Electronic Capture of Adherence Barriers for HIV Care (CTNPT039)

McGill University

Status: Unknown

Conditions: HIV Infections

Treatments: Other: The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04702412

2021-7190

Details and patient eligibility

About

Adherence to antiretroviral therapy (ART) remains problematic. Our team has thus developed a new patient-reported measure of barriers to ART adherence (the I-Score) which will be completed by HIV patients through the Opal patient portal for routine HIV care. This 6-month mixed method pilot study will implement the I-Score/Opal intervention with 5 HIV physicians at the McGill University Health Centre (Montreal, Quebec) and 30 of their patients. The study's primary objectives are to assess patient and physician perceptions of the intervention (e.g., acceptability) and evaluate the implementation strategy. The data collected will help plan and determine the feasibility of a definitive effectiveness trial.

Full description

Background: Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to facilitate the systematic capture of this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy.

Methods: This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Five HIV physicians and 30 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score in the Opal smartphone application, before meeting with their physician. Both patient and physician will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention's adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention's acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2-3) and patient interviews (Times 2-3) will help evaluate the implementation strategy and inform any methodological adaptations.

Discussion: This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• be aged 18 years or older
• be diagnosed with HIV-1 infection
• be treated with a combination antiretroviral therapy (composed of 2 to 3 different drugs)
• be treated for HIV at the Chronic Viral Illness Service of the McGill University Health Centre
• be able to speak and understand either French or English
• possess a smartphone
• be willing to download the smartphone app

Exclusion criteria

• 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 3 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Opal patient portal

Experimental group

Description:

Exposure to routine use of a patient portal (Opal) through which HIV patients are expected to complete a measure on barriers to ART adherence for screening purposes, before each HIV care visit.

Treatment:

Other: The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure