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Implementation of a Simplified, Low-barrier Primary Care HCV Treatment Model for High Risk, High Prevalence Populations in Austin, Texas
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Gilead Sciences, Inc.
interventional
64
1 country
1
Study Start
September 29, 2022
Actual (reported)Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2022
Actual (reported)July 15, 2022
Actual (reported)September 29, 2022
Actual (reported)June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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
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
Persons infected with the hepatitis C virus who meet the study inclusion criteria and do not meet one or more of the exclusion criteria.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CommUnityCare Health Centers
Austin, Texas, 78704, United States
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.
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.
Timothy I Mercer, MD,MPH
The University of Texas at Austin Dell Medical School
Darlene Bhavnani, PhD MPH
The University of Texas at Austin Dell Medical School
64 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2022
First Posted
July 15, 2022
Study Start
September 29, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 6, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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