Implementing HCV Treatment for High-risk Populations in Austin, Texas

NCT ID: NCT05460130

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-29
• Study Completion Date: 2023-09-20

Brief Summary

Highly-effective, pan-genotypic direct acting antivirals (DAAs) have made elimination of hepatitis C virus (HCV) a real possibility. A minority of the population infected with HCV has access to care or been prescribed such HCV treatment. Among people experiencing homelessness in the US, and seeking care at Health Care for the Homeless (HCH) clinics, prevalence is 31%, and 70% among people who experience homeless and inject drugs. In N. America, 55% of people who inject drugs (PWID) have HCV. Austin, TX has over 7,000 people experiencing homelessness with about 20% having a substance use disorder.

Treatment of HCV via DAAs is feasible and effective in primary care settings, and is as effective as treatment by specialists. Among people with opioid use disorder receiving opioid agonist therapy it's both effective and cost-effective. Treatment in the primary care setting has also been shown to be feasible and effective for people experiencing homelessness, with supporting evidence of engaging and retaining people in care. Furthermore, a novel HCV treatment model, featuring a simplified HCV treatment algorithm for front-line health care providers (primary care physicians, Nurse Practitioners, Physicians Assistants), has now been published, to help increase capacity, scale-up treatment and achieve elimination.

This study takes the foregoing new simplified approach one step further: Implementing this simplified algorithm for front-line health care providers in primary care settings caring for high-risk populations such as individuals experiencing homelessness and PWID. The novelty is providing treatment in diverse primary care settings, and targeting clinical sites serving high-risk populations, including people experiencing homelessness and PWID. Investigators use an implementation science approach to study the feasibility and effectiveness of the HCV treatment model in achieving HCV cure in high-risk populations.

Investigators hypothesize that by training front-line health care providers on a simplified, low-barrier HCV treatment model and adapting it using a locally contextualized, protocol-driven approach, investigators will effectively scale up HCV treatment across multiple primary care clinical sites serving high-risk populations, yielding sustained virologic response at 12 weeks (SVR-12) in 75% of enrolled participants. Investigators predict theHCV treatment model to measure favorably across implementation process and outcome measures of reach, adoption, implementation, and maintenance.

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Participants

Persons infected with the hepatitis C virus who meet the study inclusion criteria and do not meet one or more of the exclusion criteria.

Group Type: OTHER

Simplified Hepatitis C Virus (HCV) Treatment Protocol

Intervention Type: BEHAVIORAL

A simplified, low-barrier, locally contextualized, HCV treatment protocol delivered by trained front-line health care providers (primary care physicians and mid-level providers) serving hard-to-reach-populations.

Interventions

Simplified Hepatitis C Virus (HCV) Treatment Protocol

A simplified, low-barrier, locally contextualized, HCV treatment protocol delivered by trained front-line health care providers (primary care physicians and mid-level providers) serving hard-to-reach-populations.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult patients age 18 years and older.
• Enrolled in care at one of CommunityCare's clinical sites participating in the study.
• Laboratory diagnosis of HCV
• Chronic hepatitis C infection

Exclusion Criteria

• Have decompensated cirrhosis.
• Have received hepatitis C treatment previously.
• Had a liver transplant or actively on the transplant list awaiting a liver transplant.
• Have resistant HCV virus
• Infected with HIV
• Infected with hepatitis B
• Currently pregnant

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

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Tim Mercer

Assistant Professor, Chief of the Division of Global Health, Departments of Population Health and Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy I Mercer, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin Dell Medical School

Darlene Bhavnani, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin Dell Medical School

Locations

CommUnityCare Health Centers

Austin, Texas, United States

Countries

United States

References

Desai A, Reinis K, O'Neal L, Chang P, Brown C, Stefanowicz M, Kuang A, Agrawal D, Mercer T, Bhavnani D. Implementation of Site-Specific Hepatitis C Virus Treatment Workflows for Vulnerable, High-Risk Populations: A Prospective Single-Arm Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251330622. doi: 10.1177/21501319251330622. Epub 2025 Mar 31.

Reference Type: DERIVED

PMID: 40162901 (View on PubMed)

Desai A, O'Neal L, Reinis K, Chang P, Brown C, Stefanowicz M, Kuang A, Agrawal D, Bhavnani D, Mercer T. Development, implementation, and feasibility of site-specific hepatitis C virus treatment workflows for treating vulnerable, high-risk populations: protocol of the Erase Hep C study - a prospective single-arm intervention trial. Pilot Feasibility Stud. 2023 May 8;9(1):78. doi: 10.1186/s40814-023-01311-4.

Reference Type: DERIVED

PMID: 37158965 (View on PubMed)

Other Identifiers

IN-US-987-6016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Study 1656

Identifier Type: -

Identifier Source: org_study_id