PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS
Phase: NA
Conditions: HIV/AIDS
Sponsor: Dimagi Inc.

ID: 9R44MH117956-02 
Title: PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With 
HIV/AIDS 
NCT ID: NCT03758066 
Date of Protocol: 3/15/2018 
Dates Approved by Sites: 1/2/2019 (BCH) and 2/01/2019 (BMC) 
 
Study Objective and Overview: To conduct a mixed-methods, non-randomized pre-post study 
to test PlusCare, a mobile application, in real-world clinical settings. In a Phase I project, 
members of the research team demonstrated the acceptability and feasibility of PlusCare, a 
mobile application system developed by Dimagi, Inc. to support HIV case management for 
youth living with HIV (YLH) aged 13 to 25 years old. In this Phase II SBIR project, we will enhance 
the PlusCare system to best serve the team-based care delivery model identified in Phase I and 
test it in a non-randomized, pre-post intervention study conducted in multiple clinical settings. 
The objective of this Phase II project is to test and demonstrate the effectiveness of PlusCare on 
HIV case management process and care continuum outcome measures. 
 
Study Design: Patients and case managers (CMs) will be recruited from three HIV case 
management programs in two hospitals in the metro Boston area. Patients will use the PlusCare 
application for 12 months, while CMs will use the system for at least 15 months in order to 
account for rolling patient recruitment (i.e., 3 months to enroll target number of patients). We 
will perform a process and outcomes evaluation of the system to determine the effect of the 
PlusCare intervention on HIV health status and case management outcomes.  
 
Patient Selection and Inclusion/Exclusion Criteria: A research assistant (RA) will recruit CMs 
(N=20) and patients (N=50).  
 
The patient eligibility criteria are as follows: 
Inclusions: 
 
1) between 13-25 years old, 
2) patient of the BCH HAPPENS or BCH CHAP program, 
3) HIV-positive,  
4) own or ability to access a smartphone (e.g., iPhone, Android) for one year, and 
5) be in care for at least 1 year prior (for access to historical control data) 
Exclusions: 
1) Non-English speaker or 
2) Visually or hearing impaired 
 
These criteria were selected to ensure the focus and inclusion of YLH to fulfill the purpose and 
function of this proposed application for case management to serve this population, who most 
benefit from the support for care and services that the case management model provides. 
Additionally, our team wanted to ensure that the patients would be able to run the PlusCare 
app on their device for the needed length for the study. 
 

The CM eligibility criteria are as follows: 
Inclusions: 
 
1) are actively employed BCH and  
2) perform case management duties with HIV-positive patients 13-25 years old 
 
Description of Study Treatments or Exposures/Predictors: Study participants will be given a 
username and access to the PlusCare app on their own personal devices. CMs will have access 
to the mobile app available on a study tablet that will be provided to each program or web app 
accessible from their own work computers. 
 
Definition of Primary and Secondary Outcomes/Endpoints: Primary outcomes will be CD4 
count, viral load, and HIV medical visit frequency. Secondary outcomes include emergency 
room visits and hospitalizations, adherence, patient reported quality of life, system usage data 
(such as log-ins) and system usability and satisfaction. This is detailed further in the table 
below: 
 
 
Data Collection Methods, Assessments, Interventions and Schedule (what assessments 
performed, how often) 
For case managers:  
Patient Measures 
Pre 
Post 
Data Source 
 
1-year 
prior 
Base 6-mos 12-mos 
 
Baseline Demographics 
 
 
 
 
 
Current gender1, sexual orientation identity 
(BRFSS2), age/date of birth, income & employment 
(STRIVE3), years since diagnosis, time spent in case 
management, housing stability, insurance, 
retention and quality of care, treatment 
x 
Survey, EHR 
Experience with Technology 
x 
Survey 
Primary Outcomes 
CD4, viral load4 
x 
x 
 
x 
EHR (Lab data) 
HIV medical visit frequency and gaps4 
x 
x 
 
x 
Billing data, 
EHR 
Secondary Outcomes 
 
 
 
