Trial-related discrimination in HIV vaccine clinical trials

Participants in preventive HIV vaccine trials may experience negative socia l consequences of trial participation, including problems related to a vacc ine-induced positive HIV antibody test, yet few vaccine studies have report ed on this issue. From October 1995 through November 1998, 1516 AIDS Vaccin e Evaluation Group (AVEG) volunteers were assessed for reports of trial-rel ated discrimination (TRD), Ninety TRD events were reported by 76 (5%) of 15 16 volunteers, The most commonly reported incidents (n = 52, 57.8%) were ne gative reactions of friends, family, and co-workers to the volunteer. Few i ncidents (approximately 10%) were reported as linked to HIV testing. The ma jority of events (n = 47, 52%) were described by volunteers as "resolved" a t the time of reporting, 36 (40%) as "not resolved," and for 7 (8%) events: volunteers did not report resolution status. Reported incidents were analy zed by logistic regression to determine their association with the voluntee r's age, sex, race, sexual orientation, and HIV risk category. There was no association between volunteer characteristics and TRD, Logistic regression and analysis of variance (ANOVA) were used to analyze association of trial sites with the number of TRD events reported. After controlling for site v ariation in data collection and reporting, no significant differences were found between the sites in terms of the number or type of TRD reported. Fea rs that TRD would be widespread and severe have not been borne out by this analysis. While the results of this study are reassuring, they should be in terpreted with caution, as it is unclear whether these results may be exten ded to phase III trials enrolling large numbers of individuals at higher ri sk of HIV acquisition.