An observational study in HIV Infection, sponsored by Dr. Bertrand Lebouche. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Dr. Bertrand Lebouche · Observational
Migrant populations represent an increasing proportion of newly referred people living with HIV in Canada, particularly in Quebec. Timely HIV care of newly referred patients has important individual-level health benefits that can result in decreased transmission and benefit the society as a whole. Yet, the timing of events in the HIV care cascade (from linkage to care to sustained viral suppression) together with the specific experience of care of these vulnerable populations (asylum-seekers, international students, patients with no status) who often face specific psycho-social and/or financial issues, has rarely been studied. In particular, little is known about their experience of HIV care whether they are referred to a multidisciplinary clinic or a physician-only clinic.
In a context where B/F/TAF will be provided free-of-charge to all enrolled participants including migrant populations, we aim to investigate what model of care can best address current deficiencies in the standard HIV care cascade for newly-referred patients, which often involves delays in linkage to care and starting ART.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 75 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Dr. Bertrand Lebouche is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-1 infected patients, ART-naïve, newly referred at the study sites (CVIS or JGH). Based on experience, over 70% of these new patients would qualify as vulnerable (asylum seekers, migrants, international students with low healthcare coverage).
Exclusion Criteria:
The Chronic Viral Illness Service at the Glen hospital of the MUHC will provide care with a multidisciplinary assessment, according to local current standard practice. Each newly-referred patient at the CVIS will be first received by a dedicated nurse, who then orients referral to a physician and/or a social worker and/or a pharmacist.
Drug: Biktarvy · Behavioral: Patient Experience
The Jewish General Hospital will provide care as per current local standard practice. Each newly-referred patient will be assessed by a clinician. Blood tests will be performed by central laboratory nurses who are not part of the HIV clinic.
Drug: Biktarvy · Behavioral: Patient Experience
B/F/TAF (Biktarvy®) is a fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), administered orally, once daily, without food requirements. Participating patients will receive the medication free of charge.
Also known as: B/F/TAF
To capture and integrate the patient experience, this study will collect patient-reported experience measures, conduct qualitative interviews, and engage patients as well as providers.
Change in perceived problem solving
Subscale of the Patient-Assessment of Chronic Illness Care (PACIC) measure. The PACIC consists of 5 scales and an overall summary score. Items 12 to 15 are about "Problem Solving/Contextual"; each can be scored from 1 to 5 (higher scores mean a better outcome and lower scores mean a worse outcome).
Time frame: Change through study completion, an average of 2 years by model of care
Change in perceived provider empathy
The Consultation and Relational Empathy (CARE) measure
Time frame: Change through study completion, an average of 2 years by model of care
Change in treatment satisfaction
HIV Treatment Satisfaction Questionnaire (HIVTSQ). The revised version of the HIVTSQ-status contains 10 items (Woodcock et al., 2006). Items are rated from 0 to 6, with response options adjusted to the item (higher scores mean a better outcome and lower scores mean a worse outcome).
Time frame: Change through study completion, an average of 2 years by model of care
Perceived unmet healthcare needs
Question taken from the Canadian Community Health Survey (CCHS 2.1)
Time frame: Change through study completion, an average of 2 years by model of care
Change in self-reported adherence to ART
Self-reported ART in the past 30 days
Time frame: Change through study completion, an average of 2 years by model of care
Time to viral suppression
Time to viral suppression (i.e. less than 50 copies/ml), from treatment initiation, by model of care
Time frame: From weeks 1 to 96
Time to treatment initiation
Days between the first appointment at the clinic and first patient-reported dose of ART
Time frame: From first clinic appointment (prior to week 1)
Change in adherence to ART
Based on pill counts each time a patient returns for refills
Time frame: Between weeks 1 and 96
Change in appointment attendance
Attendance to each scheduled study visit (+- 7 days or +- 14 days)
Time frame: Between weeks 1 and 96
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Dr. Bertrand Lebouche