Nurse Case Management to Improve Linkage to Hepatitis C Care and Treatment Initiation in HIV Co-infection: A Randomized Controlled Trial
Phase: NA
Conditions: HIV, Hepatitis C, Chronic
Sponsor: Johns Hopkins University

 
 
Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection 
 
NCT02707991 
 
Study Protocol 
 
May 8, 2017 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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JHM IRB - eForm A – Protocol 
1. 
Abstract 
 
Hepatitis C virus (HCV) is a leading cause of liver cancer and HCV-related liver disease is among the 
most common causes of non-AIDS related death among people living with HIV (PLWH)1,2. One quarter of 
PLWH in the U.S. are co-infected with HCV, which leads to a 3-fold increase in progression to end stage liver 
disease and hepatocellular carcinoma2-5. HCV can be cured6, but less than half of PLWH with chronic HCV in 
the U.S. have linked to HCV care, and about 7% initiated treatment7-10. Poor treatment initiation rates 
historically have been due to low efficacy among PLWH, but HCV care now is at a turning point. We have the 
ability to substantially decrease HCV-related morbidity and mortality in PLWH with the availability of effective 
all-oral treatment11. As patients are funneled into HCV care, improving the process of linking to care and 
treatment preparation related to HIV medication modifications necessary for current HCV regimens is essential 
to maximize the lifesaving potential of available therapies among PLWH. 
There are several barriers to linkage to HCV care and treatment. HCV is a “silent epidemic”12 often 
presenting no symptoms for 20 years. Thus, perceived need for treatment is low among persons infected with 
HCV10,13-16. Knowledge about HCV and its available therapies is also low and lags behind new advancements in 
HCV treatment17-20. For PLWH who are linked to HCV care, drug interactions between new HCV therapies and 
HIV treatment regimens introduce a new barrier to HCV treatment initiation21,22. Up to 88% of PLWH will need 
to switch their HIV treatment regimen to avoid contraindicated drug interactions23. The April 8, 2015 updated 
Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents emphasize the need 
to modify HIV regimens to treat HCV in many PLWH21. But modifying HIV treatment regimens can have 
severe negative consequences, including decreased quality of life, increased symptom burden, and loss of viral 
suppression24. New approaches to modifying HIV treatment regimens are now crucial to smooth the transition 
into initiating HCV therapy for PLWH. 
In similar settings and populations, nurse case management interventions have been shown to improve 
these outcomes25-31. However, few of these interventions have been rigorously tested in the context of HCV. 
Evidence supports combining existing intervention components from similar populations to improve HCV care. 
Strengths-based education25-31, patient navigation26,29,32, and reminder systems33-36 improve knowledge and 
adherence to appointments. The addition of novel nurse-initiated referral and HIV/HCV drug interaction 
coordination has never been tested, but may further improve knowledge and motivation to engage in care and 
address this important barrier for PLWH22. Therefore, it is hypothesized that nurse case management consisting 
of nurse-initiated HCV referral, strengths-based HCV education, patient navigation, appointment reminders, 
and care coordination for HIV treatment modifications will improve linkage to HCV care and treatment 
initiation among PLWH. 
 
2. 
Objectives 
 
The specific aims of the proposed RCT are to:  
 
1. 
Test whether a nurse case management intervention will increase linkage of persons with 
HIV/HCV co-infection to an HCV treatment pathway via the Viral Hepatitis Center compared to 
enhanced usual care 
H0: A higher proportion of those who are randomized to the intervention arm will attend the Viral 
Hepatitis Clinic or enroll in an HCV-treating clinical trial within 60 days of randomization 
compared to those who receive enhanced usual care. 
2. 
Determine if a nurse case management intervention will decrease time to HCV treatment 
initiation among persons with HIV/HCV co-infection compared to enhanced usual care 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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H0: Those who are randomized to the intervention arm will have a decreased time to HCV 
treatment initiation from the point of randomization compared to those who receive enhanced usual 
care. 
3.  Describe the characteristics associated with uptake of HCV care among PLWH, controlling for 
covariates. 
 
