BACKGROUND: Global health researchers are celebrating notable success in their efforts to develop preventive vaccines to curb the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) pandemic. HIV vaccine trial participants play a vital role, devoting their time, effort, and bodies to HIV prevention success. However, the conclusion of vaccine trials often shifts the spotlight from trial participants to the broader implications of the trial results, which may leave participants feeling neglected or abandoned. Little is documented regarding participants' psychological wellbeing after HIV vaccine trials end. AIM: This study aimed to explore psychological harms experienced by former trial participants after participation in HIV vaccine trials in Tanzania. METHODOLOGY: This qualitative study is part of a larger sequential exploratory mixed-methods design that aimed to explore the nonphysical risks and benefits of HIV vaccine trial participation and their effects on peoples' willingness to participate in similar trials. A snowball technique was used to sample 25 former trial participants and 11 researchers who conducted HIV vaccine trials from 2007 to 2015 in Tanzania. In-depth interviews were conducted followed by thematic qualitative analysis. RESULTS: The findings of this study reveal that former trial participants experienced psychological harms, categorized by three distinct themes: (1) psychological uncertainties, (2) dependance on the trials and (3) unmet emotional needs. Both trial researchers and former trial participants concurred on the first two themes. But the third theme-unmet emotional needs-was deeply personal to individual participants and hence reported by only the former trial participants. CONCLUSION: The psychological uncertainties experienced by former trial participants were expected to be prevented by the extensive education and information provided during the trials. Dependance to the trial could indicate the need for continuation of incentives such as free medical care and it is not uncommon in most low- and middle-income settings. Researchers in collaboration with Institutional Review Boards/Research Ethics Committees (IRBs/RECs) and community research stakeholders should agree on balanced incentives for specific vaccine trials that will not instill unrealistic expectations. Continuous participant engagement could provide an opportunity for trial results dissemination and correcting misconceptions as well as addressing the emotional needs of former trial participants. Future research should assess the extent of post-trial uncertainties and their effect on participants' mental health, which may affect their attitudes toward participation in similar future trials and their trust in research.
Shayo et al. (Thu,) studied this question.