Comparison of HIV Testing Algorithms
1 other identifier
observational
495
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 22, 2014
January 1, 2014
7 months
October 25, 2012
January 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV result by Western Blot
one week
Interventions
Addition of confirmation test to serial testing algorithm, including dilution test
Eligibility Criteria
Patients presenting the Counseling and Testing centres in the two study sites
You may qualify if:
- Age \>= 59 months (to help ensure success of venepuncture)
- Informed consent from the individual or guardian to participate in study
You may not qualify if:
- Inability to obtain venous blood sample
- Withdrawal of consent to test or to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Abdurafi Health Center
Ābderafī, Amhara Regional State, Ethiopia
Humera Hospital
Humera, Tigray, Ethiopia
Related Publications (2)
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.
PMID: 25972188DERIVEDShanks 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.
PMID: 25645240DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Shanks, MD
Medecins Sans Frontieres, Netherlands
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, MSF-OCA
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 29, 2012
Study Start
December 1, 2010
Primary Completion
July 1, 2011
Study Completion
December 1, 2013
Last Updated
January 22, 2014
Record last verified: 2014-01