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

Completed

• Conditions: Hepatitis C
• Interventions: Behavioral: Research transitional care coordination

• Registration Number: NCT04036760
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2017-04
• Study Completion: 2017-12-14
• Status Verified: 2019-07
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-29
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Research transitional care coordination	Research transitional care coordination	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Retention in care as defined as two sequential clinic ID clinic visits during 12 months	2 Years	Number of patients who are able to retain 2 sequential visits during 12 months
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 were linked to ancillary services.	2 Years
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 went onto achieve an Sustained Virologic Response (SVR) when treated.	2 Years
Documented sustained virologic response (SVR)	2 Years	no detectable RNA in 2 years post treatment
Documented sustained HCV cure	2 Years	Showing no symptoms of HCV for 2 years

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States