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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary model of care | 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. |
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| Physician-only model of care | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biktarvy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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). | 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) | Change through study completion, an average of 2 years by model of care |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported adherence to ART | Self-reported ART in the past 30 days | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand Lebouché, MD | Contact | +1-514-843-2090 | bertrand.lebouche@mcgill.ca | |
| Edmundo Huerta Patricio, M.Biol.Sc. | Contact | +1-514-934-1934 | edmundo.huerta@muhc.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Bertrand Lebouché, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of the McGill University Health Centre | Recruiting | Montreal | Quebec | H4A3T2 | Canada |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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| Patient Experience | Behavioral | 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. |
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| From weeks 1 to 96 |
| Time to treatment initiation | Days between the first appointment at the clinic and first patient-reported dose of ART | From first clinic appointment (prior to week 1) |
| Change in adherence to ART | Based on pill counts each time a patient returns for refills | Between weeks 1 and 96 |
| Change in appointment attendance | Attendance to each scheduled study visit (+- 7 days or +- 14 days) | Between weeks 1 and 96 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |