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

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05460130
• Other study ID #: Study 1656
• Secondary ID: IN-US-987-6016
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: September 20, 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection

Intervention

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.

Locations

Country	Name	City	State
United States	CommUnityCare Health Centers	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Implementation Outcome: Adoption	Proportion of clinical sites that adopt the HCV treatment protocol	Approximately one year from date of enrollment of first participant
Other	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
Other	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
Primary	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	Clinical outcome: Time to treatment	Time elapsed (in days) from being offered treatment to initiating treatment	Approximately 10 months from time of enrollment
Secondary	Clinical outcome: Complete HCV Treatment	Proportion of participants enrolled in the study who complete HCV treatment	Approximately 10 months from time of enrollment
Secondary	Clinical outcome: Initiate HCV treatment	Proportion of participants enrolled in the study who initiate HCV treatment	Approximately 10 months from time of enrollment