In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL.
HIV co-infection drastically increases the risk of developing active VL. Clinical outcomes are dire in immune-compromised patients even with the best available treatment, and relapse is frequent. The incubation period may provide an important window of opportunity for a pre-emptive "screen an treat" approach in HIV co-infected patients to prevent progression from infection to the active disease. However, no recommendations exist to date due to lack of solid evidence. It is not known which patients are at highest risk of disease progression, which role parasite/host/HIV factors play in the asymptomatic infection phase, and what the diagnostic values of existing Leishmania infection markers are. Such information is needed to develop a prognostic clinical tool for the detection of HIV patients at high risk of developing active VL. Therefore, the aim is to study the asymptomatic period preceding the onset of active VL in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL. This will be a prospective cohort study with one year of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed until the end of the study duration.
Study Type
OBSERVATIONAL
Enrollment
566
No intervention
Abdurafi Health Center
Ābderafī, Amhara, Ethiopia
Prevalence of asymptomatic Leishmania infection
The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
Time frame: January 2018
Incidence rate of asymptomatic Leishmania infection
The number of individuals with newly diagnosed asymptomatic Leishmania infection per person-years at risk during follow-up, among participants without Leishmania infection at enrolment
Time frame: January 2020
Evolution of Leishmania infection markers
The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
Time frame: January 2020
Incidence rate of active VL
The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
Time frame: January 2020
Risk factors for active VL
The association between the risk to develop active VL during follow-up and demographic/clinical characteristics as well as HIV/host immunity/Leishmania infection markers from baseline onwards
Time frame: January 2020
Prognostic tool for active VL
A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing active VL within 12 months
Time frame: January 2021
Patterns in host immune markers for asymptomatic Leishmania infection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The association between asymptomatic Leishmania infection and the levels of the different host immune markers, among participants tested for host immune markers
Time frame: January 2020
Evolution of host immune markers
The average levels of the different host immune markers at each follow-up visit
Time frame: January 2020
Patterns in host immune markers for VL treatment failure
The association between the risk of VL treatment failure and the levels and evolution of the different host immune markers, among participants who develop active VL and receive VL treatment
Time frame: January 2021
Patterns in host immune markers for VL relapse
The association between the risk of VL relapse and the levels and evolution of the different host immune markers, among participants who develop active VL
Time frame: January 2021