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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
  Purpose

The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Hmong Americans.


Condition Intervention
Liver Cancer
 Behavioral: HBV Screening - Small group educational session
Behavioral: Nutrition - Small group educational session

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Community-Based Hepatitis B Interventions for Hmong Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

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

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

Estimated Enrollment: 1500
Study Start Date: September 2006
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Nutritional education for the Hmong population.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888407

Locations
United States, California
UC Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Moon S. Chen, Jr., PhD, MPH University of California, Davis
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Moon S. Chen, Jr., PhD, MPH, University of California, Davis
ClinicalTrials.gov Identifier: NCT00888407     History of Changes
Other Study ID Numbers: 200614458-3, P01CA109091
Study First Received: April 23, 2009
Last Updated: April 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Asian American Health
Cancer
Hepatitis
Hepatitis B
Liver Cancer

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013