Treatment for Hepatitis C

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CommUnityCare Health Centers, Austin, TX
Hepatitis C+1 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Hepatitis C
  • Hepatitis C Virus Infection

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Approximately one year from date of enrollment of first participant

Month 10
Clinical outcome: Complete HCV Treatment
Clinical outcome: Initiate HCV treatment
Clinical outcome: Time to treatment
Approximately one year from date of enrollment of first participant
Implementation Outcome: Adoption
Implementation Outcome: Implementation
Implementation Outcome: Maintenance
Implementation Outcome: Reach
Week 12
Proportion of participants with chronic HCV infection enrolled in the study that achieve SVR-12

Trial Safety

Trial Design

0 Treatment Group

289 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately one year from date of enrollment of first participant
Closest Location: CommUnityCare Health Centers · Austin, TX
Photo of Austin 1Photo of Austin 2Photo of Austin 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Hepatitis C
0 CompletedClinical Trials

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
283 Previous Clinical Trials
66,952 Total Patients Enrolled
Darlene Bhavnani, PhD MPHPrincipal InvestigatorThe University of Texas at Austin Dell Medical School
Timothy I Mercer, MD,MPHPrincipal InvestigatorThe University of Texas at Austin Dell Medical School

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are enrolled in care at one of CommunityCare's clinical sites participating in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.