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

NCT03214679 | Completed Results DMC

• 2 other identifiers: 1612017838A001R01DA041298
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hepatitis C; HCV; People who inject drugs

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Accessible Care

EXPERIMENTAL

"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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Accessible Care OTHER

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.

Accessible Care

Usual Care OTHER

Usual care entails referral to an on site HCV care coordinator (not provided by study)

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• City University of New York, School of Public Health: lead
• National Development and Research Institutes, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Lower East Side Harm Reduction Center

New York, New York, 10022, United States

Location

Related Publications (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.

  PMID: 35285851 BACKGROUND

• Kapadia SN, Aponte-Melendez Y, Rodriguez A, Pai M, Eckhardt BJ, Marks KM, Fong C, Mateu-Gelabert P. "Treated like a Human Being": perspectives of people who inject drugs attending low-threshold HCV treatment at a syringe service program in New York City. Harm Reduct J. 2023 Jul 27;20(1):95. doi: 10.1186/s12954-023-00831-9.

  PMID: 37501180 DERIVED

• 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.

  PMID: 34819070 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Access to Primary Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Health Services Accessibility; Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

he study limitations to generalizability include that the study was conducted at a single site and in an urban environment with a high concentration of harm reduction services and minimal state HCV DAA prescribing restrictions. As observed in this trial, most patients were insured or eligible for insurance, and no participants had their insurance company deny treatment with HCV DAA therapy.

Results Point of Contact

• Title: Ben Eckhardt
• Organization: University School of Medicine, New York

benjamin.eckhardt@nyumc.org

212-562-1000

Study Officials

• Kristen Marks

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 11, 2017
• Study Start: July 20, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 22, 2023
• Results First Posted: February 22, 2023

Record last verified: 2021-07

Locations

US (1)