Clinical trial NCT04897243: Antiretroviral Speed Access Program
Official title: A Prospective Cohort Study Examining Two Models of Care for B/F/TAF Initiation in HIV-infected, ART-naïve Newly Referred Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infection
Keywords: HIV
multidisciplinary model of care
patient-reported experience
ART initiation
patient engagement
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in perceived problem solving
timeFrame: Change through study completion, an average of 2 years by model of care
measure: Change in perceived provider empathy
timeFrame: Change through study completion, an average of 2 years by model of care
measure: Change in treatment satisfaction
timeFrame: Change through study completion, an average of 2 years by model of care
measure: Perceived unmet healthcare needs
timeFrame: Change through study completion, an average of 2 years by model of care
Secondary outcomes:
measure: Change in self-reported adherence to ART
timeFrame: Change through study completion, an average of 2 years by model of care
measure: Time to viral suppression
timeFrame: From weeks 1 to 96
measure: Time to treatment initiation
timeFrame: From first clinic appointment (prior to week 1)
measure: Change in adherence to ART
timeFrame: Between weeks 1 and 96
measure: Change in appointment attendance
timeFrame: Between weeks 1 and 96
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Bertrand Lebouché, MD
role: PRINCIPAL_INVESTIGATOR
References: