An interventional study of Simplified Hepatitis C Virus (HCV) Treatment Protocol in Hepatitis C Virus Infection, sponsored by University of Texas at Austin. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 64 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: The measurement of SVR12 is assessed 12 weeks after completing treatment.
Clinical outcome: Time to treatment
Time elapsed (in days) from being offered treatment to initiating treatment
Time frame: Approximately 10 months from time of enrollment
Clinical outcome: Complete HCV Treatment
Proportion of participants enrolled in the study who complete HCV treatment
Time frame: Approximately 10 months from time of enrollment
Clinical outcome: Initiate HCV treatment
Proportion of participants enrolled in the study who initiate HCV treatment
Time frame: Approximately 10 months from time of enrollment
Implementation Outcome: Reach
Proportion of participants with chronic HCV enrolled in the study who are offered treatment
Time frame: Approximately one year from date of enrollment of first participant
Implementation Outcome: Adoption
Proportion of clinical sites that adopt the HCV treatment protocol
Time frame: 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)
Time frame: 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
Time frame: Approximately one year from date of enrollment of first participant
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University of Texas at Austin