Trial record 15 of 24 for:    " January 04, 2012":" February 03, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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: February 17, 2014
Last verified: February 2014
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Device sensitivity/specificity [ Time Frame: same-day ] [ Designated as safety issue: No ]
    Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests


Secondary Outcome Measures:
  • Percent agreement with clinical diagnosis [ Time Frame: same-day ] [ Designated as safety issue: No ]
    Percent agreement with HIV & syphilis rapid tests completed at clinic


Enrollment: 2900
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
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 Names:
  • MBIO
  • SnapEsi-beta HIV-1/Syphilis

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530672

Locations
Kenya
New Nyanza Provincial General Hospital
Kisumu, Nyanza, Kenya
Kisumu District 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

Additional Information:
No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01530672     History of Changes
Other Study ID Numbers: HS647
Study First Received: January 23, 2012
Last Updated: February 17, 2014
Health Authority: Kenya: Ethical Review Committee
United States: Federal Government

Keywords provided by PATH:
HIV
Syphilis
Combination
POC
point-of-care
MBIO

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 17, 2014