search
Back to results

Community-based Hepatitis B Interventions for Hmong Adults

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HBV Screening - Small group educational session
Nutrition - Small group educational session
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cancer focused on measuring Asian American Health, Cancer, Hepatitis, Hepatitis B, Liver Cancer

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC Davis Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HBV Screening

Nutrition

Arm Description

Small group educational session with HBV screening resources provided.

Small group educational discussion, diet & nutrition resources provided.

Outcomes

Primary Outcome Measures

Obtain HBV Screening Test

Secondary Outcome Measures

Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition

Full Information

First Posted
April 23, 2009
Last Updated
May 24, 2017
Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00888407
Brief Title
Community-based Hepatitis B Interventions for Hmong Adults
Official Title
Community-based Hepatitis B Interventions for Hmong Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Asian American Health, Cancer, Hepatitis, Hepatitis B, Liver Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBV Screening
Arm Type
Experimental
Arm Description
Small group educational session with HBV screening resources provided.
Arm Title
Nutrition
Arm Type
Sham Comparator
Arm Description
Small group educational discussion, diet & nutrition resources provided.
Intervention Type
Behavioral
Intervention Name(s)
HBV Screening - Small group educational session
Other Intervention Name(s)
Hepatitis B screening in Hmong population
Intervention Description
Small group HBV focused discussion with HBV screening resources.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition - Small group educational session
Other Intervention Name(s)
Nutritional education for the Hmong population.
Intervention Description
Small group session with diet & nutrition focused, topic related resources provided.
Primary Outcome Measure Information:
Title
Obtain HBV Screening Test
Time Frame
September 2006-August 2011
Secondary Outcome Measure Information:
Title
Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition
Time Frame
September 206 - August 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moon S. Chen, Jr., PhD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Community-based Hepatitis B Interventions for Hmong Adults

We'll reach out to this number within 24 hrs