HIVMBIONCT01530672
Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
A study testing MBIO POC combined HIV syphilis test ( SnapEsi) in people with HIV and Syphilis, run by PATH at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- MBIO POC combined HIV syphilis test ( SnapEsi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 2 sitesKenya
- Study dates
- Jan 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Kisumu District Hospital
Kisumu, Nyanza
New Nyanza Provincial General Hospital
Kisumu, Nyanza
About this study
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.
- Being tested
- MBIO POC combined HIV syphilis test ( SnapEsi)
- Keywords
- HIV, Syphilis, Combination, POC, point-of-care, MBIO
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBIO POC combined HIV syphilis test ( SnapEsi)Device
Also called MBIO, SnapEsi-beta HIV-1/Syphilis
Venipuncture for routine ANC screening plus additional for device validation purposes.
| Study group | Role | What they receive |
|---|---|---|
| ANC clients | Experimental | Not described Receives: Device: MBIO POC combined HIV syphilis test ( SnapEsi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device sensitivity/specificity
Sensitivity \& specificity of the MBIO device against HIV and syphilis reference tests
Measured: same-day
Secondary outcomes (1)
Percent agreement with clinical diagnosis
Percent agreement with HIV \& syphilis rapid tests completed at clinic
Measured: same-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Matthew Steele, Ph.D, M.P.H., Principal investigator, PATHJohn Waitumbi, Ph.D, D.V.M., Principal investigator, Walter Reed ProjectKathleen Tietje, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530672
- Sponsor's protocol ID
- HS647
- Acronym
- MBIO
- Status last verified
- Oct 2014
- First submitted
- 23 Jan 2012
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
- ClinicalTrials.gov ID
- NCT01530672
- Acronym / sponsor ID
- MBIO / HS647
- Keywords
- HIV, Syphilis, Combination, POC, point-of-care, MBIO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,900 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Kenya Medical Research Institute
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANC clients | Experimental | Device: MBIO POC combined HIV syphilis test ( SnapEsi) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBIO POC combined HIV syphilis test ( SnapEsi)Also: MBIO, SnapEsi-beta HIV-1/SyphilisVenipuncture for routine ANC screening plus additional for device validation purposes. | Device | ANC clients |
Primary outcome
Device sensitivity/specificity
Time frame: same-day
Sensitivity \& specificity of the MBIO device against HIV and syphilis reference tests
1 secondary outcome
Percent agreement with clinical diagnosis
Time frame: same-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Steele, Ph.D, M.P.H. principal investigator
PATH
John Waitumbi, Ph.D, D.V.M. principal investigator
Walter Reed Project
Kathleen Tietje, PhD principal investigator
PATH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBIO POC combined HIV syphilis test ( SnapEsi) in people with HIV and Syphilis, run by PATH at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device sensitivity/specificity (time frame: same-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.