Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Sponsor: Columbia University

Title of Project: Use of mHealth Technology for Supporting Symptom Management in 
Underserved Persons Living with HIV 
IRB: AAAP1258 
NCT: NCT02897141 
 
Principal Investigator and Team Members: 
Principal Investigator: Rebecca Schnall, RN, PhD 
Co-Investigators: Suzanne Bakken, RN PhD, Susan Olender MD, Haomiao Jia, PhD 
Organization: The Trustees of Columbia University in the City of New York 
Grant Award Number: R21HS23963 
 
Date Document Last Edited: 6/17/18 
 

Protocol: AAAP1258 Abbreviated Title: mVIP Principal Investigator: Schnall, Rebecca 
Title: Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living 
with HIV 
 
STUDY PURPOSE AND RATIONALE: 
 
HIV has changed from an acute illness to a chronic disease. The success of HIV medications and 
treatments has significantly altered the course of the disease. While AIDS-related illnesses are no longer 
the primary threat, a new set of HIV-associated complications have emerged, resulting in a chronic 
disease that for many will span several decades of life. The ability to self- manage adverse symptoms of 
HIV illness has been shown to improve patient- centered outcomes. In response to this need a team at 
UCSF developed a paper-based symptom management manual with self-management strategies for 21 
common HIV/AIDS adverse symptoms (PCOR evidence). The efficacy of the manual was demonstrated in 
a 775-person RCT over three months at 12 sites. However, subsequent use of these strategies has been 
very limited; mHealth offers an ideal platform for the implementation and dissemination of evidence-
based strategies for HIV symptom management. Due to the high incidence of HIV among racial and 
ethnic minority populations, it is appropriate to develop mHealth tools tailored to the needs of these 
populations. mHealth technology has the potential to address many of the healthcare needs of persons 
living with HIV/AIDS (PLWH) including symptom management. In response to these current issues, our 
proposal seeks to inform the development and testing of a mHealth application that will incorporate 
findings from PCOR studies to improve the outcomes of PLWH. 
 
To improve outcomes for those most in need, our study activities are focused on communities with the 
greatest burden of HIV in the US, including racial and ethnic minorities and those of low socioeconomic 
status. 
 
The goal of this study is to facilitate the dissemination and implementation of PCOR using mHealth 
technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). 
Symptom management in PLWH is especially important because the US HIV epidemic continues to exact 
a huge toll, especially among AHRQ priority populations including racial, ethnic, and sexual minorities 
and low-income persons. The incorporation of HIV symptom management strategies into patient’s lives 
through the use of mHealth technologies has the potential to advance the effective dissemination and 
implementation of PCOR finding. The overall research question is to test the efficacy of the mVIP app 
which will be created as part of this study. 
 
SPECIFIC AIMS 
1) Apply participatory design, heuristic evaluation, and end-user usability testing (using eye 
tracking software) and think-aloud protocol method to incorporate PCOR evidence for HIV symptom 
management into a mobile health application (mVIP) for use in patient self-management. 
2) Using a randomized design, examine the effect of mVIP as compared to an attention control 
group on primary outcomes of symptom frequency and intensity. 
Hypothesis: Study participants who use the mVIP system to access symptom strategies are more 
likely to have decreased symptom frequency and intensity at the end of 12 weeks. 
3) Guided by the PRECEDE-PROCEED model of health program planning and evaluation, 

examine PLWH’s perceptions of the predisposing, enabling, and reinforcing factors for mVIP 
use. 
 
 
Overview of Design, Methods, Target/Accrual Enrollment, Recruitment/Enrollment Status 
Aim 
Design/Methods 
Target 
Enrollment 
Enrolled/ 
Accrued 
Enrollment Status 
1 
A) Participatory design using 
card sorting activity 
40 
31 
Closed to further enrollment. Study- 
related procedures ongoing. 
 
B) heuristic evaluation 
5 
5 
Closed to further enrollment. Study- 
related procedures ongoing. 
C)End-user usability testing 
Utilizing eye tracking 
software and 
think-aloud protocol 
20 
20 
Closed to further enrollment. Study- 
related procedures ongoing. 
2 
Randomized controlled 
design 
80 
(Intervention:40, 
control: 40) 
80 
Closed to further enrollment. Study- 
related procedures ongoing. 
3 
Descriptive: focus groups/in-
depth interviews 
Focus groups: 40 
In-depth 
interviews: 12 
0 
Closed to further enrollment. Study- 
related procedures ongoing. 
 
 
Subject Population: We anticipate two categories of research subjects in our study: 
 
1) 
Persons living with HIV/AIDS 
 
2) 
Experts in human computer interaction. 
 
 
Setting and Sample 
 
Eligibility Criteria (Aim 1a): In order to participate in Aim 1a of this study, participants must be: 
 
1) Diagnosed with HIV/AIDS 
2) Over the age of 18 years 
3) Able to provide written informed consent 
4) Able to communicate in English 
5) Report at least 2 HIV related adverse symptoms in the past week 
6) Cognitive state (as assessed by a modified version of the standard Mini Mental State Exam 
(MMSE): total score of 3 or higher) 
 
This process, which is an accepted and necessary component prior to final mVIP implementation, will 
include an electronic survey. After survey completion we will conduct a card sorting exercise utilizing a 

think –aloud protocol in which the participants will be presented with a stack of cards, representing the 
content of mVIP app, while they are encouraged to share their insights with us and sort/group the cards 
in a way that would make sense to them.  
Data Analysis: A hierarchy analysis will be conducted for establishing the rank order of symptoms and 
self-management strategies. 
 
Eligibility Criteria (Aim 1b): Five informaticians will participate as usability experts. 
Study participants must be at least a masters-level prepared in human computer interaction, clinical 
informatics or public health informatics. 
 
Each usability expert will be asked to evaluate the system using the Heuristic Evaluation Checklist and to 
think-aloud while performing the usability testing. The process will be recorded using Morae software™, 
which allows the researcher to record and analyze the audio recording and screen shots that are 
captured during the heuristic evaluation. 
Data Analysis: At the end of this evaluation, the frequencies of usability issues will be calculated according 
to Nielsen’s heuristic principles. Following the heuristic evaluation, the mVIP app will be refined. 
 
Eligibility Criteria (Aim 1c): 
1) 
Diagnosed with HIV/AIDS 
2) 
Over the age of 18 years 
3) 
Able to provide written informed consent 
4) 
Able to communicate in English 
5) 
Report at least 2 HIV related adverse symptoms in the past week 
6) 
Be the owner of a smartphone and/or tablet. 
7) 
Cognitive state (as assessed by a modified version of the standard Mini Mental State Exam 
(MMSE): total score of 3 or higher) 
 
For end-user usability testing, we will conduct end-user usability testing on 10 Android smartphone 
users and 10 OS smartphone users. 
 
Data Analysis: The analysis will be based on the Tobii recordings of user sessions including voice/screen 
and eye movement/fixation, transcriptions, notes, and the user surveys. Mean task performance time will 
be calculated. Critical incidents characterized by comments, silence, and repetitive actions will be 
identified with eye movement. We will review these incidents in detail using Tobii Eye-tracking software. 
The incidents identified and the users’ written comments will be summarized. Eye-tracking analysis, and 
content analysis, a technique for making objective, replicative and valid inferences from data, will be 
performed. 
 
Eligibility Criteria (Aim 2) 
 
1) 
Diagnosed with HIV/AIDS 
2) 
Over the age of 18 years 
3) 
Able to provide written informed consent 
4) 
Able to communicate in English 
5) 
Report at least 2 HIV related adverse symptoms in the past week 
6) 
Be the owner of a smartphone and/or tablet. 
7) 
Cognitive state (as assessed by a modified version of the standard Mini Mental State 
Exam (MMSE): total score of 3 or higher) 
 

Aim 2: Using a randomized design, examine the effect of mVIP as compared to an attention control 
group on primary outcomes of symptom frequency and intensity. We will conduct a 12 week trial of the 
mVIP. We will recruit 80 HIV+ persons with the proposed sample size of 40 in each of the following two 
groups: 
1) Intervention group: mVIP app with access to symptom strategies 
2) Control group: mVIP app without access to symptom strategies 
 
The symptom frequency and intensity will be compared between the two groups aiming to test the 
effectiveness of improvement in symptom intensity score for the mVIP group over the control 
group. 
 
Randomization: Patients will be randomized (1:1) to mVIP or an attention control group. Both groups 
will receive the mVIP app on their smartphones. The allocation sequence of participants will be 
concealed from the research assistant who will be responsible for randomizing study participants. This 
will be a single-blinded study and control group participants will not have access to the symptom 
strategies. We had initially planned to give a smartphone to each study participant as a compensation. 
However, during the first aim of our study, we learned that many of our study participants already have 
smartphones. For those who do not, the learning process for the basic use of a smartphone, in addition 
to the training needed to use our intervention, will be too difficult. Thus, we have decided to change the 
initial compensation plan. Instead, we will be giving our participants a token of appreciation for their 
participation in the study. Both groups will report their symptoms on their smartphone app every week. 
Participants in the mVIP (intervention) group will receive targeted symptom strategies from the UCSF 
symptom management manual (PCOR evidence) based on the symptoms that they report. 
 
Contact information will be retained and used by study staff to remind participants about their follow 
up appointments.   Contact information will be kept in a separate database from research data.   
 
Eligibility Criteria (Aim 3): 
 
For Aim 3: They must have participated in AIM 2  
 
 
PROCEDURES 
 
Aim 1: Participatory Design, Heuristic Evaluation and End-User Usability Testing. 
 
During the initial stages of designing a mVIP health management app Inclusion of stakeholders 
throughout the app design process is vital to ensure that patient needs unknown to the investigators 
are taken into account. This process, which is an accepted and necessary component prior to final 
mVIP implementation. 
 
Aim 1a) Participatory Design: Participants will complete an electronic survey, on site, containing 
demographic questions, technology use, medication adherence, and health-related quality of life. Upon 
survey completion they will be asked to perform a card sorting exercise/think aloud protocol. They will 
be presented with a stack of cards that represent the content and functionality for the mVIP app. They 
will be encouraged to try and sort the cards into groups that make sense to them and share their 
insights with our team. 
 

Aim 1b) Heuristic Evaluation: Five informaticians will participate as usability experts. Study participants 
must be at least a masters-level prepared in human computer interaction, clinical informatics or public 
health informatics. The usability experts will be provided with a prototype of mVIP. Each usability expert 
will be asked to evaluate the system using the Heuristic Evaluation Checklist and to think-aloud while 
performing the usability testing. The process will be recorded using Morae software™ (Techsmith 
Corporation, Okemos, MI) (102), which allows the researcher to record and analyze the audio recording 
and screen shots that are captured during the heuristic evaluation. At the end of the evaluation, each 
expert will be compensated $150. Each heuristic will be evaluated by one or more items and the overall 
severity of the identified heuristic violations will be rated. 
Data Analysis: The frequencies of usability issues will be calculated according to Nielsen’s heuristic 
principles. 
Following the heuristic evaluation, we will refine the mVIP. 
 
 
Once the mVIP prototype is refined and implemented by the programmer, we will conduct an 
evaluation: Aim 1c) End- User Usability Testing. 
 
Aim 1c) End-User Usability Testing. Usability testing of a Beta version of mobile Video Information 
Provider (mVIP). We will be conducting usability testing of a Beta version of the mVIP app. The purpose 
of the usability testing is to improve the effectiveness, efficiency and user satisfaction of the mVIP app. 
To achieve this goal, we will be using eye-tracking and think-aloud method to examine the end-user 
task performance to assess mVIP system validation and human- communication interaction (HCI) in a 
laboratory setting. We will recruit 20 persons living with HIV (PLWH) (10 PLWH for the usability testing 
on Android smartphones and 10 PLWH for the usability testing on iPhones. All participants will be 
provided with scenarios and asked to complete tasks using mVIP system on a smartphone. While they 
are doing the tasks, their eye movements and smartphones screen will be recorded using Tobii Pro Eye-
tracker. During each task, the start and stop times of tasks will be also measured. After completing the 
tasks, they will be asked to think aloud and verbalize their thoughts about the tasks they completed, 
through a replay of the screen recordings. Participant’s reactions and verbal comments will be video 
and audio recorded. As part of the usability assessment, participants will complete electronic surveys 
containing demographic questions, health literacy, technology use, medication adherence, and health-
related quality of life. 
 
Aim 2) Randomized controlled design: Examine the effect of mVIP intervention as compared to an 
attention control group on primary outcomes of symptom frequency and intensity. 
 
We will recruit 80 PLWH to participate in a 12 week trial. The sample size and statistical power 
calculation is based on the hypothesis test of improvement of the symptom frequency and intensity 
after the implementation of the mVIP system. The effect size is based on our 12 week feasibility study 
with 42 participants. The criterion for significance (alpha) has been set at 0.05 for the two- sided test. 
We will recruit 80 HIV+ persons with the proposed sample size of  40 in each of the two groups 
(assuming a 1:1 allocation ratio).To account for a potential attrition rate of 20%, we propose to 
achieve a final sample of 64 patients (32 per group). Additionally, each patient will have 20% chance to 
miss any one of the symptom reporting opportunities between week 2 and week 10. 
For the symptom frequency outcomes, this study will have 87.9% power to detect 20% decrease in 
symptom frequency (for example, from an average 8 symptoms to average 6.4 symptoms) from the 

baseline to the end of study (i.e., 12th week). For the comparison between the mVIP group and the 
control group, this study will have 85.4% power to yield a statistically significant result (assuming an 
intention-to-treat principle for the analysis) to test 15% improvement in one group over another group 
(i.e., the mVIP group decreases 20% in symptom frequency and the control group decreases 
20%+15%=35% in symptom frequency). For the symptom intensity outcomes, this study will have 96% 
power to detect decrease in symptom intensity score of a medium effect size of 0.6 from the baseline 
to the end of study. For the comparison of the two groups, this study will have about 95% power to 
yield a statistically significant result to test an effective size of 0.6 improvement in symptom intensity 
score for the mVIP group over the control group. 
 
Following randomization of participants, both the intervention and control groups will receive the mVIP 
on their phones. All participants will complete all study-related questionnaires electronically on their 
smartphone. All subjects will complete a demographic questionnaire as well as the Newest Vital Sign 
instrument to measure health literacy at baseline in addition to the judgment of a team member that 
they are cognitively intact. Similar to our feasibility study, participants will use the system at least once 
every week and will receive a reminder email or phone call if they have not used the system in more 
than 1 week. Symptom frequency and intensity will be collected every week. The remainder of the 
measures will either be collected at weeks 0 and 12 or week 12 only.  See the outcome measures table 
below for details. 
 
Aim 3) In-Depth Interviews and Focus Groups to evaluate PLWH’s perceptions of the predisposing, 
enabling, and reinforcing factors for mVIP use 
 
In-Depth Interviews will be approximately 30 minutes in length and will occur immediately following a 
participant’s follow up appointment.  We will include a $10 reimbursement for participants’ time.  
After obtaining informed consent, study staff will audio record a structured interview aimed at 
collecting feedback on usage habits, potential technical or usability issues, and the session reminder 
structure. Each interview recording will be transcribed and transcripts will be analyzed independently 
for content by research team members. 
 
The focus groups will be 60-90 minutes in length. We will include $40 reimbursement for participants’ 
time. Following completion of the informed consent process, all focus group sessions will be audio-
recorded. The focus group guide will be informed by the Predisposing, Reinforcing, and Enabling 
Constructs in Evaluation (PRECEDE) portion of the PRECEDE-PROCEED Model of health program 
planning and evaluation The integration of these frameworks for application in HIT implementation 
evaluation has been proposed by a number of authors as a strategy for assessing predisposing, 
enabling, and reinforcing factors for use and acceptance of HIT.   
 
The team will adhere to qualitative research processes to ensure the credibility, confirmability, 
dependability and transferability of the qualitative data from these analyses. To support the credibility 
of the data, we will conduct peer debriefing and triangulate findings across multiple data sources 
(surveys, focus group data). In addition, we will use “member checks,” i.e., sharing of initial data 
interpretations with participants, to ensure accurate interpretations. Triangulation of findings, along 
with reflexivity, will enhance the confirmability of the interpretations. The investigators will carefully 
record an audit trail and keep extensive field notes to facilitate transferability of study findings into 

other contexts. Each focus group recording will be transcribed; transcripts will be analyzed 
independently for content by research team members. 
Overview of Study Instruments 
Please note that all study instruments for the trial are included as attachments entitled mVIP Baseline 
12-9-2016 and mVIP Follow-up 12-2-2016 
Primary Outcome Measure: Change in HIV related symptom status as measured by the PROMIS-29. 
 
Baseline Measures: 
 
Demographics 
 
PROMIS-29 
 
PROMIS-GI 
 
SF-12 
 
RAND-36 
 
Case adherence index and ART adherence VAS  
 
TOFLHA 
 
NVS 
 
Symptoms distress module  
 
Healthcare Provider Engagement 
 
Non-CPT/Study Medical and Other Services (CTN-0051) 
 
Health ITUES 
 
PSSUQ 
 
Follow-up Measures:  
 
PROMIS-29 
 
PROMIS-GI 
 
SF-12 
 
RAND-36 
 
Case Adherence Index and ART adherence VAS  
 
Symptom distress module 
 
Healthcare Provider Engagement 
 
Non-CPT/Study Medical and Other Services (CTN-0051) 
 
Health ITUES 
 
PSSUQ 
 
 
 

Data Analysis 
The study analysis followed an intention-to-treat approach. Intervention and control 
characteristics collected at baseline were summarized with descriptive statistics (mean ± SD or 
frequency). To assess the effect of the intervention on symptom burden during the follow-up 
period, we used linear mixed model to analyze repeated measured data, and the models 
controlled for age, sex, race, education and CD4 count. 
 
For all secondary outcome measures, which were collected at baseline and 12 week follow-up, 
we used a same linear mixed model or a generalized linear mixed model. We used linear mixed 
model for continuous outcomes (e.g. PROMIS score); generalized linear mixed model (Poisson 
or Negative binomial model) for count outcomes (e.g. number of ER visits); the generalized 
linear mixed models (logistic model) for binary outcomes (e.g. CASE Adherence Index). All 
models were controlled for age, sex, race/ethnicity, education and CD4 count.