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

Not Applicable

Completed

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

• Registration Number: NCT03214679
• Lead Sponsor: City University of New York, School of Public Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-07-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Results First Submitted: 2023-01-26
• Results First Submitted QC: 2023-01-26
• Last Update Submitted: 2023-01-26
• Results First Posted: 2023-02-22
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider	each participant will be assessed at 1 year post entry	Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months
Proportion of Patients to Achieve SVR12 at 1 Year	each participant will be assessed at 1 year post entry	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
Proportion of Participants in Each Arm Who Initiated Treatment	Each participant will be assessed 1 year post entry	Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)
The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit	end of study (12 months)	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	each participant will be assessed at 1 year post entry	Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation

Trial Locations

Locations (1)

Lower East Side Harm Reduction Center; 🇺🇸 New York, New York, United States