PreLeisH: Predicting Visceral Leishmaniasis in HIV Infected Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV HIV infected individuals residing in VL-endemic areas in Northern Ethiopia |
Other: No intervention
No intervention
|
Outcome Measures
Primary Outcome Measures
- Prevalence of asymptomatic Leishmania infection [January 2018]
The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
- Incidence rate of asymptomatic Leishmania infection [January 2020]
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
- Evolution of Leishmania infection markers [January 2020]
The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
- Incidence rate of active VL [January 2020]
The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
- Risk factors for active VL [January 2020]
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
- Prognostic tool for active VL [January 2021]
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
Secondary Outcome Measures
- Patterns in host immune markers for asymptomatic Leishmania infection [January 2020]
The association between asymptomatic Leishmania infection and the levels of the different host immune markers, among participants tested for host immune markers
- Evolution of host immune markers [January 2020]
The average levels of the different host immune markers at each follow-up visit
- Patterns in host immune markers for VL treatment failure [January 2021]
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
- Patterns in host immune markers for VL relapse [January 2021]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed HIV-positive
-
Enrolled in HIV care at the study site
Exclusion Criteria:
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Age under 18 years
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Diagnosis of active Visceral Leishmaniasis at enrolment
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Unlikely to seek health care again at this site during the next two years
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Not able or willing to provide informed consent. For patients not able to provide informed consent: No guardian available or willing to provide IC
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Medical emergency, underlying chronic medical condition, or other circumstances that make adherence to the study unlikely, or participation in the study medically inadvisable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abdurafi Health Center | Abderafi | Amhara | Ethiopia |
Sponsors and Collaborators
- Institute of Tropical Medicine, Belgium
- University of Gondar, Gondar, Ethiopia
- Medecins Sans Frontieres, Netherlands
- Bureau of Health, Abdurafi, Ethiopia
Investigators
- Study Chair: Johan van Griensven, MD PhD, Institute of Tropical Medicine, Antwerp, Belgium
- Study Director: Ermias Diro, MD, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITM0915