NCT05460130

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-29
• Primary completion: 2023-06-01
• Completion: 2023-09-20
• First posted: 2022-07-15
• Last updated: 2023-04-06

Locations

1 site across 1 country: United States