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

NCT04036760 | Completed

• 1 other identifier: 14-02105
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  2 Years

Study Arms (2)

Standard of Care transitional care coordination

Research transitional care coordination

Behavioral: Research transitional care coordination

Interventions

Research transitional care coordination BEHAVIORAL

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.

Research transitional care coordination

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 31395019 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Benjamin Eckhardt, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 30, 2019
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: December 14, 2017
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)