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Clinical Trials

MainTitle

Comparison of HIV Testing Algorithms

This study has been completed
Sponsor
Medecins Sans Frontieres, Netherlands


Information provided by (Responsible Party)
Leslie Shanks, Medecins Sans Frontieres

ClinicalTrials.gov Identifier
NCT01716299

First received: October 25, 2012
Last updated: January 20, 2014
Last Verified: January 2014
History of Changes
Purpose

Purpose

The primary objective of the study is to assess whether an improved MSF HIV diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than WHO recommended RDT testing algorithms that do not include confirmatory testing.

Condition Intervention
HIV Infection

Other : application of a confirmation test

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of HIV Testing Algorithms in Two Sites in Ethiopia

Further study details as provided by Leslie Shanks, Medecins Sans Frontieres:

Primary Outcome Measures

  • HIV result by Western Blot [ Time Frame: one week ]

Enrollment: 495
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Detailed Description:

Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland has therefore changed the testing algorithm to introduce a confirmation test. This proposal outlines an evaluation study of the results of the new confirmatory testing algorithm. It aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm which is based on WHO recommendations. A secondary objective of the study is to determine if there is a correlation between kala-azar infection and risk of false positive HIV RDT results as clinicians in the projects suspect such a correlation. Furthermore, the study will look at the positive predictive value of weak test lines, which have been associated with higher risk of false positive results. Finally, the study aims to evaluate the results of a new simplified confirmation test, the dilution testing. Clients for the study will be recruited at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of 200 serial-algorithm positive and 200 negative samples in each site.

Eligibility

Eligibility

Ages Eligible for Study: 5 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

Patients presenting the Counseling and Testing centres in the two study sites

Criteria

Inclusion Criteria:

  • • Age >= 59 months (to help ensure success of venepuncture)
    • Informed consent from the individual or guardian to participate in study


    Exclusion Criteria:
  • • Inability to obtain venous blood sample
    • Withdrawal of consent to test or to participate in the study

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716299

Locations

Ethiopia
Abdurafi Health Center
Abderafi, Amhara Regional State, Ethiopia
Humera Hospital
Humera, Tigray Regional State, Ethiopia

Sponsors and Collaborators

Medecins Sans Frontieres, Netherlands

Investigators

Principal Investigator: Leslie Shanks, MD Medecins Sans Frontieres, Netherlands
More Information

More Information


Responsible Party: Leslie Shanks, Medical Director, MSF-OCA, Medecins Sans Frontieres  
ClinicalTrials.gov Identifier: NCT01716299   History of Changes  
Other Study ID Numbers: msf09  
Study First Received: October 25, 2012  
Last Updated: January 20, 2014  

Keywords provided by Leslie Shanks, Medecins Sans Frontieres:

HIV
Diagnostics

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.