Hepatitis CNCT03316313
Hepatitis C Screening in the Primary Care Setting
An observational study of Hepatitis C, run by New York Institute of Technology.
Trial summary
The purpose of this study is to determine whether patient education improves Hepatitis C screening in the primary care setting. Read more about this study
- Who is it for?
- Ages 50 to 71 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hepatitis C Antibody
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Apr 2017
- Phase
- Observational
- 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 50 to 71 years
- All sexes
- Adult, Older adult
Study population: Screening was performed at two locations with differing socioeconomic data per census reports.
Who may be able to join
- All patients born between the years 1945 and 1965.
Who cannot join
- Patients who had already received a prior screening test for Hepatitis C before the office visit.
About this study
Official title: Prospective Cohort Study: Hepatitis C Screening in the Primary Care Setting
The purpose of this study is to determine whether patient education improves Hepatitis C screening in the primary care setting.
Read the detailed description
Hepatitis C is a chronic, asymptomatic infection that progresses to liver cirrhosis and cancer in the later stages if left untreated. The Centers for Disease Control (CDC) recommends a one-time screening for high risk birth cohort between the years 1945-1965. Prior studies have evaluated methods to improve screening for hepatitis c with focus on increasing awareness in health professionals. Targets included nursing staff and electronic medical records. This study targets providing patients with education resources to see if screening rates improve.
- Conditions
- Hepatitis C
- Being tested
- Hepatitis C Antibody
- Keywords
- Public Health, Patient Education as Topic, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C AntibodyDiagnostic test
Patients who received a blood test to screen for the Hepatitis C virus.
| Study group | Role | What they receive |
|---|---|---|
| Date of birth | Those people born within the years 1945-1965 Receives: Diagnostic Test: Hepatitis C Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Screened for Hepatitis C
Change from baseline in number of patients from high-risk birth cohort screened for Hepatitis C during intervention period.
Measured: June 2016 to October 2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startJun 2016
- Primary completionOct 2016
- Study completionApr 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316313
- Sponsor's protocol ID
- BHS-1194
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study: Hepatitis C Screening in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT03316313
- Acronym / sponsor ID
- BHS-1194
- Conditions
- Hepatitis C
- Keywords
- Public Health, Patient Education as Topic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Oct 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.
The purpose of this study is to determine whether patient education improves Hepatitis C screening in the primary care setting.
Detailed description
Hepatitis C is a chronic, asymptomatic infection that progresses to liver cirrhosis and cancer in the later stages if left untreated. The Centers for Disease Control (CDC) recommends a one-time screening for high risk birth cohort between the years 1945-1965. Prior studies have evaluated methods to improve screening for hepatitis c with focus on increasing awareness in health professionals. Targets included nursing staff and electronic medical records. This study targets providing patients with education resources to see if screening rates improve.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Date of birth | – | Diagnostic Test: Hepatitis C AntibodyThose people born within the years 1945-1965 |
Who may qualify
- Ages
- 50 to 71 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Screening was performed at two locations with differing socioeconomic data per census reports.
Key inclusion criteria (1 listed)
- All patients born between the years 1945 and 1965.
Key exclusion criteria (1 listed)
- Patients who had already received a prior screening test for Hepatitis C before the office visit.
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 |
|---|---|---|
| Hepatitis C AntibodyPatients who received a blood test to screen for the Hepatitis C virus. | Diagnostic test | Date of birth |
Primary outcome
Number of Patients Screened for Hepatitis C
Time frame: June 2016 to October 2016.
Change from baseline in number of patients from high-risk birth cohort screened for Hepatitis C during intervention period.
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 19 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by New York Institute of Technology.
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 1 inclusion and 1 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 19 Nov 2018. 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?
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?
Number of Patients Screened for Hepatitis C (time frame: June 2016 to October 2016.). 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 19 Nov 2018.