HIV Infection
Conditions
Keywords
HIV, multidisciplinary model of care, patient-reported experience, ART initiation, patient engagement
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.
Interventions
DRUGBiktarvy
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.
BEHAVIORALPatient 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.
Sponsors
Dr. Bertrand Lebouche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived problem solving | Change through study completion, an average of 2 years by model of care | 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 in perceived provider empathy | Change through study completion, an average of 2 years by model of care | The Consultation and Relational Empathy (CARE) measure |
| Change in treatment satisfaction | Change through study completion, an average of 2 years by model of care | 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). |
| Perceived unmet healthcare needs | Change through study completion, an average of 2 years by model of care | Question taken from the Canadian Community Health Survey (CCHS 2.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported adherence to ART | Change through study completion, an average of 2 years by model of care | Self-reported ART in the past 30 days |
| Change in appointment attendance | Between weeks 1 and 96 | Attendance to each scheduled study visit (+- 7 days or +- 14 days) |
| Time to viral suppression | From weeks 1 to 96 | Time to viral suppression (i.e. less than 50 copies/ml), from treatment initiation, by model of care |
| Time to treatment initiation | From first clinic appointment (prior to week 1) | Days between the first appointment at the clinic and first patient-reported dose of ART |
| Change in adherence to ART | Between weeks 1 and 96 | Based on pill counts each time a patient returns for refills |
Countries
Canada
Contacts
Primary ContactBertrand Lebouché, MD
Backup ContactEdmundo Huerta Patricio, M.Biol.Sc.
Outcome results
None listed