title: Preventing discrimination against volunteers in prophylactic HIV vaccine trials: lessons from a phase II trial.
abstract: BACKGROUND
  Preventive HIV vaccines can temporarily cause uninfected individuals to have positive results on HIV testing. As preparations are underway to mount larger efficacy trials, the social risks of trial participation should be studied.
  
  
  OBJECTIVE
  To describe frequency of HIV testing and discrimination among participants in a preventive phase II HIV vaccine trial.
  
  
  METHODS
  266 vaccine trial volunteers were eligible; 247 participated in a confidential survey.
  
  
  RESULTS
  63 volunteers (26% of respondents) reported 185 HIV tests during the prior 12 to 24 months; most tests were for other research studies, health care, insurance, incarceration, or employment. Only 5 volunteers reported having positive HIV test results. Volunteers reported 99 adverse social incidents or problems, 53 of which were related to the trial. The most common type of event occurred when volunteers disclosed their trial participation and were mistakenly presumed to be infected with HIV. Few reported difficulty obtaining insurance, job loss, and inadvertent disclosure of their participation in the trial.
  
  
  CONCLUSIONS
  In this vaccine trial, few serious social harms were reported. Those who conduct HIV tests for insurance, employment, health care, or other reasons should be made aware that HIV vaccines can cause false-positive HIV test results. Those planning future trials must continue to provide needed support to volunteers. Social harms should be monitored with the same vigilance accorded to physical harms.
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA. ASheon@umich.edu
authors.forename: A R
authors.initials: AR
authors.lastname: Sheon
authors.forename: L
authors.initials: L
authors.lastname: Wagner
authors.forename: M J
authors.initials: MJ
authors.lastname: McElrath
authors.forename: M C
authors.initials: MC
authors.lastname: Keefer
authors.forename: E
authors.initials: E
authors.lastname: Zimmerman
authors.forename: H
authors.initials: H
authors.lastname: Israel
authors.forename: D
authors.initials: D
authors.lastname: Berger
authors.forename: P
authors.initials: P
authors.lastname: Fast
mesh_terms: D015492:AIDS Serodiagnosis / Q000523:psychology*; D016915:AIDS Vaccines / Q000276:immunology; D000293:Adolescent; D000328:Adult; D017322:Clinical Trials, Phase II as Topic / Q000523:psychology*; D004651:Employment; D005189:False Positive Reactions; D005260:Female; D015658:HIV Infections / Q000517:prevention & control / Q000523:psychology*; D006801:Humans; D007348:Insurance, Health; D008297:Male; D008875:Middle Aged; D011287:Prejudice; D011795:Surveys and Questionnaires; D014838:Volunteers / Q000523:psychology*
chemical_list: D016915:AIDS Vaccines