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

NCT ID: NCT04036760

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-14

Brief Summary

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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

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard of Care transitional care coordination

No interventions assigned to this group

Research transitional care coordination

Research transitional care coordination

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Eckhardt, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31395019 (View on PubMed)

Other Identifiers

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14-02105

Identifier Type: -

Identifier Source: org_study_id