Clinical trial NCT03214679: Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)
Official title: Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in HCV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
People Who Inject Drugs
PWID
HCV Coinfection
Keywords: Hepatitis C
HCV
People who inject drugs
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: National Development and Research Institutes, Inc.
name: National Institute on Drug Abuse (NIDA)
name: Weill Medical College of Cornell University
First posted: 2017-07-11
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Patients to Achieve SVR12 at 1 Year
timeFrame: each participant will be assessed at 1 year post entry
measure: Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
timeFrame: each participant will be assessed at 1 year post entry
measure: The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit
timeFrame: end of study (12 months)
measure: Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment
timeFrame: each participant will be assessed at 1 year post entry
measure: Proportion of Participants in Each Arm Who Initiated Treatment
timeFrame: Each participant will be assessed 1 year post entry
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Lower East Side Harm Reduction Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Kristen Marks
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.