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

Summary

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.

Conditions

• Hepatitis C
• People Who Inject Drugs
• PWID
• HCV Coinfection

Interventions

OTHER

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.

OTHER

Usual Care

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

Sponsors & Collaborators

• National Development and Research Institutes, Inc.

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Weill Medical College of Cornell University

  collaborator OTHER

• City University of New York, School of Public Health

  lead OTHER

Principal Investigators

• Kristen Marks · Weill Medical College of Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-20

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• United States

Study Locations