Document 2277
 DOCN  M94A2277
 TI    Psychiatric follow-up of volunteers in an HIV vaccine trial.
 DT    9412
 AU    Linard F; Stoessel P; Giami A; Souteyrand Y; INSERM U. 158, France.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):340 (abstract no. PC0294). Unique
       Identifier : AIDSLINE ICA10/94370298
 AB    OBJECTIVES: 1. To assess the psychological risks for volunteer
       participation in an HIV Vaccine trial, through a psychiatric evaluation;
       2. To estimate the quality of the volunteers' commitment throughout the
       trial and to limit the risk of dropping out of the protocol; 3. To watch
       over the ethical aspects of the whole process particular with respect to
       the integrity of individuals considered as human subjects. METHOD: 1.
       Dimensions of psychiatrists' participation in the selection process: A.
       Conception--with the other members of the staff--of the ANRS call for
       volunteers through the press; B. Examination and selection of
       volunteers' motivation letters; C. Double Consultation (internist and
       psychiatrist) of the preselected volunteers; D. Participation in the
       final decision to include--or not--candidates in the volunteers'
       network. 2. Setting up the possibility of a psychological follow-up
       during the trials (upon volunteer's request) and Psychological interview
       after one year. RESULTS AND DISCUSSION: 1. Out of the 435 completed and
       returned files by the volunteers, 177 individuals were preselected for a
       psychiatric consultation; 60 were included in the volunteers' network
       and 45 participated in the VAC 001 and VAC 002 trials in 1992-93. The
       individuals not included in the network were: individuals presenting a
       risk linked to a previous history of psychotic disorder, inappropriate
       motivation or lack of commitment to the trial 2. No psycho pathological
       incidents nor any dropping out of the protocol were observed. 3. 44/45
       volunteers accepted the final interview and expressed a positive
       attitude towards the trial. Therefore, some volunteers expressed
       emotional, imaginary and psycho-social repercussions linked to being HIV
       positive without the virus as a result of having been vaccinated.
 DE    AIDS Vaccines/*ADMINISTRATION & DOSAGE  Clinical Trials/*PSYCHOLOGY
       *Ethics, Medical  Feasibility Studies  Human  HIV Infections/*PREVENTION
       & CONTROL/PSYCHOLOGY/TRANSMISSION  HIV
       Seropositivity/PSYCHOLOGY/TRANSMISSION  Motivation  *Patient Acceptance
       of Health Care  Patient Care Team  Patient Dropouts/*PSYCHOLOGY
       Personality Assessment  Risk Factors  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).