Hepatitis BNCT04503993
Healthy Planet Hepatitis B
A study testing Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody in people with Hepatitis B, run by University of California, Davis at 1 site in United States.
Trial summary
This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,004 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to 31 Dec 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record
Who cannot join
- previously completed hepatitis B screening tests
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B
This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibodyOther
The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B Healthy Planet Arm | Experimental | This is a single arm study where all patients eligible patients will receive a hepatitis B order set Receives: Other: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of hepatitis B order panel
Measured: Within 1 year after placement of the order
Secondary outcomes (1)
Linkage to care of those found to be infected with hepatitis B
Measured: Within 3 months after a positive HBsAg test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start25 Feb 2020
- Primary completion24 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503993
- Sponsor's protocol ID
- 1423112
- Status last verified
- May 2022
- First submitted
- 4 Aug 2020
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT04503993
- Acronym / sponsor ID
- 1423112
- Conditions
- Hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,004 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Aug 2020 (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.
This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B Healthy Planet Arm | Experimental | Other: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibodyThis is a single arm study where all patients eligible patients will receive a hepatitis B order set |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record
Key exclusion criteria (1 listed)
- previously completed hepatitis B screening tests
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 B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibodyThe hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools. | Other | Hepatitis B Healthy Planet Arm |
Primary outcome
Completion of hepatitis B order panel
Time frame: Within 1 year after placement of the order
1 secondary outcome
Linkage to care of those found to be infected with hepatitis B
Time frame: Within 3 months after a positive HBsAg test
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 10 May 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody in people with Hepatitis B, run by University of California, Davis 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 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 10 May 2022. 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?
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?
Completion of hepatitis B order panel (time frame: Within 1 year after placement of the order). 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 10 May 2022.