Chronic Hepatitis B Virus (Hbv)NCT05621304
Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
An observational study of Chronic Hepatitis B Virus (Hbv), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Hepatitis B Virus (Hbv)
- How many people
- 274 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2017to 26 Feb 2026
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Foreign Born subjects with Chronic HBV
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
University of Southern California
Los Angeles, California, 90033
About this study
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.
Read more
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.
...
Read the detailed description
Study Description:
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
- Chronic Hepatitis B Virus (Hbv)
- Keywords
- Healthcare Retention, Natural History, Acculturation-Related Barriers
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Foreign Born subjects w/Chronic HBV | foreign born (FB) chronic hepatitis B subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start3 Jan 2017
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus (Hbv)Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christine C Hsu, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621304
- Sponsor's protocol ID
- 10001125
- Other IDs
- 001125-DK
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
- ClinicalTrials.gov ID
- NCT05621304
- Acronym / sponsor ID
- 10001125
- Conditions
- Chronic Hepatitis B Virus (Hbv)
- Keywords
- Healthcare Retention, Natural History, Acculturation-Related Barriers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 18 Nov 2022 (actual)
- 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.
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.
...
Detailed description
Study Description:
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foreign Born subjects w/Chronic HBV | – | –foreign born (FB) chronic hepatitis B subjects |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Foreign Born subjects with Chronic HBV
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Visit 1
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.
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 2 Mar 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Christine C Hsu, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B Virus (Hbv), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites 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 4 inclusion and 2 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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 (time frame: Visit 1). 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 2 Mar 2026.