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

National Development and Research Institutes, Inc., National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University

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.

"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.

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.

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.

SVR12 is a sustained virologic response to HCV treatment defined as HCV RNA below the limit of quantification 12 weeks post completion of HCV treatment

The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit

The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.

Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation

Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)

Inclusion Criteria: 18 years or older, injected heroin, cocaine, or other drugs in the past 90 days. test HCV Ab and RNA positive 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.

Eckhardt B, Mateu-Gelabert P, Aponte-Melendez Y, Fong C, Kapadia S, Smith M, Edlin BR, Marks KM. Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial. JAMA Intern Med. 2022 May 1;182(5):494-502. doi: 10.1001/jamainternmed.2022.0170.

Aponte-Melendez Y, Mateu-Gelabert P, Fong C, Eckhardt B, Kapadia S, Marks K. The impact of COVID-19 on people who inject drugs in New York City: increased risk and decreased access to services. Harm Reduct J. 2021 Nov 24;18(1):118. doi: 10.1186/s12954-021-00568-3.