Marseille 2007
| Abstract #468 - PSYCHOSOCIAL EVALUATION OF THE PHASE I OF THE SAFETY AND IMMUNOGENICITY TRIAL OF RECOMBINANT HIV TAT PROTEIN IN HIV INFECTED AND UNINFECTED ADULT VOLUNTEERS | ||||
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Session: 16.8: Methodology Matters (Parallel) on Monday @ 14.00-16.00 in 5 Chaired by Graham Hart, Dominique Costagliola Authors: Presenting Author: Dr Raffaele Visintini - H San Raffaele Turro, Vita Salute University, Italy |
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| Additional Authors: Dr Elisabetta Cattaneo, Dr Simona Balestra, Dr Alessandro Ubbiali, Dr Maria Carta, Dr Marinella Giulianelli, Dr Massimo Giuliani, Dr Valeria Fiorelli, Dr Barbara Ensoli, | ||||
| Aim: This study takes place within the A phase 1 Safety and Immunogenicity Trial of Recombinant HIV-1 TAT Protein in HIV-1 Uninfected and Infected Adult Volunteers, sponsored by Istituto Superiore di Sanit, Italy. The introduction of a psychosocial evaluation of all the potential volunteers has come out from two different needs: the early identification of those subjects who show psychological traits that are not compatible with the vaccine trial partaking and to give proper support to the enrolled volunteers. Furthermore the right psychosocial evaluation could identify trial premature interruption indicators, which consequences could be negative for the single participant, the group of volunteers and the whole trial quipe. Finally the information coming from the psychosocial evaluation could suggest some useful guidelines for future clinical trials. | ||||
| Method / Issue: Clinical interviews and the administration of the following questionnaires has been used to achieve the goals of the psychosocial evaluation: - Minnesota Multiphasic Psychological Inventory 2 (MMPI-2) - Questionnaire based on the Information-Motivation-Behavioural Skills (IMB) - World Health Organization Quality of Life- Short Form (WHOQOL) - Self Rating Anxiety Scale (ZUNG) - Cognitive Subjective Symptoms Questionnaire The psychosocial protocol has been based upon the pre-screening, screening and follow up clinical trial visits. At first, personality profile, social-behavioural traits, neuropsychological and anxious symptoms has been evaluated. As middle step all those aspects have been monitored and the opportunity of psychological support has been given to the volunteers. At the end of the trial, participants psychological profiles have been assessed in order to evaluate possible changes related to the vaccine/placebo inoculation. | ||||
| Results / Comments: The initial evaluation has pointed out that the most part of volunteers do not show pathological personality traits, they are heterogeneous for socio-cultural characteristics, with a prevalence of unmarried individuals, with a medium-high level of education and regularly employed. These data suggest that the accordance to biological exclusion criteria, together with the information concerning the trial given to all possible volunteers, could have helped in a kind of self-selection of participants. The results of the monitoring phase have shown some changes in quality of life levels but any variation in personality profile related to the vaccine/placebo inoculation. | ||||
| Discussion: In conclusion this psychosocial evaluation has shown encouraging results both in the pre-selection of volunteers with adequate psychological characteristics to become participants and in supporting participants for their compliance to the trial. Finally the psychosocial evaluation has suggested some possible variations in the questionnaire selection as well as in those psychosocial criteria which have to be monitored; these aspects could be useful as guidelines for future vaccine trials. | ||||
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