Information Visualizations to Facilitate Patient-provider Communication in HIV Care: Info Viz HIV
Phase: NA
Conditions: Health Communication
Sponsor: Columbia University

Protocol: Information visualizations to facilitate clinician-patient communication in HIV care: 
Info Viz HIV 
Outline of organizational structure of the multicenter protocol 
All recruitment, enrollment, and data collection will take place at Clínica de Familia La 
Romana, in the Dominican Republic. Samantha Stonbraker, a postdoctoral fellow at Columbia 
University and co-investigator on this study, will be on-site throughout the course of the study and will 
be responsible for all administrative duties, subject/data/and site monitoring, and will also facilitate 
communications and lead all data analysis. Clínica de Familia is in the process of obtaining and FWA 
number. Once it is obtained, it will be provided to the IRB prior to any study activities beginning. 
Samantha Stonbraker, a postdoctoral fellow at Columbia University and co-investigator on this 
study, will be responsible for reviewing and reporting all adverse events. She will be responsible for 
training any local study team members to identify and report any adverse events.  
Samantha Stonbraker will be in charge of maintaining records of all IRB/ethics committee 
review and approval of all protocol and consent forms for all collaborating sites for the duration of the 
study. She will apply for a renewal at least 60 days prior to the end of the approval period at CUMC’s 
IRB. CONABIOS, the ethical review board in the Dominican Republic, does not require renewals for 
approved protocols.  
Samantha Stonbraker will be responsible for all administrative duties, subject/data/site 
monitoring, facilitating communication, and data analysis. She is working on this study as part of an 
NIH funded career development award and will be monitored closely by her mentoring team who are 
all indicated as co-investigators on this study. 
Provide a description of the responsibilities of the coordinating center / lead institution with 
regard to communication and training of research personnel across sites: 
Samantha Stonbraker, a postdoctoral fellow at Columbia University, will be the point person for 
communication with Columbia University. She has already received training in the protection of 
human research subjects.  
Samantha Stonbraker will also be in charge of training any local staff to ensure accurate and 
consistent instrument training and data management across sites. She will also oversee all study 
procedures at Clínica de Familia La Romana. All data will be entered into encrypted tablets into 
Columbia University’s REDCap Survey Management Software. No special equipment is needed for 
data transfer. 
Samantha Stonbraker will meet individually with any local study team members daily at the 
beginning of the study to ensure that all procedures are being carried out correctly, that the study 
protocol is well understood, and that everything is completed in a confidential and ethically 
appropriate way. 
Provide a plan to ensure that collaborating sites do not begin any research-related activity 
until IRB approval has been granted for the conduct of research at that site: 
Samantha Stonbraker will be responsible of overseeing all research activities at Clinica de 
Familia La Romana and will not begin data collection until all IRB approvals have been obtained. 
Provide a description of the transmission of data to the data coordinating center: 
NCT03616106
Version: 01/14/2019

