Increasing Hepatitis B Screening Among Korean Church Attendees
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Behavioral: Educational Small Group Session Behavioral: Educational small group session |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Screening |
| Official Title: | Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans |
- Obtaining HBV Screening Test [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
- Knowledge and Attitudes Regarding HBV Screening [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Educational small group session with HBV screening resources provided
|
Behavioral: Educational Small Group Session
1 hour small group HBV focused discussion with HBV screening resources
|
|
Sham Comparator: 2
Educational small group discussion, diet/PA resources provided
|
Behavioral: Educational small group session
1 hour small group session with diet/PA focus, topic related resources provided
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Roshan Bastani, PhD | 310-206-9266 | bastani@ucla.edu |
| Contact: Beth A Glenn, PhD | 310-206-9715 | bglenn@ucla.edu |
| United States, California | |
| UCLA, Division of Cancer Prevenion and Control Research | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Alison K Herrmann, MS 310-206-8483 aherrmann@ucla.edu | |
| Contact: Beth A Glenn, PhD 310-206-9715 bglenn@ucla.edu | |
| Principal Investigator: Roshan Bastani, PhD | |
| Sub-Investigator: Annette E Maxwell, DrPH | |
| Sub-Investigator: Beth A Glenn, PhD | |
| Sub-Investigator: Angela Jo, MD | |
| Sub-Investigator: Weng Kee Wong, PhD | |
| Principal Investigator: | Roshan Bastani, PhD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Roshan Bastani, PhD / Professor and Associate Dean of Research, University of California, Los Angeles - School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00760721 History of Changes |
| Other Study ID Numbers: | P01CA109091-01A1 |
| Study First Received: | September 25, 2008 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
Hepatitis B Screening Korean Americans |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 19, 2013