HIV/AIDS
Conditions
Keywords
youth, young adults, digital health, mobile application, case management
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.
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.
Interventions
DEVICEPlusCare
PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
Sponsors
Boston Children's Hospital
Boston Medical Center
Dimagi Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Pre-post quasi-experimental design
Eligibility
Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD4 Cell Count | 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 |
| Viral Load | 1 year prior to baseline (pre), 1 year post-baseline (post) | Comparison of average viral load (copies/mL) between pre and post time points |
| Appointment Adherence Rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal Outcomes (Monthly Medication Adherence Item) | 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. |
| System Usability (User Satisfaction): System Usability Scale | 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. |
| Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey | 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). |
| Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 14 |
Baseline characteristics
| Characteristic | PlusCare |
|---|---|
| Age, Categorical AYA living with HIV <=18 years | 12 Participants |
| Age, Categorical AYA living with HIV >=65 years | 0 Participants |
| Age, Categorical AYA living with HIV Between 18 and 65 years | 33 Participants |
| Age, Categorical CM <=18 years | 0 Participants |
| Age, Categorical CM >=65 years | 0 Participants |
| Age, Categorical CM Between 18 and 65 years | 20 Participants |
| Education AYA living with HIV Bachelor's Degree | 0 Participants |
| Education AYA living with HIV Doctoral Degree | 0 Participants |
| Education AYA living with HIV High school graduate or less | 24 Participants |
| Education AYA living with HIV Master's Degree | 0 Participants |
| Education AYA living with HIV Professional Degree | 0 Participants |
| Education AYA living with HIV Some college credit or more | 20 Participants |
| Education CM Bachelor's Degree | 7 Participants |
| Education CM Doctoral Degree | 4 Participants |
| Education CM High school graduate or less | 0 Participants |
| Education CM Master's Degree | 7 Participants |
| Education CM Professional Degree | 2 Participants |
| Education CM Some college credit or more | 0 Participants |
| Hours on the phone per day AYA living with HIV 0-3 hours | 8 Participants |
| Hours on the phone per day AYA living with HIV 4-6 hours | 19 Participants |
| Hours on the phone per day AYA living with HIV 7+ hours | 18 Participants |
| Hours on the phone per day CM 0-3 hours | 9 Participants |
| Hours on the phone per day CM 4-6 hours | 8 Participants |
| Hours on the phone per day CM 7+ hours | 3 Participants |
| Race/Ethnicity, Customized AYA living with HIV Hispanic/Latino | 8 Participants |
| Race/Ethnicity, Customized AYA living with HIV Not Hispanic, Black | 24 Participants |
| Race/Ethnicity, Customized AYA living with HIV Not Hispanic, Other (incl. Native American, Asian/Pacific Islander, More than one) | 6 Participants |
| Race/Ethnicity, Customized AYA living with HIV Not Hispanic, White | 4 Participants |
| Race/Ethnicity, Customized AYA living with HIV Unknown ethnicity | 3 Participants |
| Race/Ethnicity, Customized CM Hispanic/Latino | 1 Participants |
| Race/Ethnicity, Customized CM Not Hispanic, Black | 4 Participants |
| Race/Ethnicity, Customized CM Not Hispanic, Other (incl. Native American, Asian/Pacific Islander, More than one) | 1 Participants |
| Race/Ethnicity, Customized CM Not Hispanic, White | 12 Participants |
| Race/Ethnicity, Customized CM Unknown ethnicity | 2 Participants |
| Sex: Female, Male AYA living with HIV Female | 23 Participants |
| Sex: Female, Male AYA living with HIV Male | 22 Participants |
| Sex: Female, Male CM Female | 18 Participants |
| Sex: Female, Male CM Male | 2 Participants |
| Smartphone ownership AYA living with HIV Android | 5 Participants |
| Smartphone ownership AYA living with HIV iPhone | 40 Participants |
| Smartphone ownership CM Android | 3 Participants |
| Smartphone ownership CM iPhone | 17 Participants |
| Tech savvy AYA living with HIV | 7.86 units on a scale STANDARD_DEVIATION 1.58 |
| Tech savvy CM | 7.05 units on a scale STANDARD_DEVIATION 1.23 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
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
Time frame: 1 year prior to baseline (pre), 1 year post-baseline (post)
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| PlusCare | Appointment Adherence Rate | Pre | 0.60 appointment adherence ratio | Standard Deviation 0.19 |
| PlusCare | Appointment Adherence Rate | Post | .67 appointment adherence ratio | Standard Deviation 0.25 |
Primary
CD4 Cell Count
Comparison of average CD4 cell count (cells/mm\^3) between pre and post time points
Time frame: 1 year prior to baseline (pre), 1 year post-baseline (post)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PlusCare | CD4 Cell Count | Pre | 996 cells/mm^3 |
| PlusCare | CD4 Cell Count | Post | 1049 cells/mm^3 |
Primary
Viral Load
Comparison of average viral load (copies/mL) between pre and post time points
Time frame: 1 year prior to baseline (pre), 1 year post-baseline (post)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PlusCare | Viral Load | Pre | 32.0 copies/mL |
| PlusCare | Viral Load | Post | 24.7 copies/mL |
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).
Time frame: 1 year (Baseline, 6-month, 12-month)
Population: Participants who completed the quality of life general health assessment (CDC HRQOL-4) at baseline, 6 months, and 12 months (end of study).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PlusCare | Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey | Baseline | 3.6 score on a scale | Standard Deviation 0.12 |
| PlusCare | Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey | 6-month | 3.6 score on a scale | Standard Deviation 0.16 |
| PlusCare | Patient-centered Outcomes (Quality of Life): Self-reported Responses to Survey | 12-month | 3.9 score on a scale | Standard Deviation 0.16 |
Comparison: A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).p-value: 0.03Sign test
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.
Time frame: 1 year (Baseline, 6-month, 12-month)
Population: Participants who completed self-efficacy assessment (SEMCD6) at baseline, 6 months, and 12 months (end of study).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PlusCare | Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey | Baseline | 7.8 score on a scale | Standard Deviation 0.3 |
| PlusCare | Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey | 6-month | 7.8 score on a scale | Standard Deviation 0.36 |
| PlusCare | Patient-centered Outcomes (Self-efficacy): Self-reported Responses to Survey | 12-month | 8.6 score on a scale | Standard Deviation 0.27 |
Comparison: A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).p-value: 0.02Sign test
p-value: 0.02Sign test
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.
Time frame: Monthly
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PlusCare | Proximal Outcomes (Monthly Medication Adherence Item) | 4.7 score on a scale | Standard Deviation 0.23 |
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PlusCare | System Usability (User Satisfaction): System Usability Scale | CM | 51 score on a scale | Standard Deviation 7.9 |
| PlusCare | System Usability (User Satisfaction): System Usability Scale | AYA living with HIV | 63 score on a scale | Standard Deviation 10.6 |