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临床试验/NCT05621304
NCT05621304招募中不适用

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2017年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
255
试验地点
2
主要终点
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

研究概览

简要总结

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.

...

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Foreign Born subjects w/Chronic HBV

foreign born (FB) chronic hepatitis B subjects

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

研究点 (2)

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