Erschienen:
[Erscheinungsort nicht ermittelbar]: University of New South Wales. Kirby Institute, 2013
Sprache:
Englisch
Entstehung:
Hochschulschrift:
Dissertation, University of New South Wales. Kirby Institute, 2013
Anmerkungen:
Beschreibung:
This thesis presents the results of the first hepatitis C virus (HCV) vaccine preparedness study. Drawing on data from the first three years of HITS-c and HITS-i, two community-based prospective observational studies, six studies examined the feasibility of conducting efficacy trials of candidate HCV vaccines with people who inject drugs (PWID) in an Australian community-based setting. The first study examined the effectiveness of respondent driven (RDS) and targeted outreach (TOS) sampling in identifying and recruiting anti-HCV negative PWID (n=156). While RDS resulted in more enrollments, TOS was more efficient in identifying eligible individuals. Retention was high, with 89% of participants retained at 48 weeks, while the third study found that 76% of participants were adherent to follow-up protocols, completing at least 75% of study visits within two weeks of schedule.Hypothetical willingness to participate" (WTP) in HCV vaccine trials also provides an indication of future trial viability, and the fourth study found the majority (80%) of participants indicated WTP. The fifth study documented a significant increase in HCV vaccine clinical trial literacy (CTL) following a brief intervention designed to improve understanding of key HCV vaccine trial concepts.The rate of primary HCV infection was 7.9/100py, substantially lower than 30.8/100py observed a decade earlier in a similar Sydney-based cohort, highlighting the need for future trials to be informed by contemporary data. While sample size estimates suggest that a primary infection rate of at least 16/100py would be required for standalone trials of candidates designed to prevent chronic HCV infection, results support the feasibility of Sydney participating in large multi-centre HCV vaccine trials. Results demonstrate it is possible to identify, recruit and retain at-risk PWID who adhere to study protocols. PWID in Sydney indicate high levels of WTP in future trials, with increases in CTL suggesting this group has the capacity to provide truly informed consent. Taken together, findings suggest that the ethical implementation of future HCV vaccine trials is possible in Australia, with demonstration of HCV candidate vaccine effectiveness feasible as part of multi-site trials. Data presented here will inform models of best practice for conducting future prevention trials with PWID."