A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV
Phase: NA
Conditions: Cardiovascular Disease, HIV
Sponsor: Duke University

 
2 
 
 
 
 
 
 
 
A Clinic-Based Case Manager Administered Telephone 
Intervention to Reduce Cardiovascular Disease Risk in 
Persons Living with HIV 
 
 
 
 
 
Pro00085562 
 
  
NCT03839394 
 
 
 
Version 9.0 
 
 
  
06 JUL 2023 
 
 
 
 
 
 

  
 
Funding Sponsor: 
National Heart, Lung, and Blood Institute (NHLBI) 
Building 31 
31 Center Drive 
Bethesda, MD 20892  
 
 
  
  
 
 
 
 

  
 
 
 
 
Table of Contents 
Study Summary ........................................................................................................................................................... 1 
1 
Introduction ........................................................................................................................................................ 2 
1.1 BACKGROUND AND SIGNIFICANCE ....................................................................................................................... 2 
1.2 INNOVATION ........................................................................................................................................................ 3 
2 
Study Objectives ................................................................................................................................................. 4 
3 
Study Design ....................................................................................................................................................... 4 
3.1 GENERAL DESIGN ................................................................................................................................................ 4 
3.2 DESIGN TEAM CONSULTATIONS .......................................................................................................................... 5 
4 
Subject Selection and Withdrawal.................................................................................................................... 5 
4.1 INCLUSION CRITERIA ........................................................................................................................................... 5 
4.2 EXCLUSION CRITERIA .......................................................................................................................................... 5 
4.3 SUBJECT RECRUITMENT AND SCREENING ............................................................................................................ 6 
4.4 EARLY WITHDRAWAL OF SUBJECTS .................................................................................................................... 6 
4.4.1 
Reasons for Withdrawal of Subjects ...................................................................................................... 6 
4.4.2 
Handling of Withdrawals ....................................................................................................................... 7 
5 
Study Procedures ............................................................................................................................................... 7 
5.1 DESIGN TEAM PROCEDURES  ....................................................................... ERROR! BOOKMARK NOT DEFINED. 
5.2  PRE-TRIAL DEMONSTRATION……………………………………………………………………………………7 
5.3 STUDY TIMELINE ................................................................................................................................................. 8 
5.4 INFORMED CONSENT ............................................................................................................................................ 8 
5.5 DATA COLLECTION……………………………………………………………………………………………..8 
5.6 RANDOMIZATION ................................................................................................................................................. 9 
5.7 CONTROL GROUP ................................................................................................................................................. 9 
5.7 STUDY INTERVENTION ......................................................................................................................................... 9 
5.9 SOCIAL WORKER REPSONSIBILITES .................................................................................................................... 10 
5.10  POST STUDY INTERVENTION…………………………………………………………………………………..11  
5.11 POST INTERVENTION INTERVIEWS                                                                                                                                                  11 
6 
Statistical Plan .................................................................................................................................................. 11 
6.1 SAMPLE SIZE DETERMINATION .......................................................................................................................... 11 
6.2 STATISTICAL METHODS ..................................................................................................................................... 11 
6.3 SUBJECT POPULATION(S) FOR ANALYSIS ........................................................................................................... 12 
7 
Safety.. ............................................................................................................................................................... 12 
7.1 POTENTIAL RISKS .............................................................................................................................................. 12 
7.1.1 
Loss of Confidentiality ......................................................................................................................... 12 
7.1.2 
Detection of Clinically Significant Problems ....................................................................................... 12 
7.1.3 
Physical Activity .................................................................................................................................. 12 
7.1.4 
Smoking ............................................................................................................................................... 12 
7.1.5 
Psychological Risks ............................................................................................................................. 12 
7.2 PROTECTION AGAINST RISKS ............................................................................................................................ 12 
7.2.1 
Protection of Participants' Confidentiality .......................................................................................... 13 
7.2.2 
Blood Pressure ..................................................................................................................................... 13 
7.2.3 
Medication Adverse Effects.................................................................................................................. 13 
7.2.4 
Adverse Event Reporting ..................................................................................................................... 14 
8 
Data Handling and Record Keeping.. ............................................................................................................. 14 
8.1 CONFIDENTIALITY  ............................................................................................................................................ 14 
8.2 SOURCE DOCUMENTS ........................................................................................................................................ 15 
8.3 CASE REPORT FORMS ................................................................................... ERROR! BOOKMARK NOT DEFINED. 
9 
Ethical Considerations ................................................................................................................................... 155 

  
 
10 
Study Finances...................................................................................................... Error! Bookmark not defined. 
10.1 FUNDING SOURCE ...................................................................................... ERROR! BOOKMARK NOT DEFINED. 
10.2 CONFLICT OF INTEREST ............................................................................. ERROR! BOOKMARK NOT DEFINED. 
10.3 SUBJECT STIPENDS OR PAYMENTS ............................................................. ERROR! BOOKMARK NOT DEFINED. 
14 
References ......................................................................................................................................................... 17 
15 
Appendix ........................................................................................................................................................... 20 
16    Key Informant Interview Guides for PLHIV……………………………………………………………….21 
 

  
 
List of Abbreviations 
 
HIV 
Human Immunodeficiency Virus 
ASCVD 
Atherosclerotic Cardiovascular Disease 
CVD 
Cardiovascular Disease 
MI 
Myocardial Infarction 
HINTS  
Hypertension Intervention Nurse Telemedicine Study  
CITIES 
Cardiovascular Intervention Improvement Telemedicine Study 
CCM 
Clinical Case Manager 
PLWH 
People Living With HIV 
LDL 
Low density lipoprotein  
SBP  
Systolic Blood Pressure 
 
 

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Study Summary 
Title 
A Clinic-Based Case Manager Administered Telephone Intervention to 
Reduce Cardiovascular Disease Risk in Persons Living with HIV 
Short Title 
SWOBI-CVD 
Protocol Number 
Pro00085562 
Phase 
Phase 3 
Methodology 
Randomized Controlled Trial  
Study Duration 
24 months 
Study Center(s) 
Single-center   
Objectives 
To assess the impact of telephone-based case manager administered 
interventions in improving ASCVD risk factor outcomes among HIV-
infected clinic patients.  
Number of Subjects 
50 
Diagnosis and Main 
Inclusion Criteria 
Patients diagnosed with HIV and either hyperlipidemia or hypertension 
Duration of 
administration 
24-weeks  
Statistical 
Methodology 
Generalized linear mixed regression models will be used to assess the 
changes in systolic blood pressure and LDL-c over the period of the 
intervention, accounting for repeated measurements within subjects as 
well as clustering of subjects within providers. Bivariable and 
multivariable analyses will be conducted for all covariates. To test for 
the effect of time on the differences in SBP and LDL-c between the 
groups, we will fit a constrained longitudinal data model (cLDA).57 
We will fit models with time as a categorical variable (based on the 
time of outcome measure collection) and as a continuous variable, to 
determine the best model fit. 
 

 
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Introduction 
1.1 Background and Significance 
Scientific Premise: Atherosclerotic cardiovascular disease (ASCVD) is now a leading cause of 
mortality in persons living with HIV (PLWH), accounting for approximately 10% of deaths in 
large HIV clinical cohorts.
1-5 With widespread availability of effective antiretroviral therapy, 
deaths due to AIDS-related conditions will continue to decrease. Concurrently, ASCVD will 
continue to increase as a proportion of overall mortality among PLWH, especially in light of the 
aging HIV population.
6 Multiple cohort studies have shown a 40-50% higher incidence of 
myocardial infarction (MI) among PLWH with suppressed viremia compared to uninfected 
persons.
7-9,  These observations highlight the need to adopt a comprehensive approach to 
decreasing ASCVD risk in this population, beyond durable viral suppression. Although chronic 
immune activation is thought to drive vascular inflammation and atherogenesis in PLWH
10-12, 
the higher prevalence of reversible ASCVD risk factors (smoking, hyperlipidemia and 
hypertension) among PLWH is also well established.
13-16 Recent studies show that these risk 
factors are more deleterious in PLWH than in uninfected persons. As an example, in a large 
Danish cohort (n= 16,255), 72% of MIs observed among persons with HIV were at least partially 
attributable to smoking compared to 24% of MIs in uninfected persons.
17 These data emphasize 
the need for investigating models of HIV care that are responsive to the complexities of ASCVD 
risk among PLWH. 
Despite the increased risk of major ASCVD events in PLWH, ASCVD primary prevention 
in this group may be inferior to that of uninfected persons.
18 A study at the University of 
Alabama showed that 17% of persons who were eligible for aspirin by USPSTF guidelines had 
received recommendations from their provider to take it.
19 Similarly, data from our group 
showed that PLWH were 30% less likely to receive statins, 47% less likely to receive aspirin 
and 37% less likely to receive anti-hypertensives when indicated than age, sex and race matched 
controls.
20 Unfortunately, behavioral interventions targeted at modifying provider practices 
pertaining to CVD risk reduction are often ineffective.
21-24 Using non-physician clinical staff to 
augment care is a potentially effective way to overcome barriers to improving CVD risk 
management in this setting. 
Behavioral interventions conducted by non-physician clinical staff are effective in reducing 
ASCVD risk. A meta-analysis of 39 randomized controlled trials assessing nurse and/or 
pharmacist-led CVD risk-reduction interventions, reported that systolic blood pressure dropped 
by 7.6mm Hg from baseline readings compared to usual care. The mean duration of the 
interventions assessed was only 8.3 months (range 3-13 months), demonstrating the rapid 
impact these interventions can have on CVD risk parameters.
25 In a randomized study of 636 
patients with hypertension, patients who received a 2-year nurse-administered behavioral 
intervention were 11% more likely to achieve blood pressure control than patients who received 
usual care.
26 The scientific premise of the proposed intervention is that clinical encounter 
supplementation provided by telephone, and delivered by trained professionals, will provide 
additional time and opportunity to establish and reinforce behaviors associated with CVD risk 
reduction. A measurable manifestation of this intervention will be reduction of blood pressure 
and low density lipoprotein (LDL) levels. 
27,28 
 

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Significance of the Expected Research Contribution: With the large sample size of the 
retrospective analysis from Aim 1, findings from our study will provide insight into what care 
delivery models have worked historically for ASCVD primary prevention in PLWH. Our 
proposed study will also look at the utility of leveraging the unique, multidisciplinary structure 
of the HIV clinical care team for improving ASCVD outcomes in this high-risk 
population. If the proposed telephone-based intervention proves effective, similar interventions 
could be applied to addressing other non-AIDS chronic diseases including non-AIDS-related 
cancer, chronic kidney disease and osteopenia/osteoporosis. Our findings will also give 
validation to the paradigm of incorporating, non-provider HIV clinical staff into longitudinal 
chronic disease management initiatives for HIV clinic patients. 
 
1.2 Innovation 
1) Our study will be the first comparative analysis to examine ASCVD-related outcomes 
based on models of healthcare delivery in an HIV population. By 2019, 50% of all 
patients with HIV in the United States will be aged 50 or older.
29,30 Understanding trends in 
chronic disease care delivery (particularly ASCVD primary prevention) in this aging 
population is critical to informing healthcare delivery interventions that are responsive to the 
ever-increasing burden of HIV clinical care. Although our data suggest that PLWH who 
receive medical care solely from HIV subspecialists are prescribed CVD medications less 
frequently than uninfected persons,
20 how these outcomes deviate from PLWH receiving 
chronic disease care from non-HIV PCPs is unclear. The retrospective analysis proposed in 
Aim 1 will provide valuable insight on whether or not the intervention proposed in Aim 3 
(and other interventions aimed at improving CVD risk management) should be restricted to 
persons who receive all non-AIDS chronic disease care exclusively from their HIV provider. 
In addition, no studies to date have looked at whether receiving CVD preventative care 
exclusively from an HIV provider has an adverse impact on hard CVD risk factor outcomes 
(successful blood pressure and lipid control). Our study will be the first to address this 
question. 
 
2) The intervention design will be customized based on patient and provider input. 
Telephone-based interventions have been previously shown to improve blood pressure in 
patients with hypertension.
26, 31-33 The framework of our proposed intervention will be based 
upon the nurse and pharmacist administered instruments from the Hypertension Intervention 
Nurse Telemedicine Study (HINTS) and the Cardiovascular Intervention Improvement 
Telemedicine Study (CITIES) respectively.
26,34 However, implementing such interventions 
in the context of HIV care presents unique complexities. To better understand the nuances of 
HIV care relevant to the development of the intervention, we will adopt a mixed methods 
approach. Semi- structured interviews and focus groups of HIV clinic patients and clinical 
case managers will be used to inform our research team of precise ways to modify our 
proposed intervention to best fit the needs of the HIV clinic population. This approach will 
provide the unique opportunity to tailor a previously validated ASCVD risk management 
intervention to specifically meet the needs of HIV-infected persons. 
 
3) The intervention will be generalizable, sustainable and time-efficient. Unlike the HINTS 
and CITIES studies which were administered by nurses and pharmacists hired specifically 
for the research study, 26,34 we will pilot our proposed intervention with clinical case managers 
(CCMs) who are primarily employed by the HIV clinic, and are part of many HIV clinics. 

4 
 
Given the prominent role of CCMs in HIV care, our intervention (if effective) will be highly 
generalizable to a variety of clinical settings. The total telephone encounter time of the 
proposed intervention is approximately 30-45 minutes per encounter. In addition, the short 
duration of the intervention (24 weeks) also enhance ease of implementation in real-world 
practice. Most importantly, using clinic-employed CCMs will allow for easy incorporation 
of this strategy into practice, making it more sustainable over time, and immediately 
applicable. 
 
4) The intervention will leverage the therapeutic rapport between CCMs and HIV 
clinic patients to enhance the effectiveness of the proposed intervention. CCMs typically 
have a nuanced knowledge of the HIV clinic patient’s psychosocial barriers to care and how 
to resolve them. Of all the members of the HIV clinical care team, this depth of knowledge 
is usually exclusive to the CCM, given them the ability to quickly establish a unique 
therapeutic rapport with clinic patients. According to the New York State AIDS Institute, the 
goal of case management is “to promote and support independence and self-sufficiency”.35 
This goal aligns with the central tenets of the HINTS and CITIES interventions predicated 
on enhancing self-efficacy in accordance with the Health Belief Model (HBM), one of the 
preeminent psychological theories of health behavior.36 These parallel objectives make HIV 
CCMs ideal providers to implement the proposed interventions. The pre-existing therapeutic 
rapport between CCMs and their clinic patients is centered around the restoration of self-
efficacy, a key component absent from both aforementioned studies. Given the work- time 
compression characteristic of the physician-patient interaction, CCMs may be more effective 
than providers in motivating lifestyle modification because they have more time to promote 
change in a systematic manner based on sound cognitive constructs. Although using CCMs 
will increase the amount of training needed to implement the intervention, the benefits of 
using these professionals to deliver chronic disease interventions have never been formally 
assessed. Examining the role of this therapeutic dynamic in the in the implementation of the 
behavioral intervention is novel and a primary focus of our study. 
 
