Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection
NCT ID: NCT02707991
Last Updated: 2019-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2016-07-31
2018-08-31
Brief Summary
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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.
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Detailed Description
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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?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Enhanced Usual Care
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
No interventions assigned to this group
Nurse Case Management
Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management
Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
Interventions
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Nurse Case Management
Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Emergency medical care needed
* Unable to provide informed consent
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Jason E Farley, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C
Other Identifiers
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IRB00081068
Identifier Type: -
Identifier Source: org_study_id
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