All study data will be stored on an encrypted password protected Columbia University 
Computer and will be on Columbia University Servers. Data will be collected on an encrypted tablet 
into Columbia University’s REDCap Survey Management Software. No data will be stored on the 
tablets. Any data that needs to go back and forth between CUMC and the DR will be saved in these 
servers as Samantha Stonbraker will have access to them both in the Dominican Republic and on the 
CUMC campus. Samantha Stonbraker will review all data for completeness as it is being collected 
and will be responsible for obtaining any missing data and correcting any errors that she finds. All 
participant information will be stored on Columbia University servers that Samantha Stonbraker will be 
able to access both from the study site in the Dominican Republic and from the CUMC campus. If any 
data needs to be transmitted beyond the servers, it will be de-identified and shared through secure 
Columbia University email accounts. 
Specify how and where the data will be analyzed and who is responsible for the analysis(es): 
Data will be analyzed using the methods that are detailed in the procedures section. Samantha 
Stonbraker will be responsible for data analysis. She consistently travels back and forth between the 
Dominican Republic and the CUMC campus so data analysis will take place in both sites.  
Study Purpose and Rationale 
The Caribbean has among the highest HIV prevalence in the world.1,2 Regionally, the majority of 
HIV/AIDS cases are located on the island of Hispaniola, comprised of the Dominican Republic (DR) 
and Haiti.3 Due to a large international response and widespread availability of antiretroviral therapy 
(ART), in recent years the incidence of HIV in the DR has declined and prevalence hovers around 1% 
in the general population.2,4 The effective and long-term management of this condition depends on 
infected individuals being able to acquire ART and apply the learned information and self-
management skills that lead to optimal adherence. 
HIV-related disparities exist in developing countries, such as the DR, where minority groups 
and/or those with low socioeconomic status experience higher disease burdens and worse health 
outcomes than those with higher socioeconomic status.1,3,5,6 These disparities may be exacerbated 
when individuals are unable to understand the health information,7,8 as low health literacy has been 
associated with worse health outcomes, less use of healthcare services, poorer knowledge of illness, 
and worse self-management.9-11 The effective management of HIV requires patients to acquire, 
comprehend, and use large amounts of complex information, including how to manage variations in 
health status, medications and their side effects, nutrition and exercise needs, and healthy coping. 12-
14 Health care providers can help patients understand pertinent health information by offering it in 
targeted, culturally-, language-, and literacy-appropriate ways.15  
One such strategy is to use infographics to assist communication through visual representations of 
information.16,17 Participatory design of infographics supports presentation of information in a culturally 
appropriate and visually appealing format which can improve information understanding, health 
behaviors, attention span, and ability to recall information.17-19 It is critical to develop and test methods 
to improve the way health information is delivered to patients in these clinical contexts so patients, 
including those with low health literacy, can acquire and comprehend the information needed to 
improve self-management behavior and treatment outcomes.15,20  
Preliminary studies (T32 NR013454) showed many persons living with HIV (PLWH) attending 
Clínica de Familia La Romana do not fully comprehend and use the health information they receive 
through current modalities.21,22 In response, culturally relevant, evidence-based infographics to 
improve information delivery during clinical visits were developed (T32 NR007969) with a participatory 
design methodology (manuscript under review).19 The next phase of this study is to rigorously assess 
if using these infographics is a feasible, acceptable, and efficacious method to enhance HIV-related 
clinician-patient communication and lead to improved patient outcomes. Additionally, a thorough 
exploration into the cultural factors of patient-provider communication in the Dominican Republic that 
can influence infographic use for clinician-patient communication in a clinical setting is warranted.  

The purpose of this study is, therefore, to complete the following research aims: 
Aim 1. Explore the usability of infographics (designed during preliminary studies) to facilitate HIV-
related clinician-patient communication and to assess their feasibility using established 
guidelines.23  
Aim 2. Pilot test measures to assess treatment outcomes within this population and estimate 
measurement parameters for future efficacy testing (means and standard deviations). 
Aim 3. Measure the effect of infographic use on PLWH’s treatment outcomes at three-, six- and nine-
month intervals following initial exposure to the intervention. 
Aim 4. Generate an explanatory model of HIV infection among patients in this clinical context and 
explore how it may be used to guide HIV-related communication using infographics. 
Study Design 
To complete the study aims, a mixed methods study that includes a single group pretest posttest 
study design will be used to pilot test the infographic intervention. In-depth interviews will be 
completed with a selection of participants to explore participant perceptions of HIV-related 
communication using infographics. Data will be collected from participants through baseline (at 
enrollment) and follow up assessments (at 3-, 6-, and 9-month follow up visits). Follow up interviews 
will be conducted with the providers involved in the intervention to ascertain their perspectives on the 
clinical utility of infographics. Participant’s most recent CD4 count and viral loads will be collected 
from participants’ medical records at each study visit.  
Quantitative Data Analysis
See Statistical Procedures Attachment. 
Qualitative Data Analysis
We will conduct semi-structured individual interviews using an iterative interview guide (see attached 
interview guide) developed following the recommendations of Kallio 2016 which includes 1) internal 
testing by the research team; 2) expert assessment by specialists outside the research team; and 3) 

field-testing with the potential study participants.31 The guide includes open-ended questions and 
probes designed to generate an explanatory model of participants’ experience living with HIV and 
communicating about it in a clinical setting.32,33 Recruitment for in-depth interviews will continue until 
we have reached data saturation, when no new information is gleaned from the most recent 
interviews.34 Analysis of transcripts from in-depth interviews (Aim 4) will be guided by a qualitative 
descriptive (QD) methodology and will include conventional QD content analysis methods such as 
inductive line-by-line latent coding. Recognizing that the researcher is the instrument in QD methods, 
only one researcher will conduct all interviews. An iterative content analysis method will then be used 
to generate codes and extract meaning from each question.35-37 A coding guide will be developed by 
one member of the research team after initial review of a subset of transcripts. Other team members 
will then review and refine the coding guide. Then, two members of the research team will code each 
transcript and discrepancies will be resolved by discussion until consensus is achieved. Analyses will 
be conducted in Spanish then translated to English for final dissemination. NVivo will be used to 
support data management and Gioia’s methodology to ensure rigor in qualitative research will be 
followed.38 A summary of the findings will be shared with a subset of participants (selected through 
purposive sampling) to determine if the findings resonate with them (“member check”). Any changes 
suggested will be made and the findings will be finalized.  
Privacy and Data Security 
All data collected will be coded to ensure confidentiality. Data from baseline and follow up 
assessments will be collected in Columbia University’s REDCap online survey management system 
then downloaded and stored on Columbia University Servers. Audio recordings of intervention visits 
and in-depth interviews will also be coded then saved on Columbia University Servers. Only members 
of the research team will have access to the list that matches codes with participants. That list will be 
stored in password protected Columbia University Servers. 
Data will be collected in a private interview setting to maintain participant comfort and 
confidentiality. All collected data will be coded. Only the study team will have access to the file which 
can link participants to their study data. It will be password protected on Columbia University Servers. 
Audio Recordings will be transcribed by a secure transcription service outside of Columbia after a 
data use agreement has been signed. 
Procedures 
Columbia University researcher, Samantha Stonbraker, will be in charge of completing and 
overseeing all study procedures in collaboration with local study team members. 
Study Setting 
All study activities will take place at Clínica de Familia La Romana, which is a non-profit health 
center in the Dominican Republic licensed by the Dominican Ministry of Health that specializes in the 
education, diagnosis, treatment, and management of sexually transmitted infections, including HIV. 
More than 40 interdisciplinary professionals offer free care, treatment, and support to over 2,000 
persons living with HIV during more than 17,000 visits annually.39  
Intervention 
Interventionists (N=2), will be physicians with two or more years of experience providing care to 
adults living with HIV at the Clinic. They will initially attend a training to guide patient education with 
infographics in a clinical setting, and will receive coaching on intervention fidelity, including how to 
maintain it.40,41 During the intervention, in normal clinic visits, interventionists will guide education 
using the paper-based set of infographics developed in preliminary studies. Infographics will provide a 
visual representation of the pertinent information to be included. Paper versions of the infographics to 

be used during the intervention will be kept in participants’ medical records to enable easy access 
during visits, prevent providers from accessing them with non-study participants, and enable providers 
to mark graphics while teaching. Intervention fidelity will be verified by audio recording one-half of total 
intervention visits with equal numbers of visits over the three time points and an equal number of 
recorded visits with each interventionist with patient permission as is detailed in the informed consent 
document. Members of the study team will listen to audio recordings to confirm interventionists are 
using infographics during visits as specified in the intervention training, that both providers are using 
them in the same way, and that they are delivering the intervention consistently across visits. 
Additionally, participants will be asked about provider’s infographic use during follow up assessments. 
 Participant eligibility will be verified in the medical records of patient’s scheduled appointments at 
the beginning of each day. Eligible participants will then be recruited by the receptionist when they 
present to the Clinic for their regular clinic visit and referred to speak to an on-site researcher who will 
further introduce the study (see attached recruitment script) and then if a participant is interested, 
complete the informed consent process. After completing the informed consent process, participants 
will complete a baseline assessment using REDCap software with the help of a study team member 
prior to their visit (Table 1). Participants will then receive the intervention during the enrollment visit 
and at three and six-month visits and complete the follow up assessment at each of these time. Time 
intervals were selected as CD4 count and viral load may change as early as three months after ART 
initiation.42-44 Interventionists will time visits and no extra time will be allowed for study visits. Following 
their six-month study visit, participants will be asked to participant in in-depth interviews. At the nine-
month study visit, participants will complete a follow up assessment to assess ability to recall 
information from infographics over time. At the end of the study, the interventionists will be interviewed 
to assess feasiblity of infographic use in a clinical setting.  
Measures 
Outcome selection was guided by a conceptual model to 
theoretically guide communication studies.45,46 This model 
illustrates pathways through which clinician-patient 
communication may influence health outcomes in the short 
(proximal), medium (intermediate), and long-term. Primary 
outcomes of CD4 count and viral load will be collected from 
patient medical records at each study visit. Measures of 
information recall/comprehension, engagement with clinician47, 
satisfaction with care,48 self-efficacy to manage HIV,49 
adherence,50 health related quality of life,51 and health status 
(self-reported status and CD4 count and viral load) will all be 
included in the baseline and follow up assessments.  
Baseline assessments will collect demographic information, 
evaluate health literacy level,52 and contain the instruments to 
assess outcome measures. 
Follow up assessments for PLWH will include the outcome measures as well as open-ended 
questions exploring the usability of infographics, satisfaction with designs and recommendations for 
improvement. Open-ended questions regarding interventionists’ communication strategies and 
intervention delivery will be included to assess providers’ communication variability. Participants’ 
responses to open-ended questions on the follow up assessments will be audio-recorded with 
participants’ permission and then transcribed to enable more effective analysis. 
Follow up interview for health care providers. Interventionists will complete a semi-structured 
interview containing questions on the following aspects of feasibility: acceptability, demand, 
implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing23 and 
Table 1. Research activity at each 
time point 
Time 
point 
Activity 
Enrollment 
Health literacy
assessment
Baseline assessment
Exposure to intervention
3 months 
Exposure to intervention
Follow-up assessment
6 months 
Exposure to intervention
Follow-up assessment
9 months 
Follow up assessment
Study end Follow-up interview for
health care providers
Note: In-depth interviews will take 
place after participant’s 6 month visits 

