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Micro-elimination of HCV infection among People Who Use Drugs (PWUD) in British Columbia A comprehensive, multidisciplinary, scalable programmatic approach
University of British Columbia
Vancouver Infectious Diseases Centre
Dr. Brian Conway
Dr. Brian Conway
Type of Research Project
- Clinical Project without Laboratory work
What is the background of the project?
The World Health Organization has endorsed the goal of eliminating Hepatitis C virus (HCV) as a public health concern by 2030. Newer, all-oral, pan-genotypic direct-acting antiviral (DAA) lead to a cure of infection in > 95% cases. Although these well-tolerated, highly effective treatments are widely available to all viremic patients in British Columbia, significant barriers undermine our ability to increase HCV treatment starts, especially in vulnerable inner-city populations. These largely relate to the inability of the health care system to engage and maintain individuals in care in such a way that HCV treatment can be delivered on a large scale. Multidisciplinary outreach models that include a concerted program to diagnose and treat HCV infection will likely be the most effective way to produce the requisite level of engagement with people who have disengaged from most health and social services, with a view to eliminating HCV in this vulnerable population. The primary objective is to identify 300 people who use drugs (PWUD) with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment.
What is the aim of the project?
The objectives of the project are: 1. To determine the rate of SVR12 (cure of HCV infection) among PWUD engaged in care and receiving HCV treatment. 2. To determine the rate of early recurrent viremia 24 weeks after the end of successful HCV treatment.
What techniques and methods are used?
At the VIDC site, we have over 250 individuals identified through our community pop-up clinic (CPC) model who have not followed up to fully engage in care and receive HCV treatment. This non-attendance could be due to a number of reasons, including: forgetting the appointment, not having appropriate transportation to the clinic, not prioritizing engagement in HCV care, or having other competing priorities which are a barrier to appointment attendance. We will develop a strategy to ensure that these individuals feel supported to re-book these initial missed appointments. We have extensive information about them, collected with their consent, and access to their current prescription records through a provincial database. With this as a starting point, we will implement a process of case finding in the community. We will contact known places of residence, pharmacies where medications are known to be obtained, community centres where they were originally recruited, and other approaches suggested by our team peer support workers. Once an individual is identified, we will engage them in an individualized plan of multidisciplinary plan of care to address their most pressing needs and develop a plan for HCV treatment. A novel intervention will be introduced to improve the current model. We will add to our existing program a requirement for attendance at three appointments at VIDC within the six weeks following initial contact at a CPC. During the three appointments, patients will be supported in preparing for HCV treatment and points of priority will be revisited for each patient based on our established model of care. The patient may visit clinic at any time for additional assistance with multidisciplinary needs – including other medical, social, psychiatric, or addictions-related requirements. The additional interventions to secure increased engagement in care within the specified shorter time frame will include: 1. Involvement of peer support worker at the CPC recruitment site to act as a liaison with the patient 2. Full review of all social needs at the first appointment, with an individualized plan of intervention developed 3. Development of a tool for social re-integration, to detail all services available to the patient in the neighborhood, including: food banks/free meals, dental services, other essential services (clothing, haircuts, etc.) and social activities. To assess the achievement of our objectives, statistical analysis will be performed. All statistical analyses will be conducted on a strict intent to treat (ITT) basis. A modified intent-to-treat (mITT) analysis will also be conducted, excluding from analysis only those participants who fail to achieve a primary or secondary endpoint for reasons unrelated to HCV infection or its potential treatment. For the primary objective (initiation of HCV treatment), the ITT population will include any patient who is known to be productively infected with HCV and is a candidate to be engaged in care. For the secondary objective based on HCV treatment efficacy, we will compare our results based on the historical efficacy of the sofosbuvir/velpatasvir combination in population of people who use drugs (PWUD), as shown in the SIMPLIFY study, with the SVR12 rate of 94%. For the secondary objective based on recurrent viremia, no statistical calculation is required. This is a descriptive objective. We will present the rate of recurrent viremia and its correlates, based on demographic and clinical data that will have been collected.
What is the role of the student?
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
The student will take an active role in all aspects of the conduct of the study. This will include attending and participating in our community pop-up clinics, preparing data collection forms, study consent forms, and recruitment materials, assisting in the recruitment, screening, and evaluation of research participants, performing data coding, entry, and checking using electronic data capture systems, tracking patients’ engagement with care and assisting clinic staff in ensuring ongoing engagement, tracking and analyzing laboratory data (such as Hepatitis C RNA levels over the course of treatment), and assisting with ongoing data analysis. The 8 week exchange will involve more in-depth data analysis using the same methods as the 4 week.
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- The student will prepare a poster - The student will prepare a presentation - The student will prepare a scientific report - The student will prepare an abstract
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
Students should have: • Demonstrated knowledge in using PubMed, Medline, Google Scholar, Microsoft Office Software, and reference manager software. • Demonstrated knowledge of medical terminology, medical charting, and clinical trials. • Excellent time management skills including the ability to prioritize work and meet deadlines. • Demonstrated data entry and data management skills. • Ability to communicate effectively both verbally and in writing. • Ability to work collaboratively with other team members and ability to work independently. • Ability to work with vulnerable populations (such as people who use drugs) in an empathetic and non-judgmental manner
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students
- Alimohammadi A; Holeksa J; Parsons R; Yung; R; Amiri N; Truong D; Conway B. Diagnosis and treatment of hepatitis C virus infection: a tool for engagement with people who inject drugs in Vancouver’s Downtown Eastside. Canadian Liver Journal. 1.2. (2018): 4-13.
- Alimohammadi; A.; Holeksa; J.; Truong; D.; Conway; B. (2018). Real-world efficacy of direct-acting antiviral therapy for HCV infection affecting people who inject drugs delivered in a multidisciplinary setting. Open Forum Infectious Diseases; Volume 5; Issue 6; 1 June 2018; https://doi.org/10.1093/ofid/ofy120
- Bruggmann P; Litwin AH. Models of care for the management of hepatitis c virus among people who inject drugs: one size does not fit all. Clinical infectious diseases. 2013;57(Suppl 2):61. doi:10.1093/cid/cit271
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