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NCT00888407 Clinical Trial

Community-based Hepatitis B Interventions for Hmong Adults

Liver Cancer Clinical Trial

Official title:
Community-based Hepatitis B Interventions for Hmong Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00888407
Other study ID # 200614458
Secondary ID P01CA109091
Status Completed
Phase N/A
First received April 23, 2009
Last updated May 24, 2017
Start date September 2006
Est. completion date August 2011

Study information
Verified date December 2015
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• HBV Screening - Small group educational session
Small group HBV focused discussion with HBV screening resources.
• Nutrition - Small group educational session
Small group session with diet & nutrition focused, topic related resources provided.

Locations
Country Name City State
United States UC Davis Cancer Center Sacramento California

Sponsors (3)
Lead Sponsor Collaborator
University of California, Davis National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Obtain HBV Screening Test September 2006-August 2011
Secondary Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition September 206 - August 2011
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