Asymptomatic Leishmania Infection in HIV Patients

Study Overview
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Brief Summary
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To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV co-infected individuals in East-Africa (Ethiopia).

Official Title
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Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study

Conditions
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Visceral Leishmaniasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection without a history of VL in the last 5 years stable residents of a VL-endemic area willing to participate and giving free informed consent Exclusion Criteria: younger than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of individuals with L.donovani asymptomatic infection at baseline in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia. | Proportion of individuals with asymptomatic infection, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology) | End of study (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of individuals with asymptomatic infection during follow-up in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia | Proportion of individuals with asymptomatic infection during follow-up, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology) amongst those without asymptomatic infection during the cross-sectional evaluation. | End of study (2 years) | 
| Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection. |  | End of study (2 years) | 
| Proportion of asymptomatic infected patients in clinical determinant groups. | Clinical determinant groups are constructed with key clinical characteristics and history | End of study (2 years) | 
| Total proportion of baseline asymptomatic infected patients, with positive infection status at 3, 6, 9 and 12 months follow-up. |  | 3, 6, 9 and 12 months of follow-up | 
| Proportion of baseline asymptomatic infected patients, with positive infection status for each baseline leishmanial marker at 3, 6, 9 and 12 months |  | 3, 6, 9 and 12 months of follow-up | 
| Proportion of individuals developing VL within the following year (= One-year risk of VL) | VL will be diagnosed as per national guidelines. | End of study (2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visceral leishmaniasis, HIV co-infection, Asymptomatic