Comparison of HIV Testing Algorithms
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Purpose
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 | Intervention |
|---|---|
|
HIV Infection |
Other: application of a confirmation test |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Comparison of HIV Testing Algorithms in Two Sites in Ethiopia |
- HIV result by Western Blot [ Time Frame: one week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
-
Other: application of a confirmation test
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.
Eligibility| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Ethiopia | |
| Abdurafi Health Center | |
| Abderafi, Amhara Regional State, Ethiopia | |
| Humera Hospital | |
| Humera, Tigray Regional State, Ethiopia | |
| Principal Investigator: | Leslie Shanks, MD | Medecins Sans Frontieres |
More Information
No publications provided
| Responsible Party: | Leslie Shanks, Medical Director, MSF-OCA, Medecins Sans Frontieres |
| ClinicalTrials.gov Identifier: | NCT01716299 History of Changes |
| Other Study ID Numbers: | msf09 |
| Study First Received: | October 25, 2012 |
| Last Updated: | October 27, 2012 |
| Health Authority: | Ethiopia: Ministry of Health |
Keywords provided by Medecins Sans Frontieres:
|
HIV Diagnostics |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013