Asymptomatic Leishmania Infection in HIV Patients

Institute of Tropical Medicine, Belgium540 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

540

Conditions

Visceral Leishmaniasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Metema District Hospital

Metemma, Ethiopia

Outcomes

Primary Outcomes

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)

Time frame: End of study (2 years)

Secondary Outcomes

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.

Time frame: End of study (2 years)

Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 3, 6, 9 and 12 months of follow-up

Proportion of individuals developing VL within the following year (= One-year risk of VL)

Data from ClinicalTrials.gov

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