Trial-Related Discrimination in HIV Vaccine Clinical Trials

Abstract

Participants in preventive HIV vaccine trials may experience negative social consequences of trial participation, including problems related to a vaccine-induced positive HIV antibody test, yet few vaccine studies have reported on this issue. From October 1995 through November 1998, 1516 AIDS Vaccine Evaluation Group (AVEG) volunteers were assessed for reports of trial-related discrimination (TRD). Ninety TRD events were reported by 76 (5%) of 1516 volunteers. The most commonly reported incidents (n = 52, 57.8%) were negative reactions of friends, family, and co-workers to the volunteer. Few incidents (approximately 10%) were reported as linked to HIV testing. The majority of events (n = 47, 52%) were described by volunteers as "resolved" at the time of reporting, 36 (40%) as "not resolved," and for 7 (8%) events volunteers did not report resolution status. Reported incidents were analyzed by logistic regression to determine their association with the volunteer'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 variation in data collection and reporting, no significant differences were found between the sites in terms of the number or type of TRD reported. Fears 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 interpreted with caution, as it is unclear whether these results may be extended to phase III trials enrolling large numbers of individuals at higher risk of HIV acquisition.

Issues in Women's Participation in a Phase III Community HIV Vaccine Trial in Thailand

“…16,27,32,33 In several studies, discrimination ranged from < 5% to 30%. [34][35][36][37][38][39][40] Only about 4% of participants reported PIEs in this study, a finding that was similar to another trial in Thailand. 40 This could be due to differences in the background and culture of the study community as well as different procedures in assessing PIEs among participants.…”

“…Similar to other studies, the most frequent PIE reported in this study was personal relationship problems, especially for women. 35,37 In addition, female student participants experienced stigma during the first 6 months after enrollment. This could be due to lack of knowledge and misunderstanding about HIV/AIDS at the early phase of the trial, as PIEs were much less frequent after that period.…”

Vaccine-induced HIV seropositivity: A problem on the rise

“…HIV vaccine recipients may experience stigmatization or discrimination in situations where an HIV test is determining important decisions, such as donating blood, obtaining a life or health insurance, or for purposes of immigration or employment. 4,22,23 In Belgium, the PRISM HIV O Plus test is used for the centralized screening of blood donors, in combination with HIV nucleic acid testing (NAT) of pooled samples. A positive screening test result, as observed in 48% of subjects in this study, will automatically lead to exclusion from blood donation, irrespective of NAT and confirmation test results.…”

Barriers to Volunteer Enrollment in HIV Preventive Vaccine Clinical Research Trials: A Review of the Literature

“…Provide clear and accurate descriptions of the study design (Mills et al, 2004). Be prepared to address the volunteers' concerns, especially regarding safety and trial-related discrimination (Allen et al, 2001). Take an active role in the community by giving presentations about the research, providing educational information on how vaccines protect, and by discussing ways individuals can reduce risk factors for HIV (Ravanfar et al, 2009).…”