Community-Based Hepatitis B Interventions for Hmong Adults

This study is enrolling participants by invitation only.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Information provided by:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT00888407

First received: April 23, 2009

Last updated: April 24, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 23, 2009

Last Updated Date

April 24, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Obtain HBV Screening Test [ Time Frame: September 2006-August 2011 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00888407 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition [ Time Frame: September 206 - August 2011 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Community-Based Hepatitis B Interventions for Hmong Adults

Official Title ^ICMJE

Community-Based Hepatitis B Interventions for Hmong Adults

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Liver Cancer

Intervention ^ICMJE

Behavioral: HBV Screening - Small group educational session
Small group HBV focused discussion with HBV screening resources.

Other Name: Hepatitis B screening in Hmong population
Behavioral: Nutrition - Small group educational session
Small group session with diet & nutrition focused, topic related resources provided.

Other Name: Nutritional education for the Hmong population.

Study Arm (s)

Experimental: HBV Screening
Small group educational session with HBV screening resources provided.

Intervention: Behavioral: HBV Screening - Small group educational session
Sham Comparator: Nutrition
Small group educational discussion, diet & nutrition resources provided.

Intervention: Behavioral: Nutrition - Small group educational session

Publications *

Not Provided

* 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

Enrolling by invitation

Estimated Enrollment ^ICMJE

1500

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00888407

Other Study ID Numbers ^ICMJE

200614458-3, P01CA109091

Has Data Monitoring Committee

Responsible Party

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

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Moon S. Chen, Jr., PhD, MPH

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

April 2009

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

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