Perceptions, experiences, and motivation of COVID-19 vaccine trial participants in South Africa: a qualitative study.

ABSTRACT

BACKGROUND: The informed consent process is an important step in conducting ethical clinical trials, as it ensures that research participants are aware of their rights and responsibilities in clinical trials. This study explored participants' perceptions, experiences and the factors motivating their participation in a COVID-19 vaccine trial in South Africa. METHODS: This descriptive qualitative study was conducted among twenty-five adult participants (18 to 64 years old) who participated in a COVID-19 vaccine trial in South Africa. Three focus group discussions and fifteen semi-structured interviews were carried out. Data were collected at a Clinical Research Site located in Prince Mshiyeni Memorial Hospital, in Umlazi Township, Durban, South Africa, where the COVID-19 vaccine trial participants were initially enrolled. Data were analysed iteratively using a thematic analysis approach. RESULTS: Four key findings emerged 1) Participants who experienced an event (such as tested positive for COVID-19) during the clinical trial were more likely to talk about the informed consent more thoroughly compared to the other participants. 2) Participants understood the purpose of informed consent process better when it was repeated multiple times throughout the course of the trial. 3) Where participants did not recall or understand various elements of the informed consent, participants were likely to create their own interpretations. 4) Factors influencing participations in trials were reimbursement for participation, access to health care, protection of family members, and ability to socialize without fear of COVID-19. CONCLUSION: Overall, the findings show that the informed consent process should be regarded as an ongoing process rather than a once-off event that only happens at the start of a clinical trial. An understanding of participants' perspectives, experiences, and motivations for participating in clinical trials, can help trial staff strengthen the consent documents and processes.