Community-based Hepatitis B Interventions for Hmong Adults

May 24, 2017 updated by: University of California, Davis
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Hmong Americans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBV Screening
Small group educational session with HBV screening resources provided.
Behavioral: HBV Screening - Small group educational session
Small group HBV focused discussion with HBV screening resources.
Other Names:
  • Hepatitis B screening in Hmong population
Sham Comparator: Nutrition
Small group educational discussion, diet & nutrition resources provided.
Behavioral: Nutrition - Small group educational session
Small group session with diet & nutrition focused, topic related resources provided.
Other Names:
  • Nutritional education for the Hmong population.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200614458
  • P01CA109091 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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