Social Impacts among Participants in HIV Vaccine Trial Network (HVTN) preventive HIV vaccine trials.

Background: Given the persistent stigma and discrimination against HIV worldwide, preventive HIV vaccine trials face unique challenges. Negative social impacts (NSIs)-problems that HIV vaccine trial participants face in many different spheres of their lives related to trial participation-have received a great deal of attention. Beneficial social impacts (BSIs)-perceived benefits experienced by a participant and resulting from their trial participation-are a critical component of participants' experiences, yet they have received little attention. Setting: All HIV Vaccine Trials Network trial participants for whom social impact data were available-8347 participants in 13 countries who enrolled in 48 phase 1, 2a, and 2b trials. Methods: A cross-protocol analysis to assess self-reported BSIs and NSIs related to participating in a preventive HIV vaccine trial. Data were obtained from 48 completed HIV Vaccine Trials Network vaccine trials from December 2000 to September 2017. Results: Overall, 6572 participants (81%) reported at least one BSI, and 686 participants (8%) reported 819 NSI events. Altruism/feeling good helping others was the BSI most often endorsed by study participants (43%), followed by receiving risk-reduction counseling (30%). Most NSI events (81%) were reported by US/Swiss participants, and most (79%) trial-related NSIs were negative reactions from friends, family, and partners. Of the NSIs reported, 7% were considered to have a major impact on the participant's quality of life. Conclusion: Our results underscore the relatively common experiences of BSIs among preventive HIV vaccine trial participants and mirror the results of other studies that find infrequent reports of NSIs.