Study Objectives 
The overall objective of this study is to assess the impact of telephone-based case manager 
administered interventions in improving ASCVD risk factor outcomes among HIV-infected 
clinic patients.  
 
2.1 Primary Objective 
To assess the effect of a telephone based CVD risk reduction intervention on decreasing systolic 
blood pressure (SBP) and fasting LDL-c levels from baseline.  
 
2.2 Secondary Objective 
To assess the effect of a telephone based CVD risk reduction intervention on weight loss and 
change in 10-year ASCVD risk score.  
 
Study Design 
3.1 General Design 
Fifty high CVD risk clinic patients will be randomized 1:1 to receive either a series of 
educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction 

5 
 
curriculum delivered over 24 weeks [intervention arm], or the educational pamphlets alone 
[control arm]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from 
patients at baseline and at the end of the study (24 weeks) to assess the efficacy of the 
intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL). 
 
3.2 Design Team Consultations 
 
We will conduct a series of participatory, iterative design consultation team meetings held over 
the course of 2-4 weeks.  The design team will include a combination of 2-4 clinical social 
workers from Clinic 1K, 1-3 persons living with HIV. Each member of the design team will be 
recruited by personal invitation.  The purpose of the design teams will be to provide refine the 
intervention designed by the study investigator and SW consultant. The design process will 
involve three main phases: brainstorming, conceptualization, and creation described below in 
study procedures. The results from the first two design team meetings will inform one additional 
design team meeting to iteratively refine the intervention. Informed consent will be obtained 
from all members of the consultation team. We anticipate that each design team session will take 
between 3-4 hours. Design team members will be compensated $150 per session completed.  
 
Subject Selection and Withdrawal 
 
4.1 Inclusion Criteria 
1. Age 40-75 years.  
2. In care at the Duke Infectious Disease Clinic for at least 12 months. 
3. HIV+ and on antiretroviral therapy for at least one year, with six consecutive months 
of documented viral suppression (HIV-1 RNA <200 copies/ml at time of enrollment.  
4. Diagnosis of hypertension or hyperlipidemia.  
Hypertension is defined as: a) “Essential hypertension”, “Primary Hypertension” or 
“Hypertension” listed on their problem list in the electronic health record b) On 
antihypertensive medication for the indication of hypertension  c) two consecutive 
ambulatory blood pressures of > 130/80 separated by 3 months or more. 
Hyperlipidemia is defined as: a) “Hyperlipidemia” or “Dyslipidemia” (with allowed 
modifiers) listed in patient’s problem list in EHR b) On any of the following lipid-
lowering medications: statins, fibrates, PCSK-9 inhibitors, niacin, ezetimibe. 
5. Able to speak and read English at least at the 6th grade level  
 
4.2 Exclusion Criteria  
1. Prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and 
end stage renal disease, coronary revascularization (percutaneous coronary intervention or 
coronary artery bypass grafting) or congestive heart failure. 
2. Pregnant, breastfeeding, or planning a pregnancy during study period. 
3. Planning to move out of the area in the next 6 months. 
4. No reliable access to telephone. 
5. Terminal illness with life expectancy <4 months. 
6. In a nursing home and/or receiving in-patient psychiatric care. 
7. Severely hearing or speech impaired, or other disability that would limit participation 
in the intervention components. 

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8. Documented mental health diagnosis with component of psychosis. 
9. Longitudinal follow up by a hyperlipidemia specialist (endocrinology or cardiology), 
hypertension specialist (nephrology or cardiology) or a cardiologist for any indication.  
 
4.3 Subject Recruitment and Screening 
Pre-screening: we will use the electronic medical records at our site to identify potential 
subjects for our study according to the inclusion/exclusion criteria. Potential subjects may 
also be recommended by providers within the Division of Infectious Diseases based on 
the inclusion/exclusion criteria. Potential subjects will initially be mailed a recruitment 
letter signed by his or her primary HIV provider. Potential subjects will have the 
opportunity to opt out of the study by calling a toll-free number.  
 
In addition to receipt of letters, prospective participants will be approached with the 
permission of their providers during routinely scheduled clinical encounters, by a 
member of the study team. During such encounters, the study team will inform 
participants about the study and the reasons why they are eligible to participate. At that 
point, the patient will have the option to proceed with a baseline screening visit or not.  
 
This study will also utilize cold-calling recruitment methods. This will include contacting 
the patients directly if they meet eligibility criteria to enroll them into this study. 
Research coordinator(s) will refer to patients’ electronic medical records (EMR) to 
confirm that the patient(s) have not opted out from being contacted for research studies.  
 
Screening: A research coordinator will contact all subjects who do not opt out. 
Following a telephone script, the research assistant will describe the study in detail, 
ensure the patient is eligible and willing to participate, and schedule a baseline study visit 
at the next clinical visit with an HIV provider where they will be enrolled following the 
informed consent process described below in section 5.1.  
  
 
4.4 Early Withdrawal of Subjects 
 
Throughout the course of the study, patients will be encouraged to complete the all study 
assessments. However, it is possible that a subject may discontinue study participation at any 
time for any reason. The reason for early withdrawal must be documented in the subject’s case 
file, subject tracking document and subject withdrawal form on REDCap.  
 
4.4.1 Reasons for withdrawal: 
The voluntary nature of studies allows for participants to withdraw from the study at any point 
for any reason. Subjects may be withdrawn from the study if a serious adverse event (SAE) 
occurs. Subjects may be withdrawn if: 
1. They withdraw their consent 
2. In the opinion of the investigator, continuation of study participation would be hazardous 
to the participant, or compromise study findings.  
 
The reason for any subject’s discontinuation and the date of withdrawal will be recorded in the 
subject’s case file. The subject’s case file, which will be completed up to the point of withdrawal 
will be retained for six years. The study report will include reasons for subjects’ withdrawals as 

7 
 
well as details relevant to the subjects’ withdrawals. Any subject withdrawn from the trial prior 
to completion will undergo all procedures indicated in this protocol as being scheduled to occur 
at discharge or upon early withdrawal. Any subject withdrawn due to an adverse event (whether 
serious or non-serious) or any clinically significant abnormal laboratory test value will be 
evaluated by the principal investigator, and will be treated and followed up until the symptoms or 
values return to normal or acceptable levels, as judged by the Principal Investigator. Relevant 
post-study procedures will be performed, wherever possible, on subjects who elect to withdraw. 
 
4.4.2 Handling of Withdrawals: 
If a subject is withdrawn from participation in the study at any time at his or her request, at the 
IRB or Principal Investigator’s discretion, the reason(s) for discontinuation shall be documented 
thoroughly in the source documents and subject’s case file. If a subject is discontinued because 
of an adverse event, this event will be followed until it is resolved or the subject is clinically 
stable and will also be documented in the source documents and the subject’s case file. 
 
Study Procedures 
 
5.1 Design Team Procedures: 
 
This intervention adaptation aim will involve three phases: brainstorming, conceptualization, and 
creation: 
 
During the brainstorming (meeting #1): the design team will review the mixed-methods data 
obtained during aim 2 of the study, which sought to gain detailed knowledge about HIV clinic 
patients’ perception of their own CVD risk and the HIV clinic’s role in CVD risk reduction. The 
following topics will be discussed: perception of CVD risk (perceived susceptibility), provider 
accessibility (perceived barriers), provider prioritization of CVD risk management (perceived 
barriers), and interventions likely to motivate risk reducing behaviors (perceived benefits and 
cue to actions). The team will discuss these findings and brainstorm ideas to refine the SWOBI 
intervention in response to the data. Possible targets for adaptation include a) targeting the staff 
training to include relevant aspects of perceived risk into the care coordination and adherence 
support; (b) developing and tailoring staff training to facilitate acceptance, uptake, and 
effectiveness; and (c) helping us to quickly identify and troubleshoot any problems with the 
implementation of the intervention. 
 
During the conceptualization phase (meeting #2): the team will evaluate advantages and 
disadvantages of ideas generated during the brainstorming phase, and the educational material 
developed ahead of this meeting. The team will then develop concrete changes to the 
intervention. The feasibility of each of the discussed intervention modification will be discussed 
and finalized into the intervention by the study PI.  
 
During the creation phase (meeting #3): the team will be involved in the creation of refined 
manuals of procedures and education materials. After the feasibility testing is completed, the 
design team will meet for a final time to discuss feasibility testing results from meeting #2 and 
refine the intervention as needed. At this meeting, the design team members who have given 
consent to participate in a focus group discussion will reflect on the design process.  

8 
 
5.2 Pre-trial demonstration 
Prior to the commencement of the trial, we will recruit one clinic patient to participate in a 
demonstration of the study intervention telephone modules. The purpose of this demonstration is 
to give the study social worker the opportunity to execute the trial intervention modules and 
resolve workflow/logistical concerns with the intervention prior to study launch. The 
demonstration patient will be recruited by personal invitation of the study investigator. They will 
be consented prior to their participation in the process. The study patient will be expected to 
participate in no more than three demonstration sessions. They will serve as a mock recipient of 
the telephone-based intervention. After conclusion of the demo intervention call, the study team 
will ask the demo participant questions about the acceptability of the telephone call, as well as 
their perceived strengths and weaknesses of the telephone module. The demonstration participant 
will be compensated $50 for each session for a total of $150.  
 
5.3 Study Timeline  
 
All enrolled patients will complete 4 study visits as outlined in the flow chart below: 
  
 
 
 
 
 
 
 
 
 
 
 
5.4 Informed Consent 
Each subject will give informed consent, either using a hard copy consent in person or via the e-
consent process in REDCap, prior to enrollment into study during the baseline visit. Research 
coordinator(s) will read, review, and discuss consent forms with all potential participants prior to 
asking them to sign. If the candidate appears confused or indicates a lack of understanding, the 
interviewer will attempt to identify the misunderstanding and to explain the form again. Any 
candidate who still does not comprehend the form will be excluded from the study. We will ask 
questions to confirm understanding of the material covered in the consent procedure, both open 
ended (e.g. “Could you tell me what’s going to happen of you enroll in this study?) and closed 
(e.g. “is your participation in this study voluntary?”). Persons who understand the consent form 
and agree to participate in the study will be asked to sign an authorization for the release of 
medical information to us. Interviewers will witness and date the signed forms and complete the 
corresponding informed consent checklist to document the participant’s understanding of the 
informed consent process. Consent procedures will take place in a private room or office. 
Consent forms will be kept in a locked file cabinet within a locked room.  
 
5.5 Data collection 
Baseline  
(0 weeks) 
Visit 2  
(6 months) 
Visit 3  
(12 months) 
Visit 4  
(18 months) 
CCM 
Intervention 
Post-Intervention follow-up to 
test for durability of intervention 

9 
 
Data will be collected through the electronic data capture system – REDCap. Patients will have 
the option of providing e-consent on this platform. Participants will be asked to complete patient 
reported outcome measures via REDCap at various timepoints throughout the study including: 
single item health literacy, demographics, adherence, IPAQ physical activity, and perception of 
risk of heart disease scale. In addition, the clinical research coordinators will collect patient 
information for: medical chart screen, participant screening, BP and cholesterol medications, 
physical measurements, and outcomes. Adverse events will also be collected to track and ensure 
safety of the patient throughout the duration of their participation in the study. 
 
5.6 Randomization 
 
We will conduct a randomized controlled pilot trial of the intervention vs. education control 
group among 50 PLWH on suppressive ART who have either hypertension or 
hypercholesterolemia. Control participants will receive general prevention education. The 
intervention will consist of prevention education plus a 24- week intensive telephone-based, 
social work administered intervention focused on heart-healthy behaviors.  
 
5.7 Control group   
Participants assigned to the control group will receive usual clinical care enhanced with a series 
of 12 packets of educational handouts delivered to patients every two weeks for 24 weeks. . 
Educational pamphlets will be delivered on one of six topics on a rotational basis (two rotations 
over a 6-month study period). The topics to be covered by the educational material are as 
follows: CVD Knowledge and Risk Perception, Medication Reconciliation, Dietary Assessment 
and Education, Physical Activity and Weight Management, Smoking Cessation, Stress 
Management. On enrollment, participants will determine the optimal mode of delivery for the 
educational material (email, regular mail, or text). All participants in the control and intervention 
arm will complete the following study assessments: 1) in-office BP obtained by a trained 
research assistant (0, 6, 12, 18 months) 2) lipid profile (0, 6, 12, 18 months)(the default will be to 
collect data from lipid profiles done as part of routine clinical care, within 4 weeks of baseline 
visit; if lipid information is not available or exceeds acceptable time point, lipid panel will be 
collected by the research staff). 3) 10-year ASCVD risk score (0, 6, 12, 18 months 4) provider 
trust and communication survey (0, 6, 12, 18 months).  
 
5.8 Study Intervention  
In addition to the educational material delivered to the control arm participants, participants 
randomized to the intervention arm will receive a 24-week telephone-based intervention, 
customized for the delivery to PLWH by social workers (SW). Participants will be contacted 
every 2 weeks for a total of 12 calls in the 24-week period by the study social worker. During 
each call, the participant will have the chance to select a module from 6 modules in a rotating 
fashion on topics relevant to CVD risk (Table 2). Once a module is chosen, it can only be chosen 
once more for the duration of the study period. Each telephone session will involve the study SW 
providing education on the selected module to promote improved CVD health. For the diet, 
physical activity, and overview of CVD risk factors modules, there will be a low and high 
literacy version. At baseline the coordinator will assess whether the participant should be low or 
high literacy based on their discussions. The coordinator will then relay this assessment when 
notifying the social worker that the participant has been randomized to intervention. During the 

10 
 
first module, the social worker will make a secondary assessment of the participant’s health 
literacy level. The social worker will have the final decision as to which version of the module 
the participants will receive. During the call, the social worker will follow the prompts of a 
telephone script. As part of the intervention, the SW will incorporate MI techniques at different 
times during the phone call based on the direction of the conversation. Towards the end of each 
call, the participant will have the option to review any or all of the corresponding educational 
materials relevant to the module. Each of these calls will take between 30-45 minutes to 
administer. At the conclusion of the study telephone visit, participants will be delivered a 
package of educational pamphlets similar to those administered to participants in the control arm. 
Like the control arm, a total of 12 packets will be delivered to intervention participants via their 
method of choice. Since this pilot study seeks to determine the independent effect of the SW-
based intervention, SWs will be instructed not to feedback on study-related telephone 
interactions to the participant’s provider. This will be facilitated by the physical separation 
between the SW offices and the provider work area. Recruitment efforts will also be tailored to 
inform providers about the study with the minimal amount of details on the intervention 
available to avoid undue influence on their practice patterns.  
 
All study follow up visits will be conducted within a +/- 21 day window. 
 
5.9 Social Worker Responsibilities 
Responsibilities of interventionist social worker (ISW) are as follows:  
a. The ISW will assist in the development of educational material and scripts for the 
intervention  
b. The ISW will participate in all design consultation team sessions aimed at refining the 
modules for the intervention  
c. The ISW will edit and review modified versions of the study intervention after feedback 
from the design consultation team is obtained.  
d. The ISW will participate in post design consultation forums for finalization of the study 
intervention  
e. The ISW will participate in all pre-intervention training associated with the intervention, 
including (and not limited to): training on medication side effects, simulation sessions for 
scripted material, review of all educational material, use of Zoom (or other 
teleconferencing platform for consultation)  
f. The ISW will deliver the intervention as configured including: pre-telephone call 
documentation, study-telephone call, telephonic transmission of visual educational aids 
(when applicable), post-telephone call documentation (including use of SW-based 
techniques). The ISW will also be called to use their discretion in employing SW-based 
techniques for individual patients. All techniques used during the interaction must be 
documented as part of the study fidelity worksheet to be provided to the ISW by the study 
team  
g. The ISW will answer questions posed by study participants to the best of their ability. 
Any questions that cannot be answered, and deemed outside their scope of practice by the 
ISW as part of the intervention will be documented and sent on to the study investigator 
for resolution. The ISW is specifically instructed not to answer detailed questions on:  
a. CVD medication interactions with current medications  

11 
 
b. Medical issues not directly related with CVD primary prevention related topics 
(hypertension, hyperlipidemia, diabetes, smoking cessation etc)  
c. Medication dosing, up-titration or down-titration  
d. Referrals to specialty providers with the exception of mental health practitioners  
e. Medications or supplements not-approved by the US Food and Drug 
Administration  
f. Other questions by the ISW’s determination is outside the scope of routine social 
work practice  
h. This documentation and transmission to the study investigator should be conducted as 
soon as possible, but no later than 24 hours after completion of the phone call. 
Notification will be conducted ideally via institutional e-mail or MyChart messaging. The 
study investigator will be expected to give a response to such questions within 48 hours 
of receipt.  
i. The ISW will communicate all concerns about logistics of the study to the study 
coordinator in a timely manner 
j. The ISW will report all potential adverse events to the study team (study coordinator and 
study PI) as soon as they are aware as delineated in Section 7.2. 
 
The following documents will be provided to the ISW by the study team prior to study launch:  
 
a. Telephone call intake forms  
b. Educational material associated with module administration  
c. Baseline assessment data for individual participants including participant’s learning 
preferences  
d. Current contact information (phone and e-mail) of the study PI and the study coordinator  
e. A cell phone for the execution of study phone call with SMS transmission capability and 
associated data  
f. List of CVD-related community resources in Raleigh-Durham Metropolitan area  
g. Resource document with side effect profiles of major classes of medication used in 
cardiovascular disease primary prevention.  
h.  
5.10 Post study intervention 
Participants will be followed after the 24-week intervention at 48 (6-month post intervention) 
and 72 weeks (1 year post intervention) to assess the durability of the intervention’s impact. At 
those visits, we will collect blood pressures, anthropomorphic and lipid panels similar to the first 
two study visits. We will also conduct patient-reported data on the durability of the intervention 
using formal assessment tools for heart-healthy behaviors at each visit. 
 
5.11 Post Intervention Interviews 
After the 6 month intervention is complete, we will approach a convenience sample of 10 
participants to participate in an additional key informant interview. All interviews will be 
completed between the end of the intervention and the participants 12 month visit. These 
interviews will take place at the participants 6 month visit or by phone at a mutually agreed upon 
time. Questions will address the participants perception of the intervention’s characteristics and 
program outcomes. All interviews will take approximately 30 minutes and audio recordings 
using an encrypted recorder if participant agrees to be recorded, will later be transcribed using a 

12 
 
Duke-approved transcription service (rev.com) to transcribe the audio files. Audio recordings 
will be destroyed after results of study are published. An interview information sheet will be 
shared with participants asked to participate in interview. They will be verbally consented to 
participate or decline if they choose. Participants who complete this key informant interview will 
be compensated an additional $50 by check for their time and insights.  
 
Statistical Plan 
6.1 Sample size Determination: 
Given that this is a pilot study, our goal is to determine the effect size of the intervention to 
determine the statistical power needed for subsequent larger studies. Based on our assessment 
of the recruitment pool and resources available through the award, we will enroll 25 patients in 
each arm (n = 50) with anticipated 20% dropout rate over 6 months for an estimated final 
analysis sample of 40 patients. Based on previous studies, 25 we can anticipate a mean systolic 
blood pressure change of 7.6 mmHg, and a standard deviation of 15 mm Hg, for an effect size of 
0.51. An effect size of < 0.3 will be considered insignificant. 
6.2 Statistical Methods 
Data on the outcome variables (blood pressure, non-HDL/LDL, 10-year ASCVD risk score) for 
each arm will be collected at weeks 0, 6, 12 and 18 months. Summary statistics of the study 
cohort will be reported for every interim timepoint. Generalized linear mixed regression models 
will be used to assess the changes in systolic blood pressure and LDL-c over the period of the 
intervention. Models will be fit with an interaction term to account for the difference of 
differences (DID) at each timepoint in the study (on intervention and post intervention timepoints 
to assess durability of the intervention’s effect) to assess the treatment effect between the two 
arms. The p-value of the interaction term will serve as significance testing for the difference 
between the outcome value difference of the two study arms. The same technique will be used 
for the secondary analysis of ASCVD risk scores.  
 
Missing data will be handled as follows:  
• 
Variables with more than 30% missingness will be dropped from the analysis regardless of 
reason  
• 
Variables with less than 30% missingness will be evaluated by individual observations. If the 
data point is determined to be missing at random, then values will be imputed in its place 
using multiple dataset imputation methods. If the data point is determined to be not missing at 
random, then the observation of missingness will be reported in the summative reporting after 
the reasons for the patterns of missingness have been determined. The missing values will 
then be imputed by the predicted linear regression model.  
• 
Any observations without data from the intervention completion (week 24) timepoint will be 
excluded from the analysis 
 
6.3 Subject Population(s) for Analysis 
All randomized subjects with at least partial outcome data for the baseline and week 24 
timepoints will be included in the analysis, regardless of missingness of the post-intervention 
timepoints.  
Safety  
7.1 Potential Risks 

13 
 
 
 Loss of confidentiality  
The risks associated with potential loss of confidentiality are low. The staff obtaining data will 
be properly trained and supervised. Participant data, including audio recordings, will be stored in 
files on the Duke Division of Infectious Diseases private server, managed by the Duke Office of 
Information Technology.  
 
Detection of clinically significant problems 
Although not caused by study participation, it is possible that clinically significant problems will 
be detected by study staff. Subjects entering the study will have a history of hypertension or 
hyperlipidemia so abnormal systolic, diastolic and lipid values are expected. All values that 
reach a safety threshold (<90 or >180 systolic BP, or <40 or >110 diastolic BP) will be reported 
to the subjects’ care provider immediately (See Section on Adverse Event Reporting).  
 
Physical activity 
During the course of the study, SWs may encourage participants to increase their physical 
activity, increasing the possibility of musculoskeletal injury or unmasking of ischemic heart 
disease. Risks from increased physical activity will be minimized by encouraging moderate 
rather than vigorous activity. Providers will respond to these patient problems per usual medical 
care.  
 Smoking  
Smoking participants will be encouraged to quit smoking, increasing the possibility of 
withdrawal symptoms from nicotine dependence.  
 
Psychological risks 
For the purpose of the study assessments, participants will be asked about personal 
characteristics such as race/ethnicity, and socioeconomic status that may be uncomfortable to 
answer. Only questions that are important to inform the study outcomes will be asked during the 
course of the trial. Participants will be informed that they may refuse to answer any questions, 
and continue to participate in the study. It is also possible that participants may be uncomfortable 
talking to the SW about some topics that will be discussed as part of the intervention.     
 
