Clinical Trials

MainTitle

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

This study has been completed
Sponsor
PATH

Collaborator
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute

Information provided by (Responsible Party)
PATH
ClinicalTrials.gov Identifier
NCT01530672

First received: January 23, 2012
Last updated: October 27, 2014
Last Verified: October 2014
History of Changes
Purpose

Purpose

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 Intervention
HIV
Syphilis

Device : MBIO POC combined HIV syphilis test ( SnapEsi)

Study Type: Interventional
Study Design: 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

Further study details as provided by PATH:

Primary Outcome Measures

  • Device sensitivity/specificity [ Time Frame: same-day ]
    Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests
Secondary Outcome Measures:
  • Percent agreement with clinical diagnosis [ Time Frame: same-day ]
    Percent agreement with HIV & syphilis rapid tests completed at clinic

Enrollment: 2900
Study Start Date: January 2012
Study Completion Date: September 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: ANC clients

Device: MBIO POC combined HIV syphilis test ( SnapEsi)

Venipuncture for routine ANC screening plus additional for device validation purposes.

Other Name:
  • MBIO
  • SnapEsi-beta HIV-1/Syphilis

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
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

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: NCT01530672

Locations

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

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

More Information

Additional Information:

Related Info

Responsible Party: PATH  
ClinicalTrials.gov Identifier: NCT01530672   History of Changes  
Other Study ID Numbers: HS647  
Study First Received: January 23, 2012  
Last Updated: October 27, 2014  

Keywords provided by PATH:

HIV
Syphilis
Combination
POC
point-of-care
MBIO

Additional relevant MeSH terms:
Syphilis

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.