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Increasing Hepatitis B Screening Among Korean Church Attendees

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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

Tracking Information
First Submitted Date  ICMJE September 25, 2008
First Posted Date  ICMJE September 26, 2008
Last Update Posted Date November 28, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2008)
Obtaining HBV Screening Test [ Time Frame: 6 months post-intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2008)
Knowledge and Attitudes Regarding HBV Screening [ Time Frame: 6 months post-intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Hepatitis B Screening Among Korean Church Attendees
Official Title  ICMJE Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE Hepatitis B
Intervention  ICMJE Behavioral: Educational Small Group Session
1 hour small group health-related discussion
Study Arms  ICMJE
  • Experimental: 1
    Educational small group session with HBV screening resources provided
    Intervention: Behavioral: Educational Small Group Session
  • Sham Comparator: 2
    Educational small group discussion, diet/physical activity resources provided
    Intervention: Behavioral: Educational Small Group Session
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2015)
1123
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2008)
850
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00760721
Other Study ID Numbers  ICMJE P01CA109091-01A1( U.S. NIH Grant/Contract )
P01CA109091-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Roshan Bastani, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP