Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2021-06-30

Brief Summary

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The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.

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Detailed Description

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Conditions

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Hepatitis C People Who Inject Drugs PWID HCV Coinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Accessible Care

"Accessible Care" for PWID is low-threshold care provided in the needle exchange programs, where they can comfortably access services without fear of the shame or stigma that often attends them in mainstream institutions.It includes features such as an informal, nonjudgmental atmosphere, availability of walk-in appointments, and a harm reduction framework to help them identify and pursue their own personal health goals. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.

Group Type EXPERIMENTAL

Accessible Care

Intervention Type OTHER

Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.

Usual Care

Usual care represents the current process after someone tests positive for HCV antibody on site at the syringe exchange program. An on site care coordinator (not provided by study) assists with insurance and linkage to HCV medical provider at sites throughout NYC through the NYC Dept of Health Check Hep C program.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care entails referral to an on site HCV care coordinator (not provided by study)

Interventions

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Accessible Care

Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.

Intervention Type OTHER

Usual Care

Usual care entails referral to an on site HCV care coordinator (not provided by study)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 18 years or older,
2. injected heroin, cocaine, or other drugs in the past 90 days.
3. test HCV Ab and RNA positive
4. provide written consent (including consent for researchers to examine their hepatitis C medical records)

Exclusion Criteria

Persons already in care for hepatitis C, defined as having had at least 2 visits with a hepatitis treatment provider within the past 6 months, will be excluded.

People with decompensated cirrhosis will be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No