Using ethnographic fieldwork to inform hepatitis C vaccine preparedness studies with people who inject drugs

Background: Feasibility studies are an important component of preparations for field trials of biomedical prevention interventions, including vaccines. Methods: We conducted ethnographic fieldwork to assess feasibility, including eligibility and willingness to participate, prior to recruitment of a prospective observational study of hepatitis C negative people who inject drugs (PWID) in Sydney, Australia. Five staff conducted ethnographic fieldwork in 16 locations during 2008. Observations and interactions with PWID were recorded as field notes and data were used iteratively to guide targeting of locations and the follow-up of networks and individuals. Results: Findings informed the development of the study protocol, resulting in changes in the amount and type of participant reimbursement and the quantity of blood collected at screening, as well as highlighting the need for increased emphasis on communicating eligibility and exclusion criteria and study remuneration procedures. Conclusion: Results illustrate the value of ethnographic research in facilitating consultation and discussion with potential participants in natural settings, identifying motivations and concerns prior to study commencement and providing affected community input into the development of research protocols. (C) 2009 Elsevier B.V. All rights reserved.