HIV This Week

Doab A, Topp L, Day CA, Dore GJ, Maher L. Clinical trial literacy among injecting drug users in Sydney, Australia: a pilot study. Contemp Clin Trials. 2009 Apr 16. [Epub ahead of print]

This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users in Sydney, Australia. Participants were clinical trial-experienced (n=17) and trial-naïve (n=99) people who inject drugs who were recruited from community needle and syringe programs, and through institutions involved in clinical trials with injecting drug using participants.  Cross-sectional data were collected via a study-specific interviewer-administered survey. Following detailed verbal explanations, higher proportions of trial-experienced than trial-naïve participants demonstrated an understanding of all clinical trial concepts assessed, including single blinding (94% versus 60%); placebo (94% versus 49%); equipoise (71% versus 60%); comparison (59% versus 46%); randomisation (59% versus 21%); and double blinding (47% versus 3%).  Multivariate analyses indicated a better understanding among trial-experienced participants. Participants who demonstrated an understanding of ‘placebo’ and ‘double blinding’ were significantly more likely to perceive these concepts to be acceptable than those who did not. The results indicate the need for targeted education programs that adequately inform people who inject drugs about clinical trial concepts prior to recruitment to a clinical trial, and support adaptations of informed consent procedures to ensure trial participants’ comprehensive understanding of methodologies and their implications.

Editors’ note: Despite a generally good understanding of trial concepts among people who inject drugs, with those who had already participated in a trial unsurprisingly knowing more, the perceived acceptability of equipoise, placebo, and double blinding was only 55-60%. Given that future candidate hepatitis C and HIV vaccine trials will need to recruit and retain large numbers of injecting drug users, clinical trial literacy programmes are needed for this key population. Among the adaptations that could improve informed consent procedures would be considering them in the context of wider community engagement, with informed consent viewed as an ongoing process rather than simply a procedure at recruitment (cf UNAIDS/AVAC Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials).