Increasing Hepatitis B Screening Among Korean Church Attendees

Hepatitis B Clinical Trial

Official title:

Increasing Hepatitis B Screening Among Korean Church Attendees (Component Project) Program Project Title: Liver Cancer Control Interventions for Asian Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760721
• Other study ID #: P01CA109091-01A1
• Secondary ID: P01CA109091-01A1
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: November 23, 2016
• Start date: September 2006
• Est. completion date: August 2012

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1123
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Behavioral:
• Educational Small Group Session
1 hour small group health-related discussion

Locations

Country	Name	City	State
United States	UCLA, Division of Cancer Prevenion and Control Research	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtaining HBV Screening Test		6 months post-intervention	No
Secondary	Knowledge and Attitudes Regarding HBV Screening		6 months post-intervention	No