Electronic Capture of Adherence Barriers for HIV Care

HIV Infections Clinical Trial

— CTNPT039  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04702412
• Other study ID #: 2021-7190
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: January 2022

Study information

• Verified date: January 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Bertrand Lebouché, MD
• Phone: 514-843-2090
• Email: bertrand.lebouche[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Canada	Research Institute of the McGill University Health Centre	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	CIHR Canadian HIV Trials Network

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Engler K, Ahmed S, Lessard D, Vicente S, Lebouché B. Assessing the Content Validity of a New Patient-Reported Measure of Barriers to Antiretroviral Therapy Adherence for Electronic Administration in Routine HIV Care: Proposal for a Web-Based Delphi Study. JMIR Res Protoc. 2019 Aug 2;8(8):e12836. doi: 10.2196/12836. — View Citation

Kildea J, Battista J, Cabral B, Hendren L, Herrera D, Hijal T, Joseph A. Design and Development of a Person-Centered Patient Portal Using Participatory Stakeholder Co-Design. J Med Internet Res. 2019 Feb 11;21(2):e11371. doi: 10.2196/11371. — View Citation

Lessard D, Engler K, Toupin I; I-Score Consulting Team, Routy JP, Lebouché B. Evaluation of a project to engage patients in the development of a patient-reported measure for HIV care (the I-Score Study). Health Expect. 2019 Apr;22(2):209-225. doi: 10.1111/hex.12845. Epub 2018 Oct 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient management as indicated by the proportion of clinical visits where physicians took action based on I-Score results	Only among visits that identified an adherence barrier of concern with the I-Score PROM	Change from baseline (week 1) to study completion (week 24)
Other	Barriers to ART adherence as measured by the I-Score PROM	Score range: 1 to 20, where higher scores indicate a greater number of problematic barriers	Change from baseline (week 1) to study completion (week 24)
Other	Adherence to ART as measured by the Self-Rating Scale Item	Score range: 1 to 6, where higher scores indicate higher adherence	Change from baseline (week 1) to study completion (week 24)
Other	HIV RNA viral load as indicated in the patient's medical file	Range: Detectable, where > 50 copies/mL = detectable, an undesirable clinical outcome, or Undetectable	Change betweem baseline (week 1) and study completion (week 24)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Feasibility of the Intervention as indicated by the consent rate	Reasons for refusal will also be collected (Threshold: = 70 percent)	At baseline
Secondary	Feasibility of the Intervention as indicated by the retention rate	(Threshold: = 80 percent)	Cumulative until study completion (week 24)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)