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

City University of New York, School of Public Health

Status: Completed

Conditions: PWID; Hepatitis C; People Who Inject Drugs; HCV Coinfection

Treatments: Other: Usual Care; Other: Accessible Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03214679

R01DA041298 (U.S. NIH Grant/Contract)

1612017838A001

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

167 participants in 2 patient groups

Accessible Care

Experimental group

Description:

"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.

Treatment:

Other: Accessible Care

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care