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Completed

NCT Number: NCT04036760

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 2 Years

Secondary outcomes

  1. 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.

    Time frame: 2 Years

  2. 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.

    Time frame: 2 Years

  3. 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.

    Time frame: 2 Years

  4. 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.

    Time frame: 2 Years

  5. Retention in care as defined as two sequential clinic ID clinic visits during 12 months

    Time frame: 2 Years

    Number of patients who are able to retain 2 sequential visits during 12 months

  6. Documented sustained virologic response (SVR)

    Time frame: 2 Years

    no detectable RNA in 2 years post treatment

  7. Documented sustained HCV cure

    Time frame: 2 Years

    Showing no symptoms of HCV for 2 years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 30, 2019
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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