Recruiting

Antiretroviral

Sponsor:

Dr. Bertrand Lebouche

Code:

NCT04897243

Conditions

HIV Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biktarvy

Patient Experience

Study Details

Brief 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. 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

Study ID

NCT04897243

Start date

Aug 1, 2019

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years or older
2. Newly referred at the study site
3. HIV-1 infected (fourth generation HIV Ag/Ab combination assay)
4. 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
5. Estimated GFR >30 mL/min/1.73m2 according to the Cockcroft-Gault formula for creatinine clearance
6. Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening
7. Female participants who are willing to use acceptable methods of birth control as defined in the protocol

Exclusion Criteria:

1. Have received anti-HIV therapy previously, except for PrEP or PEP taken up to one month prior to screening
2. Viral load <100 copies/mL, high suspicion of non-reported ART use or being a long-term nonprogressor or elite controller
3. Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF
4. Documented historic or baseline allergy to any of the components of B/F/TAF
5. Estimated eGFR (by Cockcroft-Gault formula) < 30 mL/min
6. Pregnant, breast-feeding or planning or suspected to get pregnant
7. Involvement in any other interventional HIV studies during the study period
8. Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Biktarvy

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 Experience

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.

Primary outcome measure

  • Change in perceived problem solving [ Time Frame: Change through study completion, an average of 2 years by model of care ]
  • Change in perceived provider empathy [ Time Frame: Change through study completion, an average of 2 years by model of care ]
  • Change in treatment satisfaction [ Time Frame: Change through study completion, an average of 2 years by model of care ]
  • Perceived unmet healthcare needs [ Time Frame: Change through study completion, an average of 2 years by model of care ]

Central Contacts and Locations

Central contacts

Bertrand Lebouché, MD

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

Edmundo Huerta Patricio, M.Biol.Sc.

+1-514-934-1934edmundo.huerta@muhc.mcgill.ca

Locations

Research Institute of the McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A3T2

Contacts

Bertrand Lebouché, MD

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

Edmundo Huerta Patricio, M.Biol.Sc.

+1-514-836-4468edmundo.huerta@muhc.mcgill.ca

More Information

Sponsor

Dr. Bertrand Lebouche

Last update posted

Feb 21, 2024

Last verified

Feb, 2024

Keywords

  • HIV
  • multidisciplinary model of care
  • patient-reported experience
  • ART initiation
  • patient engagement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Bertrand Lebouche on 2024-02-21.