Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
NCT ID: NCT05621304
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
255 participants
OBSERVATIONAL
2017-01-03
2025-12-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
People who were born outside of the country are the largest group of adults infected with chronic hepatitis B virus (HBV) in the US. HBV affects the liver. If not treated, HBV infection can lead to serious liver disease, including cancer. One recent study showed that only 35% of foreign-born US adults were aware of their HBV infections. Foreign-born US adults may also have trouble getting proper care after they are diagnosed with HBV. In one small survey, language, cultural, and financial barriers were cited as the biggest reasons for not receiving care. To help more people with HBV, researchers want to learn how to find and overcome any barriers to care.
Objective:
This natural history study seeks to identify and better understand barriers that prevent foreign-born US adults from getting proper care for HBV infections.
Eligibility:
People aged 18 years and older with chronic HBV who were born outside of the US.
Design:
Participants will visit the NIH clinic 1 time. This visit will take about 20 minutes.
Researchers will review participants medical records and collect information about their HBV.
Participants will complete a survey. They will answer questions about:
Where they came from.
When they came to the US.
How well they have adapted to living in the US.
The health care they have received for HBV.
Their age, gender, and education.
Participants will be paid $10 for completing the survey.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is an observational, prospective study in which Foreign-Born (FB) participants with chronic hepatitis B virus (HBV) will be consented and then surveyed to better understand and identify acculturation-related barriers in the HBV care cascade and to optimize healthcare retention for those with HBV.
Objectives:
Primary Objective:
-To assess the association between recent immigration (defined by less than 10 years length of residence in US) and progression through the HBV care cascade post-diagnosis among foreign-born diagnosed with chronic HBV infection.
Secondary Objectives:
* To characterize and quantify completion of HBV care metrics after diagnosis (both proportion and time to completion) for a multi-ethnic cohort of foreign-born adults
* To compare gaps in completion of post-diagnosis care metrics by recent immigrant status and racial/ethnic group
* To develop and pilot a multi-national survey instrument to accurately and reliably measure immigration-related factors
* To determine impact of immigration-related factors (e.g. acculturation, language proficiency, region of origin) on completion of care metrics overall and among recent immigrants
Endpoints:
Primary Endpoint:
-The primary endpoint is to assess the proportion of FB diagnosed with HBV who have completed an initial visit for diagnosis of chronic HBV infection (defined as a visit with either primary or specialty provider during which testing for treatment eligibility was ordered).
Secondary Endpoints:
* Completion of testing to determine eligibility for treatment
* Minimum sufficient set of labs including hepatitis B e-antigen (HBeAg), ALT, HBV DNA, and HIV testing
* Fibrosis assessment which can be non-invasive (FIB-4/APRI, US elastography or MR elastography) or invasive (liver biopsy)
* Treatment uptake if eligible based on AASLD guidelines on treatment eligibility
* HBV DNA\>2000 IU/mL and ALT\>2x ULN if HBeAgnegative
* HBV DNA\>20000 IU/mL and ALT\>2x ULN if HBeAgpositive
* Cirrhosis or HCC
* Family history of HCC
* Retention in care
* At least annual visit for HBV diagnosis with appropriate lab tests ordered
* Ultrasound and AFP for HCC surveillance screening for those who are indicated
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Foreign Born subjects w/Chronic HBV
foreign born (FB) chronic hepatitis B subjects
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female, aged \>=18 years
* Diagnosed of chronic HBV (HBsAg-positive)
* Self-reported country of birth outside of the US
Exclusion Criteria
-Individuals not able to understand and sign the informed consent document will not be included in the study.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christine C Hsu, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Southern California
Los Angeles, California, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kali Zhou
Role: primary
NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
001125-DK
Identifier Type: -
Identifier Source: secondary_id
10001125
Identifier Type: -
Identifier Source: org_study_id