About The Study

In CTN 283, researchers designed and tested an electronic questionnaire (I-Score) to measure, from the point of view of people living with HIV, the factors that make it difficult to consistently take antiretroviral therapy (ART). This tool aims to help doctors discuss treatment issues with their patients. Now that the tool is developed, pilot study CTNPT 039 will begin to test the I-Score questionnaire in routine HIV care. Patients will fill out the questionnaire through a smartphone application called Opal. As a pilot, this study will focus on evaluating how participants feel about using the tool and will lay the groundwork for a larger trial to test its effectiveness. You can read more about this study on our website.

About The Disease

Patient-reported outcome measures (PROMs) give valuable information that can improve and streamline care, benefitting both patients and care providers. However, they are not often used in HIV care. Many people living with HIV face a variety of barriers that make it difficult to consistently take their ART. Care providers may not always know when their patients face these barriers. This can limit communication about these issues and provider efforts to address them. The I-Score tool is PROM that is accessed through a smartphone application and is specifically focused on barriers to ART adherence in people living with HIV.

Study Approach

Information about the I-Score tool will be collected from study participants via Opal, a patient portal and smartphone app. This app is already used at the McGill University Health Centre (MUHC) and allows patients to book appointments, view lab results, and access educational materials and PROMs like the I-Score. The app will be tailored to meet the needs of people living with HIV.

CTNPT 039 will enroll 30 patients and five physicians from one clinic at the MUHC. During the study, participants will meet with their physician three times over six months and will complete the I-Score using their smartphone before their visit. Participating physicians will receive the I-Score results before each visit so they can review them with the patient during the study visit. Participants will also complete study questionnaires, clinical testing, and interviews about their experiences. Physicians will participate in focus groups to understand how the tool worked from their perspective.

The information collected from this pilot study will help inform researchers about how acceptable and usable the I-Score tool is. It will also provide information about any improvements that could be made for a larger trial. A larger trial would aim to understand if this tool can effectively improve ART adherence for people living with HIV.

Eligibility Requirements


To be eligible, participants must:

  • be aged 18 years or older
  • be diagnosed with HIV-1 infection
  • be treated with a combination ART (composed of 2 to 3 different drugs)
  • have had known or suspected adherence problems in the past 12 months based on a detectable viral load test result per local standards, patient report, and/or report by physician, nurse, social worker, or pharmacist
  • be treated for HIV at the Chronic Viral Illness Service of the MUHC
  • be able to speak and understand either French or English
  • possess a smartphone with an appropriate data plan and/or home Wi-Fi connection
  • be willing to download the smartphone app

Not Allowed

People may not participate if they:

  • are participating in a clinical trial at the time of enrollment in this study
  • have a cognitive impairment or medical instability that prevents them from participating in the interview
  • have insufficient mastery of French or English to participate in the interview and complete the questionnaires
  • have insufficient ability to use the app with the technical support provided
  • are co-infected with hepatitis C and are being treated for it or have completed treatment three months or less ago
  • are co-infected with hepatitis B and are either not treated for it or are being treated for it with a medication other than their anti-HIV medication

Additional Information

Please contact the principal investigators for additional information or for participation inquiries.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Participating Sites

Here’s where this study is being conducted.

Chronic Viral Illness Service (CVIS)

McGill University Health Centre, Montreal Adriana Rodriguez Cruz, PhD Adriana.rodriguez@muhc.mcgill.ca

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