Comparison of HIV Testing Algorithms

HIV Infection Clinical Trial

Official title:

Comparison of HIV Testing Algorithms in Two Sites in Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716299
• Other study ID #: msf09
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: January 20, 2014
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Medecins Sans Frontieres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: December 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years and older

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection

Intervention

Other:
• application of a confirmation test
Addition of confirmation test to serial testing algorithm, including dilution test
• application of a confirmation test
use of rapid confirmation test

Locations

Country	Name	City	State
Ethiopia	Abdurafi Health Center	Abderafi	Amhara Regional State
Ethiopia	Humera Hospital	Humera	Tigray Regional State

Sponsors (1)

Lead Sponsor	Collaborator
Medecins Sans Frontieres

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV result by Western Blot		one week	No