Increasing Hepatitis B Screening Among Korean Church Attendees
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Educational Small Group Session
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis B focused on measuring Hepatitis B Screening, Korean Americans
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- UCLA, Division of Cancer Prevenion and Control Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Educational small group session with HBV screening resources provided
Educational small group discussion, diet/physical activity resources provided
Outcomes
Primary Outcome Measures
Obtaining HBV Screening Test
Secondary Outcome Measures
Knowledge and Attitudes Regarding HBV Screening
Full Information
NCT ID
NCT00760721
First Posted
September 25, 2008
Last Updated
November 23, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00760721
Brief Title
Increasing Hepatitis B Screening Among Korean Church Attendees
Official Title
Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B Screening, Korean Americans
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Educational small group session with HBV screening resources provided
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Educational small group discussion, diet/physical activity resources provided
Intervention Type
Behavioral
Intervention Name(s)
Educational Small Group Session
Intervention Description
1 hour small group health-related discussion
Primary Outcome Measure Information:
Title
Obtaining HBV Screening Test
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Knowledge and Attitudes Regarding HBV Screening
Time Frame
6 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan Bastani, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA, Division of Cancer Prevenion and Control Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26104909
Citation
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.
Results Reference
result
Learn more about this trial
Increasing Hepatitis B Screening Among Korean Church Attendees
We'll reach out to this number within 24 hrs