Social Harms in Injecting Drug Users Participating in the First Phase III HIV Vaccine Trial in Thailand
Punnee Pitisuttithum MBBS, DTM&H, FRCPT*, Kachit Choopanya MD**, Valai Bussaratid MD*, Suphak Vanichseni MD**, Frits van Griensven MD***, Benjaluck Phonrat MSc*, Michael Martin MD***, Eiam Vimutsunthorn MD****, Udomsak Sangkum MD**, Dwip Kitayaporn MD*, Jordan W Tappero MD***, William Heyward MD*****, Donald Francis MD*****
Affiliation : * Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand ** Bangkok Vaccine Evaluation Group, Bangkok, Thailand *** Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand **** Bangkok Metropolitan Administration, Bangkok, Thailand ***** Global solutions, CA, USA
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.
Materials and 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.
Conclusion : 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.
Keywords : HIV vaccine, Phase III trial, Social harm, Injecting drug users, Thailand
