Grant: Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant - LOI

Innovative "test and treat" clinical trial designs that incorporate new diagnostic devices have been shown to be effective interventions for reaching the undiagnosed living with sexually transmitted and blood borne infections (STBBI) and linking them to care. By demonstrating the successful outcomes and benefits of these innovative Clinical Trials (iCT)'s, pathways to Health Canada approval and broader applications for use are established. Recently REACH Nexus Centre at MAP Centre for Urban Health Solutions has completed an initial iCT that evaluated the INSTI HIV self-test that lead to Health Canada approval for use in November 2020. Since then use of this self-test by key populations has been rapidly growing across Canada. More recently, a "test and treat" study called Point-of-Care Tests for Syphilis and HIV (POSH), let by Dr. Ameeta Singh at the University of Alberta, found excellent performance of the two dual syphilis and HIV rapid test devices. The study found over 200 cases of active syphilis and 24 cases of HIV which allowed for immediate treatment and linkage to care interventions. Based on these successful and highly relevant iCTs, we propose to conduct new and expanded "test and treat" iCTs designed to utilize new investigative devices to reach and test underserved populations for STBBIs, link them to care and treatment, and provide performance data to manufacturers for use in license applications to Health Canada. Together with our research partners and our strong partnerships with industry we intend to implement at least two expanded patient-oriented research programs as well as studies of at least two new investigational STBBI test devices in Alberta, Saskatchewan and Manitoba.