Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05181956 |
| Other study ID # |
IN-US-980-6356 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
December 2021 |
| Source |
Asian Pacific Liver Center at Coalition of Inclusive Medicine |
| Contact |
Mimi Chang, D.N.P. |
| Phone |
2133871009 |
| Email |
mimi.chang[@]cimtoday.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Study is to
1. Understand the pattern of hepatitis delta screening among medical providers for Asian
patients with chronic hepatitis B
2. Determine the proportion of Asian hepatitis B patients who have been screened and who
have chronic hepatitis delta
3. Determine the pattern of hepatitis delta screening after education of medical providers
on hepatitis delta
Description:
Chronic hepatitis B (CHB) affects more than 257 million people world-wide with two-thirds of
CHB infected people living in Asia and Sub-Saharan Africa. Although the overall prevalence of
CHB is high in Asia, the regional prevalence varies; ranging from less than 0.5% in Japan to
greater than 12% in Vietnam and Cambodia. Hepatitis delta virus (HDV) is a satellite virus
that can infect individuals with hepatitis B virus (HBV) infection to the extent that at
least 15-20 million people are conservatively estimated to be chronically infected with HBV
and HDV. Chronic HBV/HDV infection is associated with more rapid progression to cirrhosis and
a higher incidence of hepatocellular carcinoma (HCC) compared to patients with CHB
mono-infection. Prevalence of chronic HBV/HDV remains high in Mongolia, the Mediterranean and
Sub-Saharan countries and in the Amazon basin but the true prevalence remains to be
determined among many populations and demic groups. Asian Americans are the fastest-growing
minority group in the United States, comprising a heterogeneous population from more than 60
different ethnic groups speaking more than 100 different languages, exhibiting substantial
socioeconomic diversity. While Asian Americans account for more than 60% of CHB infection in
the United States, CHB prevalence varies among the ethnic groups. Similarly, prevalence of
chronic hepatitis C and genotype distribution are different among the various Asian groups,
underscoring the importance of disaggregating ethnic populations in hepatitis research. We
recently reported the high prevalence of HDV infection among Mongolians living in Southern
California. However, HDV infection among other Asian-American groups has not been studied,
largely because outside of Mongolia and pockets in Vietnam, chronic HBV/HDV infection in Asia
appears to below.
Recommendations for routine screening for HDV from various major professional liver societies
are not consistent. Asian Pacific Association for the Study of the Liver (APASL) and the
European Association for the Study of the Liver (EASL) recommend HDV screening for all HBsAg
positive individuals. The American Association for the Study of Liver Diseases recommend
testing of HBsAg positive individuals with "low or undetectable HBV DNA but high ALT levels",
"persons who inject drugs, men who have sex with men, and immigrants from areas of high HDV
with endemicity". However, the accurate prevalence of HDV infection in Asia is not well
characterized.
To address this gap in knowledge, there is an important need to accurately characterize
prevalence, clinical testing patterns and the epidemiology of HDV infection among
disaggregated Asian-American groups.
This study will be conducted in 3 parts. The first part will involve a survey of hepatitis
delta (HDV) testing practices among 100-125 physicians and other health care providers that
have high volumes of Asian CHB patients. Special care will be made to include physicians and
health care providers for patients across different Asian ethnic communities. Almost 45% of
U.S. Asians live in the West with 30% residing in California alone. Chinese, Filipinos,
Vietnamese and Koreans account for the 4 largest Southeast Asian groups but there are large
communities of Thais, Cambodians and Burmese in Southern California and Hmongs in Central
California. With over 150,000 Armenians residing in Los Angeles, this is another ethnic group
that will be studied. Asian Pacific Liver Center (APLC) has worked closely with community CHB
health care providers in previous studies and will build on these collaborations. In
addition, APLC plans to collaborate with physicians from Texas (Vietnamese), Minnesota
(Hmong) and New York City (Chinese, Koreans). In addition, physicians and providers from
other settings will be surveyed; academic (USC, UCLA, Cedars-Sinai, Loma Linda, UCSD, UCSF,
Stanford, NYU, Mount-Sinai, University of Hawaii, Southwestern, University of Minnesota) and
large managed care organization (Southern California Kaiser, Veterans Administration and
Sutter Health). Response to this survey will provide an overview of current practice of HDV
testing and management among health care professionals with high numbers of Asian CHB
patients and also develop a collaboration for subsequent objectives. Each survey responder
will be asked to participate in the second and third parts of the study. Each responder will
be individually engaged by the PI with respect to the association of hepatitis delta and
chronic hepatitis B and the current guidelines and standards of practice for HDV testing
among all CHB patients.
The second part involves a chart review of 50-60 physicians and other providers who follow a
minimum of 100 CHB patients in their practice. A retrospective chart review will be performed
of all 18 years and older CHB patients with the collection of demographic and clinical data
including HDV testing results. These results will be compared with estimates based on
physicians' responses to the survey. The data extraction will be performed by trained
research coordinators familiar with chart reviews of CHB patients. The quality of data will
be regularly monitored by the PI and Mimi Chang DNP (who has conducted CHB studies for more
than 10 years).
The third part of the study involves prospectively testing all HDV-untested CHB patients
which is the recommendation of APASL and EAS and therefore the standard of care for Asian CHB
patients. Participating HCPs will be educated regarding the current recommendations for
hepatitis delta testing in patients with chronic hepatitis B, but they will not be coerced to
perform hepatitis delta testing nor will hepatitis delta testing be a requirement for
participation in the study.
Since CHB patients should be evaluated at least every 6 months, all 18 years and older CHB
patients in this study should be captured during the 12-month period of the study. The
combined data from part 2 and 3 will be used to calculate the prevalence of HDV among the
disaggregated Asian CHB patients. The demographic and clinical characteristics of HDV-CHB
co-infected patients will be compared to CHB mono-infected patients. During this study there
will be ample opportunity to educate those providing care on the current guidelines for
management of CHB patients, which includes testing for HDV.
The study protocol, documentation, data, and all other information generated will be held in
strict confidence. Data will be collected at multiple sites with procedures designed to
ensure the data's accuracy, confidentiality, and security. The PI will assign participating
healthcare providers a site number. Identifying information for the providers will be
accessed and stored at a secure locked location accessible to only APLC study team members
and destroyed upon completion of the study. Identifiable data for the CHB patients will not
be collected by assigning a unique numeric identifier. In addition, carefully specified
procedures will be adhered to in all aspects of data collection, analysis, and management
throughout the study. Standardized rules for entering data will be maintained to ensure the
uniformity of data. Patients' data will be entered into a central database at APLC, with a
secured access code. As APLC receives data from the participating sites, only the authorized
study team members will log in and review the records for completeness and data accuracy.
