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The role of volunteer recruitment in HIV vaccine trials has recently been considered particularly with respect to critical issues, such as motivation, psychological assessment and social impact. The preventative and therapeutic phase I trials based on the recombinant biologically active Tat vaccine candidate, sponsored in Italy by the Istituto Superiore di Sanità, included a specific centralised procedure (SCP) developed to support both the sponsor and the volunteers during trial enrolment and conduction. This process, which is an integrated, multidisciplinary, biomedical and psycho-socio-behavioural network, represented a novel and important aspect for the conduction and success of the clinical study. A specific flow of information from the sponsor to the population was developed through the SCP which started from the national announcement of the trials (through a press conference and a press release) to the enrolment of the volunteers. To this aim a telephone counselling intervention was performed to supply the scientific information translated in personalised message, allowing to select potential participants prior to the first contact with the clinical sites. Furthermore, the multi-step procedure contributed in reinforcing the motivation to participation and trial retention, providing important hints for the design of standardised enrolment procedures to be used in clinical studies. Indeed, this methodological approach, which foresees the joined participation of researchers and expert of communication, could be followed in future vaccine trials in order to improve the effectiveness of enrolment procedures.

We carried out a telephone survey to assess willingness to participate in HIV vaccine trials. The survey was conducted by interviewing randomly selected callers to the Italian National AIDS Help line. The questionnaire consisted of four sections: demographic information, knowledge about HIV vaccines and vaccines in general, factors related to participation in HIV vaccine trials, and acceptability of a future HIV vaccine. Over 50% of the sample had adequate knowledge about HIV and vaccines. Among the individuals interviewed, 37% would volunteer for a vaccine trial; those reporting high-risk behaviours were more likely to volunteer. Of the participants, 83% would agree to be vaccinated with a highly effective vaccine, and 92% would pay for the vaccine. Although the limits of telephone surveys should not be neglected, the results of this survey are encouraging.