Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

NCT ID: NCT03221309

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2026-01-31

Brief Summary

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

Detailed Description

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. However, despite the availability of effective therapy, the global epidemic of HCV infection continues to be driven by people with ongoing injection drug use (PWID), who are largely excluded from HCV therapy. Several critical barriers exist preventing high-risk patients' entry to care, including (1) lack of engagement in the traditional healthcare system by marginalized patient populations, and (2) insurance restrictions due to concerns regarding treatment adherence and HCV reinfection. Furthermore, ongoing injection drug use places these individuals at high risk of HIV acquisition. However, studies have repeatedly demonstrated that pre-exposure prophylaxis (PrEP) reduces HIV acquisition and opioid substitution therapy with buprenorphine reduces HIV and HCV acquisition in PWID.

As such, we propose a comprehensive model of care to engage individuals with ongoing injection drug use in treatment of HCV, in conjunction with collocated services to prevent HIV acquisition and HCV reinfection, including pre-exposure prophylaxis and opioid substitution therapy. This pilot trial will demonstrate whether a comprehensive model of care can simultaneously treat HCV, and prevent HCV reinfection, HIV acquisition and effectively treat opioid use disorder.

Conditions

HCV; Buprenorphine; PreP

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults infected with HCV

Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening

Phase 2 (enrolled participants 101-200) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening

Evaluate model of care for HCV-infected adults with on-going opioid misuse

Intervention Type: OTHER

Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated

Interventions

Evaluate model of care for HCV-infected adults with on-going opioid misuse

Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 years old

2. Able and willing to sign informed consent

3. Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).

4. Willing to have samples stored for future use

5. Ongoing injection drug use, defined as self-report of either:

1. Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or

2. Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit

Exclusion Criteria

1. Decompensated liver disease (Childs Pugh B or C)

2. Unable to comply with research study visits

3. Poor venous access not allowing screening laboratory collection

4. Have any condition that the investigator considers a contraindication to study participation

5. Pregnant or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Elana Rosenthal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elana Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

HIPS

Washington D.C., District of Columbia, United States

University of Maryland Drug Treatment Center

Baltimore, Maryland, United States

Countries

United States

References

Rosenthal ES, Silk R, Mathur P, Gross C, Eyasu R, Nussdorf L, Hill K, Brokus C, D'Amore A, Sidique N, Bijole P, Jones M, Kier R, McCullough D, Sternberg D, Stafford K, Sun J, Masur H, Kottilil S, Kattakuzhy S. Concurrent Initiation of Hepatitis C and Opioid Use Disorder Treatment in People Who Inject Drugs. Clin Infect Dis. 2020 Oct 23;71(7):1715-1722. doi: 10.1093/cid/ciaa105.

Reference Type: DERIVED

PMID: 32009165 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00071577

Identifier Type: -

Identifier Source: org_study_id