Michele P Andrasik1,2, Fredericka Albertina Sesay2, Abby Isaacs1, Linda Oseso1, Mary Allen3. 1. Vaccine and Infectious Disease Division (VIDD), Fred Hutchinson Cancer Research Center, Seattle, WA. 2. Department of Global Health, University of Washington, Seattle, WA; and. 3. Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health, Bethesda, MD.
Abstract
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.
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.
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