Comparison of HIV Testing Algorithms

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdurafi Health Center, Ābderafī, Amhara Regional State, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

application of a confirmation test

Other

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

Primary outcomes

HIV result by Western Blot

Time frame: one week

Sponsors and collaborators

Lead sponsor

Medecins Sans Frontieres, Netherlands

Other

Registry information

Official study title

Comparison of HIV Testing Algorithms in Two Sites in Ethiopia

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2013
First posted: Oct 29, 2012
Registry last updated: Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed