The I-Score Study: The Development and Validation of a Patient-Reported Measure of Antiretroviral Therapy's Interference With Life: A Clinical Patient-management Tool for Healthcare Providers

This 24-month study aims to develop and validate a theoretically founded patient-reported outcome measure for use in routine HIV care with patients on antiretroviral therapy (ART). Eight clinical sites will be involved (4 in Canada and 4 in France). The measure will centre on patients' reported barriers to ART adherence and will be adapted for administration via electronic tablet. The study has four main steps. The psychometric validation of the tool and core of the study will be conducted in Step 3. The Observational -Prospective design applies to the field test and retest phase of Step 3. The four steps are nevertheless described below.

Step 1 -Development of the measure's conceptual framework (Start: October 2015)

1. A scoping review of existing HIV-specific patient-reported outcome measures
2. A meta-ethnography of qualitative research on HIV-positive persons' reported barriers to antiretroviral therapy (ART) adherence
3. A content analysis of qualitative interviews with HIV-positive patients on ART about their perceived barriers to adherence (n = 30 patients) The meta-ethnography and content analysis will serve to develop the conceptual framework on which the tool will be based. It will not only define the tool's conceptual domain but outline its relationship to other concepts that will be verified statistically as a part of the tool's validation. Once the framework is completed, the measure will be specified and a bank of items will be generated.

Step 2 -Linguistic validation of the preliminary measure The tool's linguistic validation will involve the professional harmonization of the English and French versions and the creation of a universal French version adapted to all French sites.

Step 3 - Exploration and validation of the measure's psychometric properties