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

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of a Simplified, Low-barrier Primary Care HCV Treatment Model for High Risk, High Prevalence Populations in Austin, Texas

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Behavioral: Simplified Hepatitis C Virus (HCV) Treatment Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Participants<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: Time to treatment | Time elapsed (in days) from being offered treatment to initiating treatment | Approximately 10 months from time of enrollment | 
| Clinical outcome: Complete HCV Treatment | Proportion of participants enrolled in the study who complete HCV treatment | Approximately 10 months from time of enrollment | 
| Clinical outcome: Initiate HCV treatment | Proportion of participants enrolled in the study who initiate HCV treatment | Approximately 10 months from time of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAAs, SVR12, Implementation Science, homelessness, direct-acting antivirals, sustained virological response, healthcare for the homeless, people who inject drugs