JMIR Publications

ABSTRACT

Background:

Adherence to life-saving antiretroviral therapy (ART) for human immunodeficiency virus (HIV) infection remains a challenge for many patients. Routinely screening for barriers to ART adherence could help make HIV care more patient-centered and prevent virologic rebound or failure. Our team is currently developing a new HIV-specific patient-reported outcome measure (PROM) of these barriers for use in Canada and France along with a digital application for its electronic administration. In our prior work, we developed the e-PROM’s multidimensional conceptual framework and generated 100 English items, which have been translated to French.

Objective:

This study’s general objective is to use an online Delphi to validate the content of a new HIV-specific e-PROM, from the perspective of patients and providers in Canada and France. It will help prioritize the measure’s items and provide partial evidence not only of its content validity, but of its actionability for HIV care (i.e. utility for decision-making), clarity, and cross-cultural equivalence. Here, we present the Delphi protocol.

Methods:

This modified Delphi will involve a diverse panel of patients (n=26) and providers (n=46) recruited among the nine sites of the e-PROM development study. Two rounds of online questionnaires will be conducted. The threshold for consensus is set at 60% and will determine which items are carried forward to the second round. Per item, three aspects will be rated: importance as a barrier to ART adherence (content validity); relevance for HIV care (actionability); and clarity (clarity, cross-cultural validity). In both rounds, space will be available for free text comments.

Results:

This study has undergone methodological review by experts in patient-oriented research and research ethics board evaluation. It is financially supported, in part, by the Canadian Institutes of Health Research’s Strategy for Patient-Oriented Research -Quebec Support Unit (M006).

Conclusions:

To our knowledge, this is the first Delphi to seek consensus on the most important and actionable barriers to ART adherence, considering a comprehensive list of barriers. Drawing on a relatively large and diversified panel of HIV patients and providers, it essentially engages key stakeholders in decision-making about the e-PROM’s final content, helping to ensure its utility and adoption.