Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

NCT ID: NCT02766933

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2024-12-31

Brief Summary

The natural history and response to therapy of chronic hepatitis B infection in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will be offered enrollment. Disease monitoring and treatment will be provided following current WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens will be frozen for future analysis.

Detailed Description

Chronic hepatitis B (CHB) is common in Cameroon, and hepatitis B-related hepatocellular carcinoma is a leading cause of cancer death throughout West and Central Africa. Little is known about the natural history of CHB in sub-Saharan Africa and the long term response to antiviral therapy. The study hypothesis is that these can be determined by prospective follow-up of a population-based cohort.

Aims, purpose, or objectives:

1. To determine the characteristics of a population of asymptomatic Cameroonian adults who work for the Cameroon Baptist Convention Health Board (CBCHB) who have chronic hepatitis B infection.

2. To determine the phase of infection into which these Hepatitis B carriers fall.

3. To determine the incidence and risk factors for cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma in this cohort over time.

4. To offer treatment according to a standardized protocol, and to determine the outcome of treatment.

5. To archive serum samples from patients for potential future studies of specific markers associated with hepatitis B and liver disease outcomes.

Methods: Adult employees of the Cameroon Baptist Convention Health Board (CBCHB) and their spouses who are known to be positive for hepatitis B surface antigen (HBsAg+) will be offered the enrollment in a cohort study for CHB. Following enrollment, their stage of disease will be determined using clinical, laboratory and imaging studies. Patients will then be followed at regular intervals for 5 years. Antiviral therapy will be offered to patients who qualify according to current World Health Organization guidelines.

Significance: This protocol will prospectively determine the scope of CHB-related illness in an initially asymptomatic, population-based cohort and the outcomes of current WHO treatment guidelines in this African cohort.

Conditions

Hepatitis B; Hepatitis B, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

hepatitis B cohort

CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age at least 18yrs.
• CBCHB employee or spouse of an employee.
• Able to provide written informed consent.
• Willing to comply with follow-up visits.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cameroon Baptist Convention Health

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Lewis R. Roberts

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norah Nyah, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cameroon Baptist Convention Health Board

Locations

Mbingo Baptist Hospital

Bamenda, Northwest, Cameroon

Countries

Cameroon

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-001716

Identifier Type: -

Identifier Source: org_study_id