title: Social harms in injecting drug users participating in the first phase III HIV vaccine trial in Thailand.
abstract: 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.
authors.affiliation: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. tmppt@mahidol.ac.th
authors.forename: Punnee
authors.initials: P
authors.lastname: Pitisuttithum
authors.forename: Kachit
authors.initials: K
authors.lastname: Choopanya
authors.forename: Valai
authors.initials: V
authors.lastname: Bussaratid
authors.forename: Suphak
authors.initials: S
authors.lastname: Vanichseni
authors.forename: Frits
authors.initials: F
authors.lastname: van Griensven
authors.forename: Benjaluck
authors.initials: B
authors.lastname: Phonrat
authors.forename: Michael
authors.initials: M
authors.lastname: Martin
authors.forename: Eiam
authors.initials: E
authors.lastname: Vimutsunthorn
authors.forename: Udomsak
authors.initials: U
authors.lastname: Sangkum
authors.forename: Dwip
authors.initials: D
authors.lastname: Kitayaporn
authors.forename: Jordan W
authors.initials: JW
authors.lastname: Tappero
authors.forename: William
authors.initials: W
authors.lastname: Heyward
authors.forename: Donald
authors.initials: D
authors.lastname: Francis
mesh_terms: 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
chemical_list: D016915:AIDS Vaccines; D013287:Illicit Drugs