Africa, Alcohol Use Disorder, Antiretroviral Therapy, Hepatitis B Virus, HIV, Liver Fibrosis
Conditions
Keywords
antiretroviral therapy, Hepatitis C virus
Brief summary
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.
Detailed description
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.
Interventions
OTHERStandard of care
routine standard of care per Ministry of Health protocol including blood draws and examinations.
Sponsors
Centre for Infectious Disease Research in Zambia
University of Bern
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunological response | 12 months post enrollment | A linear mixed effect model will be used to evaluate immunological response to ART in patients with and without viral hepatitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 12 months | Deaths will be ascertained |
| Hepatotoxicity events | 6 and 12 months | These events will be defined as an increase in the level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 time the upper limit within the first year of ART. |
| Prevalence liver fibrosis | Baseline and one year after start of ART | The prevalence of liver fibrosis will be measured to compare HIV/hepatitis coinfected versus HIV monoinfected patients using transient elastography. |
| HIV virological response | 12 months post enrollment | Virological response will be evaluated using Cox regression analyses. |
| Incidence of HBV infection | 12 and 24 months post enrollment | The incidence of HBV infection during ART will be measured. |
| Prevalence of HIV/HCV coinfection | Baseline | Describe prevalence of coinfection at ART initiation |
| Alcohol use patterns | Baseline, 12, and 24 months | Describe the proportion with unhealthy levels of drinking before and after ART |
| HBV drug resistance | 1 and 2 years post enrollment | The presence of HBV drug resistance in co-infected patients who fail treatment after 1 year will be measured |
Countries
Zambia
Outcome results
None listed