Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection

NCT02707991 | Completed Results DMC

• 1 other identifier: IRB00081068
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Hepatitis C, Chronic

Keywords

Continuity of Patient Care; Treatment Cascade

Outcome Measures

Primary Outcomes (1)

• Number of Participants Linked to Care

  This will be assessed based on the number of participants who attend an appointment at the Viral Hepatitis Clinic within 60 days of enrolling in the study. A participant is considered "linked to care" if he/she attends an appointment at the clinic. A participant is considered "not linked to care" if he/she does not attend an appointment at the clinic. Whether a participant linked to care will be determined by looking at the medical record, where all attended appointments are documented. If no attended appointment is documented, this will be considered non-attendance/not linked to care.

  60 days

Secondary Outcomes (1)

• Time to Hepatitis C Treatment Initiation

  6 months

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet

Nurse Case Management

EXPERIMENTAL

Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention

Behavioral: Nurse Case Management

Interventions

Nurse Case Management BEHAVIORAL

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.

Also known as: Care Coordination

Nurse Case Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• Emergency medical care needed
• Unable to provide informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (25)

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Related Links

• AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Starbird
• Organization: Johns Hopkins University

Lstarbi1@jhu.edu

9787587909

Study Officials

• Jason E Farley, PhD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 15, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 2, 2019
• Results First Posted: May 2, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)