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OpenTrials
Completed

NCT Number: NCT03214679

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HCV Coinfection Hepatitis Hepatitis, Viral, Human Infections Liver Diseases PWID People Who Inject Drugs RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lower East Side Harm Reduction Center

New York, 10022, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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)

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.

Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

  1. Proportion of Patients to Achieve SVR12 at 1 Year

    Time frame: 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

  2. Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider

    Time frame: 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

  3. The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit

    Time frame: end of study (12 months)

    The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.

  4. Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment

    Time frame: 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

  5. Proportion of Participants in Each Arm Who Initiated Treatment

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

City University of New York, School of Public Health

Other

Collaborators

  • National Development and Research Institutes, Inc.
  • National Institute on Drug Abuse (NIDA)
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 11, 2017
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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