7.2 Protection against risks 
 
Protection of participants’ confidentiality  
Since this study involves people with HIV, steps will be taken to protect patient data and 
identities. All research staff will be trained in initial, follow up and monitoring training specific 
to the trial in addition to the Research Ethics and Compliance training via Collaborative 
Institutional Training Initiative (CITI), which will ensure the understanding of all the ethical 
issues involved in research. All consent forms signed by the participants will be maintained in 
locked files with limited access, separate from any subject data and will only be accessible to the 
study team. Any personal identifiers linked to the data will be replaced with subject IDs in all 
patient records. Participants will be made aware of these risks at the time of informed consent, 
prior to study participation.    
 
Blood Pressure 

14 
 
The participants will have a high risk for CVD and thus many will be prescribed hypertension 
medications by their health care provider at the outset of the study. It is likely that as a result of 
increased monitoring, we will detect more episodes of abnormal BP values. BP will be measured 
at each follow up visit. Participants will have access to their regular providers as well as the 
study investigator designated as the clinical contact for the study: Dr. Okeke (infectious disease 
physician; Duke Health). An average SBP at any study visit >180 mm Hg and/or diastolic is 
>110 mm Hg will be considered an alert value and will trigger assessment by the study clinician. 
Additionally, an average BP at any study visit that is <90 systolic of <40 diastolic would also be 
considered an alert value and would trigger an assessment by the study clinician.  
 
Participants who have an alert BP reading during study visits will be directly assessed for 
cardiovascular symptoms during the visit. Once an alert value has been confirmed, the 
participant will be triaged according to follow-up recommendations from Joint National 
Committee Recommendations (JNC 8). If at any time, participants have symptoms of acute end 
organ damage (i.e. current chest pain, dyspnea at rest, new onset of blurry vision, or new 
neurological deficits consistent with a stroke) in the context of an elevated BP measurement 
(SBP >180, and/or DBP >110), participants will be asked to contact the clinician and will be 
advised and assisted in seeking emergency medical care. 
 
For participants in the intervention group whose average SBP >180 and DBP >110 or SBP < 90 
or DBP < 40 but are without acute symptoms, the participant’s primary provider will be notified. 
Follow up contact with the study staff will occur within one week. All abnormal blood pressure 
results will be communicated to the clinic director at each site who will be an integral part of 
triage and ensuring follow up. The SW will then generate a note to be entered into the electronic 
medical record and will communicate directly with the subject’s PCP. 
 
Medication adverse effects 
The usual health care provider of the participants on antihypertensive and/or on lipid lowering 
medication will take primary responsibility for counseling the patient about side-effects and 
ordering follow-up laboratories. In addition, each participant will be counselled by the SW 
about possible side effects, drug interaction with ART and adherence.  
  
Adverse Event Reporting 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in 
severity during the course of the study. Intercurrent illnesses or injuries should be regarded as 
adverse events. Abnormal results of diagnostic procedures are considered to be adverse events if 
the abnormality: a) results in study withdrawal; b) is associated with a serious adverse event; c) is 
associated with clinical signs or symptoms; d) leads to additional treatment or to further diagnostic 
tests; or d) is considered by the investigator to be of clinical significance.  
A serious adverse event (SAE) is any AE that is: fatal, life-threatening, requires or prolongs 
hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or 
birth defect, an important medical event (an event that may not be immediately life threatening, 
but are clearly of major clinical significance).  
 
All subjects will be informed about their rights prior to participation and will be encouraged to 
report any incidents or adverse effects to the investigators and the Duke University Institutional 

15 
 
Review Board (IRB). Contact information for the investigators and the IRB will be provided in 
the consent forms. During assessments the research staff will inquire about AEs and complete an 
AE form for each subject. At baseline, clinically significant abnormalities will be recorded along 
with other preexisting conditions. If a preexisting condition is reported at baseline, it will be 
reported as an AE if the frequency, intensity, or the character of the condition worsens during the 
study period. All reportable AEs will be captured in the Electronic Data Capture (EDC) on the AE 
Case Report Form (CRF) where the responsible research staff will report the nature, the severity 
and the resolution of the AE. When an AE is considered to be a SAE and study-related, the study 
PI will be responsible for reviewing and signing off on the AE.  
 
Research staff will be trained on procedures for AE identification, collection and reporting in 
detail. Study staff will also be trained to provide crisis intervention and referral as standard 
operating procedure within each clinic for such situations, should they become dangerous or life-
threatening (i.e. suicidal ideation or attempts).   
 
AEs will be managed in conjunction with clinic medical staff, with permission from the 
participant. All subjects will be ongoing patients at a study site clinic and thus subjects can be 
monitored and have access to medical staff through the study period.    
 
All unresolved adverse events at the end of the study will be followed by the investigator until 
the events are resolved, the subject is lost to follow-up, or the adverse event is otherwise 
explained. At the last scheduled visit, the investigator will instruct each subject to report any 
subsequent event(s) that the subject, or the subject’s personal physician, believes might 
reasonably be related to participation in this study. The investigator will notify the study sponsor 
of any death or adverse event occurring at any time after a subject has discontinued or terminated 
study participation that may reasonably be related to this study.   
 
Data Handling and Record Keeping 
8.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). A 
signed subject authorization will be obtained on the informed consent document informing the 
subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI.  
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, will retain the ability to use all information collected prior to the revocation of subject 
authorization. For subjects that have revoked authorization to collect or use PHI, attempts should 
be made to obtain permission to collect at least vital status (i.e. that the subject is alive) at the 
end of their scheduled study period. 
8.2 Source Documents 
Any source data (i.e. all information original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the construction and evaluation of this trial) collected 
during the course of the trial, will be kept in a locked filing cabinet in a locked office. All subject 

16 
 
data with PHI will be kept separate from the master list that links subjects to their subject IDs. All 
data stored on the computer will be maintained on duke computers secured by duke firewall. All 
essential study documents will be retained for 6 years after study completion.  
 
8.3 Case Report Forms 
All study CRFs will be obtained via an electronic data capture (EDC) called REDCap. All data 
will be monitored by a designated data manager at the Duke Office of Clinical Research (DOCR), 
who will be responsible for developing, generating, and managing ongoing study data to ensure 
accuracy and complete acquisition of study data. To minimize data-entry error and data-
management miscoding, questionnaire data will be collected via tablet computers and immediately 
uploaded to a secure web-based server, ensuring backup. Source documents and electronic data 
will also be checked for accuracy and adherence to study protocols. 
  
Ethical Considerations 
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), 
applicable government regulations and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
Ethics Committee (EC) or Institutional Review Board (IRB), in agreement with local legal 
prescriptions, for formal approval of the study conduct. The decision of the EC/IRB concerning 
the conduct of the study will be made in writing to the investigator and a copy of this decision 
will be provided to the sponsor before commencement of this study. The investigator should 
provide a list of EC/IRB members and their affiliate to the sponsor. 
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 
study. This consent form will be submitted with the protocol for review and approval by the 
EC/IRB for the study. The formal consent of a subject, using the EC/IRB-approved consent 
form, must be obtained before that subject is submitted to any study procedure. This consent 
form must be signed by the subject or legally acceptable surrogate, and the investigator-
designated research professional obtaining the consent.  
 
Study Finances 
 
10.1Funding Source 
This study is funded by a grant through the National Heart, Lung and Blood Institute (NHLBI; 
K23HL137611). 
 
10.2 Conflict of Interest  
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the 
conflict reviewed by a properly constituted Conflict of Interest Committee with a Committee-
sanctioned conflict management plan that has been reviewed and approved by the study sponsor 
prior to participation in this study. All Duke University investigators will follow the University 
conflict of interest policy. 

17 
 
10.3 Subject Stipends or Payments 
All participants will be required to complete four study visits over the course of the pilot trial. 
For each completed visit, they will receive $25 primarily as a Duke Gift Card (ClinCard) or 
check when necessary. Remuneration will be received by the participant at the end of the study 
visit.   
 
References 
1. 
Smith CJ, Ryom L, Weber R. Law, M, Monteforte AD, Kirk O, Friis-Moller N, Philips 
A, Reiss P, El Sadr W, Pradier C, Worm SW. Trends in underlying causes of death in 
people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 
2014;384(9939):241-248. 
2. 
Antiretroviral Treatment Cohort Collaboration. Causes of death in HIV-1-infected 
patients treated with antiretroviral therapy, 1996-2006: collaborative analysis of 13 
HIV cohort studies. Clin Infect Dis 2010;50(10):1387-1396. 
3. 
Weber R, Ruppik M, Rickenbach M, Spoerri A, Furrer H, Battegay M, Cavassini M, 
Calmy A, Bernasconi E, Flepp M, Kowalska J, Ledergerber B and the Swiss HIV 
Cohort Study. Decreasing mortality and changing patterns of causes of death in the 
Swiss HIV Cohort Study. HIV Medicine. 2013;14(4):195-207. 
4. 
Rodger AJ, Lodwick R, Schechter M, Deeks S, Amin J, Gilson R, Paredes R, 
Bakowsnak E, Engsig FN, Philips A and the Insight Smart/ESPIRIT Study Groups . 
Mortality in well controlled HIV in the continuous antiretroviral therapy arms of the 
SMART and ESPRIT trials compared with the general population. AIDS. 
2013;27(6):973-979. 
5. 
Insight Smart Study Group. Initiation of Antiretroviral Therapy in Early Asymptomatic 
HIV Infection. N Engl J Med. 2015; 373: 795-807.  
6. 
Centers for Disease Control and Prevention. HIV Surveillance Report, 2014; Vol. 26. 
2016. Accessed July 25, 2016. URL: 
http://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-
us.pdf 
7. 
Freiberg MS, Chang CC, Kuller LH, Skanderson M, Lowy E, Kraemer KL, Butt AA, 
Bidwell Goetz M, Leaf D, Oursler KA, Rimland D, Rodriguez Barradas, M, Brown S, 
Gibert C, McGinnis K, Crothers K, Sico J, Crane H, Warner A, Gottlieb S, Gottdiener 
J, Tracy RP, Budoff M, Watson C, Armah KA, Doebler D, Bryant K, Justice AC. HIV 
infection and the risk of acute myocardial infarction. JAMA Intern Med. 
2013;173(8):614-622. 
8. 
Silverberg MJ, Leyden WA, Xu L, Horberg MA, Chao CR, Towner WJ, Hurley LB, 
Quesenberry CP, Klein DB. Immunodeficiency and risk of myocardial infarction 
among HIV-positive individuals with access to care. J Acquir Immune Defic Syndr. 
2014;65(2):160-166. 
9. 
Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction 
rates and cardiovascular risk factors among patients with human immunodeficiency 
virus disease. J Clin Endocrinol Metab. 2007;92(7):2506-2512. 
10. 
Deeks SG, Tracy R, Douek DC. Systemic effects of inflammation on health during 
chronic HIV infection. Immunity. 2013;39(4):633-645. 
11. 
Boccara F, Lang S, Meuleman C, Ederhy S, Mary-Krause M, Costagliola D, Capeau 
J, Cohen A. HIV and coronary heart disease: time for a better understanding. J Am 
Coll Cardiol. 2013;61(5):511-523. 
12. 
Hsue PY, Hunt PW, Schnell A, Kalapus SCm Hoh R, martin JN, Deeks SG, Bolger 
AF. Role of viral replication, antiretroviral therapy, and immunodeficiency in HIV-
associated atherosclerosis. AIDS. 2009;23(9):1059-1067. 

18 
 
13. 
Mdodo R, Frazier EL, Dube SR, Mattson CI, Sutton MY, Brooks JT, Skarbinski J. 
Cigarette smoking prevalence among adults with HIV compared with the general 
adult population in the United States: cross-sectional surveys. Ann Intern Med. 
2015;162(5):335-344. 
14. 
Grunfeld C, Kotler DP, Shigenaga JK, Doerller W, Tierney A, Wang J, Pierson RN, 
Feingold KR. Circulating interferon-alpha levels and hypertriglyceridemia in the 
acquired immunodeficiency syndrome. Am J Med. 1991;90(2):154-162. 
15. 
Grunfeld C, Pang M, Doerrler W, Shigenaga JK, Jensen P, Feingold KR. Lipids, 
lipoproteins, triglyceride clearance, and cytokines in human immunodeficiency virus 
infection and the acquired immunodeficiency syndrome. J Clin Endocrinol Metab. 
1992;74(5):1045-1052. 
16. 
Shor-Posner G, Basit A, Lu Y, Cabrejos C, Chang J, Fletcher M, Mantero-Atienza E, 
Baum MK. Hypocholesterolemia is associated with immune dysfunction in early 
human immunodeficiency virus-1 infection. Am J Med. 1993;94(5):515-519. 
17. 
Rasmussen LD, Helleberg M, May MT, Afzal S, Kronborg G, Larsen CS, Pedersen 
C, Gerstoft J, Nordestgaard BG, Obel N. Myocardial infarction among Danish HIV-
infected individuals: population-attributable fractions associated with smoking. Clin 
Infect Dis 2015;60(9):1415-1423. 
18. 
Lichtenstein KA, Armon C, Buchacz K, Chmiel JS, Buckner K, Tedaldi E, Wood K, 
Holmberg S, Brooks JT. Provider compliance with guidelines for management of 
cardiovascular risk in HIV-infected patients. Prev Chronic Dis. 2013;10:E10. 
19. 
Burkholder GA, Tamhane AR, Salinas JL, Mugavero MJ, Raper JL, Westfakk AO, 
Saag MS, Willig JH. Underutilization of aspirin for primary prevention of 
cardiovascular disease among HIV-infected patients. Clin Infect Dis 
2012;55(11):1550-1557. 
20. 
Okeke NL, Chin T, Clement M, Chow SC, Hicks CB. Coronary artery disease risk 
reduction in HIV-infected persons: a comparative analysis. AIDS Care. 
2016;28(4):475-482. 
21. 
Bonds DE, Hogan PE, Bertoni AG, Chen H, Clinch CR, Hiott AE, Rosenberge EL, 
Goff DC. A multifaceted intervention to improve blood pressure control: The 
Guideline Adherence for Heart Health (GLAD) study. Am Heart J. 2009;157(2):278-
284. 
22. 
Hyman DJ, Pavlik VN, Greisinger AJ, Chan W, Bayona J, Mansyur C, Simms V, Pool 
J. Effect of a physician uncertainty reduction intervention on blood pressure in 
uncontrolled hypertensives--a cluster randomized trial. J Gen Intern Med. 
2012;27(4):413-419. 
23. 
Navar-Boggan AM, Fanaroff A, Swaminathan A, Belasco A, Stafford J, Shah B, 
Peterson ED. The impact of a measurement and feedback intervention on blood 
pressure control in ambulatory cardiology practice. Am Heart J. 2014;167(4):466-
471. 
24. 
Petersen LA, Simpson K, Pietz K, Urech TH, Hysong SJ, Profit J, Conrad DA, 
Dudley RA, Woodard ID. Effects of individual physician-level and practice-level 
financial incentives on hypertension care: a randomized trial. JAMA. 
2013;310(10):1042-1050 
25. 
Santschi V, Chiolero A, Colosimo AL, Platt  RW, Taffe P, Burnier M, Burnand B, 
Paradis G. Improving blood pressure control through pharmacist interventions: a 
meta-analysis of randomized controlled trials. J Am Heart Assoc. 2014;3(2):e000718. 
26. 
Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, 
Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure 
management and improved blood pressure control: results from a randomized 
controlled trial. Arch Intern Med. 2011;171(13):1173-1180. 

