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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):
Leslie Shanks, Medecins Sans Frontieres, Netherlands

Brief Summary:
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 or disease Intervention/treatment
HIV Infection Other: application of a confirmation test

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.

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Study Type : Observational
Actual Enrollment : 495 participants
Time Perspective: Prospective
Official Title: Comparison of HIV Testing Algorithms in Two Sites in Ethiopia
Study Start Date : December 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • 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

Primary Outcome Measures :
  1. HIV result by Western Blot [ Time Frame: one week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716299

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Abdurafi Health Center
Abderafi, Amhara Regional State, Ethiopia
Humera Hospital
Humera, Tigray Regional State, Ethiopia
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
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Principal Investigator: Leslie Shanks, MD Medecins Sans Frontieres, Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leslie Shanks, Medical Director, MSF-OCA, Medecins Sans Frontieres, Netherlands
ClinicalTrials.gov Identifier: NCT01716299    
Other Study ID Numbers: msf09
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Leslie Shanks, Medecins Sans Frontieres, Netherlands:
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases