Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails

This study assesses the impact of a hepatitis C care coordination program on rates of linkage to hepatitis C care following release from New York City jails. Adult patients (age 18 years and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison clinic from July 1, 2015 through December 31, 2016 will be offered participation in a transitional care coordination program. The rates of linkage of these individuals following release from jail will be compared to a historical cohort of adult patients with chronic Hepatitis C infection at the 19 North prison clinic from January 1, 2014 through June 31, 2015.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: Research transitional care coordination

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.

Description

Inclusion Criteria:

• HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.

Exclusion Criteria:

• Individuals who refuse to participate in the study when approached
• Individuals who are unable or unwilling to sign a consent form agreeing to participate. Participants must have sufficient literacy to sign their name, as written informed consent is required for study participation
• Individuals who are unable to successfully negotiate the use of a telephone interpreter if required
• Individuals who have received a sentence that extends beyond the interval of follow up (one year sentence in city jail)
• Individuals who will be moved upstate to prison directly from jail
• Individuals who die prior to discharge from Rikers Island

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care transitional care coordination
Research transitional care coordination	Behavioral: Research transitional care coordination; Though care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of adult inmates linked to care following release from jail between the period of January 1st 2014 to January 31st 2014 compared with February 1st 2015 to December 31st 2015 after the implementation of care coordination.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of those adult inmates who were successfully linked to care at Bellevue Hospital Center (BHC) during the period before and after the implementation of care coordination who subsequently had at least two visits with an HCV provider.		2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then initiated Hepatitis C Virus (HCV) treatment.		2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then went onto achieve an Sustained Virologic Response (SVR) when treated.		2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who were linked to ancillary services.		2 Years
Retention in care as defined as two sequential clinic ID clinic visits during 12 months	Number of patients who are able to retain 2 sequential visits during 12 months	2 Years
Documented sustained virologic response (SVR)	no detectable RNA in 2 years post treatment	2 Years
Documented sustained HCV cure	Showing no symptoms of HCV for 2 years	2 Years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Benjamin Eckhardt, MD, New York Langone Health

Publications and helpful links

General Publications

• Akiyama MJ, Columbus D, MacDonald R, Jordan AO, Schwartz J, Litwin AH, Eckhardt B, Carmody E. Linkage to hepatitis C care after incarceration in jail: a prospective, single arm clinical trial. BMC Infect Dis. 2019 Aug 8;19(1):703. doi: 10.1186/s12879-019-4344-1.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): December 14, 2017

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 14-02105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No