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Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test (MBIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530672
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : October 28, 2014
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
Information provided by (Responsible Party):
PATH

Study Description
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Brief Summary:
This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform is designed for use at point of care (POC), it is made to provide similar performance as reference standards. Diagnosing HIV and syphilis accurately with a single POC test will save time for clinic health workers and technicians, reduce loss-to follow-up caused by lengthy delays for lab-based tests, and save costs by eliminating the need for multiple tests. For this study, the sensitivity and specificity of the MBio HIV/Syphilis Serology System point-of-care diagnostic test will be determined using reference tests performed under controlled laboratory conditions. For this, clients receiving routine care in the ANCs at the New Nyanza Provincial General Hospital (NNPGH) and Kisumu District Hospital (KDH) will be consented to provide blood for the proposed study. Study volunteers will receive HIV and syphilis rapid tests provided as part of routine care, and will donate an additional blood for evaluating the MBio test against the reference tests in a laboratory setting. This study is an investigational prototype, not for product registration. The results from this study will be used to inform product development of a second iteration of the MBio device design. At the time that the device is ready to be registered, it will undergo another field evaluation at which time it will be submitted to the appropriate regulatory body. Because the MBIO device is an HIV test, the device would be submitted to National AIDS & STI Control Program (NASCOP), which is the appropriate regulatory body for HIV tests in Kenya.

Condition or disease Intervention/treatment Phase
HIV Syphilis Device: MBIO POC combined HIV syphilis test ( SnapEsi) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2900 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Syphilis

Arms and Interventions
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Arm Intervention/treatment
Experimental: ANC clients Device: MBIO POC combined HIV syphilis test ( SnapEsi)
Venipuncture for routine ANC screening plus additional for device validation purposes.
Other Names:
  • MBIO
  • SnapEsi-beta HIV-1/Syphilis


Outcome Measures
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Primary Outcome Measures :
  1. Device sensitivity/specificity [ Time Frame: same-day ]
    Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests


Secondary Outcome Measures :
  1. Percent agreement with clinical diagnosis [ Time Frame: same-day ]
    Percent agreement with HIV & syphilis rapid tests completed at clinic


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Attending her first routine ANC visit and willing to undergo tests for HIV/syphilis
  • Able and willing to legally consent for enrollment
  • Able to demonstrate-comprehension of study details as they are explained in the consent process by passing all the test questions of understanding. The subject is only allowed two attempts at passing the test of understanding.

Exclusion Criteria:

  • Unwilling to provide written informed consent.
  • Unable to legally consent (minor without guardian)
  • Opt out of HIV or syphilis test
  • Previously diagnosed with autoimmune disorder (lupus, Lyme disease), as determined by client recollection or clinical record.
Contacts and Locations
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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): NCT01530672


Locations
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Kenya
Kisumu District Hospital
Kisumu, Nyanza, Kenya
New Nyanza Provincial General Hospital
Kisumu, Nyanza, Kenya
Sponsors and Collaborators
PATH
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
Investigators
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Principal Investigator: Matthew Steele, Ph.D, M.P.H. PATH
Principal Investigator: John Waitumbi, Ph.D, D.V.M. Walter Reed Project
Principal Investigator: Kathleen Tietje, PhD PATH
More Information
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Additional Information:

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01530672    
Other Study ID Numbers: HS647
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by PATH:
HIV
Syphilis
Combination
 POC
point-of-care
MBIO
Additional relevant MeSH terms:
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Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
 Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female