Asymptomatic Leishmania Infection in HIV Patients

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02839603

Enrollment

540

Registered

2016-07-21

Start date

2015-09-30

Completion date

2017-01-19

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis, HIV co-infection, Asymptomatic

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	End of study (2 years)	Proportion of individuals with asymptomatic infection, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology)

Secondary

Measure	Time frame	Description
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.	End of study (2 years)	Clinical determinant groups are constructed with key clinical characteristics and history
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	End of study (2 years)	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.
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)	End of study (2 years)	VL will be diagnosed as per national guidelines.
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	—

Countries

Ethiopia

Outcome results