Antiretroviral Speed Access Program (ASAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Biktarvy; Behavioral: Patient Experience

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Bertrand Lebouché, MD; Phone Number: +1-514-843-2090; Email: bertrand.lebouche@mcgill.ca
• Study Contact Backup: Name: Edmundo Huerta Patricio, M.Biol.Sc.; Phone Number: +1-514-934-1934; Email: edmundo.huerta@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A3T2
      • Recruiting
      • Research Institute of the McGill University Health Centre
      • Contact: Bertrand Lebouché, MD; Phone Number: +1-514-843-2090; Email: bertrand.lebouche@mcgill.ca
      • Contact: Edmundo Huerta Patricio, M.Biol.Sc.; Phone Number: +1-514-836-4468; Email: edmundo.huerta@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

1. 18 years or older
2. Newly referred at the study site
3. HIV-1 infected (fourth generation HIV Ag/Ab combination assay)
4. 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
5. Estimated GFR >30 mL/min/1.73m2 according to the Cockcroft-Gault formula for creatinine clearance
6. Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening
7. Female participants who are willing to use acceptable methods of birth control as defined in the protocol

Exclusion Criteria:

1. Have received anti-HIV therapy previously, except for PrEP or PEP taken up to one month prior to screening
2. Viral load <100 copies/mL, high suspicion of non-reported ART use or being a long-term nonprogressor or elite controller
3. Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF
4. Documented historic or baseline allergy to any of the components of B/F/TAF
5. Estimated eGFR (by Cockcroft-Gault formula) < 30 mL/min
6. Pregnant, breast-feeding or planning or suspected to get pregnant
7. Involvement in any other interventional HIV studies during the study period
8. Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Biktarvy; 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.; Other Names: B/F/TAF; Behavioral: Patient Experience; 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.
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.	Drug: Biktarvy; 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.; Other Names: B/F/TAF; Behavioral: Patient Experience; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 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

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

Collaborators and Investigators

• Sponsor: Dr. Bertrand Lebouche
• Investigators: Principal Investigator: Bertrand Lebouché, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV; patient engagement; multidisciplinary model of care; patient-reported experience; ART initiation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: IN-US-380-4670

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes