 | Posted | Median | Standard Deviation | appointment adherence ratio | 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. | Posted | Mean | Standard Deviation | score on a scale | 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"). | Participants who completed the quality of life general health assessment (CDC HRQOL-4) at baseline, 6 months, and 12 months (end of study). | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants who completed self-efficacy assessment (SEMCD6) at baseline, 6 months, and 12 months (end of study). | Posted | Mean | Standard Deviation | score on a scale | 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. | Summary of SUS scores reported for 13 (out of 20) CMs and 38 (out of 45) AYA living with HIV participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Not Hispanic, Other (incl. Native American, Asian/Pacific Islander, More than one) |
|
| Unknown ethnicity |
|
| Master's Degree |
|
| Doctoral Degree |
|
| Professional Degree |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Sign test | .02 | P-value reported for self-reported self-efficacy in chronic disease management between 6- and 12-month follow-up with a statistical significance threshold of .05. | Other |
|