Multiplo HIV and syphilis self-test for adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cross-sectional, observational study asks untrained adult participants to read the instructions and perform the Multiplo TP/HIV self-test while a trained observer documents use and independently reads results. Participants also provide venous blood for central laboratory testing with a 4th-generation HIV EIA and standard syphilis serology to establish clinical truth for sensitivity and specificity calculations. A subset of 400 participants will interpret ten mock devices with a range of positive, negative, and invalid results and complete questionnaires on usability and label comprehension. No prior training is provided and self-test results will be compared to laboratory-confirmed HIV and syphilis results.

Why it matters

Who can join: the full rules

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).

Where it's running

• Cool Aid Community Health Centre
  Victoria, British Columbia, Canada Recruiting
• Hassle Free Clinic
  Toronto, Ontario, Canada Recruiting
• Women's Health in Women's Hands
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Megan Cedrone, BSc, MSc
• Email: Megan.Cedrone@unityhealth.to
• Phone: 647-786-8711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.