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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214679
• Other study ID #: 1612017838A001
• Secondary ID: R01DA041298
• Status: Completed
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: City University of New York, School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Lower East Side Harm Reduction Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
City University of New York, School of Public Health	National Development and Research Institutes, Inc., National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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