Electronic Capture of Adherence Barriers for HIV Care

McGill University Health Centre/Research Institute of the McGill University Health Centre30 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acceptability of the Intervention as assessed with the Acceptability E-scale

Score range: 6-30 (Threshold: M ≥ 24, indicates high acceptability)

Time frame: Change from baseline (week 1) to study completion (week 24)

Acceptability of the Intervention as indicated by the percent likely to recommend the I-Score

(Threshold: ≥ 80 percent)

Time frame: Change from baseline (week 1) to study completion (week 24)

Acceptability of the Intervention as assessed with the Net Promoter Score

Score range: -100 to 100 (Threshold: \> 0, indicates acceptability)

Time frame: Change from baseline (week 1) to study completion (week 24)

Secondary Outcomes

Appropriateness of the Intervention as assessed with the Perceived Compatibility subscale

Score range: 1 to 7 (Threshold: Score M ≥ 5.5, indicates high compatibility)

Time frame: Change from baseline (week 1) to study completion (week 24)

Appropriateness of the Intervention as assessed with the Appropriateness of Intervention Measure

Score range: 1 to 5 (Threshold: Score M ≥ 4, indicates high appropriateness)

Time frame: Change from baseline (week 1) to study completion (week 24)

Feasibility of the Intervention as indicated by the consent rate

Reasons for refusal will also be collected (Threshold: ≥ 70 percent)

Time frame: At baseline

Feasibility of the Intervention as indicated by the retention rate

(Threshold: ≥ 80 percent)