questions elucidating feedback on infographic design and suggestions regarding their effective 
incorporation into clinical visits.  
In-depth interviews with PLWH. To describe PLWH’s perceptions of HIV-related communication in a 
clinical setting and how it may be influenced by infographic use, directed content analysis guided by 
McGuire’s Classic Input-Output Framework for Constructing Persuasive Messages will be used.53 In-
depth interviews will be conducted using a semi-structured interview guide in a private setting by a 
study team member and will be audio-recorded and transcribed. 
Recruitment and Consent 
Describe how participants will be recruited 
At the beginning of each recruitment day, participant’s eligibility will be verified in the medical records 
of patients who have appointments scheduled for that day. The receptionists will then refer eligible 
participants to speak with an on-site researcher when they present to the Clinic for their regular clinic 
visit. The on-site researcher will further introduce the study using the recruitment script, answer any 
questions the person has, and continue with informed consent if the individual indicates interest in 
study participation.  
Describe how participants' written consent will be obtained 
Informed consent will be completed by an on-site study team member in a private space. The 
complete informed consent form will be read to participants, comprehension of procedures will be 
verified by short questions in the consent forms, and participants will be encouraged to ask questions 
prior to signing the form. A signed copy of the informed consent form will be stored in a locked file 
cabinet in a locked office in the Clinic. Participants will be given a copy of the informed consent form 
for their records.  
Research Aims and Abstracts 
Research Question(s) 
Research Question 1: To what extent are the infographics designed during preliminary studies a 
feasible and useful method to facilitate HIV-related clinician-patient communication? 
Research Question 2: How efficacious are these measures (described in the procedures section) to 
assess treatment outcomes among this population and what are their measurement parameters 
(means and standard deviations) in this population?  
Research Question 3: How much does infographic use during clinic visits influence PLWH’s 
treatment outcomes at three-, six- and nine-month intervals following initial exposure to the 
intervention? 
Research Question 4: What are PLWH’s perceptions of HIV-related communication including 
infographic use during a clinical visit with a healthcare provider? 
Scientific Abstract 
The Caribbean has among the highest HIV prevalence in the world. Regionally, the majority of 
HIV/AIDS cases are located on the island of Hispaniola, comprised of the Dominican Republic (DR) 
and Haiti. Due to a large international response and widespread availability of antiretroviral therapy 
(ART), in recent years the incidence of HIV in the DR has declined and prevalence hovers around 1% 
in the general population. The effective and long-term management of this complex chronic condition 
depends on infected individuals being able to acquire ART and apply the learned information and self-
management skills that lead to optimal adherence. Unfortunately, in developing countries, such as the 

DR, various disparities (economic, educational, social) may make it more difficult for individuals to 
acquire and understand the health information needed for effective self-management. Health care 
providers in these settings can help patients understand pertinent health information by offering it in 
targeted, culturally-, and literacy-appropriate ways, such as by using visual representations of 
information e.g. infographics. Participatory design of infographics supports presentation of information 
in a culturally appropriate and visually appealing format which can improve information understanding, 
health behaviors, attention span, and ability to recall information. In preliminary studies, a set of 
infographics was developed using a participatory design method. This next study phase is to 
rigorously assess if using these infographics is a feasible, acceptable, and efficacious method to 
enhance HIV-related clinician-patient communication and lead to improved patient outcomes. 
Additionally, an understanding of the cultural factors that may influence clinician-patient 
communication using infographics in a clinical setting will provide valuable information regarding how 
to improve clinical communication with this population.  
 
Lay Abstract 
The Caribbean region has high rates of HIV. The majority of these are found on Hispaniola, an 
island made of the Dominican Republic (DR) and Haiti. Due to a large international response and 
availability of treatment, the number of new HIV infections in the DR has gone down and about 1% of 
the general population is living with HIV. The effective management of this condition depends on 
those living with HIV being able to access treatment and apply the information and skills that improve 
adherence. Unfortunately, in developing countries such as the DR, many things make it more difficult 
for individuals to get and use this information. Health care providers can help patients understand 
health information by offering it in targeted, culturally-, and literacy-appropriate ways, such as by using 
images that contain information e.g. infographics. When well designed, infographics can support 
communication in culturally friendly and visually appealing ways. This can improve understanding, 
health behaviors, attention span, and ability to remember information. In earlier studies, a set of 
infographics was developed from input from patients and providers. This next study phase is to test if 
these infographics are a useful method to improve communication and lead to better health for 
patients. Additionally, understanding the cultural factors that change clinician-patient communication 
using infographics in a clinical setting will provide valuable information as to how to improve clinical 
communication with this population.  
 
Risks, Benefits, and Monitoring 
 
Potential Risks  
One potential risk to participants directly related to their participation in this protocol is possible 
loss of confidentiality. However, all of the data safety and monitoring procedures in this protocol will 
be strictly adhered to in order to avoid any loss of confidentiality. An additional risk is that participants 
might feel uncomfortable if they are unable to answer some of the questions in the surveys. Prior to 
beginning data collection, all participants will be reminded they do not have to answer any question 
that makes them feel uncomfortable and that they may withdraw from the study at any point without 
any consequences whatsoever. During the study visits, a study team member will also be available in 
order to provide any help that does not lead participants to the correct answer. During in-depth 
interviews participants may feel discomfort discussing their HIV status. Prior to interviews, participants 
will be reminded that they do not have to answer any question that makes them feel uncomfortable 
and that they are free to leave the interview at any time without any consequences whatsoever.  
Additionally, all study team members will be trained to identify signs of suicidal ideation and 
depression. Should they notice any of these signs while they are completing a study visit, or if 
participants are showing signs of discomfort, the study visit will be stopped immediately and the 
participant will be referred to speak to the on-site psychologist. 
 
Potential Benefits 

This study does not have any direct benefit to participants. However, participants are more likely 
to benefit from the health education provided through their visits because of the intervention. 
Additionally, by participating in this research, they will be able to actively contribute to improving the 
health care services that they and their peers receive. 
 
Alternatives 
This study does not present greater than minimal risks to participants. However, an alternative is 
to not participate in this research. 
 
Data and Safety Monitoring 
The safety of this study’s data will be regularly monitored by the study team. Any breaches of the 
study protocol will be submitted to the IRB immediately. 
 
Subjects 
 
Study population characteristics 
This study will enroll adult (≥ 18 years of age) patients at Clínica de Familia La Romana who are 
living with HIV, have detectable viral loads, and are planning to receive care at the clinic for the next 
year. Participants are likely to be economically and educationally disadvantaged and non-English 
speaking. 
 
Subject population justification  
PLWH at Clínica de Familia La Romana have low levels of education and low health literacy 22,30 
and adherence to antiretroviral medications is a perpetual concern.54 Although a vulnerable population 
because they are living with a stigmatized health condition and are economically and educationally 
disadvantaged, their participation in this research is justified because it enables them to help design a 
tool and intervention that may help them to better manage their condition and improve the clinic 
services that they and their peers receive. Furthermore, if the target population of interventions is not 
included in the research design and evaluation phases, interventions may be ineffective and 
misguided. 
 
Describe and justify reimbursement/compensation 
Participants will receive money for transportation ($3) to each of their study visits (four visits total). 
Participants who participate in the in-depth interviews will also receive $3 for that visit. Providers 
involved in the intervention will be provided a small incentive ($50) for completing the training on how 
to administer the intervention and a small incentive ($50) following the semi-structured interview that 
they will complete at the end of the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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