title: Increased hepatitis C virus vaccine clinical trial literacy following a brief intervention among people who inject drugs.
abstract: OBJECTIVE
  While people who inject drugs are at high risk of hepatitis C virus (HCV) infection and will be the target population for future HCV vaccine trials, little is known about clinical trial literacy (CTL) in this group. We assessed the impact of a brief intervention (BI) designed to improve HCV vaccine CTL among people who inject drugs in Sydney, Australia.
  
  
  METHODS
  People who inject drugs enrolled in a community-based prospective observational study between November 2008 and September 2010 (n = 102) completed a CTL assessment followed immediately by the BI. Post-test assessment was conducted at 24 weeks.
  
  
  RESULTS
  The median age of the sample was 27 years, 73% were male and 60% had 10 or less years of schooling. The median time since first injection was 5 years and 20% reported daily or more frequent injecting. The mean number of correct responses increased from 5.3 to 6.3/10 (t = -4.2; 101df, P < 0.001) 24 weeks post-intervention. Statistically significant differences were observed for three knowledge items with higher proportions of participants correctly answering questions related to randomisation (P = 0.002), blinding (P = 0.005) and vaccine-induced seropositivity (P = 0.003) post-intervention.
  
  
  CONCLUSIONS
  A significant increase in HCV vaccine CTL was observed, suggesting that new and relatively novel concepts can be learned and recalled in this group. These findings support the feasibility of future trials among this population. [Correction added on 21 November 2012, after first online publication: T-score for mean number of correct responses was corrected to '-4.2' in the Results section.]
authors.affiliation: Viral Hepatitis Epidemiology and Prevention Program, The Kirby Institute, University of New South Wales, Sydney, Australia.
authors.forename: Bethany
authors.initials: B
authors.lastname: White
authors.forename: Annie
authors.initials: A
authors.lastname: Madden
authors.forename: Margaret
authors.initials: M
authors.lastname: Hellard
authors.forename: Thomas
authors.initials: T
authors.lastname: Kerr
authors.forename: Maria
authors.initials: M
authors.lastname: Prins
authors.forename: Kimberly
authors.initials: K
authors.lastname: Page
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Dore
authors.forename: Lisa
authors.initials: L
authors.lastname: Maher
mesh_terms: D000328:Adult; D001315:Australia; D005260:Female; D057220:Health Literacy; D006526:Hepatitis C / Q000150:complications / Q000517:prevention & control / Q000523:psychology*; D006801:Humans; D008297:Male; D010353:Patient Education as Topic; D011446:Prospective Studies; D015819:Substance Abuse, Intravenous / Q000150:complications / Q000523:psychology*; D014761:Viral Hepatitis Vaccines
chemical_list: D014761:Viral Hepatitis Vaccines
keywords: brief intervention; clinical trial literacy; hepatitis C virus; injecting drug use; vaccine preparedness study