Comparison of HIV Testing Algorithms

Completed

• Conditions: HIV Infection

• Registration Number: NCT01716299
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-07
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV result by Western Blot	one week

Trial Locations

Locations (2)

Abdurafi Health Center; 🇪🇹 Abderafi, Amhara Regional State, Ethiopia

Humera Hospital; 🇪🇹 Humera, Tigray Regional State, Ethiopia