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| ID | Type | Description | Link |
|---|---|---|---|
| IN-US-987-6016 | Other Grant/Funding Number | Gilead Sciences, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Other | Persons infected with the hepatitis C virus who meet the study inclusion criteria and do not meet one or more of the exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified Hepatitis C Virus (HCV) Treatment Protocol | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome: Time to treatment | Time elapsed (in days) from being offered treatment to initiating treatment | Approximately 10 months from time of enrollment |
| Clinical outcome: Complete HCV Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Implementation Outcome: Adoption |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy I Mercer, MD,MPH | The University of Texas at Austin Dell Medical School | Principal Investigator |
| Darlene Bhavnani, PhD MPH | The University of Texas at Austin Dell Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CommUnityCare Health Centers | Austin | Texas | 78704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40162901 | Derived | Desai A, Reinis K, O'Neal L, Chang P, Brown C, Stefanowicz M, Kuang A, Agrawal D, Mercer T, Bhavnani D. Implementation of Site-Specific Hepatitis C Virus Treatment Workflows for Vulnerable, High-Risk Populations: A Prospective Single-Arm Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251330622. doi: 10.1177/21501319251330622. Epub 2025 Mar 31. | |
| 37158965 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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|
Proportion of participants enrolled in the study who complete HCV treatment
| Approximately 10 months from time of enrollment |
| Clinical outcome: Initiate HCV treatment | Proportion of participants enrolled in the study who initiate HCV treatment | Approximately 10 months from time of enrollment |
Proportion of clinical sites that adopt the HCV treatment protocol
| 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) | 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 | Approximately one year from date of enrollment of first participant |
| Desai A, O'Neal L, Reinis K, Chang P, Brown C, Stefanowicz M, Kuang A, Agrawal D, Bhavnani D, Mercer T. Development, implementation, and feasibility of site-specific hepatitis C virus treatment workflows for treating vulnerable, high-risk populations: protocol of the Erase Hep C study - a prospective single-arm intervention trial. Pilot Feasibility Stud. 2023 May 8;9(1):78. doi: 10.1186/s40814-023-01311-4. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |