Motivation to participate in HIV/AIDS clinical trials among trial participants at joint clinical research centre, Lubowa, Wakiso district, Uganda

Abstract

Background: Participation from diverse population groups in clinical trials is important but also, allowing voluntary decision making is equally important. To understand the dynamics of decision-making, contextual focus is essential as it is noted that autonomy is relative from community to community. However, most of the studies on participation in clinical trials in Uganda have always focused on willingness with a few, if not none focusing on autonomy and satisfaction with decisions to participate. This study assessed motivation for people to participate in research, level of perceived autonomy and the level of decision satisfaction in respect to trial experiences among adult participants of HIV/AIDS trial at Joint Clinical Research Centre (JCRC). Methods: The study was cross-sectional, conducted among 166 participants aged between 20- 65 years. Data was collected using interviewer-administered questionnaires and focus group discussions. Quantitative data was entered in Epi-Info and analyzed using STATA version 12. All statistical tests were done considering 95% confidence intervals and p-values of ≤ 0.05 for significance. Thematic analysis was used for qualitative data using Atlas.ti computer software. Results: Of the 166 participants, (75.9%, n=126) were females. The mean age of the participants was 48 years (SD=10). The main reason for participating in clinical trials was the need to access free medical care (63.7%, n = 106). Most participants (62.1%) reported that their decision to participate in clinical trials was entirely voluntary but a majority (84.3%), felt obliged to enroll in the studies because they did not want to disappoint their counselors which exhibits low level of autonomy among the participants. Majority (65.06 %, n = 108) of the participants were certain about their decision to participate. And 30.72% reported an informed feeling about their decision to participate whereas a big group expressed the fact they made an uninformed decision to participate in the study. Close to half (46.39%) of the participants felt that their decision and purpose to participate in research were clear and in line with their values while 37.35 % (62) were unclear about their values in relation to their decision to participate. Majority (75.3%) of the participants never experienced clinically significant decision conflict and all participants were satisfied with their decision to participate in research. Free medical care (63/166, 37.9%), being treated with dignity by health workers (50/166, 30.1%) and receiving comprehensive health education (44/166, 26.5%) were the reasons participants gave for their xi satisfaction with the decision to participate in the clinical trials while lack of feedback was one of the reasons for dissatisfaction. There was no statistically significant association between sociodemographic characteristics and reasons for motivation to participate in HIV clinical trials. Conclusions: Access to free medical care was the main reason for participating in clinical trials and most participants voluntarily chose to participate in the trials. There was high level of certainty participants’ decision to participate as more than a third of the participants did not experience clinically significant decision conflict and satisfaction with decision to participate in research among all the participants. Among reasons for satisfaction with the decision to participate in the clinical trials were free medical care, being treated with dignity by health workers and receiving comprehensive health education while lack of feedback was one of the reasons for dissatisfaction