Clinical trial NCT02839603: Asymptomatic Leishmania Infection in HIV Patients
Official title: Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Visceral Leishmaniasis
Keywords: Visceral leishmaniasis
HIV co-infection
Asymptomatic
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University of Gondar
name: Addis Ababa University
name: Metema District Hospital, Metema, Ethiopia
First posted: 2016-07-21
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult individuals enrolled in HIV care in Metema hospital

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: End of study (2 years)
Secondary outcomes:
measure: 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
timeFrame: End of study (2 years)
measure: Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.
timeFrame: End of study (2 years)
measure: Proportion of asymptomatic infected patients in clinical determinant groups.
timeFrame: End of study (2 years)
measure: Total proportion of baseline asymptomatic infected patients, with positive infection status at 3, 6, 9 and 12 months follow-up.
timeFrame: 3, 6, 9 and 12 months of follow-up
measure: Proportion of baseline asymptomatic infected patients, with positive infection status for each baseline leishmanial marker at 3, 6, 9 and 12 months
timeFrame: 3, 6, 9 and 12 months of follow-up
measure: Proportion of individuals developing VL within the following year (= One-year risk of VL)
timeFrame: End of study (2 years)
Other outcomes:
Locations:
city: Metema
country: Ethiopia
facility: Metema District Hospital
Study officials:
References:
citation: van Griensven J, van Henten S, Mengesha B, Kassa M, Adem E, Endris Seid M, Abdellati S, Asefa W, Simegn T, Debasu D, Bogale T, Gedamu Y, Van Den Bossche D, Adriaensen W, Van der Auwera G, Cnops L, Vogt F, Diro E. Longitudinal evaluation of asymptomatic Leishmania infection in HIV-infected individuals in North-West Ethiopia: A pilot study. PLoS Negl Trop Dis. 2019 Oct 8;13(10):e0007765. doi: 10.1371/journal.pntd.0007765. eCollection 2019 Oct.