Antiretroviral Speed Access Program

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Cohort Study Examining Two Models of Care for B/F/TAF Initiation in HIV-infected, ART-naïve Newly Referred Patients

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Biktarvy
* Behavioral: Patient Experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Newly referred at the study site HIV-1 infected (fourth generation HIV Ag/Ab combination assay) Treatment-naïve to all anti-HIV therapy, except for the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening Estimated GFR >30 mL/min/1.73m2 according to the Cockcroft-Gault formula for creatinine clearance Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening Female participants who are willing to use acceptable methods of birth control as defined in the protocol Exclusion Criteria: Have received anti-HIV therapy previously, except for PrEP or PEP taken up to one month prior to screening Viral load <100 copies/mL, high suspicion of non-reported ART use or being a long-term nonprogressor or elite controller Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF Documented historic or baseline allergy to any of the components of B/F/TAF Estimated eGFR (by Cockcroft-Gault formula) < 30 mL/min Pregnant, breast-feeding or planning or suspected to get pregnant Involvement in any other interventional HIV studies during the study period Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multidisciplinary model of care<br>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<br>* 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.<br>* Other names: B/F/TAF;Behavioral: Patient Experience<br>* 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.<br>|
| Physician-only model of care<br>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<br>* 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.<br>* Other names: B/F/TAF;Behavioral: Patient Experience<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived problem solving | Subscale of the Patient-Assessment of Chronic Illness Care (PACIC) measure | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, multidisciplinary model of care, patient-reported experience, ART initiation, patient engagement