HIV InfectionsPhase 4NCT06375304
The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study
A Phase 4 study testing B/F/TAF in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- B/F/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 1 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to performing study procedures;
- 18 years of age or older;
- Living with HIV (type 1) (as confirmed by a fourth generation HIV Ag/Ab combination assay);
- Patients at their first visits ever at the study site;
- Born outside of Canada, and arrived in the province of Quebec from another province or country to reside temporarily or permanently in the last 24 months;
- ART-experienced, that is, with past or current experience of taking ART to treat HIV, with or without treatment interruption(s) for any clinical or personal reason;
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- Individuals assigned female at birth may be eligible to enter and participate in the study in the following circumstances:
- is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or,
- is of child-bearing potential with a negative pregnancy test at Screening (\& baseline visit) and reporting no plans to become pregnant in the next year.
- Patients with documented historical resistance to HIV-1 reverse transcriptase inhibitors will be eligible, including: M184I/V alone or in combination with up to 2 thymidine analogue-associated mutations (TAMs) (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R).
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant;
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance;
- Active tuberculosis infection;
- Acute hepatitis < 30 days before enrollment;
- Known hypersensitivity to B/F/TAF, its metabolite or formulation excipient;
- Documented or suspected resistance to integrase inhibitors as per clinical judgment (e.g., history of poor adherence and/or poor virological control on an InSTI-based regimen);
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- Documented multi-NRTI resistance mutations/substitutions: K65R/N/E, T69 insertion, or 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, K219E/Q);
- Any of the following laboratory values at screening:
- Alkaline Phosphatase>3 × ULN
- aspartate aminotransferase (AST) >5 × upper limit of normal
- alanine aminotransferase (ALT) >5 × upper limit of normal
- Hemoglobin<8.0 g/dL
- Estimated creatinine clearance (CrCL) ≤30 mL/min/1.73 m2 based on the Cockcroft-Gault equation for creatinine clearance (CLcr)
- Platelets< 50,000/mm3
- Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor;
- Any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications (e.g., inability to understand the study information leaflet, to provide written consent);
- Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF;
- Active malignancy requiring acute systemic therapy;
- History of or current clinical decompensated liver cirrhosis (e.g., ascites, encephalopathy, or variceal bleedings).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A3T2
Bertrand Lebouché, MD, PhD, +1-514-843-2090, bertrand.lebouche@mcgill.ca
Ashkan Baradaran, MD, MSc, +1 514-863-4468, ashkan.baradaran@muhc.mcgill.ca
About this study
Official title: Antiretroviral Speed Access Program Switch Study (The ASAP Switch Study) - A Pilot Study to Switch ART-experienced and Newly-referred Migrant People With HIV to B/F/TAF
This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).
Read the detailed description
International migrants represent an increasing portion of people with HIV in Canada. Making sure migrant people with HIV have access to treatment and care is crucial for their health and wellbeing. It is also important to make sure that they have a good experience of care and treatment. Several treatments exist for HIV, and many migrant people with HIV arrive in Quebec with a current or past experience of taking an HIV treatment. Sometimes, it is a treatment that cannot be continued here, for different reasons. Thus, their treatment must be 'switched', that is, changed to another treatment more affordable, simpler, or more efficient.
B/F/TAF is one HIV treatment. B/F/TAF is simple to take (one small-sized pill a day), safe, highly effective for almost all people with HIV, and ideal when one switches from one treatment to another. If participants take part in this study, their treatment will be switched to B/F/TAF; it will be provided free of charge for the participants.
The goal of this study is to better understand the experience of migrant people with HIV of having their treatment switched to B/F/TAF. In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).
- Conditions
- HIV Infections
- Being tested
- B/F/TAF
- Keywords
- HIV, multidisciplinary model of care, patient-reported experiences, patient-reported outcomes, switch
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
The intervention consists of prescribing B/F/TAF to eligible ART-experienced migrant patients, free of charge, in four care settings, for 12 months (48 weeks).
B/F/TAF is a fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), administered orally, once daily, without food requirements.
| Study group | Role | What they receive |
|---|---|---|
| Antiretroviral Speed Access Program Switch | Other | HIV (type 1) infected adults born outside of Canada (migrants) and recently moved to province of Quebec (less than 2 years), ART-experienced, newly referred at the study sites. Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the switch
Feasibility refers to the extent to which an implementation target can be successfully used or deployed within a given setting. The investigators will measure what percentage of participants have done the switch and what percentage have not done the switch. For the rapid switch, the investigators will use a threshold of 75% achieving rapid switch (i.e., within 7 days of first clinic visit). Therefore, the investigators will report the percentage that achieved the switch within 7 days.
Measured: within 7 days of first clinic visit
Acceptability
Acceptability refers to the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. The investigators will assess the acceptability of: rapidity, the treatment being free-of-charge for patients, and the regimen choice. It will be measured with the 4-item Acceptability of Intervention Measure (AIM), using the following thresholds:
- ≥M*=4/5 for acceptability of rapid treatment;
- ≥M=4/5 for acceptability of free treatment.
Measured: From baseline to week 48.
acceptability of the regimen
After initiation, acceptability of the regimen choice will be assessed using the ACCEptance by the Patients of their Treatment (ACCEPT©) questionnaire, including the 3-item 'General acceptance' subscale and the 5-item 'Acceptability of side effects' subscale:
- ≥M=4/5 for acceptability of the new ART regimen (in general and concerning its side effects).
The response options range from 1 = "completely disagree" (worst or least acceptable) to 5 = "completely agree" (best or most acceptable).
Measured: From baseline to week 48.
Acceptability of the intervention
Acceptability of the intervention as a whole will also be assessed in terms of readiness with a 2-item readiness measure and a measure of treatment self-efficacy with thresholds of:
- ≥M=8/10 indicating readiness to start the new regimen (i.e., B/F/TAF);
- ≥M=16/20 indicating treatment self-efficacy.
- M: Mean or average.
The responses are on a scale from 0 to 10 (10 being the best or most acceptable).
Measured: From baseline to week 48.
Fidelity
Fidelity concerns the degree to which a program is delivered as intended. It will be evaluated with thresholds of:
- ≥80% for study visit attendance;
≥90% for self-reported regimen adherence in the past 30 days and in the last 7 days.
Measured: From enrolment to week 72.
Secondary outcomes (6)
ART initiation (HIV care cascade milestones)
- Treatment (ART) initiation: Proportion and/or time in days to attaining (or maintaining, as relevant).
Measured: From enrolment to baseline.
Viral suppression (HIV care cascade milestones)
- Viral suppression (HIV viral load < 50 copies/mL): Proportion and/or time in days to attaining (or maintaining, as relevant)
Measured: From enrolment to week 72 or until viral suppression happens (whichever comes first).
Retention in HIV care (HIV care cascade milestones)
- Retention in HIV care (i.e., at least 1 clinic visit with a physician per 6-month period of study participation; i.e., a minimum of two visits in total including one within the first 6 months and one within the last 6 months of the first 12 months of the study, with a buffer time period of +/- 6 weeks).
Measured: From enrolment to week 48.
consultations at the study site (Nature of clinical pathways)
- Occurrence and frequency of consultations with healthcare professionals from different disciplines (e.g., physician, pharmacist, nurse, social worker, psychologist, psychiatrist) at the study site.
Measured: From enrolment to week 72.
consultations at other care centres or organizations (Nature of clinical pathways)
- Self-reported occurrence and frequency of consultations at other care centres or organizations.
Measured: From enrolment to week 72.
healthcare coverage
Identification and changes of the type of medical coverage for HIV received by participants as mentioned on patient health records. For example, a change in healthcare coverage from the Interim Federal Health Program to the Régie de l'assurance maladie du Québec (RAMQ), along with the percentages of coverage for the participants' treatment will be noted and recorded by the investigators.
Measured: From enrolment to week 72.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bertrand Lebouche, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bertrand Lebouché, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375304
- Sponsor's protocol ID
- MP-37-2024-10384
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 19 Apr 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Speed Access Program Switch Study (The ASAP Switch Study) - A Pilot Study to Switch ART-experienced and Newly-referred Migrant People With HIV to B/F/TAF
- ClinicalTrials.gov ID
- NCT06375304
- Acronym / sponsor ID
- MP-37-2024-10384
- Conditions
- HIV Infections
- Keywords
- HIV, multidisciplinary model of care, patient-reported experiences, patient-reported outcomes, switch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Apr 2024 (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.
This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).
Detailed description
International migrants represent an increasing portion of people with HIV in Canada. Making sure migrant people with HIV have access to treatment and care is crucial for their health and wellbeing. It is also important to make sure that they have a good experience of care and treatment. Several treatments exist for HIV, and many migrant people with HIV arrive in Quebec with a current or past experience of taking an HIV treatment. Sometimes, it is a treatment that cannot be continued here, for different reasons. Thus, their treatment must be 'switched', that is, changed to another treatment more affordable, simpler, or more efficient.
B/F/TAF is one HIV treatment. B/F/TAF is simple to take (one small-sized pill a day), safe, highly effective for almost all people with HIV, and ideal when one switches from one treatment to another. If participants take part in this study, their treatment will be switched to B/F/TAF; it will be provided free of charge for the participants.
The goal of this study is to better understand the experience of migrant people with HIV of having their treatment switched to B/F/TAF. In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiretroviral Speed Access Program Switch | Other | Drug: B/F/TAFHIV (type 1) infected adults born outside of Canada (migrants) and recently moved to province of Quebec (less than 2 years), ART-experienced, newly referred at the study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to performing study procedures;
- 18 years of age or older;
- Living with HIV (type 1) (as confirmed by a fourth generation HIV Ag/Ab combination assay);
- Patients at their first visits ever at the study site;
- Born outside of Canada, and arrived in the province of Quebec from another province or country to reside temporarily or permanently in the last 24 months;
Key exclusion criteria (19 listed)
- Pregnant, breastfeeding, or planning to become pregnant;
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance;
- Active tuberculosis infection;
- Acute hepatitis < 30 days before enrollment;
- Known hypersensitivity to B/F/TAF, its metabolite or formulation excipient;
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 |
|---|---|---|
| B/F/TAFThe intervention consists of prescribing B/F/TAF to eligible ART-experienced migrant patients, free of charge, in four care settings, for 12 months (48 weeks). B/F/TAF is a fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), administered orally, once daily, without food requirements. | Drug | Antiretroviral Speed Access Program Switch |
Primary outcome
Feasibility of the switch
Time frame: within 7 days of first clinic visit
Feasibility refers to the extent to which an implementation target can be successfully used or deployed within a given setting. The investigators will measure what percentage of participants have done the switch and what percentage have not done the switch. For the rapid switch, the investigators will use a threshold of 75% achieving rapid switch (i.e., within 7 days of first clinic visit). Therefore, the investigators will report the percentage that achieved the switch within 7 days.
Acceptability
Time frame: From baseline to week 48.
Acceptability refers to the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. The investigators will assess the acceptability of: rapidity, the treatment being free-of-charge for patients, and the regimen choice. It will be measured with the 4-item Acceptability of Intervention Measure (AIM), using the following thresholds: * ≥M*=4/5 for acceptability of rapid treatment; * ≥M=4/5 for acceptability of free treatment.
acceptability of the regimen
Time frame: From baseline to week 48.
After initiation, acceptability of the regimen choice will be assessed using the ACCEptance by the Patients of their Treatment (ACCEPT©) questionnaire, including the 3-item 'General acceptance' subscale and the 5-item 'Acceptability of side effects' subscale: • ≥M=4/5 for acceptability of the new ART regimen (in general and concerning its side effects). The response options range from 1 = "completely disagree" (worst or least acceptable) to 5 = "completely agree" (best or most acceptable).
Acceptability of the intervention
Time frame: From baseline to week 48.
Acceptability of the intervention as a whole will also be assessed in terms of readiness with a 2-item readiness measure and a measure of treatment self-efficacy with thresholds of: * ≥M=8/10 indicating readiness to start the new regimen (i.e., B/F/TAF); * ≥M=16/20 indicating treatment self-efficacy. * M: Mean or average. The responses are on a scale from 0 to 10 (10 being the best or most acceptable).
Fidelity
Time frame: From enrolment to week 72.
Fidelity concerns the degree to which a program is delivered as intended. It will be evaluated with thresholds of: • ≥80% for study visit attendance; ≥90% for self-reported regimen adherence in the past 30 days and in the last 7 days.
6 secondary outcomes
ART initiation (HIV care cascade milestones)
Time frame: From enrolment to baseline.
Viral suppression (HIV care cascade milestones)
Time frame: From enrolment to week 72 or until viral suppression happens (whichever comes first).
Retention in HIV care (HIV care cascade milestones)
Time frame: From enrolment to week 48.
consultations at the study site (Nature of clinical pathways)
Time frame: From enrolment to week 72.
consultations at other care centres or organizations (Nature of clinical pathways)
Time frame: From enrolment to week 72.
healthcare coverage
Time frame: From enrolment to week 72.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
Bertrand Lebouché, MD, PhD 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?
A Phase 4 study testing B/F/TAF in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 10 inclusion and 19 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: opening soon, as of the sponsor's last update on 19 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand Lebouché, MD, PhD (+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?
Feasibility of the switch (time frame: within 7 days of first clinic visit). The study lists 5 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 19 Apr 2024.