Comparison of HIV Testing Algorithms

This study has been completed.
Sponsor:
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

October 25, 2012
January 20, 2014
December 2010
July 2011   (final data collection date for primary outcome measure)
HIV result by Western Blot [ Time Frame: one week ] [ Designated as safety issue: No ]
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.

Observational
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.
 
Completed
495
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
Both
5 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT01716299
msf09
No
Leslie Shanks, Medecins Sans Frontieres
Medecins Sans Frontieres
Not Provided
Principal Investigator: Leslie Shanks, MD Medecins Sans Frontieres
Medecins Sans Frontieres
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP