Patient Portal for HIV/AIDS

Overseen By David Lessard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Cognitive impairment, Medical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new online tool, a patient portal, to help people living with HIV manage their care more effectively. The portal provides access to medical records, appointment reminders, and health surveys, simplifying the process for both patients and doctors to track health issues and improve care. Patients with HIV at the McGill University Health Centre can participate. The trial will assess the portal's usefulness, ease of use, and potential to improve appointment attendance and satisfaction with care. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative solutions that could enhance their healthcare experience.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this patient portal is safe for HIV care?

Research shows that electronic patient portals are safe and easy for users to handle. Studies have found that these portals can improve health for people with HIV by keeping them engaged in their care and assisting in managing HIV through access to medical records and appointment reminders. Active users of these portals tend to have better control of their HIV, as demonstrated by higher rates of viral suppression, meaning the virus is less active in their body.

No evidence suggests any harm from using patient portals. They resemble apps many people use daily, making them familiar to most users. Overall, patient portals appear to be a reliable tool for managing health without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Portal for HIV/AIDS because it offers a novel approach to managing the condition. Unlike traditional treatments that focus on medication, this patient portal aims to improve patient engagement and self-management by providing easy access to health information and personalized support. By enhancing communication between patients and healthcare providers, the portal may lead to better adherence to treatment plans and ultimately improve health outcomes. This approach is particularly promising as it empowers patients to take an active role in their healthcare journey, potentially leading to more sustainable long-term management of HIV/AIDS.

What evidence suggests that this patient portal is effective for improving HIV care?

Research has shown that electronic patient portals can improve HIV care. In this trial, participants will join different arms with varying durations of control and intervention periods to assess the patient portal's effectiveness. Studies have found that people with HIV who use these portals are more likely to maintain their healthcare, attending appointments and following treatment plans more regularly. The portals also help identify health issues early, allowing for quick treatment. Additionally, patient portals can reduce disparities in care related to age, race, and other factors. Overall, patient portals prove to be a helpful tool in enhancing HIV care. ^{1 2 5 6 7}

Who Is on the Research Team?

Bertrand P Lebouché, MD, PhD

Principal Investigator

Department of Family Medicine, McGill University

Are You a Good Fit for This Trial?

This trial is for people living with HIV who are patients at the McGill University Health Centre's HIV care service. Participants need to be willing and able to use a smartphone application that includes a patient portal, which provides access to medical records, appointment reminders, health questionnaires, and educational material.

Inclusion Criteria

Confirmed living with HIV

Patient at the study site

I can read and write in English or French.

Exclusion Criteria

I do not have any cognitive issues or unstable health conditions that prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants are observed without intervention to establish baseline data

6-18 months

Intervention

Participants use the patient portal and complete PROMs every 6 months

6-18 months

Visits every 6 months

Follow-up

Participants are monitored for satisfaction, attendance, and health problem detection

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Portal

Trial Overview The study tests how using a patient portal impacts healthcare for those with HIV. It involves logging into an app for appointment calendars, completing health questionnaires chosen by patients and providers alike, getting reminders, and accessing educational content. Doctors will review questionnaire results during clinic visits.

How Is the Trial Designed?

Group I: Arm 3 Experimental Treatment 1 Intervention

In this arm, the control period will be 18 months, followed by 6 months of intervention.

Group II: Arm 2 Experimental Treatment 1 Intervention

In this arm, the control period will be 12 months followed by 12 months of intervention.

Group III: Arm 1 Experimental Treatment 1 Intervention

In this arm, the control period will be 6 months followed by 18 months of intervention.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Programme National de Mentorat sur le VIH et les Hépatites (PNMVH)

Collaborator

Unité de Soutien SSA Québec

Collaborator

Trials

1

Recruited

80+

Portail VIH/sida du Québec

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

Trials

3,369

Recruited

57,400,000+

Published Research Related to This Trial

The study involved 375 patients using an electronic patient portal called MedCheck, which aimed to improve communication about medication-related symptoms, but only 49% of patients responded to the messages.

Despite the potential of the portal to enhance communication, the trial found no significant difference in adverse drug events (ADEs) or health-care utilization between the intervention and control groups, indicating that further development is needed to improve medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. Weingart, SN., Carbo, A., Tess, A., et al.[2018]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

The implementation of an electronic Web-based system at a pediatric hospital significantly improved the completion rate of interventions related to adverse drug events (ADEs), increasing from 21% to 44.7% after the system was introduced over a 5-month evaluation period.

The new system also enhanced documentation accuracy, reducing the rate of incomplete interventions from 77% to 43.7%, indicating that a streamlined electronic approach can effectively enhance patient safety in medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of medication event interventions through use of an electronic database. Merandi, J., Morvay, S., Lewe, D., et al.[2019]

Patients can effectively identify adverse events (AEs) they experience after surgery, providing valuable information that can enhance patient safety and improve medical records, as shown in a study of 28 surgical patients.

The study found a moderate agreement (intraclass correlation coefficient of 0.35) between patients' reports of AEs and medical records, indicating that while patients can be reliable sources of information, there is still room for improvement in communication and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of information on adverse events provided by the surgical patient]. Mira, JJ., Vitaller, J., Guilabert, M., et al.[2012]

A new computer-based system has been developed for managing reports of adverse drug reactions and serious adverse events, featuring a network of three regional centers and a central database for efficient data handling.

This system is designed to be secure, reliable, and cost-effective, making it a potential model for future clinical health information networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. Swoboda, WJ., Göttler, M., Zinnhobler, K., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12443438/

Association Between Electronic Patient Portal Enrollment ... Our findings suggest that portal enrollment is associated with improved HIV care outcomes among people with HIV. Keywords: Electronic patient ...

2. medinform.jmir.org medinform.jmir.org/2022/7/e34712/

Electronic Patient Portal Access, Retention in Care, and Viral ... Studies have demonstrated that electronic patient portals offer a unique opportunity to improve outcomes that are a part of the HIV Care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9361138/

Electronic Patient Portal Access, Retention in Care, and ... Our findings show that patient portal access follows similar trends to disparities in HIV care outcomes by age, race, HIV transmission risk factor, and ...

4. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003389

A cost-effectiveness analysis | PLOS Medicine The intervention that used HIV surveillance data to identify out-of-care individuals was no longer cost-saving when the effect of HIV on an ...

5. researchgate.net researchgate.net/publication/395031855_Association_Between_Electronic_Patient_Portal_Enrollment_and_HIV_Care_Outcomes_Among_People_Living_with_HIV_at_an_Urban_Academic_Medical_Center

Association Between Electronic Patient Portal Enrollment ... Our findings suggest that portal enrollment is associated with improved HIV care outcomes among people with HIV. ResearchGate Logo. Discover the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06682468?term=NIDA&viewType=Table&rank=6

Achieving Equity in Patient Outcome Reporting for Timely ... In preliminary work, the study investigators found that nearly half of patients assessed in an HIV clinic waiting room met the criteria for an SUD, but 65% had ...

7. cdc.gov cdc.gov/hiv-data/nhss/national-hiv-prevention-and-care-objectives-2025.html

National HIV Prevention and Care Objectives: 2025 Update This report provides the latest data from the National HIV Surveillance System (NHSS) on care outcomes among persons with HIV.