Clinical trial NCT06928961: A Patient Portal and PROMs to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study
Official title: Implementation of a Patient Portal and Tailored Patient-Reported Outcome Measures to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Patient-Reported Outcomes (PRO)
Screening
Patient Portals
Keywords: HIV
Implementation
mHealth
Patient-reported outcome measures
PROMs
Screening
Patient portal
Mixed methods
Stakeholder engagement
Quebec
Canada
HIV care
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Programme National de Mentorat sur le VIH et les Hépatites (PNMVH)
name: Portail VIH/sida du Québec
name: Assistance Publique - Hôpitaux de Paris
name: Unité de Soutien SSA Québec
First posted: 2025-04-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a single-site, unblinded, 24-month pragmatic trial using a hybrid type 2 implementation-effectiveness design. The intervention will be progressively rolled out at 6-month intervals, until all participants (9 physicians and 360 patients) receive it. For rollout, 9 clusters formed of 1 physician and 40 of their patients will be randomly assigned to a rollout schedule. From 0-6 months, all participants with be in the control condition. At months 6, 12, and 18, 3 distinct clusters will begin the intervention.
Primary purpose: SCREENING

Brief summary: Too often, people living with HIV (PLHIV) face challenges, including additional health and psychosocial problems, that complicate self-care, like medication-taking and medical appointment attendance. Healthcare providers are not always aware when patients face these difficulties. A 'patient portal' is an online application that can give patients access to their medical records, appointment reminders, and questionnaires to inform providers about their health and wellbeing. Patient portals in HIV care can help providers detect patient problems and improve care. At the McGill University Health Centre's (MUHC) HIV care service, a survey showed great interest in a patient portal among both PLHIV and healthcare providers. Yet, little is known on how best to integrate a portal in HIV care settings and ensure it is accessible to patients. This project will be conducted at the MUHC's HIV care service in Montreal, Quebec which has over 2,000 patients. Participating patients will log on to a patient portal through a smartphone application and have a calendar of their HIV care appointments, health questionnaires to complete (previously chosen by people with HIV and healthcare providers), reminders for both and access to educational material. HIV physicians will be able to see their patients' questionnaire results to discuss them during clinic appointments. The project's objectives are to better understand what is needed to successfully integrate a portal in similar HIV practices with diverse patients and learn how acceptable and usable it is for HIV patients and doctors. The project will also examine how patient portal use impacts satisfaction, attendance, and physician detection of specific health problems. Furthemore, it will consider how patient sex, age, and ethnicity influence the results. People with HIV, providers, and staff at the study site will be involved in decision-making about this project. Over its 5-year duration, knowledge will be gained and shared on how to expand portal use efficiently and equitably in similar HIV care centers.

Detailed description: Background HIV care involves challenges; people living with HIV (PLHIV) face greater risks of several comorbidities and psychosocial difficulties, which often impede medication adherence, appointment attendance, and other aspects of HIV self-management. For providers, detection of many of these issues (e.g., symptoms, depression, substance use) largely relies on patients reporting them and they may go untreated. Evidence shows that patient portals and patient-reported outcome measures (PROMs) can help improve HIV management. How best to implement and ensure equitable access to these tools is less clear.

Aims This project will deploy a patient portal with a standard set of PROMs previously chosen through HIV stakeholder consultations led by the research team (PLHIV, healthcare professionals...). The study site, the Chronic Viral Illness Service (CVIS) of the McGill University Health Centre, serves over 2,000 PLHIV and is the largest university hospital-based HIV center in Montreal, Quebec. The study trial will assess an implementation strategy and patient and physician perceptions of the intervention (Aim 1) and evaluate the effectiveness of available portal functions (patient lab results, appointment calendar, PROMs, reminders, educational material) in improving health service and patient outcomes (Aim 2). HIV stakeholders will be engaged throughout this 5-year project, with representation of underserved HIV communities.

Methods A single-site, multi-method, 24-month unblinded trial will be led, with a hybrid type 2 effectiveness-implementation design and progressive intervention roll-out to all participants. Nine HIV physicians will participate with 360 of their patients, setting targets for sex, age, and race/ethnicity (factors tied to differential portal use). Patients will be trained to use the portal. Appointment and PROMs-completion reminders will be automated. Patients receiving the intervention will fill out PROMs prior to meeting their HIV physician at 6-month intervals. Physicians will be trained to consult the data via an online dashboard.

For Aim 1, study questionnaires (every 6 months), will assess patient and physician satisfaction with the intervention and perceived acceptability and usability. Portal metadata, trial data (e.g., recruitment rate) and qualitative data (e.g., semi-structured interviews, coordinator fieldnotes, meeting minutes) will be analyzed, in part, to determine fidelity and feasibility. For Aim 2, outcomes will be measured every six months. Patient outcomes include satisfaction with care and medical appointment attendance which will be based on questionnaire data and study site data, respectively. Service outcomes include physician detection of health-related problems screened for with the PROMs and patient-centered care which will be obtained from physician consultation notes and questionnaire data, respectively. Data will be analyzed, in part, with an implementation framework (NASSS) and attend to equity. The engagement approach used includes an executive committee with patient-partners and physician-champions, and a patient advisory committee. The multidisciplinary research team includes experts in all relevant areas, including implementation science.

Expected outcomes This project will build knowledge on how to implement portals and PROMs efficiently and inclusively in similar HIV centers while potentially benefiting thousands of PLHIV at the CVIS.

Eligibility criteria: Inclusion Criteria:

* Confirmed living with HIV
* Adult (at least 18 years old)
* Literate in English or French
* Patient at the study site

Exclusion Criteria:

* Cognitive impairment or medical instability that prevents participation
* Insufficient mastery of French or English to participate (e.g., complete PROMs, study questionnaires)

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: During the intervention at months 6, 12, 18, and 24
measure: Satisfaction with care
timeFrame: At baseline, then at months 6, 12, 18 and 24
Secondary outcomes:
measure: Technology usability -Ease of use
timeFrame: During the intervention at months 6, 12, 18, and 24
measure: Technology usability -Perceived usefulness
timeFrame: During the intervention at months 6, 12, 18, and 24
measure: Technology usability -Attitude
timeFrame: During the intervention at months 6, 12, 18, and 24
measure: Feasibility of the intervention -Consent rate
timeFrame: At baseline
measure: Feasibility of the intervention -Retention rate
timeFrame: From baseline to 24 months
measure: Fidelity of the intervention -PROM completion by patients
timeFrame: During the intervention at months 6, 12, 18, and 24
measure: Fidelity of the intervention -PROM data reviewed by providers
timeFrame: During the intervention at months 6, 12, 18, and 24
measure: Patient management -Provider detection of PROM-related problems
timeFrame: At baseline, then at months 6, 12, 18 and 24
measure: Patient-centered care
timeFrame: At baseline, then at months 6, 12, 18 and 24
measure: Self-management -Appointment attendance
timeFrame: At baseline, then at months 6, 12, 18 and 24
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, McGill University Health Centre - Glen Site
state: Quebec
Study officials:
affiliation: Department of Family Medicine, McGill University
name: Bertrand P Lebouché, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engler K, Lessard D, Lacombe K, Palich R, Lebouche B. Development of a core patient-reported outcome set for use in HIV care at the individual patient level in Montreal: protocol for a two-phased multimethod project. BMJ Open. 2025 Jan 15;15(1):e088822. doi: 10.1136/bmjopen-2024-088822.