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| Name | Class |
|---|---|
| University Teaching Hospital | UNKNOWN |
| Tropical Gastroenterology and Nutrition Group | UNKNOWN |
| Centre for Infectious Disease Research in Zambia | OTHER |
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The purpose of this study is to recruit a random and representative sample of individuals within several Zambian communities for markers of Hepatitis B Virus (HBV) and to characterize chronic HBV infection and indications for treatment.
The Zambian Ministry of Health (MoH) considers viral hepatitis a significant public health threat; however, there are limited representative data on HBV burden, risk factors, clinical significance, and interaction with co-infections and co-morbidities that are common in Zambia. In collaboration with the Central Statistical Office, MoH, and Centers for Disease Control and Prevention, the Zambia Population-Based HIV Impact Assessment (ZAMPHIA) will be testing a representative sample of Zambians across all 10 provinces for HBV infection. This is an important first step toward understanding the burden of disease and its distribution across the country. The goal of this study is to generate further information for consumption by local and regional health policymakers. The Investigators will research the epidemiologic risk factors for lifetime and current HBV infection, characterize clinical features of chronic HIV in Zambia, and describe key virological, serological, and comorbid factors that are critical to developing the best policies for HBV control in Zambia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals from selected households | Individuals residing in selected households in Lusaka Province, Zambia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estimates - prevalence of lifetime/chronic HBV infection | Other | Estimation of the prevalence and correlates of lifetime HBV infection defined as hepatitis B core antibody (HBcAb) positivity and chronic HBV infection defined as HBsAg positivity. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence and correlates of lifetime HBV infection | Estimates of the prevalence and correlates of lifetime HBV infection defined as hepatitis B core antibody (HBcAb) positivity and chronic HBV infection defined as HBsAg positivity in randomly selected households in Lusaka Province in Zambia. Identification of individual (such as age or sex) and community (such as province) correlates of lifetime and chronic HBV infection. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Zambian adults who require antiviral therapy for chronic HBV infection | Estimate the proportion of Zambian adults who require antiviral therapy for chronic HBV infection in randomly selected households in Lusaka Province in Zambia. | within 1 month of part 1 |
| Clinical phenotypes of patients with chronic HBV infection |
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Inclusion Criteria:
Exclusion Criteria:
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Part 1: 6,000 individuals residing in randomly selected households in Lusaka Province in Zambia regardless of the clinically health status.
Part 2: All part 1 participants who test HBsAg-positive (anticipated sample size of 250) during community testing.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Vinikoor, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Teaching Hospital | Lusaka | Zambia |
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| Ministry of Health, Zambia |
| OTHER_GOV |
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Part 1: The Investigators will test for active HBV infection using a rapid point-of-care HBsAg test. In addition, as a service to clients who have not had an HIV test in the past year (as recommended by Ministry of Health), for 10% of participants (selected randomly at household level), the Investigators will also collect a dried blood spot using finger prick method to perform HBcAb test, an epidemiologic test for lifetime exposure to HBV.
Part 2: Participants will have physical examination, a liver ultrasound, transient elastography (TE), and blood will be collected for HBV viral load and other markers.
Determining clinical phenotypes (such as chronic active or inactive) of patients with chronic HBV infection. |
| within 1 month of part 1 |
| Frequency of primary drug resistance mutations. | Frequency of primary drug resistance mutations. | within 1 month of part 1 |
| The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis. | Estimate the proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis using non-invasive tests. | within 1 month of part 1 |
| Unhealthy alcohol use in HBV-positive patients | Proportion of unhealthy alcohol users measured with the Alcohol Use Disorders Identification Test, and the association of unhealthy alcohol use with liver fibrosis markers among patients with chronic HBV infection. Among participants in part 2 of the study, the Investigators will also describe the prevalence of unhealthy drinking using data from the AUDIT-C screen. The Investigators will categorize patients as 'unhealthy drinkers' if the AUDIT-C score is >3 for men and >2 for women. The Investigators will also assess hepatosplenic schistosomiasis, defined by grade 2 or grade 3 periportal liver fibrosis on abdominal ultrasound. The Investigators will use bivariable and multivariable regression to compare liver fibrosis markers by AUDIT-C score (non/moderate drinkers versus unhealthy drinkers). | within 1 month of part 1 |
| Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection | Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection. The Investigators will also assess hepatosplenic schistosomiasis, defined by grade 2 or grade 3 periportal liver fibrosis on abdominal ultrasound. The Investigators will use bivariable and multivariable regression to compare liver fibrosis markers by the presence of hepatosplenic schistosomiasis. | within 1 month of part 1 |
| HIV prevalence in HBV-patients | HIV prevalence in HBV-patients by self-report or rapid test. | within 1 month of part 1 |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |