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Comparison of HIV Testing Algorithms

Comparison of HIV Testing Algorithms in Two Sites in Ethiopia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01716299
Enrollment
495
Registered
2012-10-29
Start date
2010-12-31
Completion date
2013-12-31
Last updated
2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV, Diagnostics

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.

Interventions

OTHERapplication of a confirmation test

Addition of confirmation test to serial testing algorithm, including dilution test

Sponsors

Medecins Sans Frontieres, Netherlands
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
HIV result by Western Blotone week

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026