19 
 
27. 
Melnyk SD, Zullig LL, McCant F, Danus S, Oddone E, Bastian L, Olsen M, 
Stechuchak KM, Edelman D, Rakley S, Morey M, Bosworth HB. Telemedicine 
cardiovascular risk reduction in veterans. Am Heart J. 2013;165(4):501-508. 
28. 
Bosworth HB, Powers BJ, Oddone EZ. Patient self-management support: novel 
strategies in hypertension and heart disease. Cardiol Clin. 2010;28(4):655-663. 
29. 
Effros RB, Fletcher CV, Gebo K, Halter JB, Hazzard WR, Horne FM, Huebner RE, 
Janoff EN, Justice AC, Kuritzkes D, Nayfield SG, Plaeger SF, Schmader KE, 
Ashworth JR, Campanelli C, Clayton CP, Rada B, Woolard NF, High KP. Aging and 
infectious diseases: workshop on HIV infection and aging: what is known and future 
research directions. Clin Infect Dis 2008;47(4):542-553. 
30. 
Justice AC, Braithwaite RS. Lessons learned from the first wave of aging with HIV. 
AIDS. 2012;26 Suppl 1:S11-18. 
31. 
Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, 
Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web 
communication, and pharmacist care on hypertension control: a randomized 
controlled trial. JAMA. 2008;299(24):2857-2867. 
32. 
Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-
led, American Heart Association Heart360 Web-enabled home blood pressure 
monitoring program. Circ Cardiovasc Qual Outcomes. 2013;6(2):157-163. 
33. 
Mehos BM, Saseen JJ, MacLaughlin EJ. Effect of pharmacist intervention and 
initiation of home blood pressure monitoring in patients with uncontrolled 
hypertension. Pharmacotherapy. 2000;20(11):1384-1389. 
34. 
Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, 
Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular 
Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored 
behavioral and educational pharmacist-administered intervention for achieving 
cardiovascular disease risk reduction. Telemed J E Health. 2014;20(2):135-143 
35. 
New York State Department of Health. Standards for HIV/AIDS Case Management. 
2006. Accessed on June 2, 2016. URL: 
www.health.ny.gov/diseases/aids/providers/standards/casemanagement/docs/casem
anagementstandards.pdf. 
36. 
Green EC, Murphy E, Health Belief Model. in “The Wiley Blackwell Encyclopedia of 
Health”, 2014: 766-769 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

20 
 
APPENDIX  
 
Table 1: Intervention Modules 
Timeline 
Module and Content 
Weeks 2 and 14 
CVD Risk Knowledge and Perception (High or Low Literacy) 
• Perceived risk of MI and Stroke 
• Education on CVD risk factors 
• Education on HIV as a CVD risk 
• Benefits of therapy and lifestyle changes  
• Goal setting 
Weeks 4 and 16 
Medication Reconciliation 
• Review of medications and indications  
• Education on drug interaction with ART 
• Medication side effects 
• Barriers to adherence assessment 
• Strategies to improve adherence 
Weeks 6 and 18 
Dietary Assessment and Education (High or Low Literacy) 
• Dietary habits assessment  
• Addressing portion control  
• Healthy carbohydrate intake and increase in fiber and protein 
consumption 
Weeks 8 and 20 
Physical Activity and Weight Management (High or Low Literacy) 
• Reasonable weight management goals 
• Motivational interviewing for exercise goals 
Weeks 10 and 22 
Smoking Cessation 
• Benefits of smoking cessation 
• Initiating and maintaining smoking cessation goals 
• Quitting strategies 
Weeks 12 and 24 
Stress Management 
• Education on stress and CVD risk 
• Overview of stress reduction techniques 
• Counseling on healthy sleep habits 
 
 
 
 
 
 
 
 

21 
 
Key Informant Interview Guides for PLHIV 
Introduction 
[Remind about Audio Recording and not to use real names] 
 
Thank you for talking with us today. We are interested in your thoughts and beliefs about a 
recent blood pressure and cholesterol study we tested in your HIV clinic. I am 
going to ask you some questions about the intervention to hear about your experiences and 
perspectives. Please know that there is no right or wrong answer. You will notice that I won’t 
give you a lot of feedback on your responses because I don’t want to influence your answers. 
Finally, you are under no obligation to talk about anything that you are not comfortable 
discussing with me. Do you have any questions or concerns before we begin? 
I. Intervention Characteristics  
What are your overall thoughts about the structure of the program? Was every two weeks too 
much? Could it have been less or more? Did you like the rotating format for the modules?  
What did you think about the material that was covered? Was it too simplistic or too 
complicated? Were things explained in a clear and comprehensible manner to you? Which 
modules were the most helpful? Which modules were the least helpful?  
What were the thoughts of the educational material you received? Was it helpful? What was 
most helpful? Did it come too often, would more or less have been better?  
What did you think about the platform? Did you use video-conference or telephone? Did you like 
using this platform? [Why or why not]. Do you think this program would have been much 
improved if it was done in person?  
What did you think of the interventionist (Keith)? [Tell me more] Were there any particular 
strengths? Were there things that could be improved upon?  
 
II. Program Outcomes 
A) Perceptions of Increased Knowledge 
Do you feel like you know more about conditions related to cardiovascular disease (high blood 
pressure, blood sugar/diabetes, cholesterol) as a result of participating in the program? [Tell me 
more] 
 
B) Perceptions of Increased Skill 
Are there any skills that you feel more empowered to perform as a result of the program? [Tell 
me more] 
Do you feel like you have more information to share with your relatives and friends about heart-
healthy living as a result of the program? 
 
C) Role of Identity as person living with HIV  

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Do you believe that being a person living with HIV influenced how important you regard the 
information that was presented as part of the program? 
 
D) Beliefs about newly gained capability 
Do you believe that you will have the ability to incorporate some of the heart-healthy habits you 
learned into your daily life? What will be the easiest to change? What will be the hardest. [Tell 
me more] 
 
E) Beliefs about consequences of having HIV on importance of heart health behavior 
Do you think that the habits you learned from this program will help you more because you have 
HIV? Why or why not? 
 
F) Goalsetting as a result of program participation 
Have you made any specific goals for change as a result of participating in this program? If no 
are you planning on making goals for yourself as a result of your participation?  
What are your specific goals for change as a result of participating in this program? Is it losing 
weight, lowering your blood pressure or cholesterol or just participating in more physical 
activity? [Tell me more] 
 
G) Expectations of learning recall from intervention  
Do you ever have any concerns that you will forget anything you learned during this program?  
Is the educational material we sent you helpful? What was most helpful? What was not as 
helpful? 
 
H) Emotions triggered by intervention 
Did any of the material covered in the program evoke an emotional response from you? Was it 
difficult or scary or sensitive to hear? 
 
I) Adoptability of Intervention Learnings 
Do you believe that the behaviors suggested to you for a more heart-healthy life were practical 
and attainable? 
 
Is there anything else that you would like to share with us about the program?