Clinical trial NCT01716299: Comparison of HIV Testing Algorithms
Official title: Comparison of HIV Testing Algorithms in Two Sites in Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Diagnostics
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 495
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting the Counseling and Testing centres in the two study sites

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV result by Western Blot
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Abderafi
country: Ethiopia
facility: Abdurafi Health Center
state: Amhara Regional State
city: Humera
country: Ethiopia
facility: Humera Hospital
state: Tigray Regional State
Study officials:
affiliation: Medecins Sans Frontieres, Netherlands
name: Leslie Shanks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shanks L, Siddiqui MR, Abebe A, Piriou E, Pearce N, Ariti C, Masiga J, Muluneh L, Wazome J, Ritmeijer K, Klarkowski D. Dilution testing using rapid diagnostic tests in a HIV diagnostic algorithm: a novel alternative for confirmation testing in resource limited settings. Virol J. 2015 May 14;12:75. doi: 10.1186/s12985-015-0306-4.
citation: Shanks L, Siddiqui MR, Kliescikova J, Pearce N, Ariti C, Muluneh L, Pirou E, Ritmeijer K, Masiga J, Abebe A. Evaluation of HIV testing algorithms in Ethiopia: the role of the tie-breaker algorithm and weakly reacting test lines in contributing to a high rate of false positive HIV diagnoses. BMC Infect Dis. 2015 Feb 3;15:39. doi: 10.1186/s12879-015-0769-3.