3. 
Background 
 
Linkage to HCV care among people co-infected with HIV/HCV is poor. The greatest gap in the United 
States HCV care cascade begins between diagnosis and linkage to care7,8. Only 25% of PLWH with chronic 
HCV have attended an HCV appointment, and less than half of those have ever initiated HCV treatment7-9. A 
large cohort study in Baltimore found that only 21% of injection drug users with HCV had ever seen an HCV 
specialist10. At the Johns Hopkins Moore Clinic, less than half of patients who are referred to an HCV 
specialist by their primary care provider actually attend the scheduled specialty appointment.   
The perceived threat of HCV and perceived need for HCV care among patients is low13. This perception, 
coupled with the fact that HCV is a “silent epidemic”12, places PLWH at great risk13-16. Qualitative studies 
describe that the absence of HCV-related symptoms leads to little interest in receiving HCV treatment16,18,19,37. 
This is exacerbated by a lack of knowledge about HCV and available therapies17-20; horror stories about 
interferon-related side effects and old ineffective treatments dominate conversations among peers with HCV 
despite these barriers being minimized with new all-oral therapy16,18-20. People with HCV also report low 
motivation to engage in HCV care due to competing demands from work, school or caregiving 
responsibilities13,38,39. Therefore, interventions to increase HCV knowledge and motivation, such as education, 
patient navigation, and appointment reminders are needed to improve linkage to HCV care. 
HIV-HCV drug interactions will exist for up to 88% of PLWH23. HCV treatment guidelines no longer 
separate patients with HIV/HCV co-infection from those with HCV only because cure rates are similar in both 
groups (over 90%)21. Currently, the only difference in management of HCV in PLWH is the need to manage 
drug interactions40. Patel and colleagues (2015) conducted a cross-sectional study to determine the frequency 
of contraindicated drug-drug interactions when PLWH are prescribed HCV therapy. Examination of 
medication lists revealed that the prevalence of interactions was as high as 88.4% depending on the HIV and 
HCV regimens23. Based on these results, it is likely that a large proportion of PLWH who are initiating HCV 
treatment will have to modify their HIV treatment regimen. Modifying HIV treatment regimens can take 
months and deter PLWH from starting HCV treatment24. A prior study found that HIV combination 
antiretroviral therapy (ART) modifications can negatively impact quality of life and increase HIV symptom 
burden24. Therefore, new approaches to modifying ART that minimize barriers to HCV treatment initiation are 
urgently needed to smooth the transition for PLWH. 
Interventions that increase perceived need and maximize enabling resources have the potential to 
improve the HCV care cascade for PLWH. Nurse case management (NCM) components used in similar 
contexts can be combined to achieve this improvement. Even in the era of interferon, brief HCV education 
alone significantly increased knowledge and linkage to HCV care by 14-25%25,29-31. Adding strengths-based 
NCM and care coordination improves linkage to HIV or HCV care by up to 30%26,27,29. Reminder systems 
using text and phone messages are also effective strategies to increase linkage to HIV care and substance use 
services in combination with other interventions33-36. Finally, the addition of care coordination for ART 
modification will further participants’ enabling resources and address this important new barrier for PLWH.  
 
4. 
Study Procedures 
 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 3 of 19 
 
 
The proposed study is a single blinded, randomized controlled trial. The trial will evaluate a nurse case 
management intervention and determine differences in linking to HCV care (primary aim) and time to HCV 
treatment initiation (secondary aim) among persons co-infected with HIV. Patients with HIV and chronic HCV 
infection will be recruited from the Johns Hopkins University AIDS Service (JHUAS). After informed consent, 
participants will be randomized to a standard nurse case management protocol or enhanced usual outpatient 
care (100 per group), described below. Information flyers, provider referral, and targeted mailings will be used 
for recruitment.  
 
Enrollment 
 
Patient Population/Setting:  The Bartlett Specialty Practice (formerly the Moore Clinic for HIV Care) at the 
Johns Hopkins Hospital provides HIV primary care to approximately 3500 men and women over the age of 18 
per year. The clinic serves a primarily adult, urban population, with approximately 80% of patients being 
African American. The average age of clinic patients is 49 years. Approximately 50% of patients with HIV are 
co-infected with HCV. In Maryland, HCV therapy currently must be managed by a hepatology, 
gastroenterology, or infectious disease specialist for Medicaid reimbursement41. The Viral Hepatitis Specialty 
Clinic, staffed with hepatologists and hepatitis-focused infectious disease physicians and nurse practitioners, is 
located within the Bartlett Specialty Practice. As of May 2015, 480 HIV/HCV co-infected patients at the Moore 
Clinic had never attended an appointment at the Viral Hepatitis Clinic; 90 patients never went to their scheduled 
appointments and 390 patients had never been scheduled for HCV care. In addition, a number of patients have 
not attended an appointment at the Viral Hepatitis Clinic in the era of all-oral therapy (including the past year). 
The median time between referral and available new patient appointment at the Viral Hepatitis Clinic is one 
week. 
  
Recruitment: Patients will either 1) self-refer by contacting the research team after seeing flyers posted in the 
Bartlett Specialty Practice waiting room or in an exam room research binder; 2) be referred from their HIV 
provider in clinic; 3) self-refer after receiving a targeted letter in the mail; or 4) self-refer after finding the study 
on clinicaltrials.gov, Trials @ Hopkins, or referral from the CFAR Hotline. Eligible prior study participants 
from the Principal Investigator’s SUSTAIN study (NA_00079147) who agreed to be contacted for future 
research (HIPAA form 3) will also be called. On a weekly basis, Bartlett Specialty Practice appointments will 
be reviewed electronically in EPIC to identify HIV/HCV co-infected patients scheduled for primary care visits. 
Letter notifications will be mailed to potentially eligible patients who have an upcoming appointment inviting 
them to contact the study team to participate in the research study. Daily, the primary HIV provider, registered 
nurse, or certified medical assistant will be approached to refer his or her eligible patients to the study. After the 
patient has contacted our research team to meet at the Bartlett Specialty Practice, a member of the study team 
will provide information regarding the study, answer any questions, and obtain informed consent. The PI will be 
available in person or via telephone to answer any questions when a student is present for the consent. Once 
enrolled, the study team will assign a study identification number (SIN) to the subject. This will be the primary 
mode of identification throughout the study. The SIN will appear on the consent form, the questionnaire, as well 
as all data collection forms. As part of the informed consent document, the participant will receive information 
on how to contact the investigators to discuss any of the nurse case management intervention components. 
 
