Clinical trial NCT05460130: Implementing HCV Treatment for High-risk Populations in Austin, Texas
Official title: Implementation of a Simplified, Low-barrier Primary Care HCV Treatment Model for High Risk, High Prevalence Populations in Austin, Texas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C Virus Infection
Keywords: DAAs
SVR12
Implementation Science
homelessness
direct-acting antivirals
sustained virological response
healthcare for the homeless
people who inject drugs
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with chronic HCV infection enrolled in the study that achieve SVR-12
timeFrame: The measurement of SVR12 is assessed 12 weeks after completing treatment.
Secondary outcomes:
measure: Clinical outcome: Time to treatment
timeFrame: Approximately 10 months from time of enrollment
measure: Clinical outcome: Complete HCV Treatment
timeFrame: Approximately 10 months from time of enrollment
measure: Clinical outcome: Initiate HCV treatment
timeFrame: Approximately 10 months from time of enrollment
Other outcomes:
measure: Implementation Outcome: Reach
timeFrame: Approximately one year from date of enrollment of first participant
measure: Implementation Outcome: Adoption
timeFrame: Approximately one year from date of enrollment of first participant
measure: Implementation Outcome: Implementation
timeFrame: Approximately one year from date of enrollment of first participant
measure: Implementation Outcome: Maintenance
timeFrame: Approximately one year from date of enrollment of first participant
Locations:
city: Austin
country: United States
facility: CommUnityCare Health Centers
state: Texas
Study officials:
affiliation: The University of Texas at Austin Dell Medical School
name: Timothy I Mercer, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Austin Dell Medical School
name: Darlene Bhavnani, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: