A Phase 4 interventional study of B/F/TAF in HIV Infections, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment
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).
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).
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 50 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
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Individuals assigned female at birth may be eligible to enter and participate in the study in the following circumstances:
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).
Exclusion Criteria:
Any of the following laboratory values at screening:
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.
Drug: B/F/TAF
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: From enrolment to week 72.
ART initiation (HIV care cascade milestones)
o Treatment (ART) initiation: Proportion and/or time in days to attaining (or maintaining, as relevant).
Time frame: From enrolment to baseline.
Viral suppression (HIV care cascade milestones)
o Viral suppression (HIV viral load \< 50 copies/mL): Proportion and/or time in days to attaining (or maintaining, as relevant)
Time frame: From enrolment to week 72 or until viral suppression happens (whichever comes first).
Retention in HIV care (HIV care cascade milestones)
o 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).
Time frame: From enrolment to week 48.
consultations at the study site (Nature of clinical pathways)
o Occurrence and frequency of consultations with healthcare professionals from different disciplines (e.g., physician, pharmacist, nurse, social worker, psychologist, psychiatrist) at the study site.
Time frame: From enrolment to week 72.
consultations at other care centres or organizations (Nature of clinical pathways)
o Self-reported occurrence and frequency of consultations at other care centres or organizations.
Time frame: 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.
Time frame: From enrolment to week 72.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre