N/A
N=167
Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)
Hepatitis C · People Who Inject Drugs · PWID · HCV Coinfection
Bottom Line
View on ClinicalTrials.gov: NCT03214679 ↗Enrolled (actual)
167
Serious AEs
13.9%
Results posted
Feb 2023
Primary outcome: Primary: Proportion of Patients to Achieve SVR12 at 1 Year — 55; 19 Participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accessible Care (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- City University of New York, School of Public Health
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients to Achieve SVR12 at 1 Year |
55; 19 | <.001 sig |
| PRIMARY Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider |
76; 37 | — |
| PRIMARY The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit |
71; 31 | — |
| PRIMARY Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment |
71; 26 | — |
| PRIMARY Proportion of Participants in Each Arm Who Initiated Treatment |
64; 22 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03214679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.