Volunteers’ Perceptions and Experiences of Clinical Research Participation in Kenya: Case Study of Kavi-icr Volunteers

Abstract

Background: The conduct of clinical research in low resource settings faces unique chal-lenges that compromise optimal recruitment and participation of volunteers into studies. In Kenya, at KAVI-Institute of Clinical Research (KAVI-ICR), where a number of clinical re-search studies are being conducted, data from the recruitment sites reveal that eligible volun-teers fail to turn up for actual enrolment even after providing consent to participate. Ques-tions regarding volunteers’ knowledge, understanding, and attitudes towards clinical research and how their experiences of participation affect their decision making have been raised. Aim: To examine volunteers’ perceptions and experiences of clinical research participation and the potential impact on decision in order to improve the overall processes of clinical re-search implementation. Specifically the study sought to: describe the characteristics of indi-viduals who participate in clinical research; examine individuals’ perceptions towards clinical research participation; document volunteers’ experiences at various stages of trial participa-tion and their potential impact on decision making to participate. It further sought to identify factors that enhance and /or constrain clinical research participation experience and explore similarities and differences of participation experiences among volunteers in the various KAVI-ICR studies. Methods: A Mixed methods study applied a phenomenological approach to collect qualitative data. Data was collected from KAVI-ICR volunteers drawn from four vaccine studies, one observation study and one drug study. A survey tool was administered to 164 volunteers drawn from the six studies. Additionally 44 in- depth interviews (IDIs) were conducted with participants purposively selected from the 164 participants. Interviews were audio recorded, transcribed and coded for analysis. For data management and analysis, SPSS Version 13.0 was used for the quantitative data while Atlas ti was used for the qualita-tive. Results: A majority of the participants were of low social- economic status. Their ages ranged from 20 and 40+ years (mean=29.5; median=29) and most falling between 20029 years. Sixty-eight percent (68%) of the participants were males reflecting gender differences in participation. Occupations included - student/unemployment (19%), causal work (35%) small business (22%) while those on permanent employment (24%). Volunteers perceptions and experiences were shaped by a number of factors that varied with type of study and its re-quirements, trust relations resulting from interpersonal relations with clinical staff and signif-icant others. Other important factors identified included information leading autonomous de-cision making, trials benefits such as health screening and continuous medical care while par-ticipating and transport reimbursement which for some was a boost to household incomes. However, volunteers raised concerns with trial demands such as collection of mucosal sam-ples which were seen to be invasive and contravening cultural and religious beliefs. Other concerns were around randomization, false positive, risks suggesting incomplete understand-ing. Conclusion: Addressing factors that impact on volunteers’ perceptions and experiences of participation is important in ensuring optimal enrolment and retention of future trials. Health inequalities resulting social and economic exclusion may impact on individuals’ per-ceptions and decision making into clinical research participation. Future studies should there-fore, consider incorporating mechanisms that will continuously engender volunteers and community members’ trust and enhance individual decision making. Informed consent and assessment of understanding should be a continuous process through the life course of trial participation.