Increasing Hepatitis B Screening Among Korean Church Atte... | NCT00760721

Studies
Increasing Hepatitis B Screening Among Korean Church Attendees

NCT00760721

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Nov 28, 2016Estimated

Enrollment

1,123Actual

Phase

Phase 3

Conditions

Hepatitis B

Interventions

Educational Small Group Session

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P01CA109091-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2016

Last Update Posted Date

Nov 28, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Educational small group session with HBV screening resources provided	Behavioral: Educational Small Group Session
2	Sham Comparator	Educational small group discussion, diet/physical activity resources provided	Behavioral: Educational Small Group Session

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational Small Group Session	Behavioral	1 hour small group health-related discussion	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obtaining HBV Screening Test		6 months post-intervention

Secondary Outcomes

Measure	Description	Time Frame
Knowledge and Attitudes Regarding HBV Screening		6 months post-intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roshan Bastani, PhD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA, Division of Cancer Prevenion and Control Research		Los Angeles	California	90095	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26104909	Result	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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections