Hepatitis CNCT06533319
Hepatitis C Treatment in Idaho County Jails
A study testing sofosbuvir/velpatasvir in people with Hepatitis C, run by Eastern Idaho Public Health.
Trial summary
To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including; 1. incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- sofosbuvir/velpatasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2025
- 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
- All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
- All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
- Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis.
Who cannot join
- All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
- All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
- Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis
About this study
Official title: Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting
To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including;
- incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and
- incarcerated persons positive for HCV in jails less than the duration of 12 weeks of treatment who receive remaining supply of study drug on discharge with appropriate linkage to care.
Assess quality of life measures in participants being treated for their HCV through the validated questionnaire EuroQol-5D at baseline and post-treatment.
Read the detailed description
Aligning with the World Health Organization (WHO) global guidance and recommendation to eliminate viral hepatitis by 2030 will require designated focus on priority populations who are disproportionately impacted by viral hepatitis. Addressing chronic hepatitis C virus (HCV) with the justice involved population is crucial in reducing HCV within the greater population. Inmate populations bear a disproportionate share of the burden of HCV infection. HCV prevalence is 10-20 fold greater in the incarcerated population than the general population, although wider uptake among people who are incarcerated remains limited. Addressing HCV in the incarcerated population is a strategy to bring the US closer to successfully eradicating the HCV epidemic. Additionally, previous qualitative research has suggested that justice involved individuals felt incarceration is an apt time to initiate treatment and is a missed opportunity to not do so, and that waiting and initiating treatment upon release faces multiple challenges, including insurance or Medicaid enrollment, making appointments, transportation and work commitments.
HCV in the jail setting is a public health issue that needs to be addressed. Extensive modelling has shown that HCV testing in people who are incarcerated prevents community spread of HCV and is cost effective. Furthermore, there is guidance and recommendations for HCV testing in the prison system where a vast majority of research is being conducted. However, there is limited guidance for HCV testing within jails. Thus, county jails are critical partners, and potentially may serve as an important setting for HCV screening, diagnosis and treatment, although data is scarce in this realm. We therefore aim to explore whether county jails are a practical and feasible setting for HCV screening, and initiating HCV treatment, including whether an incarcerated person resides in the county jail for the duration of treatment (group 1), or is released to the community in the midst of treatment with a supply of remaining study drug and linked to appropriate care (group 2).
- Conditions
- Hepatitis C
- Being tested
- sofosbuvir/velpatasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir/velpatasvirDrug
Patients who qualify for the study will be provided with sofosbuvir/velpatasvir for chronic hepatitis C treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail | Other | Patients infected with chronic hepatitis C who are also incarcerated will be enrolled into the study and provided FDA approved Epclusa (sofosbuvir/velpatasvir) for treatment of chronic hepatitis C. Epclusa (sofosbuvir/velpatasvir) is currently used as a first line treatment for chronic hepatitis C. This study will focus on effectiveness of treatment in the county jai setting. Receives: Drug: sofosbuvir/velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
Undetectable hepatitis C RNA
Measured: 12 weeks after treatment
Secondary outcomes (1)
Quality of life improvement
Improvement in quality of life measures after treatment of hepatitis C as measured by SF-12 tool
Measured: At study enrollment and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Model description
- Multi-site, prospective cohort study at Idaho county jails with quantitative methods and survey.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Idaho Public Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533319
- Sponsor's protocol ID
- CO-US-342-7112
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting
- ClinicalTrials.gov ID
- NCT06533319
- Acronym / sponsor ID
- CO-US-342-7112
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eastern Idaho Public HealthOther government
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including;
- incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and
- incarcerated persons positive for HCV in jails less than the duration of 12 weeks of treatment who receive remaining supply of study drug on discharge with appropriate linkage to care.
Assess quality of life measures in participants being treated for their HCV through the validated questionnaire EuroQol-5D at baseline and post-treatment.
Detailed description
Aligning with the World Health Organization (WHO) global guidance and recommendation to eliminate viral hepatitis by 2030 will require designated focus on priority populations who are disproportionately impacted by viral hepatitis. Addressing chronic hepatitis C virus (HCV) with the justice involved population is crucial in reducing HCV within the greater population. Inmate populations bear a disproportionate share of the burden of HCV infection. HCV prevalence is 10-20 fold greater in the incarcerated population than the general population, although wider uptake among people who are incarcerated remains limited. Addressing HCV in the incarcerated population is a strategy to bring the US closer to successfully eradicating the HCV epidemic. Additionally, previous qualitative research has suggested that justice involved individuals felt incarceration is an apt time to initiate treatment and is a missed opportunity to not do so, and that waiting and initiating treatment upon release faces multiple challenges, including insurance or Medicaid enrollment, making appointments, transportation and work commitments.
HCV in the jail setting is a public health issue that needs to be addressed. Extensive modelling has shown that HCV testing in people who are incarcerated prevents community spread of HCV and is cost effective. Furthermore, there is guidance and recommendations for HCV testing in the prison system where a vast majority of research is being conducted. However, there is limited guidance for HCV testing within jails. Thus, county jails are critical partners, and potentially may serve as an important setting for HCV screening, diagnosis and treatment, although data is scarce in this realm. We therefore aim to explore whether county jails are a practical and feasible setting for HCV screening, and initiating HCV treatment, including whether an incarcerated person resides in the county jail for the duration of treatment (group 1), or is released to the community in the midst of treatment with a supply of remaining study drug and linked to appropriate care (group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-site, prospective cohort study at Idaho county jails with quantitative methods and survey.
| Arm | Type | Receives |
|---|---|---|
| Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail | Other | Drug: sofosbuvir/velpatasvirPatients infected with chronic hepatitis C who are also incarcerated will be enrolled into the study and provided FDA approved Epclusa (sofosbuvir/velpatasvir) for treatment of chronic hepatitis C. Epclusa (sofosbuvir/velpatasvir) is currently used as a first line treatment for chronic hepatitis C. This study will focus on effectiveness of treatment in the county jai setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
- All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
- Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis.
Key exclusion criteria (3 listed)
- All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
- All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
- Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis
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 |
|---|---|---|
| sofosbuvir/velpatasvirPatients who qualify for the study will be provided with sofosbuvir/velpatasvir for chronic hepatitis C treatment. | Drug | Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail |
Primary outcome
Sustained Virologic Response
Time frame: 12 weeks after treatment
Undetectable hepatitis C RNA
1 secondary outcome
Quality of life improvement
Time frame: At study enrollment and 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sofosbuvir/velpatasvir in people with Hepatitis C, run by Eastern Idaho Public Health.
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 3 inclusion and 3 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Sustained Virologic Response (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.