Exploring willingness to participate in future Human Infection Studies in Lusaka, Zambia: A nested qualitative exploratory study.

Abstract

Human Infection Studies (HIC) involve intentional infection of volunteers with a challenge agent or pathogen with the aim of understanding and developing vaccines as well as understanding the disease pathophysiology in a well-controlled environment. Though Africa carries the highest burden of vaccine-preventable diseases, the region is only now being primed to conduct HIC relevant to its population. Given the imminent introduction of HIC in Zambia, we sought to understand potential participants' willingness to volunteer for such studies. We used a qualitative exploratory approach to understand the potential participants' perceptions on willingness to participate in HIC using the example of typhoid. Healthy adults, recruited using random selection and purposive sampling from higher learning institutions in Lusaka, participated in 15 in-depth interviews (IDIs) and 5 Focus Group Discussions (FGDs) respectively. Participants considered typhoid a serious disease with potential for life-long consequences and death. After sharing audio-visual materials introducing the concepts of HIC, some participants expressed open willingness to participate or alternatively the need to consult parents and professors, and expressed fear of death and illness. Though willing to be quarantined for up to six months, participants expressed concerns regarding separation from family and duties, having insufficient information to decide, inadequate access to care, severe disease, life-long injury or side-effects, death, and vaccine failure. These concerns along with possibility of underlying conditions that compromise individual immunity, competing priorities, parental refusal, and distrust of study or vaccine efficacy could lead to refusal to participate. Reasons for willingness to participate included monetary compensation, altruism and being part of a team that comes up with a vaccine. Though afraid of deliberate typhoid infection, potential participants are willing to consider participation if given adequate information, time to consult trusted persons, compensation and assurance of adequate care.