Clinical trial NCT05621304: Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
Official title: Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B Virus (Hbv)
Keywords: Healthcare Retention
Natural History
Acculturation-Related Barriers
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2022-11-18
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Foreign Born subjects with Chronic HBV

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.

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

Eligibility criteria: * INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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.

Primary outcomes:
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
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Christine C Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: