Multiplo Near Patient Non-HCP Study
- Conditions
- HIV InfectionsSyphilis Infection
- Interventions
- Device: INSTI Multiplex HIV/Syphilis Antibody Test
- Registration Number
- NCT06463314
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.
- Detailed Description
This is a blinded, controlled study to evaluate the ability of the Operators, including peer testers, to perform and interpret the HIV and Syphilis results of the Multiplo TP/HIV Test. The non-registered health care professionals including peer testers are defined as non-health care professional (ie. Peers) paid site personnel that have no training or hands-on experience with the Multiplo Test. This protocol involves collection of fingerstick whole blood from a minimum of 800 Participants to test with the Multiplo Test. Testing will be conducted by the study Operators in near-patient clinical settings. Results from the Multiplo Test will be compared to results from blood based serological assays, including licensed 4th generation HIV EIA and syphilis EIA/RPR assays. Study Operator qualifications and assessment of the ease of device use will be evaluated. Operators will also read and interpret various contrived devices in order to assess their ability to correctly interpret a variety of potential test results.
All enrolled Participants will voluntarily provide medical history and the specimens according to Section 4, Study Procedures at Visit 1 (Day 1), for the testing with the Multiplo Test.
All Participants will have a laboratory test done for performance comparison, but only those with unknown HIV and/or syphilis status will be instructed to return to the clinic for a follow-up visit (Visit 2), two (2) weeks later to obtain their laboratory test results. Participants may also have a separate Point-of-Care (POC) test for HIV and/or syphilis conducted on site as part of the clinic's standard of care testing, outside of the protocol.
Activities in the plan of the study include:
* Selection of study Operators with informed consent for participation in the study
* Completion of Untrained Operator Eligibility and Assessment Questionnaire - prior to study start
* Screening of participants and obtaining informed consent
* Review of inclusion/exclusion criteria and completion of Participant Enrollment Questionnaire
* Specimen Collection and Testing:
* Collection of venous blood for Clinical Laboratory testing for HIV and Syphilis
* Collection of fingerstick whole blood for testing with the Multiplo Test
* Laboratory testing for HIV and Syphilis
* Clinical follow up for Participants with positive HIV and/or Syphilis test results from Clinical Laboratory testing
* Participants who test negative will have opportunities for preventative services including PrEP
* Completion of Untrained Operator Usability and Interpretation Questionnaire - after study completion
* Untrained non-professional Operator Mock Device Interpretation Assessment Following recruitment of participants and obtaining informed consent, Participants may be enrolled in the trial.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description participants with known and unknown HIV and/or syphilis status INSTI Multiplex HIV/Syphilis Antibody Test All participants will undergo fingerstick blood testing with the test device administered by untrained non-professional health care providers, along with venous blood testing at a central laboratory using licensed gold standard comparator methods.
- Primary Outcome Measures
Name Time Method Percent positive and negative agreement of the Multiplo® TP/HIV Test performed by non-healthcare providers to the Participant's HIV and/or syphilis status confirmed by the lab results. 6 months The primary outcome for the study will be the percent positive and negative agreement of the Multiplo® TP/HIV Test performed by intended, untrained users to the Participant's HIV and/or syphilis status confirmed by the lab results. The percentages for positive and negative agreement will be calculated with the two-sided 95% confidence intervals for both as follows: % Positive Agreement= ((n) HIV or syphilis Multiplo reactive results )/((n) HIV or syphilis positive status)×100 % Negative Agreement= ((n)HIV or syphilis Multiplo non reactive results )/((n) HIV or syphilis negative status)×100 Percent positive and negative agreement will be calculated for each analyte (HIV or syphilis) separately.
- Secondary Outcome Measures
Name Time Method Percent of correctly interpreted mock devices by untrained, non-healthcare professional operators 6 months Non-health care professionals will be asked to read results from a variety of mock test results. These mock tests will be blind coded, provided to the non-HCP in random order followed by review and documentation of the panels of contrived test results to be interpreted by study Operators. The results indicated by the non-HCP will be compared against the code to determine the ability of the non-HCP to correctly interpret a variety of results including, strong positive, weak positive, invalid, weak negative and strong negative. will be given a panel of
Trial Locations
- Locations (4)
Hassle Free Clinic
🇨🇦Toronto, Ontario, Canada
Cool Aid Community Health Centre
🇨🇦Victoria, British Columbia, Canada
Women's Health in Women's Hands
🇨🇦Toronto, Ontario, Canada
Nine Circles Community Health Centre
🇨🇦Winnipeg, Manitoba, Canada