Eligibility: Adults who are co-infected with HIV and HCV who have not attended an HCV-specific 
appointment in the past year will be enrolled in the proposed study. Specific eligibility requirements are detailed 
in inclusion/exclusion criteria below. 
 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 4 of 19 
 
Participant Consent: Once the participant contacts the study team through a study flyer, letter, clinical trials 
database, or provider referral, the study will be explained with an emphasis on the use of random assignment to 
study groups. The consent process will be completed in a private area of the Bartlett Specialty Practice. To 
account for low levels of literacy, the study materials have been developed on a 5th grade reading level. 
Participants will also be given the option to have the consent form read aloud in its entirety. The consent form 
will be maintained in the study files and participants will be given the option of taking a copy of the signed 
consent form with them. They will be informed that retention of the form may lead to a breach of confidentiality 
if the information is shared with someone who does not already know their HIV and/or HCV status.  
 
Assessment of Protocol Comprehension Prior to Signing Consent: After the consent form is read by the 
participant or aloud, the study team member will evaluate comprehension with three protocol-specific 
questions: 1) What are the problems we are trying to improve?; 2) How does this study plan to improve these 
problems?; 3) How will you be assigned to the different options in this study? We will deem the participant to 
have an acceptable level of comprehension based on his/her ability to answer those questions.  
 
Allocation: This RCT will be conducted and reported following the CONSORT clinical trial guidelines. The 
study design is pictured in Figure 1. After recruitment and informed consent, patients will be randomized to the 
nurse case management intervention group or to the usual care group electronically. Participants will be 
randomized in a 1:1 fashion using REDCap, a secure online data collection program, to ensure balanced, 
random assignment to the intervention and usual care groups. REDCap employs a simple randomization 
technique. This strategy will ensure that the study team has no a priori knowledge of group assignment when 
enrolling and randomizing study participants.  
 
Blinding: The study allocation will be single-blinded; no direct communication will occur between the nurse 
case manager and the HCV provider to avoid influencing the HCV management of the patient. The intervention 
will support the HIV provider and patient without influencing the HCV provider’s decisions. The study team 
member completing data collection for the study outcomes will also be blinded to randomization to minimize 
bias in the results.   
 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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Figure 1. Integrated study flow and conceptual framework  
 
*HCV=hepatitis C virus; NCM=nurse case management; ART=HIV antiretroviral therapy 
 
 
Data Collection Measures:  
 
The baseline characteristics questionnaire used in the proposed study has been thoroughly evaluated 
with over 1000 subjects (over 50% with HIV). The current study team has used this questionnaire with study 
participants in the Moore Clinic42. Questions have been added or removed as applicable to this study and patient 
population. If a participant reports any alcohol use in the past 6 months on the questionnaire, the Alcohol Use 
Disorders Identification Test (AUDIT) will also be administered43. The AUDIT consists of 10 items about 
recent alcohol use, alcohol dependence, symptoms, and alcohol-related problems. It was first developed in 1989 
and has been validated in diverse international samples. The internal consistency reliability has been reported at 
0.8344 to the mid-0.90s43. In a primary care setting, the AUDIT is intended to be administered by a nurse or 
social worker43, and will be administered by a registered nurse in the proposed study. The research nurse case 
manager will counsel participants abut alcohol use according to the recommended actions of the World Health 
Organization based on the individual AUDIT score. Participants scoring in Zone IV, suggesting alcohol 
dependence, will be referred to their Bartlett Specialty Practice social worker to discuss further counseling and 
treatment options.  
The 19-item Brief Hepatitis C Knowledge Scale (Cronbach’s α=0.87) will also be administered to 
measure baseline HCV knowledge45. The Brief HCV Knowledge Scale includes a comprehensive list of items 
in its single factor that address the main aspects of HCV knowledge: prevention, risk reduction, transmission, 
and treatment. It was designed and tested on a diverse sample of patients, health care workers, and students with 
different socioeconomic and demographic backgrounds. It uses a simple true/false/don’t know scoring system.  
Depression can be associated with engagement in health services; therefore, the Patient Health 
Questionnaire (PHQ-9) will be administered. The PHQ-9 will be scored immediately. Participants scoring 10-
19, indicating moderate depression, will be referred to their primary care provider for further follow up. Those 
Patients with 
HIV/HCV 
Co-infection 
Usual Care 
Aim 1: Test whether a nurse case management intervention will 
increase linkage of persons with HIV/HCV co-infection to the 
Viral Hepatitis Clinic compared to enhanced usual care 
Primary 
Outcome:  
Linked to 
HCV care 
Randomization 
Predisposing 
characteristics 
Race, age, 
sex, 
substance use 
Enabling 
resources 
Referral, 
education, 
navigation, 
reminders 
Perceived 
Need 
HCV 
knowledge 
Linked to 
health 
services 
AIMS 
DESIGN 
FRAMEWORK 
NCM Phase 1: 
Linking 
-HCV Referral 
-Education 
-Navigation 
-Reminders 
Defer: 
Usual care 
and 
Intervention 
NCM Phase 2: 
Initiation 
Treatment 
preparation & 
Coordination 
Treatment 
Decision 
Secondary 
Outcome: 
Time to 
HCV 
treatment 
initiation 
Start 
Aim 2: Determine if a nurse case management 
intervention will decrease time to HCV treatment 
initiation compared to usual care among those who have 
been linked to HCV care and decide to start HCV 
treatment 
Actual Need 
Liver disease 
stage 
Enabling 
resource 
NCM treatment 
preparation 
Use of 
health 
services 
Usual Care 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 6 of 19 
 
with scores of 20 or greater (severe) will be referred to their primary provider, or, if the primary provider is not 
available, the covering urgent provider of the day, for further evaluation before the study is continued. 
All questions in the protocol will be asked in a private area and can be administered by a study team 
member in 30-45 minutes. In addition to the subject questionnaire, each instrument contains a section for the 
research team to interrogate the patient’s medical record to verify specific pieces of the medical history. These 
variables of interest include: 
• CD4+ T cell count 
• HIV viral load 
• Prescribed HIV treatment 
• Year of HCV diagnosis 
• HCV RNA 
• Fibrosis score 
• HCV genotype 
• HCV referral history 
• HCV appointment history 
• HCV treatment initiation barriers 
• Hopkins appointment no-show rate 
 
In addition to baseline and outcome data collection, monthly activity logs will be collected for each 
study participant, independent of allocated study arm. The type, quantity, and content of all encounters with a 
study participant in the Johns Hopkins system will be recorded each month, including nurse visits. This will 
define usual care for Bartlett Specialty Practice patients. The type, quantity, and content of all Care2Cure study 
visits will also be recorded to define the dose of the intervention. Data will be collected from the study 
participant’s Epic record and the interventionist’s notes.  
 
Enhanced Usual Care: After randomization into the enhanced usual care arm, the nurse case manager will 
provide participants with the CDC HCV Fact Sheet46 and phone number for the CFAR Research Study Hotline. 
Participants will then be referred to the usual clinic appointment check-out process. To check-out of Bartlett 
Specialty Practice appointments, participants return to the front desk with a paper billing page and printed 
appointment referrals if applicable. The administrative staff closes the appointment encounter and gives the 
patient the phone number for the Johns Hopkins Hospital central scheduling phone line to schedule referral-
based appointments. Patients are responsible for calling central scheduling to set up the specialty appointment. 
If an appointment is scheduled, all patients receive an automated appointment reminder call 2 days before the 
scheduled appointment from Johns Hopkins Hospital. Patients at the Bartlett Specialty Practice have access to 
nurse case managers and social workers assigned by their primary providers. Participants in the enhanced usual 
care arm will continue to have usual access to these services. Per the Bartlett Specialty Practice standard care 
protocol, once a prescription is written for HCV treatment, the assigned nurse case manager will work with the 
patient to coordinate HCV care; however, HIV nurse case managers are not directly involved in HCV care until 
after prescription for HCV treatment is written, which is the gap the proposed study seeks to fill. 
  
Nurse Case Management Intervention Phase 1 – Linking to Care:  
  
 
Following informed consent, randomization, and completion of the baseline questionnaire, participants 
allocated to the intervention group will receive the first phase of the nurse case management (NCM) 
intervention (Table 1). This phase of the intervention will increase linkage to HCV care through NCM 
consisting of nurse-initiated referral, strengths-based HCV education, patient navigation, and HCV appointment 
reminders. The research nurse case manager will initiate an HCV referral for participants randomized to the 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 7 of 19 
 
intervention group via the electronic health record. This will send a cue to the HIV provider to approve the 
referral and minimize the barrier of non-referral by the provider. Participants will then receive brief strengths-
based HCV education47. Strengths-based education can improve knowledge and motivation to achieve health-
related goals in PLWH26,27,47. The research nurse case manager will help participants identify their strengths 
within the context of engaging in HCV care, including social support and engagement in HIV primary care48-50. 
HCV education will include transmission, symptoms, treatment, and risk reduction. Participants will also 
identify barriers to linkage to care and form a plan with the research nurse case manager to minimize these 
barriers; this may include referrals to benefits counseling, substance use, mental health services, and the Johns 
Hopkins “Cure Club” HCV support group51.  
Linkage to care will be defined as attendance at one or more appointment within the HCV treatment 
pathway via the Viral Hepatitis Center, including either traditional clinical care at the Bartlett Specialty Practice 
or an HCV treatment-providing clinical trial within the Viral Hepatitis Center. This will ensure that participants 
enrolled in the Care2Cure study have the opportunity to engage in HCV treatment in all pathways offered by the 
Viral Hepatitis Center and inherent in Johns Hopkins Hospital’s standard of care as an academic institution and 
research center. Independent of randomization allocation, all study participants will be asked in the baseline 
characteristic questionnaire if he/she would like to be referred to a clinical trial, with the option to refuse or opt 
out of trials for non-FDA approved treatments. Based on this participant preference, eligibility for actively 
recruiting clinical trials at the Viral Hepatitis Center will be assessed. Participants will then be referred by the 
study nurse case manager to either traditional care at the Bartlett Specialty Practice, a clinical trial with no 
investigational drug, or a clinical trial with an investigational drug, as eligible and available. 
Multiple strengths support this approach to the outcome of linkage to care. In Maryland, patients must 
have a Metavir score greater than or equal to 2 to receive HCV treatment (Maryland Department of Health and 
Mental Hygiene, 2015). Linking patients to clinical trials that offer treatment to patients in all stages of liver 
disease, including F0 and F1, removes this barrier to treatment. This approach also minimizes selection bias. 
Participants who choose to receive HCV treatment through a trial may be different than those who seek care 
through the traditional clinical pathway; the Care2Cure study will include both.  
Because appointment scheduling is a known barrier to linkage to care, patient navigation will include 
either a) calling central scheduling during the visit so the research nurse case manager can navigate participants 
through the Viral Hepatitis Clinic scheduling process17,20,52 or b) calling a clinical trial recruitment number to 
link eligible participants with an HCV-treating clinical trial. Participants also will be encouraged to call the 
Care2Cure research nurse case manager for needs relating to linking to HCV care throughout the study period. 
All contacts and amount of time spent with the study participants will be recorded by the research nurse. 
Participants will receive a personalized HCV appointment reminder in addition to the automated phone 
reminder all patients receive through the Johns Hopkins Hospital usual care system. A plan for contacting 
participants for personalized appointment reminder will be made, including the best mode of contact (phone, 
text, or email) and time of day. Participants will be contacted 1 day before their scheduled Viral Hepatitis 
Center appointment (either at the Bartlett Specialty Practice or a clinical trial) for an appointment reminder in 
addition to the automated JHH reminder 2 days before the appointment53. If the scheduled Viral Hepatitis 
Center appointment is greater or equal to 2 weeks (10 business days) from the date of the baseline visit, 
participants will also be contacted one week before the appointment for a reminder.  
The medical record will be reviewed 60 days after the baseline visit to verify whether the participant 
was registered for one or more Viral Hepatitis Clinic appointment since randomization if referred to the Bartlett 
Specialty Practice HCV provider. If the participant was referred to a clinical trial, attendance at a study 
appointment will be confirmed with that study coordinator. 
 
Nurse Case Management Intervention Phase 2 – Treatment Initiation: 
 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 8 of 19 
 
 
 This phase of the intervention will decrease time to HCV treatment initiation by using a nurse case 
manager to coordinate communication about antiretroviral therapy (ART) modifications between the patient, 
HCV provider documentation, and HIV provider. Participants who are enrolled in another clinical trial will not 
be included in this phase. Participants in clinical trials that provide medication (such as the CHAMPS study or 
an investigational drug trial) will receive an intervention to initiate HCV treatment within that trial. These 
participants are expected to follow a different timeline than clinical patients and face different challenges. 
Therefore, this phase will include a subgroup of consented Care2Cure study participants who link to an 
appointment at the Bartlett Specialty Practice HCV provider. 
 
After the participant attends the Viral Hepatitis appointment, the research nurse case manager will 
review the HCV provider’s note in the electronic medical record to determine what decision was made about 
initiating HCV treatment (defer or start). This phase will be single-blinded; no direct communication will occur 
between the research team and the HCV provider to avoid influencing the HCV management of the patient. The 
intervention will support the HIV provider and patient without influencing the HCV provider’s decisions. Using 
a Phase 2 Algorithm, the research nurse case manager will identify participants who have a decision to start 
treatment indicated in the HCV visit note. The anticipated HCV therapy regimen(s) in the clinic note will be 
assessed for potential drug-drug interactions with the participants’ current ART regimen. If a modification in 
ART is indicated because a contraindicated drug-drug interaction exists, the research nurse case manager will 
contact the participant via his/her preferred contact method to schedule a follow-up NCM visit. At this visit, the 
participant will be given a modified one-page drug interaction sheet tailored to his/her ART regimen. The 
research nurse case manager will also send a secure email to the participant’s HIV provider notifying him/her of 
the potential need for ART modification. This email will include the latest DHHS “Concomitant Use of 
Selected HIV Drugs and FDA-Approved HCV Drugs for Treatment of HCV in HIV-Infected Adults” table 12. 
The table will serve as a decision-making aid for the HIV provider to modify the ART regimen if needed. The 
research nurse case manager will coordinate an ART modification appointment with the participant’s primary 
HIV provider as needed so the patient does not wait the usual 3 to 6 months until his or her next scheduled HIV 
primary care visit. 
 
To measure the effectiveness of NCM Phase 2, the electronic medical record will be reviewed 6 months 
after the enrollment visit. The study team will record whether a change in ART was made during the study 
period (yes/no). We will also determine if a prescription for HCV therapy was written during the study period, 
and the time to initiation of that prescribed treatment. The 6-month period for final data collection should be 
adequate to account for the various steps in HCV treatment preparation among PLWH: 1) linkage to care; 2) 
ART modification as needed; 3) rechecking the HIV viral load 4 to 8 weeks after modification to ensure viral 
suppression on new regimen21; 4) HCV-related blood tests and imaging, and 5) uncontrollable factors such as 
appointment cancellations, rescheduling, and reimbursement. 
 
Table 1. Nurse Case Management Intervention and Study Visit Schedule 
 
Enrollment 
Before 
HCV 
appt. 
HCV 
appt. 
NCM 
visit 
ART 
change 
appt.a 
6 months  
Administrative and Data Collection Procedures 
Informed Consent 
X 
 
 
 
 
 
Baseline questionnaire 
X 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
Medical record abstraction: Linkage to care 
 
 
X 
 
 
 
Medical record abstraction: Treatment 
initiation 
 
 
 
 
 
X 
Exit Interview 
 
 
 
 
 
X 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 9 of 19 
 
 
X=all participants; I=intervention arm only; appt.= appointment; NCM=nurse case management; aART change 
appointment with HIV provider; bParticipants will be encouraged to call the research nurse case manager for 
needs relating to linking to HCV care and initiating HCV treatment; cAppointment reminders will occur 1 day 
and 1 week (if applicable) before HCV appointment; dIncludes participants from Phase 1 who link to an HCV 
provider only 
 
Exit Interview (Intervention and Control Participants):  
 
 
At the time of the 6-month medical record review to evaluate the study outcomes, participants in 
both groups will be called by a study team member other than the research nurse case manager to complete an 
exit interview. The purpose of this interview is to identify barriers that participants in both groups encountered 
in linking to HCV care and initiating therapy during the study period, as well as to measure the intervention 
group’s  perception of the content, quality, and quantity of the intervention delivered by the research nurse case 
manager. This interview will also help to explain the acceptability and of the intervention as well as its success 
or failure among patients in the intervention group. 
 
Participants will be asked to answer a short survey with the opportunity to provide an open-ended 
response to explain their answer or give additional feedback about the intervention and participation in the 
study. A separate survey will be given to the control and intervention groups. The Nurse Case Management 
group will be asked about overall feedback about participation in the study, barriers to linking to HCV care and 
treatment initiation, and evaluation of the interventionist. The Enhanced Usual Care group will receive the same 
questions about overall feedback and barriers, but without the evaluation of the interventionist questions, so that 
comparisons can be made between the two groups about satisfaction with participation in the study and barriers 
to linking to and engaging in HCV care. 
 
Study Timeline 
 
The following 3-year study timeline provides an overview of the study preparation period, enrollment 
and follow-up (Table 2).    
 
Table 2: Timeline 
Year  
First 6 
months 
Second 6 
months 
Year 2 
Year 3 
Task 
Preparation 
Enrollment 
Enrollment 
Follow-Up 
IRB Process 
 
 
 
 
Identify/Train Research Assistants 
 
 
 
 
Recruitment/Informed 
Consent/Screening 
 
 
 
 
NCM Intervention and Study Visits  
 
 
 
 
Medical Record Review of Outcomes  
 
 
 
 
NCM Phase 1: Linking to Care 
Nurse-initiated Referral 
I 
 
 
 
 
 
Strengths-Based Education25,26,28-31,53 
I 
 
 
 
 
 
Patient Navigation26,29,32 
I 
Ib 
 
 
 
 
Appointment Reminders33-36 
 
Ic 
 
 
 
 
NCM Phase 2: Treatment Initiationd 
Care Coordination of ART Modification22,23,51 
 
 
I 
I 
I 
 

Date:  May 8, 2017 
Principal Investigator: Jason Farley, PhD, MPH, NP 
Application Number: IRB00081068 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 10 of 19 
 
Data Entry and Statistical Analysis 
 
 
 
 
Present at Meetings and Publish Data 
 
 
 
 
 
Study Duration: Final data collection for each participant will occur 6 months after the date of enrollment 
(Table 1). Participants will be asked to complete a maximum of two study visits. Participants in both groups 
will have a baseline study visit consisting of informed consent, baseline questionnaire, and medical record 
review. Participants in the enhanced usual care group will receive the CDC HCV Fact Sheet at this time and 
require no further follow-up visits. Participants in the NCM intervention group will receive intervention Phase 1 
at the time of the baseline visit. A second visit will occur for participants in the intervention group who are 
included in Phase 2 after 60 days to coordinate ART modifications with the nurse case manager, as described 
under Phase 2 – Treatment Initiation above. After 6 months, the study team will review the medical record for 
final data collection. Participants will be contacted via their preferred method at 6 months to respond to an exit 
survey, which may take place over the phone. 
 
5. 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
 
• HIV infection: This study is examining linkage to HCV care and treatment, with a focus on ART 
modifications among people living with HIV; therefore, participants must have an HIV diagnosis. 
People with HIV have a different, accelerated HCV disease course than those with HCV only. People 
with HIV also have different levels of engagement in healthcare and resources to attend healthcare than 
the general population due to Ryan White policies. Finally, barriers to engaging in HCV care historically 
have been different among people with HIV due to particularly low efficacy of HCV treatment options. 
• Chronic HCV infection: This study aims to improve linkage to HCV care and treatment in those who 
need it; therefore, all participants must be chronically infected with HCV. Acute HCV infection is not 
included in this study because its management and the treatment course are vastly different.  
• Age 18+: Most HIV-positive patients at the Bartlett Specialty Practice are over the age of 25 years. 
Children under the age of 18 years will not be included because management of HCV is different in this 
population, who does not receive care at the historical Moore Clinic. 
• Did not attend appointment with a viral hepatitis provider at Viral Hepatitis Clinic/Bartlett Specialty 
Practice in past year: The primary goal of this study is to improve linkage to HCV care among those 
who are not engaged in care; therefore, anyone who has not had a visit at the HCV clinic in the past 1 
year will be considered not linked to care because they have not been assessed by an HCV-specific 
provider in the all-oral era of HCV treatment. 
• Ability to speak English: The study team has limited resources to create study materials and provide the 
nurse case management intervention in multiple languages. The clinic population is primarily African 
American and Caucasian patients, with few patients speaking no English. 
• At least one visit at the Moore HIV Clinic or Bartlett Specialty Practice in the past year: This study aims 
to test an intervention that can be used in an HIV primary care clinic setting. Participants will be 
recruited from their regularly scheduled HIV clinic appointments; therefore, those who have been to the 
clinic in the past year will be considered active clinic patients.  
 
Exclusion Criteria 
 
• Pregnancy: Women who are pregnant will be excluded from this study because treatment of pregnant 
women with direct acting antivirals and/or ribavirin is not recommended.  

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• Emergency medical care needed: If a potentially eligible patient requires emergency medical care at the 
time of the HIV clinic appointment, the study team will not enroll this patient in the study so that the 
patient can receive necessary care. The patient will be able to contact the study team at a later date if 
interested in the study. 
• Unable to provide informed consent: Patients who are independently unable to provide informed consent 
will be excluded from this study to minimize the risk of coercion by the study team or other third parties. 
 
