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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).