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

NCT05460130 | Unknown

• 2 other identifiers: Study 1656IN-US-987-6016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

DAAs; SVR12; Implementation Science; homelessness; direct-acting antivirals; sustained virological response; healthcare for the homeless; people who inject drugs

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with chronic HCV infection enrolled in the study that achieve SVR-12

  A sustained virological response is defined as an undetectable HCV RNA level 12 weeks after treatment completion.

  The measurement of SVR12 is assessed 12 weeks after completing treatment.

Secondary Outcomes (3)

• Clinical outcome: Time to treatment

  Approximately 10 months from time of enrollment

• Clinical outcome: Complete HCV Treatment

  Approximately 10 months from time of enrollment

• Clinical outcome: Initiate HCV treatment

  Approximately 10 months from time of enrollment

Other Outcomes (4)

• Implementation Outcome: Reach

  Approximately one year from date of enrollment of first participant

• Implementation Outcome: Adoption

  Approximately one year from date of enrollment of first participant

• Implementation Outcome: Implementation

  Approximately one year from date of enrollment of first participant

Study Arms (1)

Study Participants

OTHER

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

Behavioral: Simplified Hepatitis C Virus (HCV) Treatment Protocol

Interventions

Simplified Hepatitis C Virus (HCV) Treatment Protocol 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.

Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

CommUnityCare Health Centers

Austin, Texas, 78704, United States

Location

Related Publications (2)

• 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.

  PMID: 40162901 DERIVED

• 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.

  PMID: 37158965 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Timothy I Mercer, MD,MPH

  The University of Texas at Austin Dell Medical School

  PRINCIPAL INVESTIGATOR

• Darlene Bhavnani, PhD MPH

  The University of Texas at Austin Dell Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Chief of the Division of Global Health, Departments of Population Health and Internal Medicine

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 15, 2022
• Study Start: September 29, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 20, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)