Benefits outweigh the social stigma of HIV vaccine trial participation

From the HIV Vaccine Trials Network and the University of Washington

HIV vaccine trials may be necessary for many coming years before a preventative vaccine is developed, requiring thousands of willing future trial participants. While HIV vaccine trial participants often experience beneficial social impacts (BSI) from the trials, the negative social impacts (NSI) resulting from global HIV stigma may discourage participants from completing or enrolling in trials and have become a focal point of vaccine trial design. With the goal of increasing HIV vaccine trial success and participant satisfaction, the HIV Vaccine Trials Network prioritizes understanding and preventing NSI. However, the data surrounding BSI and NSI in HIV vaccine trials are limited, leaving a potentially inflated perception of NSI experienced by participants. A recent HVTN publication, led by Dr. Michele Andrasik and published in the Journal of Acquired Immune Deficiency Syndromes, quantified BSI and NSI from previous vaccine trial participants.

This study pooled data from nearly 50 previous vaccine trial studies from around the world. The participants, who were HIV-negative and ranged in age from 18 to 50, were asked to detail any negative or beneficial social encounters during their enrollment and follow-up visits. NSI could include experiences with family members or employers, such as misunderstanding the participant’s HIV status or concern about side effects. BSI could include pride derived from contributing to scientific knowledge, improved healthcare access, or compensation for the study. NSI were ranked as minimally, moderately, or majorly impacting the participant’s life.

Dr. Andrasik and colleagues found that overall, 81% of participants experience at least one BSI, with the feeling of scientific altruism cited most often. However, rates of BSI differed between regions, with South American and sub-Saharan African participants reporting highly discordant least and most BSI rates, respectively. Men reported slightly higher rates of BSI than women, and participants in later-stage clinical trials reported more BSI than those in earlier stage trials. Conversely, only 8% of participants reported NSI. The most frequently reported NSI were negative reactions from people close to the participant, such as a perceived risk of acquiring HIV from the study or worry about side effects. Employment related issues were reported as the second highest NSI. Of the NSI reported, most were deemed a minimal or moderate impact on the participant’s quality of life.

NSI are a concern for the success of vaccine trials and the well-being of trial participants, but this study demonstrated that BSI are far more prevalent than NSI. Although NSI have historically been given more attention, this research quantified that the perceived benefits of vaccine trial participation far outweigh the inconveniences, supporting HIV vaccine trials as worthwhile for both vaccine research and the participants themselves. Going forward, the data generated on NSI will allow for vaccine trials to be designed to specifically mitigate potential social harm to participants, while the reported positive impacts of vaccine trials can be augmented to enhance participant experiences and ultimately, HIV vaccine research progress.

This work was supported by the National Institutes of Health.

Andrasik MP, Sesay FA, Isaacs A, Oseso L, Allen M. 2020. Social Impacts Among Participants in HIV Vaccine Trial Network (HVTN) Preventive HIV Vaccine Trials. Acquir Immune Defic Syndr. doi: 10.1097/QAI.0000000000002369.