NCT04897243|UnknownFDA Drug
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
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ASAP
A Prospective Cohort Study Examining Two Models of Care for B/F/TAF Initiation in HIV-infected, ART-naïve Newly Referred Patients
Sponsor study identifier
observational
75
1 country
1
Study Start
August 1, 2019
Actual (reported)Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2019
Actual (reported)April 13, 2021
Actual (reported)May 21, 2021
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Change in self-reported adherence to ART
Change through study completion, an average of 2 years by model of care
Time to viral suppression
From weeks 1 to 96
Time to treatment initiation
From first clinic appointment (prior to week 1)
Change in adherence to ART
Between weeks 1 and 96
Change in appointment attendance
Between weeks 1 and 96
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.
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.
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.
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).
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A3T2, Canada
Bertrand Lebouché, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
First Submitted
April 13, 2021
First Posted
May 21, 2021
Study Start
August 1, 2019
Actual (reported)Primary Completion
December 2024
Estimated (date passed)Camu Camu in ART-treated People Living with HIV
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 21, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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