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Protocol Details

Optimizing HBV Care Cascade among Foreign-Born in the United States (FOCUS-HBV Study)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001125-DK

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required

Yes

Population Exclusion(s)

Pregnant Women;
Adults who are or may become unable to consent;
Children

Keywords

Healthcare Retention;
Natural History;
Acculturation-Related Barriers

Recruitment Keyword(s)

None

Condition(s)

Chronic Hepatitis B Virus (Hbv)

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Christine C. Hsu, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CLINICAL CENTER BG RM 10N248
10 CENTER DR
BETHESDA MD 20892
(301) 443-9908
christine.hsu@nih.gov

Jaha F. Norman-Wheeler
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 4-5722
10 CENTER DR
BETHESDA MD 20814
(301) 435-6122
jaha.norman-wheeler@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05621304

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