 
6. 
Drugs/ Substances/ Devices 
 
N/A 
 
7. 
Study Statistics 
 
Analysis: 
 
Data will be cleaned and efforts made to minimize the effects of missing data. All provider visits at 
Johns Hopkins are registered in the electronic medical record, so absence of a registered appointment during the 
study period will be considered non-attendance for the primary outcome variable. A computer-based data 
collection method will be used for data collection of independent variables in attempt to minimize missing data. 
Exploratory and descriptive analysis will be completed for all study variables. Variables will be tested for 
normality and examined with means and standard deviations or medians and interquartile ranges accordingly. 
Baseline characteristics comparing the two groups (usual care vs. intervention) will be assessed. Any 
differences between the groups will be adjusted for in further analysis. The significance level will be set at 0.05. 
All tests will be two-tailed and analyzed by intention-to-treat. 
 
Primary Outcome: The primary outcome is linkage to care, measured by attendance at the Viral Hepatitis 
Center (either traditional care or an HCV-treating clinical trial) within 60 days of randomization (yes/no). This 
hypothesis will be tested using a two-sample z-test for the difference in independent proportions comparing the 
intervention to usual care groups.  
 
Secondary Outcome: The secondary outcome is time to HCV treatment initiation, measured by the number of 
days from randomization to the date HCV treatment is initiated according to the medical record. Kaplan Meier 
estimates will be conducted to compare time to HCV treatment initiation between participants in the 
intervention group and the usual care group, and a log-rank test will be used to test the difference. Covariates 
(age, sex, race/ethnicity, HCV knowledge, substance use, fibrosis score, CD4+ T cell count, HIV viral load, 
care giving responsibilities, and participation in Cure Club) will be included in the Cox regression model. To 
account for a time to treatment initiation greater than the observed time period of 6 months, right censoring will 
be implemented for participants who have not initiated HCV treatment at the end of the 6-month period. 
 
Exploratory Analysis: Binary logistic regression will be used to determine an effect on linkage to care 
controlling for differences in age, sex, race/ethnicity, HCV knowledge, substance use, fibrosis score, CD4+ T 
cell count, HIV viral load, care giving responsibilities, and participation in Cure Club. A correlation matrix will 
be used to assess multicollinearity of the independent variables, and those with a correlation of greater than 0.6 
will be considered for removal from the model. The remaining covariates will be entered into the model first, 
followed by the independent variable of interest (intervention vs. usual care). To evaluate how much predictive 

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power was added to the model by adding the variable(s) of interest, the change in likelihood ratio test will be 
evaluated54. 
 
Exit Interview: Descriptive statistics will be used to examine the overall satisfaction of participants in the 
study. One-way frequency analysis will describe the intervention group’s perceptions of the intervention and the 
interventionist to inform future studies. Participant responses to the barriers to linking to HCV care and 
initiating therapy will be grouped into categories and compared between the intervention and control group 
using a categorical Chi-Square test to determine if there is any difference in quantity and category of barriers to 
accessing care. 
 
Sample Size Justification:  
 
Currently, 40% of new Viral Hepatitis Clinic appointments are attended by patients. Based on prior 
studies testing the intervention components in similar populations, including persons living with HIV and/or 
substance use disorders, it is expected that the intervention will improve the primary outcome of linkage to care 
by 18-30%26,53. Although the effect size is not known in the context of HCV, we estimate an improvement in 
linkage of 20% (i.e., 60% attendance [0.60] in the NCM group compared to 40% attendance [0.40] in the usual 
care group) based on these prior studies. Using these figures and a two-tailed test with an alpha of 0.05, a 
conservative estimate of the total sample size required to achieve 80% power is 97 per group, or a total of 194 
participants (G*Power 3.1.9.2). With a sample size of 100 participants in each group, there should be an 
adequate number of participants to detect a difference in proportion of linkage to care for the primary aim.  
For Phase 2, participants with successful linkage to clinical care from Phase 1 (those who attend ≥1 
appointment at the Viral Hepatitis Clinic within 60 days) will be included. Therefore, the eligible sample size 
will be less than 40-60% of the original sample size because a linkage to care proportion of 0.40-0.60 is 
expected, and some participants will link to a clinical trial and not be included in this outcome  This is a 
secondary outcome and estimated effect size is unknown. However, with 100 participants in this group (half of 
the total sample size), we will have 90% power to detect a hazard ratio of 2.  
 
 
8. 
Risks 
 
Potential Risks: 
 
Potential risks of this study include loss of confidentiality, time involvement, fatigue, distress, and 
embarrassment because of the nature of some of the questions. There are no physical risks to participants who 
receive the nurse case management intervention. All participants will be informed about the potential risks of 
participating.  
Questioning participants about socially stigmatized conditions accompanied by low level of knowledge 
among the general population, such as HIV and HCV, is sensitive. There is a risk that a participant is not aware 
of his or her HCV diagnosis at the time of enrollment; however, participants will be told about the study by 
their primary HIV provider or self-referred from study flyers that list current chronic HCV infection in the 
eligibility criteria. Therefore, it is unlikely that a participant will be unaware of an HCV diagnosis at the time of 
study enrollment. While learning about HCV and HCV-related liver disease may be distressing to participants, 
studies evaluating HCV educational interventions have not reported any negative effects of providing HCV 
education to persons with chronic HCV and have demonstrated that HCV education improved patient 
outcomes33-35.  The research nurse case manager will emphasize participants’ strengths, benefits of HCV 
treatment, and HCV cure. The study’s research nurse also has experience providing education about HCV to 

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newly diagnosed patients. In the event that participants become distressed or uncomfortable during a study visit, 
the study team will stop the study and the participants’ primary HIV provider will be called to assess the 
participant. Participants will be allowed to withdraw from the study at any time.  
Initiating a discussion about drug interactions and the need to make modifications to an ART regimen 
could turn participants away from HCV care if they do not want to make a modification. However, the purpose 
of this intervention is to foster a supportive environment to make these modifications easier for the patient. 
Participants would eventually be approached by the HCV or HIV provider with the need for ART modification 
regardless of participation in this study in order to initiate HCV therapy; therefore, this study is not expected to 
generate any additional risks of distress or loss to follow-up than usual care, and may decrease distress 
associated with this process due to supportive and timely care coordination. 
 
Protection against Risks: 
 
All study team members will continue to comply with Johns Hopkins and federal human subjects 
research requirements. All participants will be informed about the potential risks in participating and notified 
that they can withdraw from the study at any time without penalty.  
 
Confidentiality: After participants have completed the necessary consent process and have agreed to 
enrollment, they will be assigned a unique study identification number. This number will be used to label all 
study documents. A key for linking participants with their IDs will be necessary to access and link appropriate 
medical records data to the study ID number. This list will be kept separately from all other study materials in a 
locked cabinet in a locked office in the School of Nursing. Participants’ names will not appear on any records or 
data collection forms. 
As noted, all research information will be kept in locked cabinets, in a secure locked office in the School 
of Nursing. Access to identifying information will be limited to the approved study team. Participants will be 
advised of the precautions that will be taken to preserve confidentiality during the consent process. Data with 
identifiers will not be permitted outside of the Johns Hopkins campus.  
All de-identified data collected from study questionnaires and medical record abstraction will be entered 
into a password protected and encrypted data management system known as REDCap (Research Electronic 
Data Capture)62. This is a university developed system that will allow direct online data capture into a password 
protected, secured server at Johns Hopkins The development of the database and security of the data and storage 
are supported by The Johns Hopkins University School of Public Health, a REDCap Consortium member. The 
database also will provide a reminder system for data entry, facilitate accurate data collection, and ensure 
confidence in data integrity.   
 
Data Security: The REDCap application is hosted on servers administered by the Data Informatics Services 
Core (DISC) of the Johns Hopkins Biostatistics Center (JHBC). The JHBC servers are protected by both a 
hardware firewall and a web application firewall. In addition, they have multi-level intrusion detection, network 
security audits, and secondary hardware on standby for immediate replacement. JHBC administrators connect to 
the REDCap servers for system administration using a VPN connection and a two-factor authentication method. 
All data transmitted between the client browser and REDCap web servers are encrypted using an SSL 
connection. JHBC system administrators regularly monitor server logs and services to ensure that the servers 
are secured. To access the REDCap website, all users of the REDCap system must have a valid username and 
password which is generated and maintained by the JHBC administrators on the REDCap server. Each user 
account has rights that can be granted or denied including: data import, data export, data comparison, data 
logging, file repository access, user rights assignment, data access groups assignment, lock/unlock records, and 
super user. In addition, they can be granted read, edit or no data entry rights for each data entry form.  

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Participant Distress: All study visits will take place in private areas within the Bartlett Specialty Practice. 
Procedures for asking sensitive questions have been developed for previous research by Dr. Farley and Dr. 
Sulkowski with this population.  Distress is unlikely, but may arise during the survey or education; in the case 
that a participant becomes distressed during a study visit, the research nurse’s experience providing care to this 
population will allow her to effectively approach any such situations. In addition, the participant’s HIV primary 
provider will be available, since recruitment takes place during a regular visit. Further support will be provided 
by the PI and Co-PI, who are clinicians active in clinical care of people living with HIV and HCV. The study 
team will be available to participants by phone or email in case participants have further questions or concerns. 
 
Plan for Reporting Unanticipated Problems or Study Deviations 
 
Data Safety and Monitoring Plan: A group of designated Johns Hopkins faculty will have responsibility for 
monitoring and oversight of protocol events for this research. This includes Laura Gitlin, PhD (School of 
Nursing), Mark Sulkowski, MD (School of Medicine), Chakra Budthathoki, PhD (School of Nursing), and 
Haera Han, PhD, RN (School of Nursing). The study team will meet biweekly to review recruitment progress, 
any issues related to data collection, and to ensure that all concerns related to intervention delivery are handled 
appropriately. Any unanticipated problems or study deviations will be reported to Dr. Farley immediately. If 
there is any concern raised by a participant that the study team cannot address, assistance will be sought through 
the Institutional Review Board.  
 
 
9. 
Benefits 
 
There may be no direct benefit to the subjects in this study; however, information obtained in this study 
may inform research and practice so that the most effective linkage to care and treatment approach is integrated 
into the care of this population to decrease morbidity and mortality related to HIV/HCV co-infection. Given the 
interaction with participants, it is possible that a participant may benefit from more timely evaluation and/or 
treatment of HCV.  
 
10. 
Payment and Remuneration 
 
Enrolled participants in both the enhanced usual care and intervention groups will receive a $20.00 gift 
card after completion of the baseline study visit. We will offer a second gift card of $20.00 to participants in the 
intervention arm on completion of the phase 2 nurse case management visit. 
 
11. 
Costs 
 
There are no direct costs to the patient in this study. 
 
 

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