Increasing Hepatitis B Screening Among Korean Church Attendees

NCT ID: NCT00760721

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Hepatitis B

Keywords

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Hepatitis B Screening Korean Americans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Educational small group session with HBV screening resources provided

Group Type EXPERIMENTAL

Educational Small Group Session

Intervention Type BEHAVIORAL

1 hour small group health-related discussion

2

Educational small group discussion, diet/physical activity resources provided

Group Type SHAM_COMPARATOR

Educational Small Group Session

Intervention Type BEHAVIORAL

1 hour small group health-related discussion

Interventions

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Educational Small Group Session

1 hour small group health-related discussion

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshan Bastani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA, Division of Cancer Prevenion and Control Research

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26104909 (View on PubMed)

Other Identifiers

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P01CA109091-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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P01CA109091-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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