Background: Clinical trials of biomedical prevention methods require extensive consultation with community members and leaders, especially when there is high level optimism for the success of the intervention.

Methods: We conducted a content analysis of documents from community consultations during the planning of a chemoprophylaxis trial in Peru. This included five focus groups with segments of the target population (i.e. transvestites, sex workers, bisexuals, etc.), official documents, transcripts, minutes, or notes from meetings with the local IRB and CAB, from meetings with activists and academic opinion leaders, and from two open community forums.

Results: Analysis revealed that at least three distinct interest groups existed including 1) opinion leaders (academics, MSM activists and reproductive rights activists), 2) HIV/AIDS activists, and 3) potential participants (focus groups). Divergent positions were observed on topics of compensation for injury, reimbursement for participation and informed consent, for example. Opinion leaders requested information about payment for medical care required for trial-related injuries, especially if care was required after the end of the trial period. They also suggested that any cash reimbursement to study participants would undermine participant autonomy and suggested that vulnerable populations would not comprehend the study. In contrast, HIV/AIDS activists asked for assurance that the study site would take responsibility for assuring adequate medical care; requested a 100-200% increase in reimbursement levels for participant costs; and provided extensive input to assure that consent forms were accurate and comprehensible. In focus groups of potential participants, there were requests to receive medical care during the trial for related injuries; requests to be “very well compensated” at rates commensurate with potential lost wages in the informal (street) economy; and requests for further services like free condoms and STI treatment; and requests that good information be provided by investigators about risks.

Conclusions: This analysis suggests that stakeholder groups are characterized by a diversity of voices and interests that are sometimes in conflict. Effective community consultation will require facilitating dialogue between stakeholders, as well as between stakeholders and investigators. Sociological and communications analysis of study environments will likely be essential for success of challenging trials.