Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa

Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa: a Collaborative Multi-country Prospective Cohort Analysis for International Epidemiologic Databases to Evaluate AIDS- Southern Africa (HIV/HBV-coinfection in IeDEA-SA)

This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.

The study will take place during routinely scheduled ART visits as per Ministry of Health guidelines. Routinely collected programmatic data will be used to assess general HIV outcomes (CD4 response, loss to follow-up, death) as well as collecting study specific data (hepatitis testing, questionnaire regarding risk factors for hepatitis/liver disease, and non-invasive liver scan) to address other aims. The study will be implemented at two sites in Southern Africa (Zambia and Mozambique) with a total enrollment across all sites of 1,900 participants. The Zambia site will only enroll 900.

Inclusion Criteria:

• HIV-infected
• Male or female aged ≥18 years
• ART naïve
• ART eligible as defined by Zambian or WHO treatment guidelines
• Initiating an ART regimen including at least 3 drugs at one of the study sites.
• Willing to provide signed informed consent and be followed at the clinical site.

Exclusion Criteria:

• Patients who are not planning to remain in the catchment area from which they were recruited for the duration of the study