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Increasing Hepatitis B Screening Among Korean Church Attendees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00760721
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Los Angeles

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatitis B Behavioral: Educational Small Group Session Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Obtaining HBV Screening Test [ Time Frame: 6 months post-intervention ]

Secondary Outcome Measures :
  1. Knowledge and Attitudes Regarding HBV Screening [ Time Frame: 6 months post-intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760721


Locations
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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
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Roshan Bastani, PhD University of California, Los Angeles
More Information
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Publications of Results:

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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00760721    
Other Study ID Numbers: P01CA109091-01A1 ( U.S. NIH Grant/Contract )
P01CA109091-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Keywords provided by University of California, Los Angeles:
Hepatitis B Screening
Korean Americans
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections