The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study

NCT06375304 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: MP-37-2024-10384
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

HIV Infections

Keywords

HIV; multidisciplinary model of care; patient-reported experiences; patient-reported outcomes; switch

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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).

  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).

  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.

  From enrolment to week 72.

Secondary Outcomes (6)

• ART initiation (HIV care cascade milestones)

  From enrolment to baseline.

• Viral suppression (HIV care cascade milestones)

  From enrolment to week 72 or until viral suppression happens (whichever comes first).

• Retention in HIV care (HIV care cascade milestones)

  From enrolment to week 48.

• consultations at the study site (Nature of clinical pathways)

  From enrolment to week 72.

• consultations at other care centres or organizations (Nature of clinical pathways)

  From enrolment to week 72.

Study Arms (1)

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.

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

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.

Antiretroviral Speed Access Program Switch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to performing study procedures;
• 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;
• 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).

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3T2, Canada

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Bertrand Lebouché, MD, PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand Lebouché, MD, PhD

CONTACT

+1-514-843-2090; bertrand.lebouche@mcgill.ca

David Lessard, PhD

CONTACT

+1 438-866-0504; david.lessard2@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist and associate professor of medicine

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CA (1)