Overview
To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-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 Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.
Description
This is a cross-sectional study that employs both observational and interview-based methods. All participants will read the instructions for use (IFU) and conduct the Multiplo TP/HIV Self-Test. They will not be provided any training prior to use. A trained Observer will observe and document the use of the test and independently read the lay user self-test result. 400 participants will also be provided with ten (10) mock devices with different results and asked to interpret those results (i.e. strong positive, weak positive, negative, invalid with no control line and no test dots, and invalid with no control line and positive test dots). The participants will then complete a questionnaire to share their opinions on usability and label comprehension of this test.
All participants will also have a venous blood sample collected for testing of serum at a central laboratory with a 4th generation HIV EIA and standard syphilis serology that will serve as the Comparator Methods (CM). All self-tests will be confirmed using laboratory-standard HIV and syphilis testing algorithms. The sensitivity and specificity of the self-test results will be calculated relative to the "clinical truth" of the participants' HIV and syphilis status determined by the comparator methods.
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 TP/HIV Self-Test. Persons with reactive syphilis self-tests may be counselled for immediate treatment.
All Participants will have a laboratory test done for performance comparison and 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.
- Subject recruitment
- Registration and confirmation of eligibility (enrolment questionnaire)
- Administering informed consent
- Review of inclusion/exclusion criteria and enrollment
- Venous blood specimen collection for laboratory testing
- Participant brought to a private room with site observer
- Observer instructs participant on study process (not testing procedure)
- Participant given one Multiplo Tp/HIV Self-Test package
- Participant performs the self-test and interprets the results
- Observer then interprets the participant's self test results
- Observer interviews participant with self-test questionnaire
- Participant given the option of participating in the Mock Result Interpretation exercise
- Participant returns to the site for the laboratory results in approximately 2 weeks
MOCK RESULTS INTERPRETATION A minimum of 400 participants across all study sites will complete device interpretation of contrived (mock) results from prepared devices. Devices will include contrived reactive, weakly reactive, negative, and 2 types of invalid results with their reactivity blinded to the participant.
Eligibility
Inclusion Criteria:
- Are ≥18 years of age.
- Can speak/read/write English or French.
- Have presented for voluntary testing for HIV and/or syphilis infection in the clinic or community-based setting.
- Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.
- Are willing to be a participant in the study.
- Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.
- Can complete the required testing on the allocated testing day.
- Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.
- Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).
Exclusion Criteria:
- Do not meet the inclusion criteria.
- Are known HIV and/or syphilis positive.
- Have ever tested positive for syphilis or HIV at any time.
- Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.
- Are familiar with the Multiplo® TP/HIV Self-Test.
- Are investigator site employees or immediate family members of sponsor or investigator sites.
- Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.
- Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).
- Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see/read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).