Increasing Hepatitis B Screening Among Korean Church Attendees

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Roshan Bastani, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00760721
First received: September 25, 2008
Last updated: June 4, 2015
Last verified: June 2015
  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 (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.


Condition Intervention Phase
Hepatitis B
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

Resource links provided by NLM:


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 ]

Enrollment: 1123
Study Start Date: September 2006
Study Completion Date: August 2012
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 health-related discussion
Sham Comparator: 2
Educational small group discussion, diet/physical activity resources provided
Behavioral: Educational Small Group Session
1 hour small group health-related discussion

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCLA, Division of Cancer Prevenion and Control Research
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Roshan Bastani, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Roshan Bastani, PI, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00760721     History of Changes
Other Study ID Numbers: P01CA109091-01A1, P01CA109091-01A1
Study First Received: September 25, 2008
Last Updated: June 4, 2015
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
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 30, 2015