Hepatitis C Virus InfectionNCT05460130
Implementing HCV Treatment for High-risk Populations in Austin, Texas
A study testing Simplified Hepatitis C Virus (HCV) Treatment Protocol in people with Hepatitis C Virus Infection, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Simplified Hepatitis C Virus (HCV) Treatment Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Simplified, Low-barrier Primary Care HCV Treatment Model for High Risk, High Prevalence Populations in Austin, Texas
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.
Read more
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.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Simplified Hepatitis C Virus (HCV) Treatment Protocol
- Keywords
- DAAs, SVR12, Implementation Science, homelessness, direct-acting antivirals, sustained virological response, healthcare for the homeless, people who inject drugs
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified Hepatitis C Virus (HCV) Treatment ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simplified Hepatitis C Virus (HCV) Treatment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The measurement of SVR12 is assessed 12 weeks after completing treatment.
Secondary outcomes (3)
Clinical outcome: Time to treatment
Time elapsed (in days) from being offered treatment to initiating treatment
Measured: Approximately 10 months from time of enrollment
Clinical outcome: Complete HCV Treatment
Proportion of participants enrolled in the study who complete HCV treatment
Measured: Approximately 10 months from time of enrollment
Clinical outcome: Initiate HCV treatment
Proportion of participants enrolled in the study who initiate HCV treatment
Measured: Approximately 10 months from time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start29 Sep 2022
- Primary completionJun 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Mercer, University of Texas at Austin
- Investigators
- Timothy I Mercer, MD,MPH, Principal investigator, The University of Texas at Austin Dell Medical SchoolDarlene Bhavnani, PhD MPH, Principal investigator, The University of Texas at Austin Dell Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460130
- Sponsor's protocol ID
- Study 1656
- Other IDs
- IN-US-987-6016
- Status last verified
- Apr 2023
- First submitted
- 7 Jul 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40162901Desai 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.
PubMed 37158965
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Simplified, Low-barrier Primary Care HCV Treatment Model for High Risk, High Prevalence Populations in Austin, Texas
- ClinicalTrials.gov ID
- NCT05460130
- Acronym / sponsor ID
- Study 1656
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Other | Behavioral: Simplified Hepatitis C Virus (HCV) Treatment ProtocolPersons infected with the hepatitis C virus who meet the study inclusion criteria and do not meet one or more of the exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simplified Hepatitis C Virus (HCV) Treatment ProtocolA 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. | Behavioural | Study Participants |
Primary outcome
Proportion of participants with chronic HCV infection enrolled in the study that achieve SVR-12
Time frame: The measurement of SVR12 is assessed 12 weeks after completing treatment.
A sustained virological response is defined as an undetectable HCV RNA level 12 weeks after treatment completion.
3 secondary outcomes
Clinical outcome: Time to treatment
Time frame: Approximately 10 months from time of enrollment
Clinical outcome: Complete HCV Treatment
Time frame: Approximately 10 months from time of enrollment
Clinical outcome: Initiate HCV treatment
Time frame: Approximately 10 months from time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 40162901Desai 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.
- Derived from this study: PubMed 37158965Desai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy I Mercer, MD,MPH principal investigator
The University of Texas at Austin Dell Medical School
Darlene Bhavnani, PhD MPH principal investigator
The University of Texas at Austin Dell Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified Hepatitis C Virus (HCV) Treatment Protocol in people with Hepatitis C Virus Infection, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with chronic HCV infection enrolled in the study that achieve SVR-12 (time frame: The measurement of SVR12 is assessed 12 weeks after completing treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460130, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.