Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
2 other identifiers
observational
274
1 country
2
Brief Summary
Background: 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. ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2017
CompletedFirst Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2026
CompletedMarch 2, 2026
February 1, 2026
9.2 years
November 16, 2022
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
The reason for this distinction is to separate visits for screening from linkage to care, which may in some clinics occur with the same provider.
Visit 1
Study Arms (1)
Foreign Born subjects w/Chronic HBV
foreign born (FB) chronic hepatitis B subjects
Eligibility Criteria
Foreign Born subjects with Chronic HBV
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged \>=18 years
- Diagnosed of chronic HBV (HBsAg-positive)
- Self-reported country of birth outside of the US
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Individuals not able to understand and sign the informed consent document will not be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Southern California
Los Angeles, California, 90033, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine C Hsu, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 18, 2022
Study Start
January 3, 2017
Primary Completion
February 26, 2026
Study Completion
February 26, 2026
Last Updated
March 2, 2026
Record last verified: 2026-02