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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT03214679

Collaborator

National Development and Research Institutes, Inc. (Other), National Institute on Drug Abuse (NIDA) (NIH)

187

Enrollment

Location

Arms

47.3

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C People Who Inject Drugs PWID HCV Coinfection	Other: Accessible Care Other: Usual Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

187 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 20, 2017

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Accessible Care "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 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.
Active Comparator: Usual Care Usual care represents the current procedure 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 Usual care entails referral to an on site HCV care coordinator (not provided by study)

Arm

Intervention/Treatment

Experimental: Accessible Care

"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

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.

Active Comparator: Usual Care

Usual care represents the current procedure 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

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

Outcome Measures

Primary Outcome Measures

Proportion of patients to achieve SVR12 at 1 year [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

Secondary Outcome Measures

The proportion of participants with Hepatitis C treatment engagement at 3 months [each participant will be assessed 3 months post entry]
The proportion of participants in each arm who (a) affirm a desire for hepatitis C treatment, (b) attend an initial visit with a hepatitis treatment provider, (c) complete a medical evaluation for antiviral treatment, including a history, physical examination,and laboratory evaluation, and (d) attend two visits with a hepatitis C treatment provider within 3 months of randomization.
Proportion of participants with antiviral treatment initiation at 3 months [each participant will be assessed at 3 months post entry]
Antiviral treatment initiation will be defined as taking the first dose of antiviral medication within 3 months of randomization

Other Outcome Measures

Cost [1 year]
Proportion of treated patients with Reinfection at 1 year [each participant will be assessed at 1 year post entry]
Proportion of patients with Substance use Treatment Entry and Retention at 1 year [each participant will be assessed at 1 year post entry]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.