Program to improve access to HIV care for migrants

A Prospective Cohort Study Examining Two Models of Care for B/F/TAF Initiation in HIV-infected, ART-naïve Newly Referred Patients

This study is testing a new way to help newly diagnosed migrants in Quebec get better and faster HIV care by comparing a team approach to regular doctor visits.

Quick facts

• Study type: Observational
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (other)
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT04897243 on ClinicalTrials.gov

What this trial studies

This observational study focuses on improving timely access to HIV care for newly referred migrant populations in Quebec, Canada. It aims to evaluate the effectiveness of a multidisciplinary model of care compared to a physician-only clinic in addressing the unique challenges faced by these vulnerable groups. Participants will receive Biktarvy free of charge, and their experiences with HIV care will be documented to identify areas for improvement in the care cascade. The study will include treatment-naïve individuals aged 18 and older who are newly diagnosed with HIV.

Who should consider this trial

Good fit: Ideal candidates are newly referred individuals aged 18 and older who are HIV-1 infected and treatment-naïve.

Not a fit: Patients who have previously received anti-HIV therapy or have a viral load below 100 copies/mL may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could enhance the quality of HIV care for migrant populations, leading to better health outcomes and reduced transmission rates.

How similar studies have performed: While there is limited research specifically targeting migrant populations in HIV care, similar multidisciplinary approaches have shown promise in improving health outcomes in other contexts.

Eligibility criteria

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

Where this trial is running

Montréal, Quebec

• Research Institute of the McGill University Health Centre — Montréal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Bertrand Lebouché, MD — McGill University Health Centre/Research Institute of the McGill University Health Centre
• Study coordinator: Bertrand Lebouché, MD

Conditions: HIV Infection, HIV, multidisciplinary model of care, patient-reported experience, ART initiation, patient engagement