Galli, Richard A.
Lo Hog Tian, Jason M.
Sumner-Williams, Michelle
McBain, Kristin
Stanizai, Emal
Tharao, Wangari
Aden, Muna
Jamieson, Heather
Da Silva, Mark
Vassal, Anne-Fanny
Guilbault, Lorie
Ireland, Laurie
Witges, Kim
King, Alexandra
Ametepee, Kehinde
Lachowsky, Nathan J.
Pant Pai, Nitika
Mazzulli, Tony
Rourke, Sean B. https://orcid.org/0000-0001-6162-7358
Funding for this research was provided by:
Canadian Institutes of Health Research (FRN 164067)
Article History
Received: 28 September 2020
Accepted: 13 May 2021
First Online: 18 July 2021
Declarations
:
: This study was approved by respective Research Ethics Boards (REB) for the Ontario, Québec and Manitoba sites participating in the study: University of Toronto REB, St. Michael’s Hospital REB, Veritas IRB Québec, and University of Manitoba HREB. This study was conducted under a Health Canada approved Investigational Testing Authorization (ITA), application No. 276320, issued on December 19, 2018. Informed consent was obtained from all individual participants included in the study. To preserve anonymity, participants read the informed consent form and the study observer signed it, attesting that they received the participant’s verbal consent to participate in the study. This procedure was approved by the REB.
: Not applicable.
: Sean B. Rourke is a strategic consultant to the Canadian Foundation for AIDS Research (CANFAR); Richard A. Galli was a paid external contractor for the INSTI HIV Self-Test manufacturer, bioLytical Laboratories, during the early phase of the study conduct and currently holds private placement shares in bioLytical Laboratories Inc; Tony Mazzuli is an Advisory Board Member for Qvella Diagnostics, Roche, Merck, Verity Pharmaceuticals and President of the Canadian Association of HIV Clinical Laboratory Specialists (CAHCLS). All other authors do not have any competing interests.