Electronic Capture of Adherence Barriers for HIV Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Patient Portal and PROMs to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study

NCT06928961

HIV Patient-Reported Outcomes (PRO) Screening +1 more

NOT_YET_RECRUITING NA

Supporting Sustained HIV Treatment Adherence After Initiation

NCT05040841

HIV Infections Adherence, Medication

ACTIVE_NOT_RECRUITING NA

Multidisciplinary Low-Barrier and Mobile HIV Care to Improve Retention and Viral Suppression: Stakeholder-Engaged Design and Evaluation

NCT05887557

HIV

RECRUITING NA

A Commitment Device for Medication Adherence Among HIV Patients

NCT01455740

Acquired Immunodeficiency Syndrome HIV

COMPLETED NA

Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

NCT01505660

HIV

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opal patient portal

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.

Group Type EXPERIMENTAL

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

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes