Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/26/2018 |
| Start Date: | July 2016 |
| End Date: | November 2018 |
Nurse Case Management to Improve Linkage to Hepatitis C Care and Treatment Initiation in HIV Co-infection: A Randomized Controlled Trial
Effective all-oral medications are finally available to cure hepatitis C virus, which affects
more than 4 million Americans and one-in-four people living with HIV. However, many barriers
exist that prevent people with HIV/HCV co-infection from getting this curative treatment,
including low knowledge, competing demands, and drug interactions with HIV medications.
This study evaluates if a hepatitis C nurse case management intervention in an HIV primary
care clinic will improve patient attendance to hepatitis C care and help people start
hepatitis C treatment earlier. Half of the participants will receive brief case management
with a nurse, while the other half will receive usual clinic care.
more than 4 million Americans and one-in-four people living with HIV. However, many barriers
exist that prevent people with HIV/HCV co-infection from getting this curative treatment,
including low knowledge, competing demands, and drug interactions with HIV medications.
This study evaluates if a hepatitis C nurse case management intervention in an HIV primary
care clinic will improve patient attendance to hepatitis C care and help people start
hepatitis C treatment earlier. Half of the participants will receive brief case management
with a nurse, while the other half will receive usual clinic care.
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).
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 liver cancer. HCV can be cured, but less than half
of PLWH with chronic HCV in the U.S. have linked to HCV care, and about 7% initiated
treatment. Poor treatment initiation rates historically have been due to low efficacy among
PLWH, but HCV care now is at a turning point. The investigators have the ability to
substantially decrease HCV-related morbidity and mortality in PLWH with the availability of
effective all-oral treatment. As patients are funneled into HCV care, improving the process
of linkage 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"
often presenting no symptoms for 20 years. Knowledge about HCV and its available therapies is
also low and lags behind new advancements in HCV treatment. Competing work, school and
caregiving demands has also historically led to low motivation to engage in HCV care. 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 initiation. Up to 88% of PLWH
will need to switch their HIV treatment regimen to avoid contraindicated drug interactions.
The April 8, 2015 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 PLWH. But
modifying HIV treatment regimens can have severe negative consequences, including decreased
quality of life, increased symptom burden, and loss of viral suppression.
Interventions that both increase HCV knowledge and support HIV treatment modifications in the
setting of drug interactions are needed to improve linkage to HCV care and decrease time to
treatment initiation. In similar settings and populations, nurse case management
interventions have been shown to improve these outcomes. However, few of these interventions
have been rigorously tested in the context of HCV.
This study is a randomized, single-blinded controlled trial to test whether a nurse case
management intervention will improve the HCV treatment cascade among PLWH in an HIV primary
care setting compared to usual care.
Specifically, this study aims to:
1. Test whether a nurse case management intervention will increase linkage to the Viral
Hepatitis Clinic among persons with HIV/HCV co-infection compared to usual care;
Hypothesis: A higher proportion of those who are randomized to the intervention arm will
attend the Viral Hepatitis Clinic within 60 days of randomization compared to those who
receive 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 usual care; Hypothesis:
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 usual
care.
3. Describe the characteristics associated with uptake of HCV care among people living with
HIV, controlling for covariates; Research question 2.1: What patient-level
characteristics are associated with increased uptake of HCV care?; Research question
2.2: Compared to the known historical barriers to engaging in HCV care, what factors
continue to be associated with uptake of HCV care in the new paradigm of HCV treatment
for people living with HIV?
among the most common causes of non-AIDS related death among people living with HIV (PLWH).
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 liver cancer. HCV can be cured, but less than half
of PLWH with chronic HCV in the U.S. have linked to HCV care, and about 7% initiated
treatment. Poor treatment initiation rates historically have been due to low efficacy among
PLWH, but HCV care now is at a turning point. The investigators have the ability to
substantially decrease HCV-related morbidity and mortality in PLWH with the availability of
effective all-oral treatment. As patients are funneled into HCV care, improving the process
of linkage 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"
often presenting no symptoms for 20 years. Knowledge about HCV and its available therapies is
also low and lags behind new advancements in HCV treatment. Competing work, school and
caregiving demands has also historically led to low motivation to engage in HCV care. 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 initiation. Up to 88% of PLWH
will need to switch their HIV treatment regimen to avoid contraindicated drug interactions.
The April 8, 2015 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 PLWH. But
modifying HIV treatment regimens can have severe negative consequences, including decreased
quality of life, increased symptom burden, and loss of viral suppression.
Interventions that both increase HCV knowledge and support HIV treatment modifications in the
setting of drug interactions are needed to improve linkage to HCV care and decrease time to
treatment initiation. In similar settings and populations, nurse case management
interventions have been shown to improve these outcomes. However, few of these interventions
have been rigorously tested in the context of HCV.
This study is a randomized, single-blinded controlled trial to test whether a nurse case
management intervention will improve the HCV treatment cascade among PLWH in an HIV primary
care setting compared to usual care.
Specifically, this study aims to:
1. Test whether a nurse case management intervention will increase linkage to the Viral
Hepatitis Clinic among persons with HIV/HCV co-infection compared to usual care;
Hypothesis: A higher proportion of those who are randomized to the intervention arm will
attend the Viral Hepatitis Clinic within 60 days of randomization compared to those who
receive 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 usual care; Hypothesis:
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 usual
care.
3. Describe the characteristics associated with uptake of HCV care among people living with
HIV, controlling for covariates; Research question 2.1: What patient-level
characteristics are associated with increased uptake of HCV care?; Research question
2.2: Compared to the known historical barriers to engaging in HCV care, what factors
continue to be associated with uptake of HCV care in the new paradigm of HCV treatment
for people living with HIV?
Inclusion Criteria:
- HIV infection
- Chronic hepatitis C infection
- Did not attend a hepatitis C specialty appointment in the past year
- Able to speak English
- Current patient at the John G. Bartlett Specialty Practice at Johns Hopkins Hospital
(at least 1 visit in the past year)
Exclusion Criteria:
- Pregnancy
- Emergency medical care needed
- Unable to provide informed consent
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Jason E Farley, PhD, MPH
Phone: 443-961-7015
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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