Electronic Capture of Adherence Barriers for HIV Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation of an Electronic Patient-reported Measure of Barriers to Antiretroviral Therapy Adherence With the Opal Patient Portal: a Mixed Method Type 3 Hybrid Pilot Study at a Large Montreal HIV Clinic

Conditions
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HIV Infections

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study with a mixed method type 3 implementation-effectiveness hybrid design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opal patient portal<br>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. | Other: The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure<br>* HIV patients will complete the I-Score PROM via Opal (patient portal) prior to three consecutive clinic visits with their HIV physician who is expected to access their PROM results in time for the visit. The clinic visits will be held at Time 1, Time 2 (3 months) and Time 3 (6 months).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Intervention as assessed with the Acceptability E-scale | Score range: 6-30 (Threshold: M ≥ 24, indicates high acceptability) | 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) | 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) | Change from baseline (week 1) to study completion (week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of the Intervention as assessed with the Perceived Compatibility subscale | Score range: 1 to 7 (Threshold: Score M ≥ 5.5, indicates high compatibility) | 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) | 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) | At baseline | 
| Feasibility of the Intervention as indicated by the retention rate | (Threshold: ≥ 80 percent) | Cumulative until study completion (week 24) | 
| Feasibility of the Intervention as indicated by the missing I-Score data rate | e.g., due to non-completion, network failure (Threshold: ≤ 10 percent) | Cumulative until study completion (week 24) | 
| Feasibility of the Intervention as assessed with the Feasibility of Intervention Measure | Score range: 1 to 5 (Threshold: M ≥ 4, indicates high feasibility) | Change from baseline (week 1) to study completion (week 24) | 
| Fidelity of the Intervention as indicated by the percentage of patients who complete the I-Score on time | (Threshold: ≥ 90 percent) | Cumulative until study completion (week 24) | 
| Fidelity of the Intervention as indicated by the percentage of physicians who review the I-Score results on time | (Threshold: ≥ 90 percent) | Cumulative until study completion (week 24) | 
| Feasibility of the implementation strategy as indicated by the percentage of physicians who participate in the implementation activities | e.g., educational meeting, focus groups (Threshold: ≥ 80 percent) | Cumulative until study completion (week 24) | 
| Feasibility of the implementation strategy as indicated by the number of technical issues encountered | Based on the Application Manager's notes | Cumulative until study completion (week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-reported outcomes, adherence, antiretroviral therapy, mHealth, smartphone app, patient portal, implementation science, care