Study Objective: To document the experience of participants and stakeholders of COVID-19 clinical studies in Botswana and begin to understand how these and similar studies could be improved for the future.
Specific Objectives
- To build an understanding of how patients make decisions around joining COVID-19 clinical studies.
- To explore the factors that enhance or diminish participant experience within COVID-19 clinical studies.
- To evaluate methods in clinical studies being implemented during the COVID-19 pandemic that are novel in Botswana.
- To learn from key stakeholders in the research process including researchers, community advisory board members and officials working for regulatory institutions
Study Design: In-depth qualitative study utilising in-depth interviews.
Study Population: COVID-19 clinical study participants; those who declined to participate and key stakeholders in the research process.
Study Duration: Data collection took place between January 2021 and May 2021.
Sponsor: World Health Organisation (WHO).
Between February and April 2021 we interviewed 21 study participants, 9 decliners and 15 key stakeholders. Among COVID-19 patients, baseline awareness of clinical research was limited. Most individuals expected the study to help them get better and we observed that individuals with severe illness appeared more likely to agree to enrolment. Participants often found it difficult to tell the difference between research procedures and usual care. Individuals who declined were almost always asymptomatic or minimally symptomatic. The research community were generally overwhelmed with work and having to adapt to new processes as a result of the pandemic. Greater integration among the community was suggested as a way to facilitate rapid approval of adaptive clinical trials.
Conclusions: Greater awareness of clinical research within the general population is required. Individuals with severe illness appear more likely to consent to clinical research as they hope for a therapeutic benefit and communication at both the consent stage and throughout study participation is key.
