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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036760
• Other study ID #: 14-02105
• Status: Completed
• Start date: May 2015
• Est. completion date: December 14, 2017

Study information

• Verified date: July 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 14, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Documented sustained virologic response (SVR)	no detectable RNA in 2 years post treatment	2 Years
Secondary	Documented sustained HCV cure	Showing no symptoms of HCV for 2 years	2 Years