Electronic Capture of Adherence Barriers for HIV Care

NCT04702412 | Unknown

• 1 other identifier: 2021-7190
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

patient-reported outcomes; adherence; antiretroviral therapy; mHealth; smartphone app; patient portal; implementation science; care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Appropriateness of the Intervention as assessed with the Perceived Compatibility subscale

  Change from baseline (week 1) to study completion (week 24)

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

  Change from baseline (week 1) to study completion (week 24)

• Feasibility of the Intervention as indicated by the consent rate

  At baseline

• Feasibility of the Intervention as indicated by the retention rate

  Cumulative until study completion (week 24)

• Feasibility of the Intervention as indicated by the missing I-Score data rate

  Cumulative until study completion (week 24)

Other Outcomes (4)

• Patient management as indicated by the proportion of clinical visits where physicians took action based on I-Score results

  Change from baseline (week 1) to study completion (week 24)

• Barriers to ART adherence as measured by the I-Score PROM

  Change from baseline (week 1) to study completion (week 24)

• Adherence to ART as measured by the Self-Rating Scale Item

  Change from baseline (week 1) to study completion (week 24)

Study Arms (1)

Opal patient portal

EXPERIMENTAL

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

Interventions

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

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).

Opal patient portal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3T2, Canada

Location

Related Publications (4)

• Engler K, Ahmed S, Lessard D, Vicente S, Lebouche 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.

  PMID: 31376275 BACKGROUND

• Lessard D, Engler K, Toupin I; I-Score Consulting Team; Routy JP, Lebouche 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.

  PMID: 30375111 BACKGROUND

• 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.

  PMID: 30741643 BACKGROUND

• Engler K, Vicente S, Ma Y, Hijal T, Cox J, Ahmed S, Klein M, Achiche S, Pant Pai N, de Pokomandy A, Lacombe K, Lebouche B. Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic. PLoS One. 2021 Dec 30;16(12):e0261006. doi: 10.1371/journal.pone.0261006. eCollection 2021.

  PMID: 34969046 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Bertrand Lebouché, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand Lebouché, MD

CONTACT

514-843-2090; bertrand.lebouche@mcgill.ca

Kim Engler, PhD

CONTACT

514-934-1934; kimcengler@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Model Details: Pilot study with a mixed method type 3 implementation-effectiveness hybrid design

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 8, 2021
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)