Hepatitis BPhase 3NCT00760721
Increasing Hepatitis B Screening Among Korean Church Attendees
A Phase 3 study testing Educational Small Group Session in people with Hepatitis B, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Korean Americans. The investigators will design a culturally specific intervention (educational sessions) and test the effect of the intervention on 1200 Korean Americans. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Educational Small Group Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,123 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2012
- Phase
- Phase 3
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Korean ancestry
- Have not previously received HBV screening or do not know the results of previous HBV screening test
- No history of liver cancer or liver disease
- Current resident of the Los Angeles area
Who cannot join
- Younger than 18 years of age or Older than 64 years of age
- Not of Korean ancestry
- Previously screened for HBV
- History of liver disease or liver cancer
- Not a current resident of the Los Angeles area
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA, Division of Cancer Prevenion and Control Research
Los Angeles, California, 90095
About this study
Official title: Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Korean Americans.
The investigators will design a culturally specific intervention (educational sessions) and test the effect of the intervention on 1200 Korean Americans.
All subjects will be interviewed before the intervention/control sessions and 6 months after the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening will be verified by a review of subjects' medical records.
The primary study hypothesis is that the intervention group will have a higher rate of HBV serologic testing at follow-up compared to the control group.
Read the detailed description
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Korean Americans.
The investigators will design a culturally specific intervention; an educational small group discussion led by a trained Korean leader. The effect of the intervention will be tested on 1200 Korean Americans.
Subjects will be recruited at Korean churches and invited to join a one-hour discussion of health issues with other members of their church. One half of the subjects will participate in the intervention group. These subjects will discuss HBV and will receive resources related to HBV and where to obtain screening. The other half of the subjects will participate in the control group. These subjects will discuss nutrition and physical activity and will receive resources related to these topics, but not related to HBV and where to obtain screening.
All subjects will be interviewed before the sessions and 6 months after the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening will be verified by a review of subjects' medical records.
The primary study hypothesis is that the intervention group will have a higher rate of HBV serologic testing at follow-up compared to the control group.
Secondary hypotheses are:
The intervention group will have a higher level of knowledge of hepatitis B and liver cancer at follow-up compared to the control group.
The effect of the intervention on hepatitis B serologic testing will be mediated by knowledge of hepatitis B and liver cancer.
- Conditions
- Hepatitis B
- Being tested
- Educational Small Group Session
- Keywords
- Hepatitis B Screening, Korean Americans
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Small Group SessionBehavioural
1 hour small group health-related discussion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Educational small group session with HBV screening resources provided Receives: Behavioral: Educational Small Group Session |
| 2 | Sham comparator | Educational small group discussion, diet/physical activity resources provided Receives: Behavioral: Educational Small Group Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining HBV Screening Test
Measured: 6 months post-intervention
Secondary outcomes (1)
Knowledge and Attitudes Regarding HBV Screening
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roshan Bastani, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760721
- Sponsor's protocol ID
- P01CA109091-01A1
- Other IDs
- P01CA109091-01A1
- Status last verified
- Nov 2016
- First submitted
- 25 Sep 2008
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bastani R, Glenn BA, Maxwell AE, Jo AM, Herrmann AK, Crespi CM, Wong WK, Chang LC, Stewart SL, Nguyen TT, Chen MS Jr, Taylor VM. Cluster-Randomized Trial to Increase Hepatitis B Testing among Koreans in Los Angeles. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1341-9. doi: 10.1158/1055-9965.EPI-14-1396. Epub 2015 Jun 23.
PubMed 26104909
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans
- ClinicalTrials.gov ID
- NCT00760721
- Acronym / sponsor ID
- P01CA109091-01A1
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B Screening, Korean Americans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,123 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Sep 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Sep 2008 (estimated)
- 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 design an intervention to increase hepatitis B (HBV) screening among Korean Americans.
The investigators will design a culturally specific intervention (educational sessions) and test the effect of the intervention on 1200 Korean Americans.
All subjects will be interviewed before the intervention/control sessions and 6 months after the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening will be verified by a review of subjects' medical records.
The primary study hypothesis is that the intervention group will have a higher rate of HBV serologic testing at follow-up compared to the control group.
Detailed description
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Korean Americans.
The investigators will design a culturally specific intervention; an educational small group discussion led by a trained Korean leader. The effect of the intervention will be tested on 1200 Korean Americans.
Subjects will be recruited at Korean churches and invited to join a one-hour discussion of health issues with other members of their church. One half of the subjects will participate in the intervention group. These subjects will discuss HBV and will receive resources related to HBV and where to obtain screening. The other half of the subjects will participate in the control group. These subjects will discuss nutrition and physical activity and will receive resources related to these topics, but not related to HBV and where to obtain screening.
All subjects will be interviewed before the sessions and 6 months after the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening will be verified by a review of subjects' medical records.
The primary study hypothesis is that the intervention group will have a higher rate of HBV serologic testing at follow-up compared to the control group.
Secondary hypotheses are:
The intervention group will have a higher level of knowledge of hepatitis B and liver cancer at follow-up compared to the control group.
The effect of the intervention on hepatitis B serologic testing will be mediated by knowledge of hepatitis B and liver cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Educational Small Group SessionEducational small group session with HBV screening resources provided |
| 2 | Sham comparator | Behavioral: Educational Small Group SessionEducational small group discussion, diet/physical activity resources provided |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Korean ancestry
- Have not previously received HBV screening or do not know the results of previous HBV screening test
- No history of liver cancer or liver disease
- Current resident of the Los Angeles area
Key exclusion criteria (5 listed)
- Younger than 18 years of age or Older than 64 years of age
- Not of Korean ancestry
- Previously screened for HBV
- History of liver disease or liver cancer
- Not a current resident of the Los Angeles area
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 |
|---|---|---|
| Educational Small Group Session1 hour small group health-related discussion | Behavioural | 1, 2 |
Primary outcome
Obtaining HBV Screening Test
Time frame: 6 months post-intervention
1 secondary outcome
Knowledge and Attitudes Regarding HBV Screening
Time frame: 6 months post-intervention
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 28 Nov 2016.
- Results publication: PubMed 26104909Bastani R, Glenn BA, Maxwell AE, Jo AM, Herrmann AK, Crespi CM, Wong WK, Chang LC, Stewart SL, Nguyen TT, Chen MS Jr, Taylor VM. Cluster-Randomized Trial to Increase Hepatitis B Testing among Koreans in Los Angeles. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1341-9. doi: 10.1158/1055-9965.EPI-14-1396. Epub 2015 Jun 23.
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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.
Roshan Bastani, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational Small Group Session in people with Hepatitis B, run by University of California, Los Angeles 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 5 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 28 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Obtaining HBV Screening Test (time frame: 6 months post-intervention). 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 NCT00760721, which also lists 1 linked publication.
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 28 Nov 2016.