Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-01 @ 8:15 PM
Study NCT ID:
NCT05621304
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05-14', 'completionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthcare Retention', 'Natural History', 'Acculturation-Related Barriers'], 'conditions': ['Chronic Hepatitis B Virus (Hbv)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_001125-DK.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nPeople 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.\n\nObjective:\n\nThis natural history study seeks to identify and better understand barriers that prevent foreign-born US adults from getting proper care for HBV infections.\n\nEligibility:\n\nPeople aged 18 years and older with chronic HBV who were born outside of the US.\n\nDesign:\n\nParticipants will visit the NIH clinic 1 time. This visit will take about 20 minutes.\n\nResearchers will review participants medical records and collect information about their HBV.\n\nParticipants will complete a survey. They will answer questions about:\n\nWhere they came from.\n\nWhen they came to the US.\n\nHow well they have adapted to living in the US.\n\nThe health care they have received for HBV.\n\nTheir age, gender, and education.\n\nParticipants will be paid $10 for completing the survey.', 'detailedDescription': 'Study Description:\n\nThis 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.\n\nObjectives:\n\nPrimary Objective:\n\n-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.\n\nSecondary Objectives:\n\n* 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\n* To compare gaps in completion of post-diagnosis care metrics by recent immigrant status and racial/ethnic group\n* To develop and pilot a multi-national survey instrument to accurately and reliably measure immigration-related factors\n* 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\n\nEndpoints:\n\nPrimary Endpoint:\n\n-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).\n\nSecondary Endpoints:\n\n* Completion of testing to determine eligibility for treatment\n\n * Minimum sufficient set of labs including hepatitis B e-antigen (HBeAg), ALT, HBV DNA, and HIV testing\n * Fibrosis assessment which can be non-invasive (FIB-4/APRI, US elastography or MR elastography) or invasive (liver biopsy)\n* Treatment uptake if eligible based on AASLD guidelines on treatment eligibility\n\n * HBV DNA\\>2000 IU/mL and ALT\\>2x ULN if HBeAgnegative\n * HBV DNA\\>20000 IU/mL and ALT\\>2x ULN if HBeAgpositive\n * Cirrhosis or HCC\n * Family history of HCC\n* Retention in care\n\n * At least annual visit for HBV diagnosis with appropriate lab tests ordered\n * Ultrasound and AFP for HCC surveillance screening for those who are indicated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Foreign Born subjects with Chronic HBV', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Male or female, aged \\>=18 years\n* Diagnosed of chronic HBV (HBsAg-positive)\n* Self-reported country of birth outside of the US\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Individuals not able to understand and sign the informed consent document will not be included in the study.'}, 'identificationModule': {'nctId': 'NCT05621304', 'briefTitle': 'Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)', 'orgStudyIdInfo': {'id': '10001125'}, 'secondaryIdInfos': [{'id': '001125-DK'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foreign Born subjects w/Chronic HBV', 'description': 'foreign born (FB) chronic hepatitis B subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kali Zhou', 'role': 'CONTACT', 'email': 'kali.zhou@med.usc.edu', 'phone': 'Not Listed'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'NIH Clinical Center Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Jaha F Norman-Wheeler', 'role': 'CONTACT', 'email': 'jaha.norman-wheeler@nih.gov', 'phone': '(301) 435-6122'}, {'name': 'Christine C Hsu, M.D.', 'role': 'CONTACT', 'email': 'christine.hsu@nih.gov', 'phone': '(301) 443-9908'}], 'overallOfficials': [{'name': 'Christine C Hsu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}