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Comparison of HIV Testing Algorithms

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ClinicalTrials.gov Identifier: NCT01716299
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):

October 25, 2012
October 29, 2012
January 22, 2014
December 2010
July 2011   (Final data collection date for primary outcome measure)
HIV result by Western Blot [ Time Frame: one week ]
Same as current
Complete list of historical versions of study NCT01716299 on ClinicalTrials.gov Archive Site
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Comparison of HIV Testing Algorithms
Comparison of HIV Testing Algorithms in Two Sites in Ethiopia
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.
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.
Time Perspective: Prospective
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Non-Probability Sample
Patients presenting the Counseling and Testing centres in the two study sites
HIV Infection
  • Other: application of a confirmation test
    Addition of confirmation test to serial testing algorithm, including dilution test
  • Other: application of a confirmation test
    use of rapid confirmation test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2013
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Leslie Shanks, Medecins Sans Frontieres
Medecins Sans Frontieres, Netherlands
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Principal Investigator: Leslie Shanks, MD Medecins Sans Frontieres, Netherlands
Medecins Sans Frontieres, Netherlands
January 2014