A Prospective Cohort Study Examining Two Models of Care for B/F/TAF Initiation in HIV-infected, ART-naïve Newly Referred Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in perceived provider empathy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Biktarvy (Drug)
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.
干预措施: Patient Experience (Behavioral)
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.
干预措施: Biktarvy (Drug)
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.
干预措施: Patient Experience (Behavioral)
结局指标
主要结局
Change in perceived provider empathy
时间窗: Change through study completion, an average of 2 years by model of care
The Consultation and Relational Empathy (CARE) measure
Change in perceived problem solving
时间窗: 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 treatment satisfaction
时间窗: 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
时间窗: Change through study completion, an average of 2 years by model of care
Question taken from the Canadian Community Health Survey (CCHS 2.1)
次要结局
- Change in appointment attendance(Between weeks 1 and 96)
- Time to viral suppression(From weeks 1 to 96)
- Change in adherence to ART(Between weeks 1 and 96)
- Change in self-reported adherence to ART(Change through study completion, an average of 2 years by model of care)
- Time to treatment initiation(From first clinic appointment (prior to week 1))
研究者
Dr. Bertrand Lebouche
Clinical Scientist and Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre