Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study) (NCT05621304) | Clinical Trial Compass
CompletedNot Applicable
Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
United States274 participantsStarted 2017-01-03
Plain-language 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.
...
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
Individuals not able to understand and sign the informed consent document will not be included in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study specifically looked at foreign-born people with chronic hepatitis B who have lived in the US for less than 10 years — if that describes my situation, does my immigration timeline affect how well I've been able to move through the steps of HBV care, and is there anything my care team should be doing differently for me?
2The FOCUS-HBV study examined what's called the 'HBV care cascade' — things like getting diagnosed, linked to care, monitored, and treated — so can you walk me through where I currently stand in that cascade and whether there are any gaps in my care we should address?
3Since this was an observational study rather than a treatment trial, it didn't test a new drug or therapy — so based on what research like this is finding about barriers for foreign-born patients, are there specific support services, language resources, or community programs you'd recommend to help me stay engaged in my hepatitis B care?
4Chronic hepatitis B can progress to serious liver disease over time, and studies like this one focus on making sure patients don't fall through the cracks after diagnosis — given my specific background and circumstances, how will you make sure I'm being monitored at the right intervals and considered for treatment if I need it?
5This study focused on foreign-born individuals as a group that may face unique challenges in navigating HBV care in the US — are there any cultural, financial, or insurance-related barriers you think might affect my ability to get consistent care, and how can we plan around them?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Visit 1
Trial details
NCT IDNCT05621304
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)