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

Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in HCV Care

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HCV Coinfection; People Who Inject Drugs; PWID
• Intervention / Treatment: Other: Accessible Care; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Lower East Side Harm Reduction Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accessible Care; "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.	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.
Active Comparator: Usual Care; 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.	Other: Usual Care; Usual care entails referral to an on site HCV care coordinator (not provided by study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients to Achieve SVR12 at 1 Year	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	each participant will be assessed at 1 year post entry
Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider	Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months	each participant will be assessed at 1 year post entry
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.	end of study (12 months)
Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment	Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation	each participant will be assessed at 1 year post entry
Proportion of Participants in Each Arm Who Initiated Treatment	Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)	Each participant will be assessed 1 year post entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with Hepatitis C treatment engagement at 3 months	The proportion of participants in each arm who (a) affirm a desire for hepatitis C treatment, (b) attend an initial visit with a hepatitis treatment provider, (c) complete a medical evaluation for antiviral treatment, including a history, physical examination,and laboratory evaluation, and (d) attend two visits with a hepatitis C treatment provider within 3 months of randomization.	each participant will be assessed 3 months post entry
Proportion of participants with antiviral treatment initiation at 3 months	Antiviral treatment initiation will be defined as taking the first dose of antiviral medication within 3 months of randomization	each participant will be assessed at 3 months post entry

Other Outcome Measures

Outcome Measure	Time Frame
Cost	1 year
Proportion of treated patients with Reinfection at 1 year	each participant will be assessed at 1 year post entry
Proportion of patients with Substance use Treatment Entry and Retention at 1 year	each participant will be assessed at 1 year post entry

Collaborators and Investigators

• Sponsor: City University of New York, School of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA); Weill Medical College of Cornell University; National Development and Research Institutes, Inc.
• Investigators: Principal Investigator: Kristen Marks, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C; People who inject drugs
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Coinfection
• Other Study ID Numbers: 1612017838A001; R01DA041298 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No