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Community-based Hepatitis B Interventions for Hmong Adults

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ClinicalTrials.gov Identifier: NCT00888407
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Liver Cancer Behavioral: HBV Screening - Small group educational session Behavioral: Nutrition - Small group educational session Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Community-based Hepatitis B Interventions for Hmong Adults
Study Start Date : September 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. Obtain HBV Screening Test [ Time Frame: September 2006-August 2011 ]

Secondary Outcome Measures :
  1. Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition [ Time Frame: September 206 - August 2011 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00888407     History of Changes
Other Study ID Numbers: 200614458
P01CA109091 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: December 2015

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

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