Community-based Hepatitis B Interventions for Hmong Adults | NCT00888407

Studies
Community-based Hepatitis B Interventions for Hmong Adults

NCT00888407

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

1,500Actual

Phase

Not Applicable

Conditions

Liver Cancer

Interventions

HBV Screening - Small group educational session
Nutrition - Small group educational 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	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2015

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 2011Actual

First Submitted Date

Apr 23, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 27, 2009Estimated

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

May 24, 2017

Last Update Posted Date

May 30, 2017Actual

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 Hmong Americans.

Detailed Description

The investigators will design an intervention to measure the baseline proportion of Hmong adults (ages 18-64) that have been serologically tested for Hepatitis B. Investigators will work with lay health workers to promote serologically testing for Hepatitis B and increase knowledge of Hepatitis B among Hmong adults. The effectiveness of the lay health worker intervention will be evaluated by conducting a randomized, controlled trial among Hmong adults aged 18-64 not previously tested for hepatitis B.

The primary hypothesis is that the proportion of Hmong adults, ages 18-64 reporting serologically testing for Hepatitis B at post-test will be significantly greater in the intervention group than in the control group.

Secondary hypotheses are:

There will be greater increases in knowledge of Hepatitis B and liver cancer in the intervention group than in the control group.

Participants with greater knowledge of hepatitis B and liver cancer at post-test will be more likely to be serologically tested for hepatitis B.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HBV Screening	Experimental	Small group educational session with HBV screening resources provided.	Behavioral: HBV Screening - Small group educational session
Nutrition	Sham Comparator	Small group educational discussion, diet & nutrition resources provided.	Behavioral: Nutrition - Small group educational session

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HBV Screening - Small group educational session	Behavioral	Small group HBV focused discussion with HBV screening resources.	HBV Screening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obtain HBV Screening Test		September 2006-August 2011

Secondary Outcomes

Measure	Description	Time Frame
Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition		September 206 - August 2011

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-64 years
Hmong ancestry
Never have been tested for Hepatitis B

Exclusion Criteria:

Children under the age of 18 years
Adults over the age of 64 years
Non-Hmong ancestry
Previous testing of Hepatitis B

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
Moon S. Chen, Jr., PhD, MPH	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Cancer Center		Sacramento	California	95817	United States

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms
D009369	Neoplasms
D006505	Hepatitis
D006509	Hepatitis B

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

Browse Leaves

Not provided

Browse Branches

Not provided