Comparison of HIV Testing Algorithms
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| ClinicalTrials.gov Identifier: NCT01716299 |
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Recruitment Status :
Completed
First Posted : October 29, 2012
Last Update Posted : January 22, 2014
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Sponsor:
Medecins Sans Frontieres, Netherlands
Information provided by (Responsible Party):
Leslie Shanks, Medecins Sans Frontieres, Netherlands
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infection | 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.
| Study Type : | Observational |
| Actual Enrollment : | 495 participants |
| Time Perspective: | Prospective |
| Official Title: | Comparison of HIV Testing Algorithms in Two Sites in Ethiopia |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | December 2013 |
Intervention Details:
- Other: application of a confirmation test
Addition of confirmation test to serial testing algorithm, including dilution test
- Other: application of a confirmation test
use of rapid confirmation test
Primary Outcome Measures :
- HIV result by Western Blot [ Time Frame: one week ]
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| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients presenting the Counseling and Testing centres in the two study sites
Criteria
Inclusion Criteria:
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• Age >= 59 months (to help ensure success of venepuncture)
- Informed consent from the individual or guardian to participate in study
Exclusion Criteria:
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• Inability to obtain venous blood sample
- Withdrawal of consent to test or to participate in the study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716299
Locations
| Ethiopia | |
| Abdurafi Health Center | |
| Abderafi, Amhara Regional State, Ethiopia | |
| Humera Hospital | |
| Humera, Tigray Regional State, Ethiopia | |
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
Investigators
| Principal Investigator: | Leslie Shanks, MD | Medecins Sans Frontieres, Netherlands |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Leslie Shanks, Medical Director, MSF-OCA, Medecins Sans Frontieres, Netherlands |
| ClinicalTrials.gov Identifier: | NCT01716299 |
| Other Study ID Numbers: |
msf09 |
| First Posted: | October 29, 2012 Key Record Dates |
| Last Update Posted: | January 22, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Leslie Shanks, Medecins Sans Frontieres, Netherlands:
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HIV Diagnostics |
Additional relevant MeSH terms:
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |