HIV Infection
Conditions
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
Addition of confirmation test to serial testing algorithm, including dilution test
Sponsors
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| HIV result by Western Blot | one week |
Countries
Ethiopia