Antiretroviral Speed Access Program

NCT04897243 | Recruiting FDA Drug

• 1 other identifier: IN-US-380-4670
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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

  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).

  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)

  Change through study completion, an average of 2 years by model of care

Secondary Outcomes (5)

• Change in self-reported adherence to ART

  Change through study completion, an average of 2 years by model of care

• Time to viral suppression

  From weeks 1 to 96

• Time to treatment initiation

  From first clinic appointment (prior to week 1)

• Change in adherence to ART

  Between weeks 1 and 96

• Change in appointment attendance

  Between weeks 1 and 96

Study Arms (2)

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.

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.

Drug: Biktarvy; Behavioral: Patient Experience

Interventions

Biktarvy DRUG

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.

Also known as: B/F/TAF

Multidisciplinary model of care; Physician-only model of care

Patient Experience BEHAVIORAL

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.

Multidisciplinary model of care; Physician-only model of care

Eligibility Criteria

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

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Bertrand Lebouche: lead

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3T2, Canada

RECRUITING

MeSH Terms

Conditions

HIV Infections; Patient Participation

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

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; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bertrand Lebouché, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand Lebouché, MD

CONTACT

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

Edmundo Huerta Patricio, M.Biol.Sc.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Scientist and Associate Professor

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 21, 2021
• Study Start: August 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CA (1)