HIV InfectionASAPNCT04897243
Antiretroviral Speed Access Program
An observational study of HIV Infection, run by Dr. Bertrand Lebouche at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Biktarvy and Patient Experience
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A3T2
Bertrand Lebouché, MD, +1-514-843-2090, bertrand.lebouche@mcgill.ca
Edmundo Huerta Patricio, M.Biol.Sc., +1-514-836-4468, edmundo.huerta@muhc.mcgill.ca
About this study
Official title: 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.
- Conditions
- HIV Infection
- Being tested
- Biktarvy, Patient Experience
- Keywords
- HIV, multidisciplinary model of care, patient-reported experience, ART initiation, patient engagement
- Medical subject headings
- HIV Infections, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiktarvyDrug
Also called B/F/TAF
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.
Patient ExperienceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Biktarvy; Behavioral: Patient Experience | |
| 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. Receives: Drug: Biktarvy; Behavioral: Patient Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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).
Measured: 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)
Measured: Change through study completion, an average of 2 years by model of care
Secondary outcomes (5)
Change in self-reported adherence to ART
Self-reported ART in the past 30 days
Measured: 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
Measured: From weeks 1 to 96
Time to treatment initiation
Days between the first appointment at the clinic and first patient-reported dose of ART
Measured: From first clinic appointment (prior to week 1)
Change in adherence to ART
Based on pill counts each time a patient returns for refills
Measured: Between weeks 1 and 96
Change in appointment attendance
Attendance to each scheduled study visit (+- 7 days or +- 14 days)
Measured: Between weeks 1 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Aug 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Bertrand Lebouche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Bertrand Lebouche, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bertrand Lebouché, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897243
- Sponsor's protocol ID
- IN-US-380-4670
- Acronym
- ASAP
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Examining Two Models of Care for B/F/TAF Initiation in HIV-infected, ART-naïve Newly Referred Patients
- ClinicalTrials.gov ID
- NCT04897243
- Acronym / sponsor ID
- ASAP / IN-US-380-4670
- Conditions
- HIV Infection
- Keywords
- HIV, multidisciplinary model of care, patient-reported experience, ART initiation, patient engagement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dr. Bertrand LeboucheUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary model of care | – | Drug: Biktarvy, Behavioral: Patient ExperienceThe 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. |
| Physician-only model of care | – | Drug: Biktarvy, Behavioral: Patient ExperienceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiktarvyAlso: B/F/TAFB/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. | Drug | Multidisciplinary model of care, Physician-only model of care |
| Patient ExperienceTo capture and integrate the patient experience, this study will collect patient-reported experience measures, conduct qualitative interviews, and engage patients as well as providers. | Behavioural | Multidisciplinary model of care, Physician-only model of care |
Primary outcome
Change in perceived problem solving
Time frame: Change through study completion, an average of 2 years by model of care
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 in perceived provider empathy
Time frame: Change through study completion, an average of 2 years by model of care
The Consultation and Relational Empathy (CARE) measure
Change in treatment satisfaction
Time frame: Change through study completion, an average of 2 years by model of care
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).
Perceived unmet healthcare needs
Time frame: Change through study completion, an average of 2 years by model of care
Question taken from the Canadian Community Health Survey (CCHS 2.1)
5 secondary outcomes
Change in self-reported adherence to ART
Time frame: Change through study completion, an average of 2 years by model of care
Time to viral suppression
Time frame: From weeks 1 to 96
Time to treatment initiation
Time frame: From first clinic appointment (prior to week 1)
Change in adherence to ART
Time frame: Between weeks 1 and 96
Change in appointment attendance
Time frame: Between weeks 1 and 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Lebouché, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Dr. Bertrand Lebouche at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand Lebouché, MD (+1-514-843-2090, bertrand.lebouche@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived problem solving (time frame: Change through study completion, an average of 2 years by model of care). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.