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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis C, People Who Inject Drugs, PWID, HCV Coinfection

Intervention / Treatment
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* Other: Accessible Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accessible Care<br>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<br>* 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.<br>|
| Active Comparator: Usual Care<br>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<br>* Usual care entails referral to an on site HCV care coordinator (not provided by study)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, People who inject drugs