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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Behavioral: Simplified Hepatitis C Virus (HCV) Treatment Protocol

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78704
      • CommUnityCare Health Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Outcome: Reach	Proportion of participants with chronic HCV enrolled in the study who are offered treatment	Approximately one year from date of enrollment of first participant
Implementation Outcome: Adoption	Proportion of clinical sites that adopt the HCV treatment protocol	Approximately one year from date of enrollment of first participant
Implementation Outcome: Implementation	Qualitative interviews to assess the extent to which the HCV treatment protocol was implemented as intended (fidelity)	Approximately one year from date of enrollment of first participant
Implementation Outcome: Maintenance	Qualitative interviews to assess the extent to which the HCV treatment protocol is sustained over time	Approximately one year from date of enrollment of first participant

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 20, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: homelessness; Implementation Science; SVR12; sustained virological response; people who inject drugs; DAAs; direct-acting antivirals; healthcare for the homeless
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: Study 1656; IN-US-987-6016 (Other Grant/Funding Number: Gilead Sciences, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No