Trial record 7 of 21 for:    " October 17, 2012":" November 16, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Comparison of HIV Testing Algorithms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leslie Shanks, Medecins Sans Frontieres
ClinicalTrials.gov Identifier:
NCT01716299
First received: October 25, 2012
Last updated: January 20, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Medecins Sans Frontieres:

Primary Outcome Measures:
  • HIV result by Western Blot [ Time Frame: one week ] [ Designated as safety issue: No ]

Enrollment: 495
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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:

  • • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716299

Locations
Ethiopia
Abdurafi Health Center
Abderafi, Amhara Regional State, Ethiopia
Humera Hospital
Humera, Tigray Regional State, Ethiopia
Sponsors and Collaborators
Medecins Sans Frontieres
Investigators
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: January 20, 2014
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

ClinicalTrials.gov processed this record on September 18, 2014