Clinical trial NCT04036760: Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
Official title: Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 Years
Secondary outcomes:
measure: 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.
timeFrame: 2 Years
measure: 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.
timeFrame: 2 Years
measure: 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.
timeFrame: 2 Years
measure: 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.
timeFrame: 2 Years
measure: Retention in care as defined as two sequential clinic ID clinic visits during 12 months
timeFrame: 2 Years
measure: Documented sustained virologic response (SVR)
timeFrame: 2 Years
measure: Documented sustained HCV cure
timeFrame: 2 Years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Benjamin Eckhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.