Hepatitis CEarly Phase 1NCT03195205
Identification to Elimination in HCV-Infected Individuals
A Early Phase 1 study testing OraQuick HCV Rapid Antibody Test in people with Hepatitis C, run by TruCare Internal Medicine & Infectious Disease at 1 site in United States.
Trial summary
Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in Pennsylvania are living with hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- OraQuick HCV Rapid Antibody Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,051 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 20 Apr 2020
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be included in the study if the following criteria is met:
- The subject must be an Opioid Substitution Treatment patient.
- The subject must fall into another high-risk population for the HCV.
Who cannot join
- Subjects may be excluded from the study if the subject falls into an exclusion category as identified as:
- The subject cannot be or suspected of being pregnant
- The subject cannot be under the age of 18 years.
- No subjects requiring a legally authorized representative will be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
TruCare Internal Medicine & Infectious Diseases
DuBois, Pennsylvania, 15801
About this study
Official title: A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this estimate, there are over 43,000 individuals affected with chronic HCV living in rural Pennsylvania. Rural county residents often experience barriers to health care by having fewer primary care providers and limited specialty care physicians available to them to address their healthcare needs.
RQ1: Will the community based delivery system for Hepatitis C screenings see an increase in positivity rates?
Read more
HO1: There is no relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.
HA1: There is a relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.
Read the detailed description
In rural Pennsylvania, transportation is considered a socioeconomic barrier and social detriment to personal health. Using an evidence-based model of population health by bringing the care into the high-risk population's community setting reduces the transportation and socioeconomic barriers of the most vulnerable at risk populations.
It is estimated that 35% to 65% of Opioid Substitution Treatment Patients (OST), are infected with HCV. Therefore, OPT programs that are already operating will be engaged and will be a primary focus for patient screening and recruitment for these services. In addition, high volume venues attracting high-risk populations will also be targeted to encourage HCV screening, education, and treatment.
Primary Objectives:
To screen Opioid Substitution Treatment Patients (OST), high-risk individual at Opioid Treatment Programs (OTP), and/or all high-risk populations in outlying sites (Anti-HCV prevalence)
To initiate HCV treatment of OST patients and other high-risk individuals at OTP facilities and/or high risk populations in outlying sites (linkage of care)
To maintain the successful HCV therapy and cure [Sustained Viral Response (SVR)] in OST patients and other high-risk individuals at OPT facility and/or high risk populations in outlying sites (retention)
To facilitate the use of a patient navigator and nursing case management staff to reduce barriers to initial screening and patient education
- Conditions
- Hepatitis C
- Being tested
- OraQuick HCV Rapid Antibody Test
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuick HCV Rapid Antibody TestDiagnostic test
HCV Screening
| Study group | Role | What they receive |
|---|---|---|
| High-Risk Patients | Other | OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations Receives: Diagnostic Test: OraQuick HCV Rapid Antibody Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity rates
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
Measured: 20 - 40 minutes
Secondary outcomes (2)
Linked to care
The study will measure the percentage of patients identified as reactive that follow up by linking to care.
Measured: 1 - 3 months
Treatment
The study will measure the percentage of patients linked to care who complete treatment.
Measured: 8 - 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Jun 2017
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- TruCare Internal Medicine & Infectious Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Tuesdae Stainbrook, DO, MPH, TruCare Internal Medicine & Infectious Disease
- Investigators
- Tuesdae R Stainbrook, DO, MPH, Principal investigator, Trucare Internals Medicine & Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195205
- Sponsor's protocol ID
- GSI-2016-09-APR
- Status last verified
- Jul 2020
- First submitted
- 31 May 2017
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
- ClinicalTrials.gov ID
- NCT03195205
- Acronym / sponsor ID
- GSI-2016-09-APR
- Conditions
- Hepatitis C
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,051 participants (actual)
- Lead sponsor
- TruCare Internal Medicine & Infectious DiseaseUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 22 Jun 2017 (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.
Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this estimate, there are over 43,000 individuals affected with chronic HCV living in rural Pennsylvania. Rural county residents often experience barriers to health care by having fewer primary care providers and limited specialty care physicians available to them to address their healthcare needs.
RQ1: Will the community based delivery system for Hepatitis C screenings see an increase in positivity rates?
HO1: There is no relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.
HA1: There is a relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.
Detailed description
In rural Pennsylvania, transportation is considered a socioeconomic barrier and social detriment to personal health. Using an evidence-based model of population health by bringing the care into the high-risk population's community setting reduces the transportation and socioeconomic barriers of the most vulnerable at risk populations.
It is estimated that 35% to 65% of Opioid Substitution Treatment Patients (OST), are infected with HCV. Therefore, OPT programs that are already operating will be engaged and will be a primary focus for patient screening and recruitment for these services. In addition, high volume venues attracting high-risk populations will also be targeted to encourage HCV screening, education, and treatment.
Primary Objectives:
To screen Opioid Substitution Treatment Patients (OST), high-risk individual at Opioid Treatment Programs (OTP), and/or all high-risk populations in outlying sites (Anti-HCV prevalence)
To initiate HCV treatment of OST patients and other high-risk individuals at OTP facilities and/or high risk populations in outlying sites (linkage of care)
To maintain the successful HCV therapy and cure [Sustained Viral Response (SVR)] in OST patients and other high-risk individuals at OPT facility and/or high risk populations in outlying sites (retention)
To facilitate the use of a patient navigator and nursing case management staff to reduce barriers to initial screening and patient education
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Patients | Other | Diagnostic Test: OraQuick HCV Rapid Antibody TestOraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject must be an Opioid Substitution Treatment patient.
- The subject must fall into another high-risk population for the HCV.
Key exclusion criteria (4 listed)
- Subjects may be excluded from the study if the subject falls into an exclusion category as identified as:
- The subject cannot be or suspected of being pregnant
- The subject cannot be under the age of 18 years.
- No subjects requiring a legally authorized representative will be enrolled
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 |
|---|---|---|
| OraQuick HCV Rapid Antibody TestHCV Screening | Diagnostic test | High-Risk Patients |
Primary outcome
Positivity rates
Time frame: 20 - 40 minutes
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
2 secondary outcomes
Linked to care
Time frame: 1 - 3 months
Treatment
Time frame: 8 - 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis C
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HCV Infection
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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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.
Tuesdae R Stainbrook, DO, MPH principal investigator
Trucare Internals Medicine & Infectious Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OraQuick HCV Rapid Antibody Test in people with Hepatitis C, run by TruCare Internal Medicine & Infectious Disease 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jul 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positivity rates (time frame: 20 - 40 minutes). 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 2 Jul 2020.