Liver CancerNCT00888407
Community-based Hepatitis B Interventions for Hmong Adults
A study testing HBV Screening - Small group educational session and Nutrition - Small group educational session in people with Liver Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Hmong Americans. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- HBV Screening - Small group educational session and Nutrition - Small group educational session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-64 years
- Hmong ancestry
- Never have been tested for Hepatitis B
Who cannot join
- Children under the age of 18 years
- Adults over the age of 64 years
- Non-Hmong ancestry
- Previous testing of Hepatitis B
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Cancer Center
Sacramento, California, 95817
About this study
The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Hmong Americans.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- HBV Screening - Small group educational session, Nutrition - Small group educational session
- Keywords
- Asian American Health, Cancer, Hepatitis, Hepatitis B, Liver Cancer
- Medical subject headings
- Liver Neoplasms, Neoplasms, Hepatitis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV Screening - Small group educational sessionBehavioural
Also called Hepatitis B screening in Hmong population
Small group HBV focused discussion with HBV screening resources.
Nutrition - Small group educational sessionBehavioural
Also called Nutritional education for the Hmong population.
Small group session with diet \& nutrition focused, topic related resources provided.
| Study group | Role | What they receive |
|---|---|---|
| HBV Screening | Experimental | Small group educational session with HBV screening resources provided. Receives: Behavioral: HBV Screening - Small group educational session |
| Nutrition | Sham comparator | Small group educational discussion, diet \& nutrition resources provided. Receives: Behavioral: Nutrition - Small group educational session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain HBV Screening Test
Measured: September 2006-August 2011
Secondary outcomes (1)
Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition
Measured: September 206 - August 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startSep 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Moon S. Chen, Jr., PhD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888407
- Sponsor's protocol ID
- 200614458
- Other IDs
- P01CA109091
- Status last verified
- Dec 2015
- First submitted
- 23 Apr 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Hepatitis B Interventions for Hmong Adults
- ClinicalTrials.gov ID
- NCT00888407
- Acronym / sponsor ID
- 200614458
- Conditions
- Liver Cancer
- Keywords
- Asian American Health, Cancer, Hepatitis, Hepatitis B, Liver Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Sep 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBV Screening | Experimental | Behavioral: HBV Screening - Small group educational sessionSmall group educational session with HBV screening resources provided. |
| Nutrition | Sham comparator | Behavioral: Nutrition - Small group educational sessionSmall group educational discussion, diet \& nutrition resources provided. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-64 years
- Hmong ancestry
- Never have been tested for Hepatitis B
Key exclusion criteria (4 listed)
- Children under the age of 18 years
- Adults over the age of 64 years
- Non-Hmong ancestry
- Previous testing of Hepatitis B
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBV Screening - Small group educational sessionAlso: Hepatitis B screening in Hmong populationSmall group HBV focused discussion with HBV screening resources. | Behavioural | HBV Screening |
| Nutrition - Small group educational sessionAlso: Nutritional education for the Hmong population.Small group session with diet \& nutrition focused, topic related resources provided. | Behavioural | Nutrition |
Primary outcome
Obtain HBV Screening Test
Time frame: September 2006-August 2011
1 secondary outcome
Knowledge and Attitudes Regarding Hepatitis B, Health and Nutrition
Time frame: September 206 - August 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moon S. Chen, Jr., PhD, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBV Screening - Small group educational session and Nutrition - Small group educational session in people with Liver Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain HBV Screening Test (time frame: September 2006-August 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.