Asymptomatic Leishmania Infection in HIV Patients

October 10, 2018 updated by: Institute of Tropical Medicine, Belgium

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

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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Metema, Ethiopia
        • Metema District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult individuals enrolled in HIV care in Metema hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

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.
Time Frame: 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)
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
Time Frame: 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.
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)
End of study (2 years)
Proportion of asymptomatic infected patients in clinical determinant groups.
Time Frame: End of study (2 years)
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.
Time Frame: 3, 6, 9 and 12 months of 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
Time Frame: 3, 6, 9 and 12 months of follow-up
3, 6, 9 and 12 months of follow-up
Proportion of individuals developing VL within the following year (= One-year risk of VL)
Time Frame: End of study (2 years)
VL will be diagnosed as per national guidelines.
End of study (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Tropical Medicine, Belgium

Collaborators

Addis Ababa University
University of Gondar
Metema District Hospital, Metema, Ethiopia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 19, 2017

Study Completion (Actual)

January 19, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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