 
 
ED visits, hospitalizations 
x 
x 
 
x 
Billing data, 
Survey 
Patient-centered: Quality of Life (CDC HRQOL-14), 
self-efficacy (based on chronic disease scale) 
 
x 
x 
x 
Survey 
System: Usage (log in frequency, dwell time) 
 
 
 
x 
System data 
System: Usability and Satisfaction5 
 
 
 
x 
Survey 

Baseline assessment and in-person training. Enrolled CMs will attend an in-person training 
session, which will be led by a RA with a Dimagi study team member with technical experience 
in the development of PlusCare. A baseline survey will be administered to collect basic 
demographic data (e.g., age, sex, race, ethnicity, education), information on professional role 
and experience (e.g., job title, years of CM experience, number of patients managed), and 
experience with technology. In the training session, Ease of training and feasibility of this model 
of patient registration will be assessed in this study through qualitative feedback collected from 
CMs at the end of the study.  
Intervention. All CMs will have access to PlusCare via mobile app installed on a study tablet or 
web app accessible from any computer for at least a period of 15 months to accommodate for 
rolling patient enrollment. During this study period, data on CM usage of PlusCare will be 
collected passively through the tablet as well as through web app access and outputted as daily 
usage logs.  
End-of-Study Interview with CMs. Towards the end of the study period (i.e., 15 months after 
Baseline), CMs in each program will be re-contacted by the respective study RA at each site to 
participate in a one-hour focus group. Focus groups will comprise 2-8 participants and will be 
led by the study RA in a private setting. For those who are unable to attend a scheduled focus 
group, a separate structured one-on-one interview will be scheduled. 
CM participant compensation. CMs will be compensated $50 for completing the Baseline 
Assessment and Training Session and $100 for completing the End-of-Study Interview. If a CM 
drops out of the study before the end of the study due to circumstances unrelated to the study 
(e.g., change in employment), s/he will still have an opportunity to participate in an end-of-the-
study interview and will receive $100 for completion of that study activity. Any CMs who are 
newly employed during the 15-month period will be recruited to participate in the study and 
compensated in the same fashion. 
For patients:  
In-person baseline interview. Upon receiving written assent or consent, the RA will then 
proceed to administer a baseline assessment and a semi-structured, open-ended interview. The 
RA will be responsible for registering the patient into the PlusCare system and setting up the 
patient’s contacts. A parent handout about the study will be prepared for distribution to 
patients who wish to share information with a parent about the study. All patients will install 
the PlusCare application on their own smartphone, with assistance from the RA if needed. Once 
PlusCare has been installed and the patient has successfully demonstrated that s/he can 1) 
access the app from his/her smartphone and 2) receive incoming SMS messages from the CM, 
the patient will be actively enrolled for one year.  
Intervention. All patients enrolled in the study will have access to all of PlusCare’s functionalities 
for a period of at least 12 months starting from the time they are enrolled. App activity will be 
monitored throughout the 12-month period.  
Monthly Adherence Assessment. A validated one-item medication adherence assessment will 
be administered once a month; this assessment consists of patients’ self-reported rating of 
their perceived ability to take all of their medications as prescribed in the past month.6,7 
Patients will receive an SMS message alerting them to submit a response to the adherence 
assessment from within the PlusCare app, thus ensuring individuals’ responses remain 
confidential. While the method of self-report may be subject to recall and social desirability bias 

compared to other more objective measures such as digital medicine systems or 
pharmacokinetic measures, it has the advantage of being feasible and acceptable and less 
susceptible to misestimation due to device non-use and pocket dosing or overestimation due 
patients opening the device without removing pills.8 Based on findings from adherence studies, 
including our previously funded SBIR project (ARemind), adherence reminders are effective in 
collecting timely, reliable measures of adherence and we recognize that there is a potential that 
they may be associated with a decrease in HIV-1 RNA viral load.9,10 
Retrospective data. The study RA will access key variables of interest from the patient’s 
electronic case management records (via PowerChart) and administrative and hospital billing 
data dating back 1 year from date of enrollment for initial cost-effectiveness analysis that will 
contribute to the evaluation and commercialization plan. Key variables will include viral load 
and CD4 counts from lab results and medical visit frequency and gaps consistent with standards 
for Ryan White Foundation-funded programs.4 
6-Month and 12-month Follow-up Assessment. At the 6-month and 12-month time point, the 
site RA will contact each patient to complete assessment items online. The RA will disseminate 
an online survey to the patient. Responses will be collected via a CommCare survey form and 
stored in the CommCare server.11 Patients will have the option of completing this assessment in 
person if they prefer, but compensation will remain the same as a remote assessment. 
Safety plan. Before completing the surveys potential participants will read and sign an informed 
consent. This form will document a potential participant’s understanding that if they identify 
any level of emotional distress above baseline on survey questions, the results will be flagged 
and e-mailed to a member of the study team. Participants will subsequently be contacted by 
the study team member or another mental health provider within two business days to have a 
safety check-in. No items have explicit safety concerns such as suicidality. We will also 
document a potential participant’s understanding that if we identify during surveys/screening 
any heavy or dangerous use of substances in the past 30 days, we will report the use to their 
provider for safety. Participants will be given a mental health resource list at the time of 
consent in case they experience emotional distress at any point throughout the course of the 
study.   
 
Statistical Analysis Plan 
The study analysis will follow an intention-to-treat approach to determine PlusCare’s effect on 
outcomes related to HIV case management. Our primary outcomes will include Ryan White 
Program core performance measures4 (HIV viral suppression, HIV medical visit frequency, and 
gaps in medical visits). Secondary outcomes will include proximal outcomes (medication 
adherence), patient-centered outcomes (quality of life, self-efficacy), and system usage and 
usability. Usage data collected passively from the system from both patients and CMs will be 
analyzed to assess trends in system usage (e.g., what module was accessed by patients most 
frequently, how many documents were sent by CMs) and system usability will be assessed via 
the SUS administered at the end of the study.5 Baseline characteristics of our sample were 
summarized with descriptive statistics (mean, median, SD, frequency) and a Wilcoxon test for 
significance will be used to assess PlusCare’s impact on our outcomes of interest pre- and post-
intervention and a repeated measures analysis will be used to determine changes in outcomes 
assessed at each respective time point during pre- and post-intervention. Under the 

assumption that some individual specific effects are uncorrelated with the independent 
variables while some other effects are correlated, we will use mixed effects modeling to 
account for both time-variant and time-invariant factors. Initial cost-effectiveness analysis will 
be performed following methods used in previous studies.12–15 Data on HIV medical visit 
frequency and gaps and ED visits and hospitalizations will be used to perform this analysis. The 
monetary benefit from the PlusCare intervention arises from the cost savings as a result of 
reduction in hospital visit frequency between pre- and post-intervention. We will compute 
preliminary cost-effectiveness of the PlusCare intervention by comparing the cost savings 
attained with the program cost of the case management program using Net Present Value (NPV 
= Present Value of Cost Savings – Present Value of Program Costs) and the Return on 
Investment (ROI = Present Value of Cost Savings / Present Value of Program Costs). We 
hypothesize that the use of PlusCare will have a positive effect on the return on investment. All 
statistical analyses were performed using R statistical software (R Foundation for Statistical 
Computing, Vienna, Austria) or SAS software, version 9.2 (SAS Institute, Cary, NC) and a two-
tailed P-value of the test < 0.05 was considered statistically significant.  
 
Statistical Power and Sample Considerations 
The power calculation was based on N=50 patients. With a confidence level of 95%, there is 
81% power to detect a 38% change in log10 HIV viral load in patients pre- and post-
intervention.16 
 
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