Social harms in injecting drug users participating in the first phase III HIV vaccine trial in Thailand.
OBJECTIVE
To study related social harms due to identification with a group of participants in an HIV-1 vaccine trial who are potentially high risk for HIV/AIDS.


METHODS
Two thousand five hundred forty six injecting drug users (IDU) were enrolled in a 36-month vaccine trial. Volunteers received education and risk reduction counseling at every six-month study visit. Social harms were not actively solicited, but volunteers were encouraged to report any during the process of counseling at every six-month visit. If a social harm was reported, a questionnaire was administered and the harm was tracked If necessary, clinic staff assisted in resolving the social harm.


RESULTS
Thirty-nine social harms were reported by 37 participants; 33 (84.6%) were disturbances in personal relationships, three (7.7%) in employment, one (2.6%) was medically related, one (2.6%) was related to admission in the military and one (2.6%) was related with misbelieve about the vaccine. The most common reason for disturbances in personal relationships was suspicion of HIV infection (n=20). The impact of these harms on quality of life was characterized as minimal by 31 (79.5%) participants, as moderate by seven (17.9%), and as major by one (2.6%). All social harms were documented to be resolved by the end of the study.


CONCLUSIONS
A few participants reported study-related social harms during the course of the trial. Most harm had minimal impact and all could be resolved by the end of the present study.
Pitisuttithum
Punnee
P
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. tmppt@mahidol.ac.th
Choopanya
Kachit
K
Bussaratid
Valai
V
Vanichseni
Suphak
S
van Griensven
Frits
F
Phonrat
Benjaluck
B
Martin
Michael
M
Vimutsunthorn
Eiam
E
Sangkum
Udomsak
U
Kitayaporn
Dwip
D
Tappero
Jordan W
JW
Heyward
William
W
Francis
Donald
D
D016915:AIDS Vaccines; D000328:Adult; D005260:Female; D015658:HIV Infections / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D013287:Illicit Drugs / Q000009:adverse effects*; D007275:Injections, Intravenous / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011287:Prejudice; D011581:Psychological Tests; D011594:Psychometrics; D011788:Quality of Life; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012309:Risk-Taking; D012917:Social Adjustment; D012934:Social Isolation; D012938:Social Perception; D019966:Substance-Related Disorders / Q000523:psychology*; D011795:Surveys and Questionnaires; D013785:Thailand
D016915:AIDS Vaccines; D013287:Illicit Drugs