Clinical trial NCT02707991: Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection
Official title: Nurse Case Management to Improve Linkage to Hepatitis C Care and Treatment Initiation in HIV Co-infection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C, Chronic
Keywords: Continuity of Patient Care
Treatment Cascade
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Linked to Care
timeFrame: 60 days
Secondary outcomes:
measure: Time to Hepatitis C Treatment Initiation
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jason E Farley, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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