Increasing Hepatitis B Screening Among Korean Church Attendees - Full Text View

Sponsors and Collaborators:	University of California, Los Angeles National Institutes of Health (NIH) National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00760721

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 850 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 III

MedlinePlus related topics: Asian-American Health Cancer Hepatitis Hepatitis B Liver Cancer

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Obtaining HBV Screening Test [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge and Attitudes Regarding HBV Screening [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	850
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
1: Experimental 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
2: Sham Comparator 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760721

Contacts

Contact: Roshan Bastani, PhD	310-206-9266	bastani@ucla.edu
Contact: Beth A Glenn, PhD	310-206-9715	bglenn@ucla.edu

Locations

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

Sponsors and Collaborators

University of California, Los Angeles

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Roshan Bastani, PhD

University of California, Los Angeles

More Information

Responsible Party:	University of California, Los Angeles - School of Public Health ( Roshan Bastani, PhD / Professor and Associate Dean of Research )
Study ID Numbers:	P01CA109091-01A1
Study First Received:	September 25, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00760721
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Hepatitis B Screening
Korean Americans

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Neoplasms
Liver Diseases
Digestive System Diseases

Liver neoplasms
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009