Antiretroviral Speed Access Program

HIV Infection Clinical Trial

— ASAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897243
• Other study ID #: IN-US-380-4670
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Bertrand Lebouché, MD
• Phone: +1-514-843-2090
• Email: bertrand.lebouche[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Research Institute of the McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Bertrand Lebouche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in self-reported adherence to ART	Self-reported ART in the past 30 days	Change through study completion, an average of 2 years by model of care
Secondary	Time to viral suppression	Time to viral suppression (i.e. less than 50 copies/ml), from treatment initiation, by model of care	From weeks 1 to 96
Secondary	Time to treatment initiation	Days between the first appointment at the clinic and first patient-reported dose of ART	From first clinic appointment (prior to week 1)
Secondary	Change in adherence to ART	Based on pill counts each time a patient returns for refills	Between weeks 1 and 96
Secondary	Change in appointment attendance	Attendance to each scheduled study visit (+- 7 days or +- 14 days)	Between weeks 1 and 96